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BackgroundImplementation science frameworks situate intervention implementation and sustainment within the context of the implementing organization and system. Aspects of organizational context such as leadership have been defined and measured largely within US health care settings characterized by decentralization and individual autonomy. The relevance of these constructs in other settings may be limited by differences like collectivist orientation, resource constraints, and hierarchical power structures. We aimed to adapt measures of organizational context in South African primary care clinics.MethodsWe convened a panel of South African experts in social science and HIV care delivery and presented implementation domains informed by existing frameworks and prior work in South Africa. Based on panel input, we selected contextual domains and adapted candidate items. We conducted cognitive interviews with 25 providers in KwaZulu-Natal Province to refine measures. We then conducted a cross-sectional survey of 16 clinics with 5-20 providers per clinic (N = 186). We assessed reliability using Cronbach's alpha and calculated interrater agreement (awg) and intraclass correlation coefficient (ICC) at the clinic level. Within clinics with moderate agreement, we calculated correlation of clinic-level measures with each other and with hypothesized predictors - staff continuity and infrastructure - and a clinical outcome, patient retention on antiretroviral therapy.ResultsPanelists emphasized contextual factors; we therefore focused on elements of clinic leadership, stress, cohesion, and collective problem solving (critical consciousness). Cognitive interviews confirmed salience of the domains and improved item clarity. After excluding items related to leaders' coordination abilities due to missingness and low agreement, all other scales demonstrated individual-level reliability and at least moderate interrater agreement in most facilities. ICC was low for most leadership measures and moderate for others. Measures tended to correlate within facility, and higher stress was significantly correlated with lower staff continuity. Organizational context was generally more positively rated in facilities that showed consistent agreement.ConclusionsAs theorized, organizational context is important in understanding program implementation within the South African health system. Most adapted measures show good reliability at individual and clinic levels. Additional revision of existing frameworks to suit this context and further testing in high and low performing clinics is warranted.

IntroductionMeaningful engagement of partners in co-creating and refining health-related programs can increase the initial uptake, sustained implementation, broad reach, and effectiveness of these programs. This is especially important for underserved communities where resources are limited and need to be prioritized. Brainwriting premortem is a novel qualitative approach to partner engagement that combines the strengths of individual idea generation with the concept of premortem exercise that addresses failure points prior to the implementation of new programs.MethodsAn adapted form of brainwriting premortem was used to inform iterative refinements to a COVID-19 testing program at a Federally Qualified Health Center (FQHC) in San Diego. Patients and providers from the FQHC participated in interviews at two time points (early- and mid-implementation of the program). Interview data were transcribed, translated, and analyzed using a rapid qualitative approach. Key themes and sub-themes were identified and used to inform refinements to the program.ResultsA total of 11 patients (7 Spanish- and 4 English-speaking) and 8 providers participated in the brainwriting premortem interviews. Key themes related to possible reasons for COVID-19 testing program failure: advertising/sharing information; access to testing; handling of test results; staff and patient safety; patient beliefs and views regarding the SARS-CoV-2 virus; and COVID-19 testing options offered. Proposed solutions were offered for the key failures except for patient beliefs and views regarding the SARS-CoV-2 virus. Additional solutions offered were related to education, physical operations, and recruitment strategies. Real-time changes to the program flow and components were made in response to 7 suggestions from patients and 11 from providers. Changes related to the process of returning results were the most common, and included sending results via email with distinct workflows based on the test result.ConclusionThe implementation of the adapted brainwriting premortem technique allowed us to incorporate the perspective of key partners in the delivery and iterative refinement of the COVID-19 testing program. This was an effective tool in the context of an FQHC and can be a promising and approach to incorporate iterative input from patients and providers to ensure successful program implementation. Future studies, particularly those requiring rapid response to public health emergencies, should consider the use of this technique.

Background: HIV treatment programs in Africa have implemented centralized testing for routine viral load monitoring (VLM), which may result in specimen processing delays inhibiting timely return of viral load results. Decentralized, point-of-care (PoC) VLM is a promising tool for expediting HIV clinical decision-making but remains unavailable in most African settings. We qualitatively explored the perceived feasibility and appropriateness of PoC VLM to address gaps along the viral load monitoring continuum in rural Uganda. Methods: Between May and September 2022, we conducted 15 in-depth interviews with HIV clinicians (facility in-charges, clinical officers, nurses, counselors) and six focus group discussions with 47 peer health workers from three south-central Ugandan districts. Topics explored centralized VLM implementation and opportunities/challenges to optimizing routine VLM implementation with PoC testing platforms. We explored perspectives on PoC VLM suitability and feasibility using iterative thematic analysis. Applying the Framework Method, we then mapped salient constraints and enablers of PoC VLM to constructs from the Consolidated Framework for Implementation Research. Results: Clinicians and peers alike emphasized centralized viral load monitoring's resource-intensiveness and susceptibility to procedural/infrastructural bottlenecks (e.g., supply stockouts, testing backlogs, community tracing of clients with delayed VLM results), inhibiting timely clinical decision-making. Participants reacted enthusiastically to the prospect of PoC VLM, anticipating accelerated turnarounds in specimen processing, shorter and/or fewer client encounters with treatment services, and streamlined efficiencies in HIV care provision (including expedited VLM-driven clinical decision-making). Anticipated constraints to PoC VLM implementation included human resource requirements for processing large quantities of specimens (especially when machinery require repair), procurement and maintenance costs, training needs in the existing health workforce for operating point-of-care technology, and insufficient space in lower-tier health facilities to accommodate installation of new laboratory equipment. Conclusions: Anticipated implementation challenges, primarily clustering around resource requirements, did not diminish enthusiasm for PoC VLM monitoring among rural Ugandan clinicians and peer health workers, who perceived PoC platforms as potential solutions to existing inefficiencies within the centralized VLM ecosystem. Prioritizing PoC VLM rollout in facilities with available resources for optimal implementation (e.g., adequate physical and fiscal infrastructure, capacity to manage high specimen volumes) could help overcome anticipated barriers to decentralizing viral load monitoring. [ABSTRACT FROM AUTHOR]

Background: Some of the most promising strategies to reduce hospital readmissions in heart failure (HF) is through the timely receipt of home health care (HHC), delivered by Medicare-certified home health agencies (HHAs), and outpatient medical follow-up after hospital discharge. Yet national data show that only 12% of Medicare beneficiaries receive these evidence-based practices, representing an implementation gap. To advance the science and improve outcomes in HF, we will test the effectiveness and implementation of an intervention called Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF), comprised of early and intensive HHC nurse visits combined with an early outpatient medical visit post-discharge, among HF patients receiving HHC. Methods: This study will use a Hybrid Type 1, stepped wedge randomized trial design, to test the effectiveness and implementation of I-TRANSFER-HF in partnership with four geographically diverse dyads of hospitals and HHAs ("hospital-HHA" dyads) across the US. Aim 1 will test the effectiveness of I-TRANSFER-HF to reduce 30-day readmissions (primary outcome) and ED visits (secondary outcome), and increase days at home (secondary outcome) among HF patients who receive timely follow-up compared to usual care. Hospital-HHA dyads will be randomized to cross over from a baseline period of no intervention to the intervention in a randomized sequential order. Medicare claims data from each dyad and from comparison dyads selected within the national dataset will be used to ascertain outcomes. Hypotheses will be tested with generalized mixed models. Aim 2 will assess the determinants of I-TRANSFER-HF's implementation using a mixed-methods approach and is guided by the Consolidated Framework for Implementation Research 2.0 (CFIR 2.0). Qualitative interviews will be conducted with key stakeholders across the hospital-HHA dyads to assess acceptability, barriers, and facilitators of implementation; feasibility and process measures will be assessed with Medicare claims data. Discussion: As the first pragmatic trial of promoting timely HHC and outpatient follow-up in HF, this study has the potential to dramatically improve care and outcomes for HF patients and produce novel insights for the implementation of HHC nationally. Trial registration: This trial has been registered on ClinicalTrials.Gov (#NCT06118983). Registered on 10/31/2023, https://clinicaltrials.gov/study/NCT06118983?id=NCT06118983&rank=1. [ABSTRACT FROM AUTHOR]

Background: Hypertensive disorders of pregnancy are among the leading causes of maternal mortality and morbidity in the U.S., with rates highest among birthing people who are Black, rural residents, and/or have low-income. Severe hypertension, in particular, increases risk of stroke and other serious pregnancy complications. To promote early detection and treatment of severe hypertension, the Alliance for Innovation on Maternal Health developed the Severe Hypertension During Pregnancy and Postpartum Period Safety Bundle (HTN Bundle). Multiple studies have demonstrated the HTN Bundle’s effectiveness in the inpatient setting. With funding from the National Heart, Lung, and Blood Institute, we engaged community partners to adapt the HTN Bundle for the outpatient setting (i.e., O-HTN Bundle) and planned for its implementation. In this paper, we describe the protocol for a study evaluating O-HTN Bundle implementation in 20 outpatient clinics serving Black, rural, and/or low-income populations. Methods: This study is a hybrid type 3 effectiveness-implementation trial with a multiple baseline design. We will implement the O-HTN Bundle in three successive cohorts of clinics using a multicomponent implementation strategy to engage community partners (coalition, patient workgroup) and support clinics (training, facilitation, education materials, and simulations of severe hypertension events). To test the strategy, we will compare clinic fidelity to evidence-based guidelines for (a) patient education on hypertension and (b) blood pressure measurement technique, with repeated measures occurring before and after strategy receipt. We will also observe strategy effects on community- and clinic-level intermediate outcomes (community engagement, organizational readiness), implementation outcomes (reach, adoption, fidelity, maintenance), and effectiveness outcomes (receipt of guideline concordant care). Analyses will address whether outcomes are equitable across Black, rural, and/or low-income subgroups. Guided by the Consolidated Framework for Implementation Research 2.0, we will use mixed methods to identify adaptations and other determinants of implementation success. Discussion: This study integrates community engagement and implementation science to promote equitable and timely response to severe HTN in the outpatient setting during pregnancy and postpartum. This is one of the first studies to implement an outpatient HTN Bundle and to use simulation as a strategy to reinforce team-based delivery of guideline concordant care. Trial registration: This study was registered with ClinicalTrials.gov as “Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle (AC3HIEVE).” Registration number NCT06002165, August 21, 2023: . [ABSTRACT FROM AUTHOR]

