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Understanding the resources needed to achieve desired implementation and effectiveness outcomes is essential to implementing and sustaining evidence-based practices (EBPs). Despite this frequent observation, cost and economic measurement and reporting are rare, but becoming more frequent in implementation science, and when present is seldom reported from the perspective of multiple stakeholders (e.g., the organization, supervisory team), including those who will ultimately implement and sustain EBPs.Incorporating a multi-level framework is useful for understanding and integrating the perspectives and priorities of the diverse set of stakeholders involved in implementation. Stakeholders across levels, from patients to delivery staff to health systems, experience different economic impacts (costs, benefit, and value) related to EBP implementation and have different perspectives on these issues. Economic theory can aid in understanding multi-level perspectives and approaches to addressing potential conflict across perspectives.This paper provides examples of key cost components especially important to different types of stakeholders. It provides specific guidance and recommendations for cost assessment activities that address the concerns of various stakeholder groups, identifies areas of agreement and conflict in priorities, and outlines theoretically informed approaches to understanding conflicts among stakeholder groups and processes to address them. Involving stakeholders throughout the implementation process and presenting economic information in ways that are clear and meaningful to different stakeholder groups can aid in maximizing benefits within the context of limited resources. We posit that such approaches are vital to advancing economic evaluation in implementation science. Finally, we identify directions for future research and application.Considering a range of stakeholders is critical to informing economic evaluation that will support appropriate decisions about resource allocation across contexts to inform decisions about successful adoption, implementation, and sustainment. Not all perspectives need to be addressed in a given project but identifying and understanding perspectives of multiple groups of key stakeholders including patients and direct implementation staff not often explicitly considered in traditional economic evaluation are needed in implementation research.

Veterans are increasingly eligible for non-VA care through the Veteran Health Administration (VA) Maintaining Internal Systems and Strengthening Integrated Outside Networks Act while maintaining care in the VA. Continuity of care is challenging when delivered across multiple systems resulting in avoidable complications. The Community Hospital Transitions Program (CHTP) intervention was developed to address challenges veterans face post non-VA hospitalization. Propensity score-matched analysis was used to compare outcomes between 334 intervention and matched control patients who were discharged from non-VA hospitals. Veterans in CHTP were more likely than matched controls to receive a follow-up appointment within 14 days (mean: 0.43 vs 0.34, P < .05) and 30 days (mean: 0.62 vs 0.50, P < .05). There were no significant differences in 30-day readmissions or 30-day emergency department visits. CHTP veterans received timely follow-up care post discharge in VA facilities. Providing quality care to dual-use veterans is dependent on coordinated transitional care.

In hospitals, improvers and implementers use quality improvement science (QIS) and less frequently implementation research (IR) to improve health care and health outcomes. Narrowly defined quality improvement (QI) guided by QIS focuses on transforming systems of care to improve health care quality and delivery and IR focuses on developing approaches to close the gap between what is known (research findings) and what is practiced (by clinicians). However, QI regularly involves implementing evidence and IR consistently addresses organizational and setting-level factors. The disciplines share a common end goal, namely, to improve health outcomes, and work to understand and change the same actors in the same settings often encountering and addressing the same challenges. QIS has its origins in industry and IR in behavioral science and health services research. Despite overlap in purpose, the 2 sciences have evolved separately. Thought leaders in QIS and IR have argued the need for improved collaboration between the disciplines. The Veterans Health Administration’s Quality Enhancement Research Initiative has successfully employed QIS methods to implement evidence-based practices more rapidly into clinical practice, but similar formal collaborations between QIS and IR are not widespread in other health care systems. Acute care teams are well positioned to improve care delivery and implement the latest evidence. We provide an overview of QIS and IR; examine the key characteristics of QIS and IR, including strengths and limitations of each discipline; and present specific recommendations for integration and collaboration between the 2 approaches to improve the impact of QI and implementation efforts in the hospital setting.

The vast eHealth literature in diabetes can provide a useful foundation to aid in the selection, adoption, and implementation of eHealth methodologies in clinical care. Despite clear potential to enhance reach, efficiency, and clinical effectiveness, research has yielded mixed and often contradictory results, and wide-spread adoption and maintenance of eHealth programs in clinical care has been limited. Furthermore, few reports have identified the unique challenges that clinicians and health systems face when attempting to incorporate eHealth systems into clinical care. To address these gaps, we address two goals in this report: first, to summarize and integrate the major findings of the diabetes-related eHealth literature based on currently available systematic and narrative reviews; and second, based on the review, to provide practical guidelines to assist clinicians and health systems in selecting and implementing eHealth programs into diabetes care using dissemination and implementation science principles and perspectives.

Background: Hypertension is a major risk factor for cardiovascular disease (CVD). Despite advances in hypertension prevention and treatment, the proportion of patients who are aware, treated and controlled is low, particularly in low-income and middle-income countries (LMICs). We will evaluate an adapted version of a multilevel and multicomponent hypertension control program in Guatemala, previously proven effective and feasible in Argentina. The program components are: protocol-based hypertension treatment using a standardized algorithm; team-based collaborative care; health provider education; health coaching sessions; home blood pressure monitoring; blood pressure audit; and feedback.Methods: Using a hybrid type 2 effectiveness-implementation design, we will evaluate clinical and implementation outcomes of the multicomponent program in Guatemala over an 18-month period. Through a cluster randomized trial, we will randomly assign 18 health districts to the intervention arm and 18 to enhanced usual care across five departments, enrolling 44 participants per health district and 1584 participants in total. The clinical outcomes are (1) the difference in the proportion of patients with controlled hypertension (< 130/80 mmHg) between the intervention and control groups at 18 months and (2) the net change in systolic and diastolic blood pressure from baseline to 18 months. The context-enhanced Reach, Efficacy, Adoption, Implementation, Maintenance (RE-AIM)/Practical Robust Implementation and Sustainability Model (PRISM) framework will guide the evaluation of the implementation at the level of the patient, provider, and health system. Using a mixed-methods approach, we will evaluate the following implementation outcomes: acceptability, adoption, feasibility, fidelity, adaptation, reach, sustainability, and cost-effectiveness.Discussion: We will disseminate the study findings, and promote scale up and scale out of the program, if proven effective. This study will generate urgently needed data on effective, adoptable, and sustainable interventions and implementation strategies to improve hypertension control in Guatemala and other LMICs. Fil: Paniagua Avila, Alejandra. Columbia University; Estados Unidos Fil: Fort, Meredith P.. Institute Of Nutrition Of Central America And Panamá; Guatemala Fil: Glasgow, Russell E.. University of Colorado; Estados Unidos Fil: Gulayin, Pablo Elías. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Hernández Galdamez, Diego. institute of Nutrition of Central America and Panamá; Guatemala Fil: Mansilla, Kristyne. institute of Nutrition of Central America and Panamá; Guatemala Fil: Palacios, Eduardo. Ministerio de Salud y Asistencia Social; Guatemala Fil: Peralta, Ana Lucia. Institute of Nutrition of Central America and Panamá ; Guatemala Fil: Roche, Dina. Institute of Nutrition of Central America and Panamá ; Guatemala Fil: Rubinstein, Adolfo Luis. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina Fil: He, Jiang. University Translational Science Institute; Estados Unidos Fil: Ramirez Zea, Manuel. Institute of Nutrition of Central America and Panamá ; Guatemala Fil: Irazola, Vilma. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina

Background. Despite demonstrated efficacy, patient decision aids (DAs) are rarely used in clinical practice in the absence of coverage mandates. Deciding whether to pursue a left ventricular assist device (LVAD) is a major, preference-sensitive decision—ideal for exploring implementation of a DA. Methods. We conducted a type II effectiveness-implementation hybrid trial at 6 LVAD programs using a stepped-wedge cluster-randomized design. Using the RE-AIM framework, we collected both quantitative and qualitative outcomes, including a checklist collected by study staff for each enrolled patient regarding DA use and interviews with LVAD program clinicians preintervention, 6 months postintervention, and at the conclusion of the study. Results. From June 2015 to January 2017, 248 patients and their caregivers were enrolled. A total of 69 interviews were conducted with 48 clinicians at 3 time points. The DA reached 95% of eligible patients. Adoption was 100%, as all sites approached agreed to participate in the trial. Interviews revealed several themes related to the implementation of the DA: clinicians had a strong desire to ensure patients were informed and embraced the DA. Despite this, they reported communication challenges among their team that impeded implementation. Five of the 6 sites have maintained use of the DA following the trial; 1 site reported concerns about decreased procedural volume with use of the DA as a reason for discontinuation. Conclusions. In this hybrid trial, a DA for patients considering LVADs and their caregivers demonstrated high reach. Adoption and implementation were facilitated by a strong desire to ensure that patients were well informed. Future dissemination research and practice should attend to concerns about procedure volume and coverage mandates and facilitate ongoing communication at sites using the DA.

Background Shared medical appointments (SMAs) have been shown to be an efficient and effective strategy for providing diabetes self-management education and self-management support. SMA features vary and it is not known which features are most effective for different patients and practice settings. The Invested in Diabetes study tests the comparative effectiveness of SMAs with and without multidisciplinary care teams and patient topic choice for improving patient-centered and clinical outcomes related to diabetes. Methods This study compares the effectiveness of two SMA approaches using the Targeted Training for Illness Management (TTIM) curriculum. Standardized SMAs are led by a health educator with a set order of TTIM topics. Patient-driven SMAs are delivered collaboratively by a multidisciplinary care team (health educator, medical provider, behavioral health provider, and a peer mentor); patients select the order and emphasis on TTIM topics. Invested in Diabetes is a cluster randomized pragmatic trial involving approximately 1440 adult patients with type 2 diabetes. Twenty primary care practices will be randomly assigned to either standardized or patient-driven SMAs. A mixed-methods evaluation will include quantitative (practice- and patient-level data) and qualitative (practice and patient interviews, observation) components. The primary patient-centered outcome is diabetes distress. Secondary outcomes include autonomy support, self-management behaviors, clinical outcomes, patient reach, and practice-level value and sustainability. Discussion Practice and patient stakeholder input guided protocol development for this pragmatic trial comparing SMA approaches. Implementation strategies from the enhanced Replicating Effective Programs framework will help ensure practices maintain fidelity to intervention protocols while tailoring workflows to their settings. Invested in Diabetes will contribute to the literature on chronic illness management and implementation science using the RE-AIM model. Trial registration ClinicalTrials.gov, NCT03590041. Registered on 5 July 2018.

Total Worker Health® (TWH), an initiative of the U.S. National Institute for Occupational Safety and Health, is defined as policies, programs, and practices that integrate protection from work-related health and safety hazards by promoting efforts that advance worker well-being. Interventions that apply the TWH paradigm improve workplace health more rapidly than wellness programs alone. Evidence of the barriers and facilitators to the adoption, implementation, and long-term maintenance of TWH programs is limited. Dissemination and implementation (D&I) science, the study of methods and strategies for bridging the gap between public health research and practice, can help address these system-, setting-, and worker-level factors to increase the uptake, impact, and sustainment of TWH activities. The purpose of this paper is to draw upon a synthesis of existing D&I science literature to provide TWH researchers and practitioners with: (1) an overview of D&I science; (2) a plain language explanation of key concepts in D&I science; (3) a case study example of moving a TWH intervention down the research-to-practice pipeline; and (4) a discussion of future opportunities for conducting D&I science in complex and dynamic workplace settings to increase worker safety, health, and well-being. Published version

Background This report describes how we refined a protocol for a pragmatic comparative effectiveness study of two models of an evidence-based diabetes shared medical appointment intervention and used the PRECIS-2 rating system to evaluate these adaptations. Methods We report primary data collected between June and August 2019, and protocol refinements completed between 2018 and 2020. Twenty-two members of the study team collaborated in protocol refinement and completed the PRECIS-2 ratings of study pragmatism. We discuss study design refinements made to achieve the desired level of pragmatism vs. experimental control for each of the nine PRECIS-2 dimensions. Study team members received training on PRECIS-2 scoring and were asked to rate the study protocol on the nine PRECIS-2 dimensions. Ratings were compared using descriptive statistics. Results In general, the PRECIS-2 ratings revealed high levels of pragmatism, but somewhat less pragmatic ratings on the categories of Delivery and Organization (costs and resources). This variation was purposeful, and we provide the rationale for and steps taken to obtain the targeted level of pragmatism on each PRECIS-2 dimension, as well as detail design changes made to a) make the design more pragmatic and b) address COVID-19 issues. There was general agreement among team members and across different types of stakeholders on PRECIS-2 ratings. Conclusions We discuss lessons learned from use of PRECIS-2 and experiences in refining the study to be maximally pragmatic on some dimensions and less so on other dimensions. This paper expands on prior research by describing actions to achieve higher levels of pragmatism and revise our protocol fit to the changed context. We make recommendations for future use of PRECIS-2 to help address changing context and other strategies for the planning of and transparent reporting on pragmatic research and comparative effectiveness research. Trial registration Clinicaltrials.gov Registration ID: NCT03590041.