Background: The benefits of lean adoption in healthcare include improved process efficiency and quality of patient care. However, research indicates that lean implementation in healthcare, and specifically hospitals, is often not sustained. Furthermore, there is a need for maturity models that guide lean implementation, specifically in hospitals. This study develops a prescriptive maturity model named the Sustaining of Lean Adoption in Hospitals Roadmap (SOLAR) that acts as a practical guideline for the sustainable adoption of lean in hospitals. Methods: The SOLAR has three theoretical foundations, namely lean implementation success factors in hospitals, implementation science, and change management theory. A systematic literature review was conducted to determine the lean implementation success factors in hospitals as the first building block. Secondly, practices from implementation science were used to create the action items in the SOLAR. Ten change steps were elicited from change management theory as the third theoretical building block of the roadmap. We refined the roadmap through three Delphi rounds that verified its useability in hospitals. Results: The final SOLAR consists of four maturity phases (prepare, plan, experiment and learn, and sustain) and includes action items for each phase related to the hospital's strategy, resources, engaging of people, and culture. The action items and change management steps shown in the SOLAR are not intended as an exhaustive list but provide guidelines on aspects hospitals must consider when they aim to adopt lean sustainably. Conclusions: The strong theoretical base of the SOLAR enables hospitals to safely experiment and learn which implementation methods are best suited to their unique environment. The SOLAR is, therefore, an actionable guideline that informs both academics and practitioners involved in lean adoption in hospitals. This roadmap can guide future retrospective longitudinal or action research. [ABSTRACT FROM AUTHOR]

Background: In low- and middle-income countries (LMICs), such as Tanzania, the competency of healthcare providers critically influences the quality of pediatric care. To address this issue, we introduced Pediatric Acute Care Education (PACE), an adaptive learning program to enhance provider competency in Tanzania's guidelines for managing seriously ill children. Adaptive learning is a promising alternative to current in-service education, yet optimal implementation strategies in LMIC settings are unknown. Objectives: (1) To evaluate the initial PACE implementation in Mwanza, Tanzania, using the construct of normalization process theory (NPT); (2) To provide insights into its feasibility, acceptability, and scalability potential. Methods: Mixed-methods study involving healthcare providers at three facilities. Quantitative data was collected using the Normalization MeAsure Development (NoMAD) questionnaire, while qualitative data was gathered through in-depth interviews (IDIs) and focus groups discussions (FGDs). Results: Eighty-two healthcare providers completed the NoMAD survey. Additionally, 24 senior providers participated in IDIs, and 79 junior providers participated in FGDs. Coherence and cognitive participation were high, demonstrating that PACE is well understood and resonates with existing healthcare goals. Providers expressed a willingness to integrate PACE into their practices, distinguishing it from existing educational methods. However, challenges related to resources and infrastructure, particularly those affecting collective action, were noted. Early indicators point toward the potential for long-term sustainability of the PACE, but assessment of reflexive monitoring was limited due to the study's focus on PACE's initial implementation. Conclusion: This study offers vital insights into the feasibility and acceptability of implementing PACE in a Tanzanian context. While PACE aligns well with healthcare objectives, addressing resource and infrastructure challenges as well as conducting a longer-term study to assess reflexive monitoring is crucial for its successful implementation. Furthermore, the study underscores the value of the NPT as a framework for guiding implementation processes, with broader implications for implementation science and pediatric acute care in LMICs. [ABSTRACT FROM AUTHOR]

Abstract Background Few implementation science (IS) measures have been evaluated for validity, reliability and utility – the latter referring to whether a measure captures meaningful aspects of implementation contexts. We present a real-world case study of rigorous measure development in IS that assesses Barriers and Facilitators in Implementation of Task-Sharing in Mental Health services (BeFITS-MH), with the objective of offering lessons-learned and a framework to enhance measurement utility. Methods We summarize conceptual and empirical work that informed the development of the BeFITS-MH measure, including a description of the Delphi process, detailed translation and local adaptation procedures, and concurrent pilot testing. As validity and reliability are key aspects of measure development, we also report on our process of assessing the measure’s construct validity and utility for the implementation outcomes of acceptability, appropriateness, and feasibility. Results Continuous stakeholder involvement and concurrent pilot testing resulted in several adaptations of the BeFITS-MH measure’s structure, scaling, and format to enhance contextual relevance and utility. Adaptations of broad terms such as “program,” “provider type,” and “type of service” were necessary due to the heterogeneous nature of interventions, type of task-sharing providers employed, and clients served across the three global sites. Item selection benefited from the iterative process, enabling identification of relevance of key aspects of identified barriers and facilitators, and what aspects were common across sites. Program implementers’ conceptions of utility regarding the measure’s acceptability, appropriateness, and feasibility clustered across several common categories. Conclusions This case study provides a rigorous, multi-step process for developing a pragmatic IS measure. The process and lessons learned will aid in the teaching, practice and research of IS measurement development. The importance of including experiences and knowledge from different types of stakeholders in different global settings was reinforced and resulted in a more globally useful measure while allowing for locally-relevant adaptation. To increase the relevance of the measure it is important to target actionable domains that predict markers of utility (e.g., successful uptake) per program implementers’ preferences. With this case study, we provide a detailed roadmap for others seeking to develop and validate IS measures that maximize local utility and impact.

Abstract Background HIV treatment programs in Africa have implemented centralized testing for routine viral load monitoring (VLM), which may result in specimen processing delays inhibiting timely return of viral load results. Decentralized, point-of-care (PoC) VLM is a promising tool for expediting HIV clinical decision-making but remains unavailable in most African settings. We qualitatively explored the perceived feasibility and appropriateness of PoC VLM to address gaps along the viral load monitoring continuum in rural Uganda. Methods Between May and September 2022, we conducted 15 in-depth interviews with HIV clinicians (facility in-charges, clinical officers, nurses, counselors) and six focus group discussions with 47 peer health workers from three south-central Ugandan districts. Topics explored centralized VLM implementation and opportunities/challenges to optimizing routine VLM implementation with PoC testing platforms. We explored perspectives on PoC VLM suitability and feasibility using iterative thematic analysis. Applying the Framework Method, we then mapped salient constraints and enablers of PoC VLM to constructs from the Consolidated Framework for Implementation Research. Results Clinicians and peers alike emphasized centralized viral load monitoring’s resource-intensiveness and susceptibility to procedural/infrastructural bottlenecks (e.g., supply stockouts, testing backlogs, community tracing of clients with delayed VLM results), inhibiting timely clinical decision-making. Participants reacted enthusiastically to the prospect of PoC VLM, anticipating accelerated turnarounds in specimen processing, shorter and/or fewer client encounters with treatment services, and streamlined efficiencies in HIV care provision (including expedited VLM-driven clinical decision-making). Anticipated constraints to PoC VLM implementation included human resource requirements for processing large quantities of specimens (especially when machinery require repair), procurement and maintenance costs, training needs in the existing health workforce for operating point-of-care technology, and insufficient space in lower-tier health facilities to accommodate installation of new laboratory equipment. Conclusions Anticipated implementation challenges, primarily clustering around resource requirements, did not diminish enthusiasm for PoC VLM monitoring among rural Ugandan clinicians and peer health workers, who perceived PoC platforms as potential solutions to existing inefficiencies within the centralized VLM ecosystem. Prioritizing PoC VLM rollout in facilities with available resources for optimal implementation (e.g., adequate physical and fiscal infrastructure, capacity to manage high specimen volumes) could help overcome anticipated barriers to decentralizing viral load monitoring.

Abstract Background In Africa, dispensing oral HIV pre-exposure prophylaxis (PrEP) within already strained public health facilities has led to prolonged waiting periods and suboptimal experiences for clients. We sought to explore the acceptability of dispensing PrEP semiannually with interim HIV self-testing (HIVST) versus quarterly PrEP dispensing with clinic-based HIV testing to optimize clinic-delivered PrEP services. Methods We conducted a qualitative study within a non-inferiority individual-level randomized controlled trial testing the effect of six-monthly PrEP dispensing with HIVST compared to the standard-of-care three-monthly PrEP dispensing on PrEP clinical outcomes in Kenya (ClinicalTrials.gov: NCT03593629). Eligible participants were ≥ 18 years, refilling PrEP for the first time, and either in an HIV serodifferent relationship (men and women) or singly enrolled (women only). A subset of participants in the intervention group completed serial in-depth interviews (IDIs) at enrollment, six months, and 12 months. We utilized stratified purposive sampling to ensure representation across participant groups. We analyzed our qualitative data thematically using a combination of inductive and deductive approaches, the latter guided by the Theoretical Framework of Acceptability (TFA). Results Between May 2018 and June 2021, we conducted 120 serial IDIs with 55 participants; 64% (35/55) were in a serodifferent relationship, 64% (35/55) were women, and the median age was 32 years (IQR 27–40). Overall, participants found this novel PrEP delivery model highly acceptable; it was well-liked, private (TFA construct: affective attitude), and less burdensome (TFA construct: burden) compared to standard PrEP delivery. Additionally, participants were confident in their ability to participate in the intervention (TFA construct: self-efficacy). Some participants, however, highlighted model disadvantages, including fewer opportunities for in-person counseling and potentially less accurate HIV testing (TFA construct: opportunity costs). Ultimately, most participants reported that the intervention allowed them to achieve their HIV prevention goals (TFA construct: perceived effectiveness) and that their confidence in at-home HIVST and PrEP continuation increased following each semiannual clinic visit. Conclusions Semiannual PrEP clinic visits supported with six-monthly drug dispensing and interim HIVST was acceptable among PrEP users who experienced the intervention in Kenya. More comprehensive pre-intervention counseling and training on HIVST may help alleviate the client concerns presented, which were often resolved over time with intervention experience.

Abstract Background Some of the most promising strategies to reduce hospital readmissions in heart failure (HF) is through the timely receipt of home health care (HHC), delivered by Medicare-certified home health agencies (HHAs), and outpatient medical follow-up after hospital discharge. Yet national data show that only 12% of Medicare beneficiaries receive these evidence-based practices, representing an implementation gap. To advance the science and improve outcomes in HF, we will test the effectiveness and implementation of an intervention called Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF), comprised of early and intensive HHC nurse visits combined with an early outpatient medical visit post-discharge, among HF patients receiving HHC. Methods This study will use a Hybrid Type 1, stepped wedge randomized trial design, to test the effectiveness and implementation of I-TRANSFER-HF in partnership with four geographically diverse dyads of hospitals and HHAs (“hospital-HHA” dyads) across the US. Aim 1 will test the effectiveness of I-TRANSFER-HF to reduce 30-day readmissions (primary outcome) and ED visits (secondary outcome), and increase days at home (secondary outcome) among HF patients who receive timely follow-up compared to usual care. Hospital-HHA dyads will be randomized to cross over from a baseline period of no intervention to the intervention in a randomized sequential order. Medicare claims data from each dyad and from comparison dyads selected within the national dataset will be used to ascertain outcomes. Hypotheses will be tested with generalized mixed models. Aim 2 will assess the determinants of I-TRANSFER-HF’s implementation using a mixed-methods approach and is guided by the Consolidated Framework for Implementation Research 2.0 (CFIR 2.0). Qualitative interviews will be conducted with key stakeholders across the hospital-HHA dyads to assess acceptability, barriers, and facilitators of implementation; feasibility and process measures will be assessed with Medicare claims data. Discussion As the first pragmatic trial of promoting timely HHC and outpatient follow-up in HF, this study has the potential to dramatically improve care and outcomes for HF patients and produce novel insights for the implementation of HHC nationally. Trial registration This trial has been registered on ClinicalTrials.Gov (#NCT06118983). Registered on 10/31/2023, https://clinicaltrials.gov/study/NCT06118983?id=NCT06118983&rank=1 .

Abstract Background The benefits of lean adoption in healthcare include improved process efficiency and quality of patient care. However, research indicates that lean implementation in healthcare, and specifically hospitals, is often not sustained. Furthermore, there is a need for maturity models that guide lean implementation, specifically in hospitals. This study develops a prescriptive maturity model named the Sustaining of Lean Adoption in Hospitals Roadmap (SOLAR) that acts as a practical guideline for the sustainable adoption of lean in hospitals. Methods The SOLAR has three theoretical foundations, namely lean implementation success factors in hospitals, implementation science, and change management theory. A systematic literature review was conducted to determine the lean implementation success factors in hospitals as the first building block. Secondly, practices from implementation science were used to create the action items in the SOLAR. Ten change steps were elicited from change management theory as the third theoretical building block of the roadmap. We refined the roadmap through three Delphi rounds that verified its useability in hospitals. Results The final SOLAR consists of four maturity phases (prepare, plan, experiment and learn, and sustain) and includes action items for each phase related to the hospital’s strategy, resources, engaging of people, and culture. The action items and change management steps shown in the SOLAR are not intended as an exhaustive list but provide guidelines on aspects hospitals must consider when they aim to adopt lean sustainably. Conclusions The strong theoretical base of the SOLAR enables hospitals to safely experiment and learn which implementation methods are best suited to their unique environment. The SOLAR is, therefore, an actionable guideline that informs both academics and practitioners involved in lean adoption in hospitals. This roadmap can guide future retrospective longitudinal or action research.

Abstract Background Hypertensive disorders of pregnancy are among the leading causes of maternal mortality and morbidity in the U.S., with rates highest among birthing people who are Black, rural residents, and/or have low-income. Severe hypertension, in particular, increases risk of stroke and other serious pregnancy complications. To promote early detection and treatment of severe hypertension, the Alliance for Innovation on Maternal Health developed the Severe Hypertension During Pregnancy and Postpartum Period Safety Bundle (HTN Bundle). Multiple studies have demonstrated the HTN Bundle’s effectiveness in the inpatient setting. With funding from the National Heart, Lung, and Blood Institute, we engaged community partners to adapt the HTN Bundle for the outpatient setting (i.e., O-HTN Bundle) and planned for its implementation. In this paper, we describe the protocol for a study evaluating O-HTN Bundle implementation in 20 outpatient clinics serving Black, rural, and/or low-income populations. Methods This study is a hybrid type 3 effectiveness-implementation trial with a multiple baseline design. We will implement the O-HTN Bundle in three successive cohorts of clinics using a multicomponent implementation strategy to engage community partners (coalition, patient workgroup) and support clinics (training, facilitation, education materials, and simulations of severe hypertension events). To test the strategy, we will compare clinic fidelity to evidence-based guidelines for (a) patient education on hypertension and (b) blood pressure measurement technique, with repeated measures occurring before and after strategy receipt. We will also observe strategy effects on community- and clinic-level intermediate outcomes (community engagement, organizational readiness), implementation outcomes (reach, adoption, fidelity, maintenance), and effectiveness outcomes (receipt of guideline concordant care). Analyses will address whether outcomes are equitable across Black, rural, and/or low-income subgroups. Guided by the Consolidated Framework for Implementation Research 2.0, we will use mixed methods to identify adaptations and other determinants of implementation success. Discussion This study integrates community engagement and implementation science to promote equitable and timely response to severe HTN in the outpatient setting during pregnancy and postpartum. This is one of the first studies to implement an outpatient HTN Bundle and to use simulation as a strategy to reinforce team-based delivery of guideline concordant care. Trial registration This study was registered with ClinicalTrials.gov as “Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle (AC3HIEVE).” Registration number NCT06002165, August 21, 2023: https://clinicaltrials.gov/study/NCT06002165 .

Abstract Background In low- and middle-income countries (LMICs), such as Tanzania, the competency of healthcare providers critically influences the quality of pediatric care. To address this issue, we introduced Pediatric Acute Care Education (PACE), an adaptive learning program to enhance provider competency in Tanzania’s guidelines for managing seriously ill children. Adaptive learning is a promising alternative to current in-service education, yet optimal implementation strategies in LMIC settings are unknown. Objectives (1) To evaluate the initial PACE implementation in Mwanza, Tanzania, using the construct of normalization process theory (NPT); (2) To provide insights into its feasibility, acceptability, and scalability potential. Methods Mixed-methods study involving healthcare providers at three facilities. Quantitative data was collected using the Normalization MeAsure Development (NoMAD) questionnaire, while qualitative data was gathered through in-depth interviews (IDIs) and focus groups discussions (FGDs). Results Eighty-two healthcare providers completed the NoMAD survey. Additionally, 24 senior providers participated in IDIs, and 79 junior providers participated in FGDs. Coherence and cognitive participation were high, demonstrating that PACE is well understood and resonates with existing healthcare goals. Providers expressed a willingness to integrate PACE into their practices, distinguishing it from existing educational methods. However, challenges related to resources and infrastructure, particularly those affecting collective action, were noted. Early indicators point toward the potential for long-term sustainability of the PACE, but assessment of reflexive monitoring was limited due to the study’s focus on PACE’s initial implementation. Conclusion This study offers vital insights into the feasibility and acceptability of implementing PACE in a Tanzanian context. While PACE aligns well with healthcare objectives, addressing resource and infrastructure challenges as well as conducting a longer-term study to assess reflexive monitoring is crucial for its successful implementation. Furthermore, the study underscores the value of the NPT as a framework for guiding implementation processes, with broader implications for implementation science and pediatric acute care in LMICs.

Abstract Background Penicillin allergy is the most frequently reported drug allergy, yet most patients can tolerate the drug if challenged. Despite this discrepancy, large scale penicillin allergy de-labeling interventions have not been widely implemented in many health care systems. The application of a multi-method implementation science approach can provide key tools to study this evidence to practice gap and provide insight to successfully operationalize penicillin allergy evaluation in real-world clinical settings. Methods We followed a four-step process that leverages qualitative analysis to design evidence-based, actionable strategies to develop an intervention. First, we specified the clinician-perceived barriers to penicillin allergy de-labeling (intervention targets). We then mapped intervention targets onto Theoretical Domains Framework (domains and constructs) and found the root causes of behavior. Next, we linked root causes of behavior with intervention functions (BCW). In the final step, we synthesized participants’ suggestions for process improvement with implementation strategies aligning with the intervention functions. Results Evidence-based strategies such as focused education and training in penicillin allergy evaluation can address knowledge and confidence barriers reported by frontline clinicians. Other key strategies involve developing a system of champions, improving communications systems, and restructuring the healthcare team. Implementation mapping can provide a powerful multi-method framework to study, design, and customize intervention strategies. Conclusion: Empowering clinicians beyond allergy specialists to conduct penicillin allergy assessments requires designing new workflows and systems and providing additional knowledge to those clinicians.

Abstract Background Sierra Leone has one of the world’s highest maternal and infant mortality rates and suffers from a shortage of well-trained health professionals, including midwives. Prior to engaging in systematic interventions, it is critical to measure organizational readiness to gauge members’ psychological and behavioral preparedness to implement change. We aimed to measure the organizational readiness for implementing change and compare results among midwives and administrative leaders at two schools of midwifery in Sierra Leone prior to the rollout of a midwifery preceptor program. Methods The Organizational Readiness for Implementing Change (ORIC) survey is a validated 12-item questionnaire designed to assess two domains of organizational readiness for change: change commitment (motivation) and change efficacy (capacity). All survey items begin with the same prompt and a five-item Likert scale response, with seven questions about change commitment and five about change efficacy. Data collection occurred in two schools of midwifery in Sierra Leone during two day-long meetings with stakeholders. Statistical analysis was conducted using descriptive statistics and Wilcoxon rank-sum test to compare independent samples: School 1 versus School 2 (site), midwife versus other roles (role). Results Participants included 42 respondents (mean age 41 years, 95% female). Surveys were distributed evenly between the two sites. Occupations included midwifery faculty (n = 8), administrators (n = 5), clinicians (n = 25), and clinical educators (n = 4). Domain 1 (change commitment) had a mean score of 4.72 (SD 0.47) while Domain 2 (change efficacy) had a mean score of 4.53 (SD 0.54) out of a total potential score of five. There were no statistically significant differences between site responses for Domain 1 (p = 0.5479) and Domain 2 (p = 0.1026) nor role responses for Domain 1 (p = 0.0627) and Domain 2 (p = 0.2520). Conclusion Stakeholders had very high overall readiness for change across all ORIC questions for both change commitment and change efficacy. Mean scores for change commitment were slightly higher which is not surprising given the low-resourced settings stakeholders work in while training students. High mean scores across sites and roles is encouraging as this novel preceptor program is currently being rolled out.

Abstract Background An essential component of future-proofing health systems against future pandemics and climate change is strengthening the front lines of care: principally, emergency departments and primary care settings. To achieve this, these settings can adopt learning health system (LHS) principles, integrating data, evidence, and experience to continuously improve care delivery. This rapid review aimed to understand the ways in which LHS principles have been applied to primary care and emergency departments, the extent to which LHS approaches have been adopted in these key settings, and the factors that affect their adoption. Methods Three academic databases (Embase, Scopus, and PubMed) were searched for full text articles reporting on LHSs in primary care and/or emergency departments published in the last five years. Articles were included if they had a primary focus on LHSs in primary care settings (general practice, allied health, multidisciplinary primary care, and community-based care) and/or emergency care settings. Data from included articles were catalogued and synthesised according to the modified Institute of Medicine’s five-component framework for LHSs (science and informatics, patient-clinician partnerships, incentives, continuous learning culture, and structure and governance). Results Thirty-seven articles were included, 32 of which reported LHSs in primary care settings and seven of which reported LHSs in emergency departments. Science and informatics was the most commonly reported LHS component, followed closely by continuous learning culture and structure and governance. Most articles (n = 30) reported on LHSs that had been adopted, and many of the included articles (n = 17) were descriptive reports of LHS approaches. Conclusions Developing LHSs at the front lines of care is essential for future-proofing against current and new threats to health system sustainability, such as pandemic- and climate change-induced events. Limited research has examined the application of LHS concepts to emergency care settings. Implementation science should be utilised to better understand the factors influencing adoption of LHS approaches on the front lines of care, so that all five LHS components can be progressed in these settings.