Background: Implementation science is concerned with the study of adoption, implementation and maintenance of evidence-based interventions and use of implementation strategies to facilitate translation into practice. Ways to conceptualize and overcome challenges to implementing evidence-based practice may enhance the field of implementation science. The concept of mental models may be one way to view such challenges and to guide selection, use and adaptation of implementation strategies. Methods: A mental model is an interrelated set of beliefs that shape how a person forms expectations for the future and understands the way the world works. Mental models can shape how an individual thinks about or understands how something or someone does, can, or should function in the world. We review the concepts of mental models and illustrate how they pertain to implementation of an example intervention, shared decision making. A range of methods to elicit and analyze mental models are reviewed, including formal methods developed specifically for a given project. Results: Mental models may be sparse or detailed, may be shared among actors in implementation or not, and may be substantially tacit, i.e., of limited accessibility to introspection. Actors’ mental models can determine what information they are willing to accept and what changes they are willing to consider. We describe and illustrate multiple methods for eliciting and analyzing mental models including semi-structured interviews, cognitive task analyses and Delphi methods. Conclusions: Understanding the mental models of actors in implementation can provide crucial information for understanding, anticipating, and overcoming implementation challenges. Successful implementation often requires changing actors’ mental models or the way in which interventions or implementation strategies are presented or implemented. Accurate elicitation and understanding can guide strategies for doing so.

There are complex issues in understanding and categorizing implementation science theories, models, and frameworks. Systematic reviews of these models are important undertakings for synthesizing current knowledge. The issues involved are even more challenging when reviewing a large number of frameworks and when some of the frameworks have evolved significantly over time. This paper addresses how the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework was described in the recent Esmail (2020) review and identifies four mischaracterizations. This is followed by a more general discussion of how advances or extensions of frameworks after an original source publication or influential review tend to be overlooked. We discuss why inadvertent mischaracterization of what a framework is and is not, and what it can and cannot be used for, can have deleterious consequences. Finally, we suggest initial ideas about what could be done to prevent or alleviate some of these problems by reviewers, framework developers, and scholars at large.

Background Veterans with healthcare needs utilize both Veterans Health Administration (VA) and non-VA hospitals. These dual-use veterans are at high risk of adverse outcomes due to the lack of coordination for safe transitions. Objectives The aim of this study was to understand the barriers and facilitators to providing high-quality continuum of care for veterans transitioning from non-VA hospitals to the VA primary care setting. Design Guided by the practical robust implementation and sustainability model (PRISM) and the ideal transitions of care, we conducted a qualitative assessment using semi-structured interviews with clinicians, staff, and patients. Setting This study was conducted at a single urban VA medical center and two non-VA hospitals. Participants A total of 70 participants, including 52 clinicians and staff (23 VA and 29 non-VA) involved in patient transition and 18 veterans recently discharged from non-VA hospitals, were included in this study. Approach Data were analyzed using a conventional content analysis and managed in Atlas.ti (Berlin, Germany). Results Four major themes emerged where participants consistently discussed that transitions were delayed when they were not able to (1) identify patients as veterans and notify VA primary care of discharge, (2) transfer non-VA hospital medical records to VA primary care, (3) obtain follow-up care appointments with VA primary care, and (4) write VA formulary medications for veterans that they could fill at VA pharmacies. Participants also discussed factors involved in smooth transition and recommendations to improve care coordination. Conclusions All participants perceived the current transition-of-care process across healthcare systems to be inefficient. Efforts to improve quality and safety in transitional care should address the challenges clinicians and patients experience when transitioning from non-VA hospitals to VA primary care.

Background Nearly half of patients do not take their cardiovascular medications as prescribed, resulting in increased morbidity, mortality, and healthcare costs. Mobile and digital technologies for health promotion and disease self-management offer an opportunity to adapt behavioral “nudges” using ubiquitous mobile phone technology to facilitate medication adherence. The Nudge pragmatic clinical trial uses population-level pharmacy data to deliver nudges via mobile phone text messaging and an artificial intelligent interactive chat bot with the goal of improving medication adherence and patient outcomes in three integrated healthcare delivery systems. Methods The Theory of mHealth, the Expanded RE-AIM/PRISM, and the PRECIS-2 frameworks were used for program planning, implementation and evaluation, along with a focus on dissemination and cost considerations. During the planning phase, the Nudge study team developed and piloted a technology-based nudge message and chat bot of optimized interactive content libraries for a range of diverse patients. Inclusion criteria are very broad and include patients in one of three diverse health systems who take medications to treat hypertension, atrial fibrillation, coronary artery disease, diabetes, or hyperlipidemia. A target of approximately 10,000 participants will be randomized to one of 4 study arms: usual care (no intervention), generic nudge (text reminder), optimized nudge, and optimized nudge plus interactive AI chat bot. The PRECIS-2 tool indicated that the study protocol is very pragmatic, although there is variability across PRECIS-2 dimensions.Discussion The primary effectiveness outcome is medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data. Implementation outcomes are assessed using the RE-AIM framework, with particular focus on reach, consistency of implementation, adaptations, cost, and maintenance/sustainability. The project has limitations including limited power to detect some subgroup effects, medication complications (bleeding) and longer-term outcomes (myocardial infarction). Strengths of the study include the diverse health care systems, a feasible and generalizable intervention, transparent reporting using established pragmatic research and implementation science frameworks, strong stakeholder engagement and planning for dissemination and sustainment.Trial registration The study was funded by the NIH grant number is 4UH3HL144163-02 issued 4/5/19. The Clinicaltrial.gov identifier number is NCT03973931 which was registered on 6/4/2019. URL: https://clinicaltrials.gov/ct2/show/NCT03973931