Abstract Background The Assessment of Burden of Chronic Conditions (ABCC-)tool is developed to facilitate a personalized approach to care in the patient-healthcare provider (HCP) conversation based on shared decision-making and individualized care plans. An effectiveness study highlighted its effect on the perceived quality of care and patient activation. Successful implementation of novel interventions necessitates an understanding of the user’s actual application, user experiences and an evaluation of implementation outcomes. This study aims to evaluate the implementation of the ABCC-tool by HCPs in Dutch primary care. Methods This study is the process evaluation of a larger type 1 effectiveness-implementation hybrid trial. Semi-structured interviews with HCPs, who were interventionists in the hybrid trial, were held at three and twelve months after they started using the ABCC-tool. The Reach-Effectiveness-Adoption-Implementation-Maintenance (RE-AIM) framework was used to evaluate implementation outcomes. The Implementation domain was further strengthened with an evaluation of implementation fidelity using Carroll’s framework. Inductive coding and thematic analysis were applied to identify relevant participant experiences and implementation outcomes within the RE-AIM framework. Results Seventeen HCPs (1 general practitioner, 16 practice nurses) participated in the study, representing 39% of potentially eligible participants. Most HCPs applied the tool after finishing their own routines instead of how it is intended to be used, namely from the beginning of the consultation. HCPs reached 2–6 patients. The ABCC-tool was initially adopted, but twelve HCPs stopped using the tool due to COVID-19 related cancellation of consultations. High fidelity was found for applying the questionnaire and visualization. Low fidelity was present for applying shared decision-making, formulating care goals and monitoring progress. HCPs indicated that maintaning the ABCC-tool depended on accompanying training and implementation support. Conclusions HCPs applied the ABCC-tool critically different from intended, potentially diminishing its benefits and ease of use. This evaluation stresses the need for a tailored implementation plan that includes more detailed training and guidance on how and when to use the ABCC-tool.

Abstract Background Individuals facing socioeconomic hardship experience higher than average rates of chronic disease, such as diabetes, with less access to evidence-based treatment. One solution to address these inequities is a team-based care (TBC) model, defined as one in which at least two providers work collaboratively with a patient and their caregiver(s) to make healthcare decisions. This paper seeks to describe the implementation of a TBC model within a safety-net healthcare setting and determine the extent to which it can be an effective, patient-centered approach to treating individuals with diabetes. Methods Semi-structured interviews were conducted with staff (n = 15) and patients (n = 18). Clinical data were extracted from the electronic medical record of patients (n = 1,599) seen at a safety-net health system in Chicago, Illinois, United States. The mixed methods study was guided by implementation science and participatory research principles. Staff interviews were 60 min and covered patient care activities, work flow, perceived patient experience, and facilitators/barriers to care coordination. Patient interviews were 60 min and covered satisfaction, attitudes about diabetes management, quality of life, and technology. Patient interviews were co-analyzed by research staff and members of a patient advisory committee. Clinical data were collected at an index visit, two years prior and at one-year follow up (n = 1,599). Results Four themes emerged from the interviews: (1) patients perceived the TBC model to be patient centered and of high quality; (2) technology can be an innovative tool, but barriers exist; (3) diabetes management is a complex process; and (4) staff communication enhances care coordination, but misinterpreting roles reduces care coordination. From pre-enrollment to the follow-up period, we found a statistically significant increase in missed visits, decrease in hemoglobin A1c (HbA1c), decrease in body mass index, and decrease in the percent of patients with high blood pressure. We found that each medical visit during the follow-up period was associated with an HbA1c decrease of 0.26 points. Conclusions A TBC model is a patient-centered approach to providing care to patients with complex health needs, such as diabetes, patients were satisfied with the care they were receiving, and the model was associated with an improvement in clinical outcomes.

Background: Penicillin allergy is the most frequently reported drug allergy, yet most patients can tolerate the drug if challenged. Despite this discrepancy, large scale penicillin allergy de-labeling interventions have not been widely implemented in many health care systems. The application of a multi-method implementation science approach can provide key tools to study this evidence to practice gap and provide insight to successfully operationalize penicillin allergy evaluation in real-world clinical settings. Methods: We followed a four-step process that leverages qualitative analysis to design evidence-based, actionable strategies to develop an intervention. First, we specified the clinician-perceived barriers to penicillin allergy de-labeling (intervention targets). We then mapped intervention targets onto Theoretical Domains Framework (domains and constructs) and found the root causes of behavior. Next, we linked root causes of behavior with intervention functions (BCW). In the final step, we synthesized participants' suggestions for process improvement with implementation strategies aligning with the intervention functions. Results: Evidence-based strategies such as focused education and training in penicillin allergy evaluation can address knowledge and confidence barriers reported by frontline clinicians. Other key strategies involve developing a system of champions, improving communications systems, and restructuring the healthcare team. Implementation mapping can provide a powerful multi-method framework to study, design, and customize intervention strategies. Conclusion: Empowering clinicians beyond allergy specialists to conduct penicillin allergy assessments requires designing new workflows and systems and providing additional knowledge to those clinicians. [ABSTRACT FROM AUTHOR]

Background: Sierra Leone has one of the world's highest maternal and infant mortality rates and suffers from a shortage of well-trained health professionals, including midwives. Prior to engaging in systematic interventions, it is critical to measure organizational readiness to gauge members' psychological and behavioral preparedness to implement change. We aimed to measure the organizational readiness for implementing change and compare results among midwives and administrative leaders at two schools of midwifery in Sierra Leone prior to the rollout of a midwifery preceptor program. Methods: The Organizational Readiness for Implementing Change (ORIC) survey is a validated 12-item questionnaire designed to assess two domains of organizational readiness for change: change commitment (motivation) and change efficacy (capacity). All survey items begin with the same prompt and a five-item Likert scale response, with seven questions about change commitment and five about change efficacy. Data collection occurred in two schools of midwifery in Sierra Leone during two day-long meetings with stakeholders. Statistical analysis was conducted using descriptive statistics and Wilcoxon rank-sum test to compare independent samples: School 1 versus School 2 (site), midwife versus other roles (role). Results: Participants included 42 respondents (mean age 41 years, 95% female). Surveys were distributed evenly between the two sites. Occupations included midwifery faculty (n = 8), administrators (n = 5), clinicians (n = 25), and clinical educators (n = 4). Domain 1 (change commitment) had a mean score of 4.72 (SD 0.47) while Domain 2 (change efficacy) had a mean score of 4.53 (SD 0.54) out of a total potential score of five. There were no statistically significant differences between site responses for Domain 1 (p = 0.5479) and Domain 2 (p = 0.1026) nor role responses for Domain 1 (p = 0.0627) and Domain 2 (p = 0.2520). Conclusion: Stakeholders had very high overall readiness for change across all ORIC questions for both change commitment and change efficacy. Mean scores for change commitment were slightly higher which is not surprising given the low-resourced settings stakeholders work in while training students. High mean scores across sites and roles is encouraging as this novel preceptor program is currently being rolled out. [ABSTRACT FROM AUTHOR]

Background: An essential component of future-proofing health systems against future pandemics and climate change is strengthening the front lines of care: principally, emergency departments and primary care settings. To achieve this, these settings can adopt learning health system (LHS) principles, integrating data, evidence, and experience to continuously improve care delivery. This rapid review aimed to understand the ways in which LHS principles have been applied to primary care and emergency departments, the extent to which LHS approaches have been adopted in these key settings, and the factors that affect their adoption. Methods: Three academic databases (Embase, Scopus, and PubMed) were searched for full text articles reporting on LHSs in primary care and/or emergency departments published in the last five years. Articles were included if they had a primary focus on LHSs in primary care settings (general practice, allied health, multidisciplinary primary care, and community-based care) and/or emergency care settings. Data from included articles were catalogued and synthesised according to the modified Institute of Medicine's five-component framework for LHSs (science and informatics, patient-clinician partnerships, incentives, continuous learning culture, and structure and governance). Results: Thirty-seven articles were included, 32 of which reported LHSs in primary care settings and seven of which reported LHSs in emergency departments. Science and informatics was the most commonly reported LHS component, followed closely by continuous learning culture and structure and governance. Most articles (n = 30) reported on LHSs that had been adopted, and many of the included articles (n = 17) were descriptive reports of LHS approaches. Conclusions: Developing LHSs at the front lines of care is essential for future-proofing against current and new threats to health system sustainability, such as pandemic- and climate change-induced events. Limited research has examined the application of LHS concepts to emergency care settings. Implementation science should be utilised to better understand the factors influencing adoption of LHS approaches on the front lines of care, so that all five LHS components can be progressed in these settings. [ABSTRACT FROM AUTHOR]

Background: The Assessment of Burden of Chronic Conditions (ABCC-)tool is developed to facilitate a personalized approach to care in the patient-healthcare provider (HCP) conversation based on shared decision-making and individualized care plans. An effectiveness study highlighted its effect on the perceived quality of care and patient activation. Successful implementation of novel interventions necessitates an understanding of the user's actual application, user experiences and an evaluation of implementation outcomes. This study aims to evaluate the implementation of the ABCC-tool by HCPs in Dutch primary care. Methods: This study is the process evaluation of a larger type 1 effectiveness-implementation hybrid trial. Semi-structured interviews with HCPs, who were interventionists in the hybrid trial, were held at three and twelve months after they started using the ABCC-tool. The Reach-Effectiveness-Adoption-Implementation-Maintenance (RE-AIM) framework was used to evaluate implementation outcomes. The Implementation domain was further strengthened with an evaluation of implementation fidelity using Carroll's framework. Inductive coding and thematic analysis were applied to identify relevant participant experiences and implementation outcomes within the RE-AIM framework. Results: Seventeen HCPs (1 general practitioner, 16 practice nurses) participated in the study, representing 39% of potentially eligible participants. Most HCPs applied the tool after finishing their own routines instead of how it is intended to be used, namely from the beginning of the consultation. HCPs reached 2–6 patients. The ABCC-tool was initially adopted, but twelve HCPs stopped using the tool due to COVID-19 related cancellation of consultations. High fidelity was found for applying the questionnaire and visualization. Low fidelity was present for applying shared decision-making, formulating care goals and monitoring progress. HCPs indicated that maintaning the ABCC-tool depended on accompanying training and implementation support. Conclusions: HCPs applied the ABCC-tool critically different from intended, potentially diminishing its benefits and ease of use. This evaluation stresses the need for a tailored implementation plan that includes more detailed training and guidance on how and when to use the ABCC-tool. Contributions to the literature: Fidelity is an important mediator of an intervention's perceived benefit and implementation success. This evaluation stresses the need for clear training and guidance on using the ABCC-tool. This type 1 effectiveness-implementation hybrid trial confirms the essential role of a thorough implementation plan when implementing the ABCC-tool in Dutch primary care. Implementation plans should include tailored strategies based on contextual influences and local needs of implementers. [ABSTRACT FROM AUTHOR]

Background: Individuals facing socioeconomic hardship experience higher than average rates of chronic disease, such as diabetes, with less access to evidence-based treatment. One solution to address these inequities is a team-based care (TBC) model, defined as one in which at least two providers work collaboratively with a patient and their caregiver(s) to make healthcare decisions. This paper seeks to describe the implementation of a TBC model within a safety-net healthcare setting and determine the extent to which it can be an effective, patient-centered approach to treating individuals with diabetes. Methods: Semi-structured interviews were conducted with staff (n = 15) and patients (n = 18). Clinical data were extracted from the electronic medical record of patients (n = 1,599) seen at a safety-net health system in Chicago, Illinois, United States. The mixed methods study was guided by implementation science and participatory research principles. Staff interviews were 60 min and covered patient care activities, work flow, perceived patient experience, and facilitators/barriers to care coordination. Patient interviews were 60 min and covered satisfaction, attitudes about diabetes management, quality of life, and technology. Patient interviews were co-analyzed by research staff and members of a patient advisory committee. Clinical data were collected at an index visit, two years prior and at one-year follow up (n = 1,599). Results: Four themes emerged from the interviews: (1) patients perceived the TBC model to be patient centered and of high quality; (2) technology can be an innovative tool, but barriers exist; (3) diabetes management is a complex process; and (4) staff communication enhances care coordination, but misinterpreting roles reduces care coordination. From pre-enrollment to the follow-up period, we found a statistically significant increase in missed visits, decrease in hemoglobin A1c (HbA1c), decrease in body mass index, and decrease in the percent of patients with high blood pressure. We found that each medical visit during the follow-up period was associated with an HbA1c decrease of 0.26 points. Conclusions: A TBC model is a patient-centered approach to providing care to patients with complex health needs, such as diabetes, patients were satisfied with the care they were receiving, and the model was associated with an improvement in clinical outcomes. [ABSTRACT FROM AUTHOR]

Background: The etonogestrel contraceptive implant is currently approved by the United States Food and Drug Administration (FDA) for the prevention of pregnancy up to 3 years. However, studies that suggest efficacy up to 5 years. There is little information on the prevalence of extended use and the factors that influence clinicians in offering extended use. We investigated clinician perspectives on the barriers and facilitators to offering extended use of the contraceptive implant. Methods: Using the Consolidated Framework for Implementation Research (CFIR), we conducted semi-structured qualitative interviews. Participants were recruited from a nationwide survey study of reproductive health clinicians on their knowledge and perspective of extended use of the contraceptive implant. To optimize the diversity of perspectives, we purposefully sampled participants from this study. We used content analysis and consensual qualitative research methods to inform our coding and data analysis. Themes arose deductively and inductively. Results: We interviewed 20 clinicians including advance practice clinicians, family medicine physicians, obstetrician/gynecologist and complex family planning sub-specialists. Themes regarding barriers and facilitators to extended use of the contraceptive implant emerged. Barriers included the FDA approval for 3 years and clinician concern about liability in the context of off-label use of the contraceptive implant. Educational materials and a champion of extended use were facilitators. Conclusions: There is opportunity to expand access to extended use of the contraceptive implant by developing educational materials for clinicians and patients, identifying a champion of extended use, and providing information on extended use prior to replacement appointments at 3 years. [ABSTRACT FROM AUTHOR]

BACKGROUND: The Veterans Affairs (VA) Clinical Resource Hub (CRH) program aims to improve patient access to care by implementing time-limited, regionally based primary or mental health staffing support to cover local staffing vacancies. VAs Office of Primary Care (OPC) designed CRH to support more than 1000 geographically disparate VA outpatient sites, many of which are in rural areas, by providing virtual contingency clinical staffing for sites experiencing primary care and mental health staffing deficits. The subsequently funded CRH evaluation, carried out by the VA Primary Care Analytics Team (PCAT), partnered with CRH program leaders and evaluation stakeholders to develop a protocol for a six-year CRH evaluation. The objectives for developing the CRH evaluation protocol were to prospectively: 1) identify the outcomes CRH aimed to achieve, and the key program elements designed to achieve them; 2) specify evaluation designs and data collection approaches for assessing CRH progress and success; and 3) guide the activities of five geographically dispersed evaluation teams. METHODS: The protocol documents a multi-method CRH program evaluation design with qualitative and quantitative elements. The evaluations overall goal is to assess CRHs return on investment to the VA and Veterans at six years through synthesis of findings on program effectiveness. The evaluation includes both observational and quasi-experimental elements reflecting impacts at the national, regional, outpatient site, and patient levels. The protocol is based on program evaluation theory, implementation science frameworks, literature on contingency staffing, and iterative review and revision by both research and clinical operations partners. DISCUSSION: Health systems increasingly seek to use data to guide management and decision-making for newly implemented clinical programs and policies. Approaches for planning evaluations to accomplish this goal, however, are not well-established. By publishing the protocol, we aim to increase the validity and usefulness of subsequent evaluation findings. We also aim to provide an example of a program evaluation protocol developed within a learning health systems partnership.

Abstract Background Assisted index case testing (ICT), in which health care workers take an active role in referring at-risk contacts of people living with HIV for HIV testing services, has been widely recognized as an evidence-based intervention with high potential to increase status awareness in people living with HIV. While the available evidence from eastern and southern Africa suggests that assisted ICT can be an effective, efficient, cost-effective, acceptable, and low-risk strategy to implement in the region, it reveals that feasibility barriers to implementation exist. This study aims to inform the design of implementation strategies to mitigate these feasibility barriers by examining “assisting” health care workers’ experiences of how barriers manifest throughout the assisted ICT process, as well as their perceptions of potential opportunities to facilitate feasibility. Methods In-depth interviews were conducted with 26 lay health care workers delivering assisted ICT in Malawian health facilities. Interviews explored health care workers’ experiences counseling index clients and tracing these clients’ contacts, aiming to inform development of a blended learning implementation package. Transcripts were inductively analyzed using Dedoose coding software to identify and describe key factors influencing feasibility of assisted ICT. Analysis included multiple rounds of coding and iteration with the data collection team. Results Participants reported a variety of barriers to feasibility of assisted index case testing implementation, including sensitivities around discussing ICT with clients, privacy concerns, limited time for assisted index case testing amid high workloads, poor quality contact information, and logistical obstacles to tracing. Participants also reported several health care worker characteristics that facilitate feasibility (knowledge, interpersonal skills, non-stigmatizing attitudes and behaviors, and a sense of purpose), as well as identified process improvements with the potential to mitigate barriers. Conclusions Maximizing assisted ICT’s potential to increase status awareness in people living with HIV requires equipping health care workers with effective training and support to address and overcome the many feasibility barriers that they face in implementation. Findings demonstrate the need for, as well as inform the development of, implementation strategies to mitigate barriers and promote facilitators to feasibility of assisted ICT. Trial registration NCT05343390. Date of registration: April 25, 2022.

Abstract Background The rapid evolution, complexity, and specialization of oncology treatment makes it challenging for physicians to provide care based on the latest and best evidence. We hypothesized that physicians would use evidence-based trusted care pathways if they were easy to use and integrated into clinical workflow at the point of care. Methods Within a large integrated care delivery system, we assembled clinical experts to define and update drug treatment pathways, encoded them as flowcharts in an online library integrated with the electronic medical record, communicated expectations that clinicians would use these pathways for every eligible patient, and combined data from multiple sources to understand usage over time. Results We were able to achieve > 75% utilization of eligible protocols ordered through these pathways within two years, with > 90% of individual oncologists having consulted the pathway at least once, despite no requirements or external incentives associated with pathway usage. Feedback from users contributed to improvements and updates to the guidance. Conclusions By making our clinical decision support easily accessible and actionable, we find that we have made considerable progress toward our goal of having physicians consult the latest evidence in their treatment decisions.

Abstract Background Patient navigation is an evidence-based intervention that reduces cancer health disparities by directly addressing the barriers to care for underserved patients with cancer. Variability in design and integration of patient navigation programs within cancer care settings has limited this intervention’s utility. The implementation science evaluation framework, RE-AIM, allows quantitative and qualitative examination of effective implementation of patient navigation programs into cancer care settings. Methods The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework was used to evaluate implementation of a community-focused patient navigation intervention at an NCI-designated cancer center between June 2018 and October 2021. Using a 3-month longitudinal, non-comparative measurement period, univariate and bivariate analyses were conducted to examine associations between participant-level demographics and primary (i.e., barrier reduction) and secondary (i.e., patient-reported outcomes) effectiveness outcomes. Mixed methods analyses were used to examine adoption and delivery of the intervention into the cancer center setting. Process-level analyses were used to evaluate maintenance of the intervention. Results Participants (n = 311) represented a largely underserved population, as defined by the National Cancer Institute, with the majority identifying as Hispanic/Latino, having a household income of $35,000 or less, and being enrolled in Medicaid. Participants were diagnosed with a variety of cancer types and most had advanced staged cancers. Pre-post-intervention analyses indicated significant reduction from pre-intervention assessments in the average number of reported barriers, F(1, 207) = 117.62, p

Abstract Background Despite being a global public health concern, there is a research gap in analyzing implementation strategies for managing off-label drug use in children. This study aims to understand professional health managers’ perspectives on implementing the Guideline in hospitals and determine the Guideline’s implementation facilitators and barriers. Methods Pediatric directors, pharmacy directors, and medical department directors from secondary and tertiary hospitals across the country were recruited for online interviews. The interviews were performed between June 27 and August 25, 2022. The Consolidated Framework for Implementation Research (CFIR) was adopted for data collection, data analysis, and findings interpretation to implement interventions across healthcare settings. Results Individual interviews were conducted with 28 healthcare professionals from all over the Chinese mainland. Key stakeholders in implementing the Guideline for the Management of Pediatric Off-Label Use of Drugs in China (2021) were interviewed to identify 57 influencing factors, including 27 facilitators, 29 barriers, and one neutral factor, based on the CFIR framework. The study revealed the complexity of the factors influencing managing children’s off-label medication use. A lack of policy incentives was the key obstacle in external settings. The communication barrier between pharmacists and physicians was the most critical internal barrier. Conclusion To our knowledge, this study significantly reduces the implementation gap in managing children’s off-label drug use. We provided a reference for the standardized management of children’s off-label use of drugs.