Health information technology (HIT) has not been broadly adopted for use in outpatient healthcare settings to effectively address obesity in youth, especially among disadvantaged populations that face greater barriers to good health. A well-designed HIT tool can deliver behavior change recommendations and provide community resources to address this gap, and the Obesity-Related Behavioral Intervention Trials (ORBIT) model can guide its development and refinement. This article reports the application of the ORBIT model to (1) describe the characteristics and design of a novel HIT tool (the PREVENT tool) using behavioral theory, (2) illustrate the use of stakeholder-centered “designing for dissemination and sustainability” principles, and (3) discuss the practical implications and directions for future research. Two types of stakeholder engagement (customer discovery and user testing) were conducted with end users (outpatient healthcare teams). Customer discovery interviews (n = 20) informed PREVENT tool components and intervention targets by identifying (1) what healthcare teams (e.g., physicians, dietitians) identified as their most important “jobs to be done” in helping adolescents who are overweight/obese adopt healthy behaviors, (2) their most critical “pains” and “gains” related to overweight/obesity treatment, and (3) how they define success compared to competing alternatives. Interviews revealed the need for a tool to help healthcare teams efficiently deliver tailored, evidence-based behavior change recommendations, motivate patients, and follow-up with patients within the constraints of clinic schedules and workflows. The PREVENT tool was developed to meet these needs. It facilitates prevention discussions, delivers tailored, evidence-based recommendations for physical activity and food intake, includes an interactive map of community resources to support behavior change, and automates patient follow-up. Based on Self-Determination Theory, the PREVENT tool engages the patient to encourage competence and autonomy to motivate behavior change. The use of this intentional, user-centered design process should increase the likelihood of the intended outcomes (e.g., behavior change, weight stabilization/loss) and ultimately increase uptake, implementation success, and long-term results. After initial tool development, user-testing interviews (n = 13) were conducted using a think-aloud protocol that provided insight into users' (i.e., healthcare teams) cognitive processes, attitudes, and challenges when using the tool. Overall, the PREVENT tool was perceived to be useful, well-organized, and visually appealing.

Background The left ventricular assist device (LVAD) has become a common medical option for patients with end-stage heart failure. Although patients’ chances of survival may increase with an LVAD compared with medical therapy, the LVAD poses many risks and requires major lifestyle changes, thus making it a complex medical decision. Our prior work found that a decision aid for LVADs significantly increased decision quality for both patients and caregivers and was successfully implemented at 6 LVAD programs. Methods In follow-up, we are conducting a nationwide dissemination and implementation project, with the goal of implementing the decision aid at as many of the 176 LVAD programs in the United States as possible. Guided by the Theory of Diffusion of Innovations, the project consists of 4 phases: (1) building a network; (2) promoting adoption; (3) supporting implementation; and (4) encouraging maintenance. Developing an LVAD network of contacts occurs by using a national baseline survey of LVAD clinicians, existing professional relationships, and an internet-based strategy. A suite of resources targeted to promote adoption and support implementation of the decision aid into standard LVAD education processes are provided to the network. Evaluation is guided by the Reach, Effectiveness, Adoption, Implementation, Maintenance framework, where clinician and patient surveys and qualitative interviews determine the reach, effectiveness, adoption, implementation, and maintenance achieved. Conclusions This project is a true dissemination study in that it targets the entire population of LVAD programs in the United States and is unique in its use of social marketing principles to promote adoption and implementation. The implementation plan is intended to serve as a test case and model for dissemination and implementation of other evidence-based decision support aids and strategies.

This report describes how stakeholder groups informed a web-based care planning tool’s development for addressing root causes of poor health. Stakeholders included community members (n = 6), researchers (n = 6), community care providers (n = 9), and patients (n = 17). Feedback was solicited through focus groups, semi-structured interviews, and user experience observations and then qualitatively analyzed to identify themes. Each group contributed a unique perspective. Researchers wanted evidence-based content; community members and providers focused on making goals manageable; patients wanted care team support and simple action-oriented language. Our findings highlight the benefits of stakeholder input. Blending perspectives from multiple groups results in a more robust intervention design.

Background: Little is known about practices used to disseminate findings to non-research, practitioner audiences. This study describes the perspectives, experience and activities of dissemination & implementation (D&I) scientists around disseminating their research findings. Methods: The study explored D&I scientists’ experiences and recommendations for assessment of dissemination activities to non-research audiences. Existing list serves were used to recruit scientists. Respondents were asked three open-ended questions on an Internet survey about dissemination activities, recommendations for changing evaluation systems and suggestions to improve their own dissemination of their work. Results: Surveys were completed by 159 scientists reporting some training, funding and/or publication history in D&I. Three themes emerged across each of the three open-ended questions. Question 1 on evaluation generated the themes of: 1a) promotional review; 1b) funding requirements and 1c) lack of acknowledgement of dissemination activities. Question 2 on recommended changes generated the themes of: 2a) dissemination as a requirement of the academic promotion process; 2b) requirement of dissemination plan and 2c) dissemination metrics. Question 3 on personal changes to improve dissemination generated the themes of: 3a) allocation of resources for dissemination activities; 3b) emerging dissemination channels and 3c) identify and address issues of priority for stakeholders. Conclusions: Our findings revealed different types of issues D&I scientists encounter when disseminating findings to clinical, public health or policy audiences and their suggestions to improve the process. Future research should consider key requirements which determine academic promotion and grant funding as an opportunity to expand dissemination efforts.

BackgroundNearly half of patients do not take their cardiovascular medications as prescribed, resulting in increased morbidity, mortality, and healthcare costs. Mobile and digital technologies for health promotion and disease self-management offer an opportunity to adapt behavioral “nudges” using ubiquitous mobile phone technology to facilitate medication adherence. The Nudge pragmatic clinical trial uses population-level pharmacy data to deliver nudges via mobile phone text messaging and an artificial intelligent interactive chat bot with the goal of improving medication adherence and patient outcomes in three integrated healthcare delivery systems.MethodsThe Theory of mHealth, the Expanded RE-AIM/PRISM, and the PRECIS-2 frameworks were used for program planning, implementation, and evaluation, along with a focus on dissemination and cost considerations. During the planning phase, the Nudge study team developed and piloted a technology-based nudge message and chat bot of optimized interactive content libraries for a range of diverse patients. Inclusion criteria are very broad and include patients in one of three diverse health systems who take medications to treat hypertension, atrial fibrillation, coronary artery disease, diabetes, or hyperlipidemia. A target of approximately 10,000 participants will be randomized to one of 4 study arms: usual care (no intervention), generic nudge (text reminder), optimized nudge, and optimized nudge plus interactive AI chat bot. The PRECIS-2 tool indicated that the study protocol is very pragmatic, although there is variability across PRECIS-2 dimensions.DiscussionThe primary effectiveness outcome is medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data. Implementation outcomes are assessed using the RE-AIM framework, with a particular focus on reach, consistency of implementation, adaptations, cost, and maintenance/sustainability. The project has limitations including limited power to detect some subgroup effects, medication complications (bleeding), and longer-term outcomes (myocardial infarction). Strengths of the study include the diverse healthcare systems, a feasible and generalizable intervention, transparent reporting using established pragmatic research and implementation science frameworks, strong stakeholder engagement, and planning for dissemination and sustainment.Trial registrationClinicalTrials.govNCT03973931. Registered on 4 June 2019. The study was funded by the NIH; grant number is 4UH3HL144163-02 issued 4/5/19.