Abstract Background Colorectal cancer (CRC) continues to be a major cause of death in the U.S. despite the availability of effective screening tools. U.S. Latinos have lower rates of CRC screening and higher rates of death due to colorectal disease compared to non-Hispanic whites. Federally Qualified Health Centers (FQHCs) serve medically underserved populations, including many Latino patients. Given the low CRC screening rates, identifying culturally sensitive and cost-effective methods of promoting screening is a priority for many FQHCs. Methods We interviewed FQHC leaders and providers using the Consolidated Framework for Implementation Research (CFIR) to identify barriers and facilitators to implementation of a multilevel, multicomponent (ML-MC) CRC screening intervention (i.e., promotor navigation and group-based education) in FQHCs. A rapid qualitative analysis approach was used to identify themes organized according to the following CFIR constructs: intervention characteristics, outer and inner settings, and characteristics of the individual. Results We completed interviews with 13 healthcare professionals in leadership positions at six FQHCs. The participating FQHCs perceived the ML-MC screening CRC program as feasible and expressed interest in implementing the program at their sites. Facilitators included financial incentives for increasing screening rates, the need for patient education programming, and involving promotores to support the work of clinical teams. Barriers included concerns about available resources to implement new programs, lack of federal reimbursement for health education, competing priorities of other health concerns, and the need for more resources for confirmatory screening and treatment following a positive screen. Conclusions FQHCs provide essential primary care to millions of underserved patients in the U.S. and have the ability and motivation to provide screenings for colorectal cancer. Partnering with an academic institution to deliver a group-based, promotor-led CRC screening intervention for patients not up to date with screening could help increase screening rates. By identifying the specific barriers and facilitators to implementing CRC intervention, findings suggest that group-based, promotor-led interventions are a promising approach.

Abstract Background The challenge of implementing evidence into routine clinical practice is well recognised and implementation science offers theories, models and frameworks to promote investigation into delivery of evidence-based care. Embedding implementation researchers into health systems is a novel approach to ensuring research is situated in day-to-day practice dilemmas. To optimise the value of embedded implementation researchers and resources, the aim of this study was to investigate stakeholders’ views on opportunities for implementation science research in a cancer setting that holds potential to impact on care. The research objectives were to: 1) Establish stakeholder and theory informed organisation-level implementation science priorities and 2) Identify and prioritise a test case pilot implementation research project. Methods We undertook a qualitative study using semi-structured interviews. Participants held either a formal leadership role, were research active or a consumer advocate and affiliated with either a specialist cancer hospital or a cancer alliance of ten hospitals. Interview data were summarised and shared with participants prior to undertaking both thematic analysis, to identify priority areas for implementation research, and content analysis, to identify potential pilot implementation research projects. The selected pilot Implementation research project was prioritised using a synthesis of an organisational and implementation prioritisation framework – the organisational priority setting framework and APEASE framework. Results Thirty-one people participated between August 2022 and February 2023. Four themes were identified: 1) Integration of services to address organisational priorities e.g., tackling fragmented services; 2) Application of digital health interventions e.g., identifying the potential benefits of digital health interventions; 3) Identification of potential for implementation research, including deimplementation i.e., discontinuing ineffective or low value care and; 4) Focusing on direct patient engagement e.g., wider consumer awareness of the challenges in delivering cancer care. Six potential pilot implementation research projects were identified and the EMBED project, to support clinicians to refer appropriate patients with cancer for genetic testing, was selected using the synthesised prioritisation framework. Conclusions Using a theory informed and structured approach the alignment between strategic organisational priorities and implementation research priorities can be identified. As a result, the implementation research focus can be placed on activities with the highest potential impact.

Abstract Background The international scale and spread of evidence-based perioperative medicine for older people undergoing surgery (POPS) services has not yet been fully realised. Implementation science provides a structured approach to understanding factors that act as barriers and facilitators to the implementation of POPS services. In this study, we aimed to identify factors that influence the implementation of POPS services in the UK. Methods A qualitative case study at three UK health services was undertaken. The health services differed across contextual factors (population, workforce, size) and stages of POPS service implementation maturity. Semi-structured interviews with purposively sampled clinicians (perioperative medical, nursing, allied health, and pharmacy) and managers (n = 56) were conducted. Data were inductively coded, then thematically analysed using the Consolidated Framework for Implementation Research (CFIR). Results Fourteen factors across all five CFIR domains were relevant to the implementation of POPS services. Key shared facilitators included stakeholders understanding the rationale of the POPS service, with support from their networks, POPS champions, and POPS clinical leads. We found substantial variation and flexibility in the way that health services responded to these shared facilitators and this was relevant to the implementation of POPS services. Conclusions Health services planning to implement a POPS service should use health service-specific strategies to respond flexibly to local factors that are acting as barriers or facilitators to implementation. To support implementation of a POPS service, we recommend health services prioritise understanding local networks, identifying POPS champions, and ensuring that stakeholders understand the rationale for the POPS service. Our study also provides a structure for future research to understand the factors associated with ‘unsuccessful’ implementation of a POPS service, which can inform ongoing efforts to implement evidence-based perioperative models of care for older people.

BackgroundThis study aimed to capture the implementation process of the ALIGN Study, (An individualized Pain Plan with Patient and Provider Access for Emergency Department care of Sickle Cell Disease). ALIGN aimed to embed Individualized Pain Plans in the electronic health record (E-IPP) and provide access to the plan for both adult patients with sickle cell disease (SCD) and emergency department providers when a person with SCD comes to the emergency department in vaso-occlusive crises.MethodsSemi-structured interviews were conducted with research teams from the 8 participating sites from the ALIGN study. Seventeen participants (principal investigators and study coordinators) shared their perspectives about the implementation of ALIGN in their sites. Data were analyzed in three phases using open coding steps adapted from grounded theory and qualitative content analysis.ResultsA total of seven overarching themes were identified: (1) the E-IPP structure (location and upkeep) and collaboration with the informatics team, (2) the role of ED champion, (3) the role of research coordinators, (4) research team communication, and communication between research team and clinical team, (5) challenges with the study protocol, (6) provider feedback: addressing over-utilizers, patient mistrust, and the positive feedback about the intervention, and (7) COVID-19 and its effects on study implementation.ConclusionsFindings from this study contribute to learning how to implement E-IPPs for adult patients with SCD in ED. The study findings highlight the importance of early engagement with different team members, a champion from the emergency department, study coordinators with different skills and enhancement of communication and trust among team members. Further recommendations are outlined for hospitals aiming to implement E-IPP for patients with SCD in ED.

BackgroundIn 2020, the Health Resources and Services Administration's HIV/AIDS Bureau funded an initiative to promote implementation of rapid antiretroviral therapy initiation in 14 HIV treatment settings across the U.S. The goal of this initiative is to accelerate uptake of this evidence-based strategy and provide an implementation blueprint for other HIV care settings to reduce the time from HIV diagnosis to entry into care, for re-engagement in care for those out of care, initiation of treatment, and viral suppression. As part of the effort, an evaluation and technical assistance provider (ETAP) was funded to study implementation of the model in the 14 implementation sites.MethodThe ETAP has used implementation science methods framed by the Dynamic Capabilities Model integrated with the Conceptual Model of Implementation Research to develop a Hybrid Type II, multi-site mixed-methods evaluation, described in this paper. The results of the evaluation will describe strategies associated with uptake, implementation outcomes, and HIV-related health outcomes for patients.DiscussionThis approach will allow us to understand in detail the processes that sites to implement and integrate rapid initiation of antiretroviral therapy as standard of care as a means of achieving equity in HIV care.

BackgroundAlcohol use disorder (AUD) is ubiquitous and its sequelae contribute to high levels of healthcare utilization, yet AUD remains undertreated. The ED encounter represents a missed opportunity to initiate medication assisted treatment (MAT) for patients with AUD. The aims of this study are to identify barriers and facilitators to the treatment of AUD in the ED, and to design interventions to address identified barriers.MethodsUsing an implementation science approach based on the Behavior Change Wheel framework, we conducted qualitative interviews with staff to interrogate their perspectives on ED initiation of AUD treatment. Subjects included physicians, nurses, nurse practitioners, clinical social workers, and pharmacists. Interviews were thematically coded using both inductive and deductive approaches and constant comparative analysis. Themes were further categorized as relating to providers' capabilities, opportunities, or motivations. Barriers were then mapped to corresponding intervention functions.ResultsFacilitators at our institution included time allotted for continuing education, the availability of clinical social workers, and favorable opinions of MAT based on previous experiences implementing buprenorphine for opioid use disorder. Capability barriers included limited familiarity with naltrexone and difficulty determining which patients are candidates for therapy. Opportunity barriers included the limited supply of naltrexone and a lack of clarity as to who should introduce naltrexone and assess readiness for change. Motivation barriers included a sense of futility in treating patients with AUD and stigmas associated with alcohol use. Evidence-based interventions included multi-modal provider education, a standardized treatment algorithm and order set, selection of clinical champions, and clarification of roles among providers on the team.ConclusionsA large evidence-practice gap exists for the treatment of AUD with Naltrexone, and the ED visit is a missed opportunity for intervention. ED providers are optimistic about implementing AUD treatment in the ED but described many barriers, especially related to knowledge, clarification of roles, and stigma associated with AUD. Applying a formal implementation science approach guided by the Behavior Change Wheel allowed us to transform qualitative interview data into evidence-based interventions for the implementation of an ED-based program for the treatment of AUD.

Background: Assisted index case testing (ICT), in which health care workers take an active role in referring at-risk contacts of people living with HIV for HIV testing services, has been widely recognized as an evidence-based intervention with high potential to increase status awareness in people living with HIV. While the available evidence from eastern and southern Africa suggests that assisted ICT can be an effective, efficient, cost-effective, acceptable, and low-risk strategy to implement in the region, it reveals that feasibility barriers to implementation exist. This study aims to inform the design of implementation strategies to mitigate these feasibility barriers by examining "assisting" health care workers' experiences of how barriers manifest throughout the assisted ICT process, as well as their perceptions of potential opportunities to facilitate feasibility. Methods: In-depth interviews were conducted with 26 lay health care workers delivering assisted ICT in Malawian health facilities. Interviews explored health care workers' experiences counseling index clients and tracing these clients' contacts, aiming to inform development of a blended learning implementation package. Transcripts were inductively analyzed using Dedoose coding software to identify and describe key factors influencing feasibility of assisted ICT. Analysis included multiple rounds of coding and iteration with the data collection team. Results: Participants reported a variety of barriers to feasibility of assisted index case testing implementation, including sensitivities around discussing ICT with clients, privacy concerns, limited time for assisted index case testing amid high workloads, poor quality contact information, and logistical obstacles to tracing. Participants also reported several health care worker characteristics that facilitate feasibility (knowledge, interpersonal skills, non-stigmatizing attitudes and behaviors, and a sense of purpose), as well as identified process improvements with the potential to mitigate barriers. Conclusions: Maximizing assisted ICT's potential to increase status awareness in people living with HIV requires equipping health care workers with effective training and support to address and overcome the many feasibility barriers that they face in implementation. Findings demonstrate the need for, as well as inform the development of, implementation strategies to mitigate barriers and promote facilitators to feasibility of assisted ICT. Trial registration: NCT05343390. Date of registration: April 25, 2022. [ABSTRACT FROM AUTHOR]