Background Uncontrolled hypertension represents a substantial and growing burden in Guatemala and other low and middle-income countries. As a part of the formative phase of an implementation research study, we conducted a needs assessment to define short- and long-term needs and opportunities for hypertension services within the public health system. Methods We conducted a multi-method, multi-level assessment of needs related to hypertension within Guatemala’s public system using the World Health Organization’s health system building blocks framework. We conducted semi-structured interviews with stakeholders at national (n = 17), departmental (n = 7), district (n = 25), and community (n = 30) levels and focus groups with patients (3) and frontline auxiliary nurses (3). We visited and captured data about infrastructure, accessibility, human resources, reporting, medications and supplies at 124 health posts and 53 health centers in five departments of Guatemala. We conducted a thematic analysis of transcribed interviews and focus group discussions supported by matrix analysis. We summarized quantitative data observed during visits to health posts and centers. Results Major challenges for hypertension service delivery included: gaps in infrastructure, insufficient staffing and high turnover, limited training, inconsistent supply of medications, lack of reporting, low prioritization of hypertension, and a low level of funding in the public health system overall. Key opportunities included: prior experience caring for patients with chronic conditions, eagerness from providers to learn, and interest from patients to be involved in managing their health. The 5 departments differ in population served per health facility, accessibility, and staffing. All but 7 health posts had basic infrastructure in place. Enalapril was available in 74% of health posts whereas hydrochlorothiazide was available in only 1 of the 124 health posts. With the exception of one department, over 90% of health posts had a blood pressure monitor. Conclusions This multi-level multi-method needs assessment using the building blocks framework highlights contextual factors in Guatemala’s public health system that have been important in informing the implementation of a hypertension control trial. Long-term needs that are not addressed within the scope of this study will be important to address to enable sustained implementation and scale-up of the hypertension control approach.

Background Clinical decision support (CDS) design best practices are intended to provide a narrative representation of factors that influence the success of CDS tools. However, they provide incomplete direction on evidence-based implementation principles. Objective This study aims to describe an integrated approach toward applying an existing implementation science (IS) framework with CDS design best practices to improve the effectiveness, sustainability, and reproducibility of CDS implementations. Methods We selected the Practical Robust Implementation and Sustainability Model (PRISM) IS framework. We identified areas where PRISM and CDS design best practices complemented each other and defined methods to address each. Lessons learned from applying these methods were then used to further refine the integrated approach. Results Our integrated approach to applying PRISM with CDS design best practices consists of 5 key phases that iteratively interact and inform each other: multilevel stakeholder engagement, designing the CDS, design and usability testing, thoughtful deployment, and performance evaluation and maintenance. The approach is led by a dedicated implementation team that includes clinical informatics and analyst builder expertise. Conclusions Integrating PRISM with CDS design best practices extends user-centered design and accounts for the multilevel, interacting, and dynamic factors that influence CDS implementation in health care. Integrating PRISM with CDS design best practices synthesizes the many known contextual factors that can influence the success of CDS tools, thereby enhancing the reproducibility and sustainability of CDS implementations. Others can adapt this approach to their situation to maximize and sustain CDS implementation success.

Background: Nearly half of patients do not take their cardiovascular medications as prescribed, resulting in increased morbidity, mortality, and healthcare costs. Mobile and digital technologies for health promotion and disease self-management offer an opportunity to adapt behavioral “nudges” using ubiquitous mobile phone technology to facilitate medication adherence. The Nudge pragmatic clinical trial uses population-level pharmacy data to deliver nudges via mobile phone text messaging and an artificial intelligent interactive chat bot with the goal of improving medication adherence and patient outcomes in three integrated healthcare delivery systems. Methods: The Theory of mHealth, the Expanded RE-AIM/PRISM, and the PRECIS-2 frameworks were used for program planning, implementation and evaluation, along with a focus on dissemination and cost considerations. During the planning phase, the Nudge study team developed and piloted a technology-based nudge message and chat bot of optimized interactive content libraries for a range of diverse patients. Inclusion criteria are very broad and include patients in one of three diverse health systems who take medications to treat hypertension, atrial fibrillation, coronary artery disease, diabetes, or hyperlipidemia. A target of approximately 10,000 participants will be randomized to one of 4 study arms: usual care (no intervention), generic nudge (text reminder), optimized nudge, and optimized nudge plus interactive AI chat bot. The PRECIS-2 tool indicated that the study protocol is very pragmatic, although there is variability across PRECIS-2 dimensions. Discussion: The primary effectiveness outcome is medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data. Implementation outcomes are assessed using the RE-AIM framework, with particular focus on reach, consistency of implementation, adaptations, cost, and maintenance/sustainability. The project has limitations including limited power to detect some subgroup effects, medication complications (bleeding) and longer-term outcomes (myocardial infarction). Strengths of the study include the diverse health care systems, a feasible and generalizable intervention, transparent reporting using established pragmatic research and implementation science frameworks, strong stakeholder engagement and planning for dissemination and sustainment. Trial registration: The study was funded by the NIH grant number is 4UH3HL144163-02 issued 4/5/19. The Clinicaltrial.gov identifier number is NCT03973931 which was registered on 6/4/2019. URL: https://clinicaltrials.gov/ct2/show/NCT03973931

Evidence-based program repositories (EBPR) report intervention characteristics and how to implement the intervention. These EBPR are a dissemination strategy to address questions such as, “I have cancer, what programs can I join?” or “What evidence-based programs for weight loss are a good fit for my community?” However, these EBPR fall short of realizing their potential and are not seen as particularly interactive, robust, or relevant to stakeholders who may benefit from their content. We propose 2 solutions for existing EBPR to enhance dissemination of evidence-based information. Addressing this critical dissemination need is one strategy for health promotion.

Introduction: Elective percutaneous coronary intervention (PCI) for stable angina is intended to reduce symptoms and enhance quality of life. However, measures of patient-reported health status are not yet routinely collected or used. Methods: We developed a telephonic interactive voice response (IVR) system to capture patient-reported health status measures before and after PCI in the Veterans Affairs (VA) Health Care System. The IVR system calls patients to collect Seattle Angina Questionnaire 7 and Rose Dyspnea questionnaire data 1 month prior to PCI and 1 and 6 months after PCI. Reports are provided to primary care and cardiology providers for patients who experience a significant change in health status. We performed a multi-method, interim analysis of sequential roll-out of the IVR system at 6 VA centers, including quantitative process data; semi-structured interviews with 13 patients; and chart review of all patients who experienced a decrement in health status. Results: Of 2,113 patients undergoing elective PCI from November 28, 2015, until September 31, 2019, health status data were collected from 692 (32.7%) prior to PCI, 457 (66.0%) 1 month after PCI, and 59 (8.5%) 6 months after PCI ( Figure 1 ). A total of 83 (18.0%) decrements in health status occurred. In response, 10 (12.0%) clinical actions were recorded in the medical record: 4 (4.8%) patients were called by providers, 2 (2.4%) had their medication regimen reviewed, 3 (3.6%) had their case reviewed by their primary care provider and/or an interventional cardiologist, and an outpatient clinic visit was scheduled earlier than planned for 1 (1.2%) patient. Many patients did not remember receiving a telephone call; others were “fine” with receiving a call and filling out a survey. Some expressed difficulty with completing the survey owing to a lack of technical literacy or difficulty with hearing. Some patients were reassured by a telephone call, saying “That’s good, because it lets me know that I haven’t slipped through the cracks. It builds confidence that they know how I’m feeling before a procedure.” Conclusions: It is feasible to capture patient-reported measures of health status in the real world and integrate their use into routine clinical care. Opportunities to improve the collection and use of patient-reported health status measures persist.

Shared decision making (SDM) facilitates delivery of medical therapies that are in alignment with patients' goals and values. Medicare national coverage decision for several interventions now includes SDM mandates, but few have been evaluated in nationwide studies. Based upon a detailed needs assessment with diverse stakeholders, we developed pamphlet and video patient decision aids (PtDAs) for implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation to help patients contemplate, forecast, and deliberate their options. These PtDAs are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients Offered Implantable Cardioverter-Defibrillators (DECIDE-ICD), a multicenter, randomized trial sponsored by the National Heart, Lung, and Blood Institute aimed at understanding the effectiveness and implementation of an SDM support intervention for patients considering ICDs. Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points. METHODS/DESIGN: A stepped-wedge randomized controlled trial was designed, guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) planning and evaluation framework using an effectiveness-implementation hybrid type II design. Six electrophysiology programs from across the United States will participate. The primary effectiveness outcome is decision quality (defined by knowledge and values-treatment concordance). Patients with heart failure who are clinically eligible for an ICD are eligible for the study. Target enrollment is 900 participants. DISCUSSION: Study findings will provide a foundation for implementing decision support interventions, including PtDAs, with patients who have chronic progressive illness and are facing decisions involving invasive, preference-sensitive therapy options.

A dramatically increased interest in dissemination and implementation (D&I) science, with relatively few training programs for D&I scientists, highlights the need for innovative ways to deliver educational materials, training, and resources. We described nine interactive, web-based D&I science resources appropriate for trainees and Clinical and Translational Science Awards. We used audience feedback and design thinking to develop resources iteratively. Primary target users are T3–T4 researchers, although T2 researchers can benefit from “designing for dissemination” resources. Workforce development resources were used in D&I science workshops, as stand-alone, self-directed resources, and for consultations and trainings. We assessed resource design (purpose, functionality), usage, user experience and engagement. Educational resources addressed included: D&I science basics, pragmatic trials, getting proposals funded, designing for dissemination, and D&I science theory selection. We reviewed the purpose, functionality, status, and usage of these interactive resources. All resources engaged users; provided interactive feedback for learners; and linked users to additional learning resources. Online resources can be valuable for preparing clinical and translational mentees for research consultations, as follow-up training activities, and as D&I workforce development resources. The resources described are publicly available and we encourage their use, further development, and evaluation by Clinical and Translational Science Awards and other programs.

Dissemination and Implementation Science (DIS) is a growing research field that seeks to inform how evidence-based interventions can be successfully adopted, implemented, and maintained in health care delivery and community settings. In this article, an overview of DIS and how it has contributed to primary care delivery improvement, future opportunities for its use, and DIS resources for learning are described. Case examples are provided to illustrate how DIS can be used to solve the complex implementation and dissemination problems that emerge in primary care. Finally, recommendations are made to guide the use of DIS to inform and drive improvements in primary care delivery.

Cost and other resources required are often primary considerations in whether a potential program or policy will be adopted or implemented and an important element in determining value. However, few economic analyses are conducted from the perspective of patient/family or small-scale stakeholders such as local clinics. We outline and discuss alternative cost assessment and resource expenditures options from the perspective of these small, proximal stakeholders. The perspective of these persons differs from larger societal or health plan perspectives, and often differs across individuals in terms of what they value and the types of expenditures about which they are concerned. We discuss key features of the perspectives of patients, health care clinics, and local leaders, and present brief examples and sample templates for collection of consumer/stakeholder relevant cost and return on investment issues. These tools can be used prospectively and iteratively during program planning, intervention delivery, summative analysis, and preparation for dissemination stages. There is an important need for this type of feasible, pragmatic, rapid, and iterative cost and resource expenditure analysis directly relevant to patients/families, small local stakeholders and their organizations. Future research on and use of these approaches is recommended.

Background There have been over 430 publications using the RE-AIM model for planning and evaluation of health programs and policies, as well as numerous applications of the model in grant proposals and national programs. Full use of the model includes use of qualitative methods to understand why and how results were obtained on different RE-AIM dimensions, however, recent reviews have revealed that qualitative methods have been used infrequently. Having quantitative and qualitative methods and results iteratively inform each other should enhance understanding and lessons learned. Methods Because there have been few published examples of qualitative approaches and methods using RE-AIM for planning or assessment and no guidance on how qualitative approaches can inform these processes, we provide guidance on qualitative methods to address the RE-AIM model and its various dimensions. The intended audience is researchers interested in applying RE-AIM or similar implementation models, but the methods discussed should also be relevant to those in community or clinical settings. Results We present directions for, examples of, and guidance on how qualitative methods can be used to address each of the five RE-AIM dimensions. Formative qualitative methods can be helpful in planning interventions and designing for dissemination. Summative qualitative methods are useful when used in an iterative, mixed methods approach for understanding how and why different patterns of results occur. Conclusions In summary, qualitative and mixed methods approaches to RE-AIM help understand complex situations and results, why and how outcomes were obtained, and contextual factors not easily assessed using quantitative measures.