Background: The rapid evolution, complexity, and specialization of oncology treatment makes it challenging for physicians to provide care based on the latest and best evidence. We hypothesized that physicians would use evidence-based trusted care pathways if they were easy to use and integrated into clinical workflow at the point of care. Methods: Within a large integrated care delivery system, we assembled clinical experts to define and update drug treatment pathways, encoded them as flowcharts in an online library integrated with the electronic medical record, communicated expectations that clinicians would use these pathways for every eligible patient, and combined data from multiple sources to understand usage over time. Results: We were able to achieve > 75% utilization of eligible protocols ordered through these pathways within two years, with > 90% of individual oncologists having consulted the pathway at least once, despite no requirements or external incentives associated with pathway usage. Feedback from users contributed to improvements and updates to the guidance. Conclusions: By making our clinical decision support easily accessible and actionable, we find that we have made considerable progress toward our goal of having physicians consult the latest evidence in their treatment decisions. [ABSTRACT FROM AUTHOR]

Background: Patient navigation is an evidence-based intervention that reduces cancer health disparities by directly addressing the barriers to care for underserved patients with cancer. Variability in design and integration of patient navigation programs within cancer care settings has limited this intervention's utility. The implementation science evaluation framework, RE-AIM, allows quantitative and qualitative examination of effective implementation of patient navigation programs into cancer care settings. Methods: The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework was used to evaluate implementation of a community-focused patient navigation intervention at an NCI-designated cancer center between June 2018 and October 2021. Using a 3-month longitudinal, non-comparative measurement period, univariate and bivariate analyses were conducted to examine associations between participant-level demographics and primary (i.e., barrier reduction) and secondary (i.e., patient-reported outcomes) effectiveness outcomes. Mixed methods analyses were used to examine adoption and delivery of the intervention into the cancer center setting. Process-level analyses were used to evaluate maintenance of the intervention. Results: Participants (n = 311) represented a largely underserved population, as defined by the National Cancer Institute, with the majority identifying as Hispanic/Latino, having a household income of $35,000 or less, and being enrolled in Medicaid. Participants were diagnosed with a variety of cancer types and most had advanced staged cancers. Pre-post-intervention analyses indicated significant reduction from pre-intervention assessments in the average number of reported barriers, F(1, 207) = 117.62, p <.001, as well as significant increases in patient-reported physical health, t(205) = − 6.004, p <.001, mental health, t(205) = − 3.810, p <.001, self-efficacy, t(205) = − 5.321, p <.001, and satisfaction with medical team communication, t(206) = − 2.03, p =.029. Referral patterns and qualitative data supported increased adoption and integration of the intervention into the target setting, and consistent intervention delivery metrics suggested high fidelity to intervention delivery over time. Process-level data outlined a successful transition from a grant-funded community-focused patient navigation intervention to an institution-funded program. Conclusions: This study utilized the implementation science evaluation framework, RE-AIM, to evaluate implementation of a community-focused patient navigation program. Our analyses indicate successful implementation within a cancer care setting and provide a potential guide for other oncology settings who may be interested in implementing community-focused patient navigation programs. [ABSTRACT FROM AUTHOR]

Background: Colorectal cancer (CRC) continues to be a major cause of death in the U.S. despite the availability of effective screening tools. U.S. Latinos have lower rates of CRC screening and higher rates of death due to colorectal disease compared to non-Hispanic whites. Federally Qualified Health Centers (FQHCs) serve medically underserved populations, including many Latino patients. Given the low CRC screening rates, identifying culturally sensitive and cost-effective methods of promoting screening is a priority for many FQHCs. Methods: We interviewed FQHC leaders and providers using the Consolidated Framework for Implementation Research (CFIR) to identify barriers and facilitators to implementation of a multilevel, multicomponent (ML-MC) CRC screening intervention (i.e., promotor navigation and group-based education) in FQHCs. A rapid qualitative analysis approach was used to identify themes organized according to the following CFIR constructs: intervention characteristics, outer and inner settings, and characteristics of the individual. Results: We completed interviews with 13 healthcare professionals in leadership positions at six FQHCs. The participating FQHCs perceived the ML-MC screening CRC program as feasible and expressed interest in implementing the program at their sites. Facilitators included financial incentives for increasing screening rates, the need for patient education programming, and involving promotores to support the work of clinical teams. Barriers included concerns about available resources to implement new programs, lack of federal reimbursement for health education, competing priorities of other health concerns, and the need for more resources for confirmatory screening and treatment following a positive screen. Conclusions: FQHCs provide essential primary care to millions of underserved patients in the U.S. and have the ability and motivation to provide screenings for colorectal cancer. Partnering with an academic institution to deliver a group-based, promotor-led CRC screening intervention for patients not up to date with screening could help increase screening rates. By identifying the specific barriers and facilitators to implementing CRC intervention, findings suggest that group-based, promotor-led interventions are a promising approach. [ABSTRACT FROM AUTHOR]

Background: The international scale and spread of evidence-based perioperative medicine for older people undergoing surgery (POPS) services has not yet been fully realised. Implementation science provides a structured approach to understanding factors that act as barriers and facilitators to the implementation of POPS services. In this study, we aimed to identify factors that influence the implementation of POPS services in the UK. Methods: A qualitative case study at three UK health services was undertaken. The health services differed across contextual factors (population, workforce, size) and stages of POPS service implementation maturity. Semi-structured interviews with purposively sampled clinicians (perioperative medical, nursing, allied health, and pharmacy) and managers (n = 56) were conducted. Data were inductively coded, then thematically analysed using the Consolidated Framework for Implementation Research (CFIR). Results: Fourteen factors across all five CFIR domains were relevant to the implementation of POPS services. Key shared facilitators included stakeholders understanding the rationale of the POPS service, with support from their networks, POPS champions, and POPS clinical leads. We found substantial variation and flexibility in the way that health services responded to these shared facilitators and this was relevant to the implementation of POPS services. Conclusions: Health services planning to implement a POPS service should use health service-specific strategies to respond flexibly to local factors that are acting as barriers or facilitators to implementation. To support implementation of a POPS service, we recommend health services prioritise understanding local networks, identifying POPS champions, and ensuring that stakeholders understand the rationale for the POPS service. Our study also provides a structure for future research to understand the factors associated with 'unsuccessful' implementation of a POPS service, which can inform ongoing efforts to implement evidence-based perioperative models of care for older people. [ABSTRACT FROM AUTHOR]

Background: The challenge of implementing evidence into routine clinical practice is well recognised and implementation science offers theories, models and frameworks to promote investigation into delivery of evidence-based care. Embedding implementation researchers into health systems is a novel approach to ensuring research is situated in day-to-day practice dilemmas. To optimise the value of embedded implementation researchers and resources, the aim of this study was to investigate stakeholders’ views on opportunities for implementation science research in a cancer setting that holds potential to impact on care. The research objectives were to: 1) Establish stakeholder and theory informed organisation-level implementation science priorities and 2) Identify and prioritise a test case pilot implementation research project. Methods: We undertook a qualitative study using semi-structured interviews. Participants held either a formal leadership role, were research active or a consumer advocate and affiliated with either a specialist cancer hospital or a cancer alliance of ten hospitals. Interview data were summarised and shared with participants prior to undertaking both thematic analysis, to identify priority areas for implementation research, and content analysis, to identify potential pilot implementation research projects. The selected pilot Implementation research project was prioritised using a synthesis of an organisational and implementation prioritisation framework – the organisational priority setting framework and APEASE framework. Results: Thirty-one people participated between August 2022 and February 2023. Four themes were identified: 1) Integration of services to address organisational priorities e.g., tackling fragmented services; 2) Application of digital health interventions e.g., identifying the potential benefits of digital health interventions; 3) Identification of potential for implementation research, including deimplementation i.e., discontinuing ineffective or low value care and; 4) Focusing on direct patient engagement e.g., wider consumer awareness of the challenges in delivering cancer care. Six potential pilot implementation research projects were identified and the EMBED project, to support clinicians to refer appropriate patients with cancer for genetic testing, was selected using the synthesised prioritisation framework. Conclusions: Using a theory informed and structured approach the alignment between strategic organisational priorities and implementation research priorities can be identified. As a result, the implementation research focus can be placed on activities with the highest potential impact. [ABSTRACT FROM AUTHOR]

Abstract Background Hospital at home (HaH) was increasingly implemented in Catalonia (7.7 M citizens, Spain) achieving regional adoption within the 2011-2015 Health Plan. This study aimed to assess population-wide HaH outcomes over five years (2015-2019) in a consolidated regional program and provide context-independent recommendations for continuous quality improvement of the service. Methods A mixed-methods approach was adopted, combining population-based retrospective analyses of registry information with qualitative research. HaH (admission avoidance modality) was compared with a conventional hospitalization group using propensity score matching techniques. We evaluated the 12-month period before the admission, the hospitalization, and use of healthcare resources at 30 days after discharge. A panel of experts discussed the results and provided recommendations for monitoring HaH services. Results The adoption of HaH steadily increased from 5,185 episodes/year in 2015 to 8,086 episodes/year in 2019 (total episodes 31,901; mean age 73 (SD 17) years; 79% high-risk patients. Mortality rates were similar between HaH and conventional hospitalization within the episode [76 (0.31%) vs. 112 (0.45%)] and at 30-days after discharge [973(3.94%) vs. 1112(3.24%)]. Likewise, the rates of hospital re-admissions at 30 days after discharge were also similar between groups: 2,00 (8.08%) vs. 1,63 (6.58%)] or ER visits [4,11 (16.62%) vs. 3,97 (16.03%). The 27 hospitals assessed showed high variability in patients’ age, multimorbidity, severity of episodes, recurrences, and length of stay of HaH episodes. Recommendations aiming at enhancing service delivery were produced. Conclusions Besides confirming safety and value generation of HaH for selected patients, we found that this service is delivered in a case-mix of different scenarios, encouraging hospital-profiled monitoring of the service.

Abstract Background The Danish Health Authority recommended the implementation of new types of emergency departments. Organizational changes in the hospital sector challenged the role, identity, and autonomy of medical specialists. They tend to identify with their specialty, which can challenge successful implementation of change. However, investigations on specialty identity are rare in implementation science, and how the co-existence of different specialty identities influences the implementation of new emergency departments needs to be explored for the development of tailored implementation strategies. The aim of this study was to examine how medical specialty identity influences collaboration between physicians when implementing a new emergency department in Denmark. Methods Qualitative methods in the form of participants’ observations at 13 oilcloth sessions (a micro-simulation method) were conducted followed up by 53 individual semi-structured interviews with participants from the oilcloth sessions. Out of the 53 interviews, 26 were conducted with specialists. Data from their interviews are included in this study. Data were analysed deductively inspired by Social Identity Theory. Results The analysis yielded three overarching themes: [1] ongoing creation and re-creation of specialty identity through boundary drawing; [2] social categorization and power relations; and [3] the patient as a boundary object. Conclusions Specialty identity is an important determinant of collaboration among physicians when implementing a new emergency department. Specialty identity involves social categorization, which entails ongoing creation and re-creation of boundary drawing and exercising of power among the physicians. In some situations, the patient became a positive boundary object, increasing the possibility for a successful collaboration and supporting successful implementation, but direct expressions of boundaries and mistrust were evident. Both were manifested through a dominating power expressed through social categorization in the form of in- and out-groups and in an “us and them” discourse, which created distance and separation among physicians from different specialties. This distancing and separation became a barrier to the implementation of the new emergency department.