Although regular physical activity (PA) is a cornerstone of treatment for type 2 diabetes (T2D), most adults with T2D are sedentary. Randomized controlled trials (RCTs) have proven the effectiveness of PA behavioral interventions for adults with T2D but have rarely been conducted in healthcare settings. We sought to identify PA interventions that are effective and practical to implement in clinical practice settings. Our first aim was to use the valid Pragmatic-Explanatory Continuum Indicator Summary 2 (PRECIS-2) tool to assess the potential for future implementation of PA interventions in clinical practice settings. Our second aim was to identify interventions that effectively increased PA and glycemic control among the interventions in the top tertile of PRECIS-2 scores. We searched PubMed MEDLINE from January 1980 through May 2015 for RCTs of behavioral PA interventions coordinated by clinical practices for patients with T2D. Dual investigators assessed pragmatism by PRECIS-2 scores, and study effectiveness was extracted from original RCT publications. The PRECIS-2 scores of the 46 behavioral interventions (n = 13,575 participants) ranged from 3.0 to 4.8, where 5 is the most pragmatic score. In the most pragmatic tertile of interventions (n = 16) by PRECIS-2 scores, 30.8 and 31.3% of interventions improved PA outcomes and hemoglobin A1c, respectively. A minority of published evidence-based PA interventions for adults with T2D were both effective and pragmatic for clinical implementation. These should be tested for dissemination using implementation trial designs.

Precision health and big data approaches have great potential, yet such benefits will be realized only when social and behavioral determinants of health and patient preferences are combined with genomic information. Literature review and co-author experiences informed this commentary. Validated health behavior, mental health, and patient preference measures were collected and summarized in real time. Integration of such data into existing data sets will advance precision health, patient-centered care, research, and policy.

Background Prehospital (ambulance) care can reduce morbidity and mortality from trauma. Yet, there is a dearth of effective evidence-based interventions and implementation strategies. Emergency Medical Services Traumatic Shock Care (EMS-TruShoC) is a novel bundle of five core evidence-based trauma care interventions. High-Efficiency EMS Training (HEET) is an innovative training and sensitization program conducted during clinical shifts in ambulances. We assess the feasibility of implementing EMS-TruShoC using the HEET strategy, and feasibility of assessing implementation and clinical outcomes. Findings will inform a main trial. Methods We conducted a single-site, prospective cohort, multi-methods pilot implementation study in Western Cape EMS system of South Africa. Of the 120 providers at the study site, 12 were trainers and the remaining were eligible learners. Feasibility of implementation was guided by the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. Feasibility of assessing clinical outcomes was assessed using shock indices and clinical quality of care scores, collected via abstraction of patients’ prehospital trauma charts. Thresholds for progression to a main trial were developed a priori. Results The average of all implementation indices was 83% (standard deviation = 10.3). Reach of the HEET program was high, with 84% learners completing at least 75% of training modules. Comparing the proportion of learners attaining perfect scores in post- versus pre-implementation assessments, there was an 8-fold (52% vs. 6%) improvement in knowledge, 3-fold (39% vs. 12%) improvement in skills, and 2-fold (42% vs. 21%) increase in self-efficacy. Clinical outcomes data were successfully calculated—there were clinically significant improvements in shock indices and quality of prehospital trauma care in the post- versus pre-implementation phases. Adoption of HEET was good, evidenced by 83% of facilitator participation in trainings, and 100% of surveyed stakeholders indicating good programmatic fit for their organization. Stakeholders responded that HEET was a sustainable educational solution that aligned well with their organization. Implementation fidelity was very high; 90% of the HEET intervention and 77% of the implementation strategy were delivered as originally planned. Participants provided very positive feedback, and explained that on-the-job timing enhanced their participation. Maintenance was not relevant to assess in this pilot study. Conclusions We successfully implemented the EMS-TruShoC educational intervention using the HEET training strategy in a single-site pilot study conducted in a low-resource international setting. All clinical outcomes were successfully calculated. Overall, this pilot study suggests high feasibility of our future, planned experimental trial.

Introduction Patients who use tobacco are too rarely connected with tobacco use treatment during healthcare visits. Electronic health record enhancements may increase such referrals in primary care settings. This project used the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework to assess the implementation of a healthcare system change carried out in an externally valid manner (executed by the healthcare system). Methods The healthcare system used their standard, computer-based training approach to implement the electronic health record and clinic workflow changes for electronic referral in 30 primary care clinics that previously used faxed quitline referral. Electronic health record data captured rates of assessment of readiness to quit and quitline referral 4 months before implementation and 8 months (May–December 2017) after implementation. Data, analyzed from October 2018 to June 2019, also reflected intervention reach, adoption, and maintenance. Results For reach and effectiveness, from before to after implementation for electronic referral, among adult patients who smoked, assessment of readiness to quit increased from 24.8% (2,126 of 8,569) to 93.2% (11,163 of 11,977), quitline referrals increased from 1.7% (143 of 8,569) to 11.3% (1,351 of 11,977), and 3.6% were connected with the quitline after implementation. For representativeness of reach, electronic referral rates were especially high for women, African Americans, and Medicaid patients. For adoption, 52.6% of staff who roomed at least 1 patient who smoked referred to the quitline. For maintenance, electronic referral rates fell by approximately 60% over 8 months but remained higher than pre-implementation rates. Conclusions Real-world implementation of an electronic health record–based electronic referral system markedly increased readiness to quit assessment and quitline referral rates in primary care patients. Future research should focus on implementation methods that produce more consistent implementation and better maintenance of electronic referral.