Abstract Background As the Canadian population ages and the prevalence of chronic illnesses increases, delivering high-quality care to individuals with advanced life limiting illnesses becomes more challenging. Community-based navigation programs are a promising approach to address these challenges, but little is known about how these programs are successfully implemented to meet the needs of this population. This study sought to identify the key determinants that contribute to the successful implementation of these programs within Canada. Methods A qualitative study was undertaken to understand the implementation of eleven innovative, community-based navigation programs that aim to address the needs of individuals with life-limiting illnesses as they approach the end of life. The Consolidated Framework for Implementation Research (CFIR) guided the study design. Key informants (n = 23) within these programs took part in semi-structured interviews where they were asked to discuss how these programs are implemented. Data were analyzed using techniques employed in qualitative description. Results We identified key determinants of successful implementation within each CFIR domain. In the outer setting domain, participants emphasized the importance of filling gaps in care to meet client needs, developing strong relationships with clients and community-based organizations, and navigating relationships with healthcare providers. At the inner setting level, leadership support, staff compatibility, and available resources were identified as important factors. In terms of intervention characteristics, the ability to adapt was cited as a facilitator, whereas costs were identified as a barrier. For the characteristics of individuals, participants described the importance of having staff whose values align with the program, and who have the experience and skills necessary to work with complex clients. Finally, having strong champions and evaluation processes were highlighted as important process-oriented determinants of successful implementation. Conclusion This study provides valuable insights into the determinants of successful implementation of community-based navigation programs in Canada. Understanding these determinants can guide the future development and integration of navigation programs to successfully meet the needs of those with life-limiting illnesses.

Abstract Background In Low-Middle-Income Countries (LMICs), young people living with Type 1 Diabetes Mellitus (T1DM) face structural barriers which undermine adequate T1DM management and lead to poor health outcomes. However, research on the barriers faced by young people living with T1DM have mostly focused on patient factors, neglecting concerns regarding plausible barriers that may exist at the point of healthcare service delivery. Objective This study sought to explore barriers faced by young people living with T1DM and their caregivers at the point of healthcare service delivery. Methods Data were drawn from a qualitative research in southern Ghana. The research was underpinned by a phenomenological study design. Data were collected from 28 young people living with T1DM, 12 caregivers, and six healthcare providers using semi-structured interview guides. The data were collected at home, hospital, and support group centres via face-to-face interviews, telephone interviews, and videoconferencing. Thematic and framework analyses were done using CAQDAS (QSR NVivo 14). Results Eight key barriers were identified. These were: shortage of insulin and management logistics; healthcare provider knowledge gaps; lack of T1DM care continuity; poor healthcare provider-caregiver interactions; lack of specialists’ care; sharing of physical space with adult patients; long waiting time; and outdated treatment plans. The multiple barriers identified suggest the need for an integrated model of T1DM to improve its care delivery in low-resource settings. We adapted the Chronic Care Model (CCM) to develop an Integrated Healthcare for T1DM management in low-resource settings. Conclusion Young people living with T1DM, and their caregivers encountered multiple healthcare barriers in both in-patient and outpatient healthcare facilities. The results highlight important intervention areas which must be addressed/improved to optimise T1DM care, as well as call for the implementation of a proposed integrated approach to T1DM care in low-resource settings.

Abstract Introduction Meaningful engagement of partners in co-creating and refining health-related programs can increase the initial uptake, sustained implementation, broad reach, and effectiveness of these programs. This is especially important for underserved communities where resources are limited and need to be prioritized. Brainwriting premortem is a novel qualitative approach to partner engagement that combines the strengths of individual idea generation with the concept of premortem exercise that addresses failure points prior to the implementation of new programs. Methods An adapted form of brainwriting premortem was used to inform iterative refinements to a COVID-19 testing program at a Federally Qualified Health Center (FQHC) in San Diego. Patients and providers from the FQHC participated in interviews at two time points (early- and mid-implementation of the program). Interview data were transcribed, translated, and analyzed using a rapid qualitative approach. Key themes and sub-themes were identified and used to inform refinements to the program. Results A total of 11 patients (7 Spanish- and 4 English-speaking) and 8 providers participated in the brainwriting premortem interviews. Key themes related to possible reasons for COVID-19 testing program failure: advertising/sharing information; access to testing; handling of test results; staff and patient safety; patient beliefs and views regarding the SARS-CoV-2 virus; and COVID-19 testing options offered. Proposed solutions were offered for the key failures except for patient beliefs and views regarding the SARS-CoV-2 virus. Additional solutions offered were related to education, physical operations, and recruitment strategies. Real-time changes to the program flow and components were made in response to 7 suggestions from patients and 11 from providers. Changes related to the process of returning results were the most common, and included sending results via email with distinct workflows based on the test result. Conclusion The implementation of the adapted brainwriting premortem technique allowed us to incorporate the perspective of key partners in the delivery and iterative refinement of the COVID-19 testing program. This was an effective tool in the context of an FQHC and can be a promising and approach to incorporate iterative input from patients and providers to ensure successful program implementation. Future studies, particularly those requiring rapid response to public health emergencies, should consider the use of this technique.

Abstract Background Variation in hospital stroke care is problematic. The Quality in Acute Stroke (QASC) Australia trial demonstrated reductions in death and disability through supported implementation of nurse-led, evidence-based protocols to manage fever, hyperglycaemia (sugar) and swallowing (FeSS Protocols) following stroke. Subsequently, a pre-test/post-test study was conducted in acute stroke wards in 64 hospitals in 17 European countries to evaluate upscale of the FeSS Protocols. Implementation across countries was underpinned by a cascading facilitation framework of multi-stakeholder support involving academic partners and a not-for-profit health organisation, the Angels Initiative (the industry partner), that operates to promote evidence-based treatments in stroke centres. .We report here an a priori qualitative process evaluation undertaken to identify factors that influenced international implementation of the FeSS Protocols using a cascading facilitation framework. Methods The sampling frame for interviews was: (1) Executives/Steering Committee members, consisting of academics, the Angels Initiative and senior project team, (2) Angel Team leaders (managers of Angel Consultants), (3) Angel Consultants (responsible for assisting facilitation of FeSS Protocols into multiple hospitals) and (4) Country Co-ordinators (senior stroke nurses with country and hospital-level responsibilities for facilitating the introduction of the FeSS Protocols). A semi-structured interview elicited participant views on the factorsthat influenced engagement of stakeholders with the project and preparation for and implementation of the FeSS Protocol upscale. Interviews were recorded, transcribed verbatim and analysed inductively within NVivo. Results Individual (n = 13) and three group interviews (3 participants in each group) were undertaken. Three main themes with sub-themes were identified that represented key factors influencing upscale: (1) readiness for change (sub-themes: negotiating expectations; intervention feasible and acceptable; shared goal of evidence-based stroke management); (2) roles and relationships (sub-themes: defining and establishing roles; harnessing nurse champions) and (3) managing multiple changes (sub-themes: accommodating and responding to variation; more than clinical change; multi-layered communication framework). Conclusion A cascading facilitation model involving a partnership between evidence producers (academic partners), knowledge brokers (industry partner, Angels Initiative) and evidence adopters (stroke clinicians) overcame multiple challenges involved in international evidence translation. Capacity to manage, negotiate and adapt to multi-level changes and strategic engagement of different stakeholders supported adoption of nurse-initiated stroke protocols within Europe. This model has promise for other large-scale evidence translation programs.

Abstract Background The Family in Intensive Care UnitS (FICUS) trial investigates the clinical effectiveness of a multicomponent, nurse-led interprofessional family support intervention (FSI) and explores its implementation in intensive care units (ICUs). The local context of each ICU strongly influences intervention performance in practice. To promote FSI uptake and to reduce variation in intervention delivery, we aimed to develop tailored implementation strategies. Methods A mixed method contextual analysis guided by the Consolidated Framework for Implementation Research (CFIR) was performed from March to June 2022 on eight ICUs assigned to the intervention group. ICU key clinical partners were asked to complete a questionnaire on CFIR inner setting measures (i.e., organizational culture, resources, learning climate and leadership engagement) and the Organizational Readiness for Implementing Change (ORIC) scale prior to group interviews, which were held to discuss barriers and facilitators to FSI implementation. Descriptive analysis and pragmatic rapid thematic analysis were used. Then, tailored implementation strategies were developed for each ICU. Results In total, 33 key clinical partners returned the questionnaire and 40 attended eight group interviews. Results showed a supportive environment, with CFIR inner setting and ORIC measures each rated above 3 (scale: 1 low—5 high value), with leadership engagement scoring highest (median 4.00, IQR 0.38). Interview data showed that the ICU teams were highly motivated and committed to implementing the FSI. They reported limited resources, new interprofessional information exchange, and role adoption of nurses as challenging. Conclusion We found that important pre-conditions for FSI implementation, such as leadership support, a supportive team culture, and a good learning climate were present. Some aspects, such as available resources, interprofessional collaboration and family nurses’ role adoption were of concern and needed attention. An initial set of implementation strategies were relevant to all ICUs, but some additions and adaptation to local needs were required. Multi-component interventions are challenging to implement within complex systems, such as ICUs. This pragmatic, theory-guided, mixed methods contextual analysis demonstrated high readiness and commitment to FSI implementation in the context of a clinical trial and enabled the specification of a tailored, multifaceted implementation strategy.

Abstract Background Conversations about goals, values and priorities with patients that are seriously ill are associated with improved palliative healthcare. The Serious Illness Care Program is a multi-component program that can facilitate more, better, and earlier conversations between clinicians and seriously ill patients. For successful and sustainable implementation of the Serious Illness Care Program, it is important to consider how stakeholders perceive it. The aim of our study was to explore physicians’ perceptions and experiences of implementing the Serious Illness Care Program. Methods Data were collected through four focus group discussions with physicians (n = 14) working at a hospital where the Serious Illness Care program was in the process of being implemented. Data were analyzed with inductive thematic analysis. Results Physicians’ perceptions of the implementation encompassed three thematic areas: hovering between preparedness and unpreparedness, being impacted and being impactful, and picking pieces or embracing it at all. Conclusions This study identified key aspects related to the individual physician, the care team, the impact on the patient, and the organizational support that were perceived to influence the implementation and sustainable integration of the Serious Illness Care Program. Describing these aspects provides insight into how the Serious Illness Care Program is implemented in practice and indicates areas for future training and development. Trial registration Not applicable.