Policy Points Fundamental changes are needed in how complex chronic illness conditions are conceptualized and managed. Health management plans for chronic illness need to be integrated, adaptive, contextual, technology aided, patient driven, and designed to address the multilevel social environment of patients' lives. Such primary care-based health management plans are feasible today but will be even more effective and sustainable if supported by systems thinking, technological advances, and policies that create and reinforce home, work, and health care collaborations. Context The current health care system is failing patients with chronic illness, especially those with complex comorbid conditions and social determinants of health challenges. The current system combined with unsustainable health care costs, lack of support for primary care in the United States, and aging demographics create a frightening probable future. Methods Recent developments, including integrated behavioral health, community resources to address social determinants, population health infrastructure, patient-centered digital-health self-management support, and complexity science have the potential to help address these alarming trends. This article describes, first, the opportunity to integrate these trends and, second, a proposal for an integrated, patient-directed, adaptive, contextual, and technology-aided support (ACTS) system, based on a patient's life context and home/primary care/work-setting "support triangle." Findings None of these encouraging trends is a panacea, and although most have been described previously, they have not been integrated. Here we discuss an example of integration using these components and how our proposed model (termed My Own Health Report) can be applied, along with its strengths, limitations, implications, and opportunities for practice, policy, and research. Conclusions This ACTS system builds on and extends the current chronic illness management approaches. It is feasible today and can produce even more dramatic improvements in the future.

There is growing interest from multiple specialties, including internal medicine, to incorporate diagnostic point of care ultrasound (POCUS) into standard clinical care. However, few internists currently use POCUS. The objective of this study was to understand the current determinants of POCUS adoption at both the health system and clinician level at a U.S. academic medical center from the perspective of multi-level stakeholders. We performed semi-structured interviews of multi-level stakeholders including hospitalists, subspecialists, and hospital leaders at an academic medical center in the U.S. Questions regarding the determinants of POCUS adoption were asked of study participants. Using the framework method, team-based analysis of interview transcripts were guided by the contextual domains of the Practical Robust Implementation and Sustainability Model (PRISM). Thirty-one stakeholders with diverse roles in POCUS adoption were interviewed. Analysis of interviews revealed three overarching themes that stakeholders considered important to adoption by clinicians and health systems: clinical impact, efficiency and cost. Subthemes included two that were deemed essential to high-fidelity implementation: the development of credentialing policies and robust quality assurance processes. These findings identify potential determinants of system and clinician level adoption that may be leveraged to achieve high-fidelity implementation of POCUS applications that result in improved patient outcomes.

Background While health systems are striving for patient-centered care, they have little evidence to guide them on how to engage patients in their care, or how this may affect patient experiences and outcomes. Objective To explore which specific patient-centered aspects of care were best associated with depression improvement and care satisfaction. Methods Design: observational. Setting 83 primary care clinics across Minnesota. Subjects Primary care patients with new prescriptions for antidepressants for depression were recruited from 2007 to 2009. Outcome measures Patients completed phone surveys regarding demographics and self-rated health status and depression severity at baseline and 6 months. Patient centeredness was assessed via a modified version of the Patient Assessment of Chronic Illness Care. Differences in rates of remission and satisfaction between positive and negative responses for each care process were evaluated using chi-square tests. Results At 6 months, 37% of 792 patients ages 18-88 achieved depression remission, and 79% rated their care as good-to-excellent. Soliciting patient preferences for care and questions or concerns, providing treatment plans, utilizing depression scales and asking about suicide risk were patient-centered measures that were positively associated with depression remission in the unadjusted model; these associations were mildly weakened after adjustment for depression severity and health status. Nearly all measures of patient centeredness were positively associated with care ratings. Conclusion The patient centeredness of care influences how patients experience and rate their care. This study identified specific actions providers can take to improve patient satisfaction and depression outcomes.

Purpose: To examine if employee health literacy (HL) status moderated reach, retention, and weight outcomes in a worksite weight loss program. Design: The study was a two-group cluster randomized controlled weight loss trial. Setting: The study was conducted in 28 worksites. Subjects: Subjects comprised 1460 employees with a body mass index >25 kg/m2. Interventions: Two 12-month weight loss interventions targeted diet and physical activity behaviors: incentaHEALTH (INCENT; incentivized individually targeted Internet-based intervention) and Livin’ My Weigh (LMW; less-intense quarterly newsletters). Measures: A validated three-item HL screening measure was self-completed at baseline. Weight was objectively assessed with the Health Spot scale at baseline and 12-month follow-up. Analysis: The impact of HL on program effectiveness was assessed through fixed-effect parametric models that controlled for individual (i.e., age, gender, race, ethnicity, income, education) and worksite random effects. Results: Enrolled employees had significantly higher HL status [13.54 (1.68)] as compared to unenrolled [13.04 (2.17)] ( p < .001). This finding was consistent in both interventions. Also, HL moderated weight loss effects ( beta = .66; SE = 027; p = .014) and losing >5% weight ( beta = −1.53; SE = .77; p < .047). For those with lower baseline HL, the INCENT intervention produced greater weight loss outcomes compared to LMW. The HL level of employees retained was not significantly different from those lost to follow-up. Conclusion: HL influences reach and moderates weight effects. These findings underscore the need to integrate recruitment strategies and further evaluate programmatic approaches that attend to the needs of low-HL audiences.

IntroductionVaccination against influenza and pertussis in pregnancy offers a ‘two-for-one’ opportunity to protect mother and child. Pregnant patients have increased risk of severe disease from influenza and newborns have increased risk of severe disease from both influenza and pertussis. Obstetricians need communication tools to support their self-efficacy and effectiveness in communicating the importance of immunisation during pregnancy and ultimately improving maternal vaccination rates.Methods and analysisWe describe the protocol for a pragmatic study testing the feasibility and potential impact of a clinician communication strategy on maternal vaccination uptake. This study will be conducted in five prenatal care settings in Colorado, USA. The Motivational Interviewing for Maternal Immunisation strategy involves training prenatal care providers to use motivational interviewing in the vaccine conversation with pregnant patients. Our primary outcomes will be the adoption and implementation of the intervention measured using the Enhanced RE-AIM/Practical Robust Implementation and Sustainability Model for dissemination and implementation. Secondary outcomes will include provider time spent, fidelity to Motivational Interviewing and self-efficacy measured through audio recorded visits and provider surveys, patients’ visit experience based on audio recorded visits and follow-up interviews, and maternal vaccine uptake as measured through chart reviews.Ethics and disseminationThis study is approved by the following institutional review boards: Colorado Multiple Institutional Review Board. Results will be disseminated through peer-reviewed manuscripts and conference presentations.Trial registration numberNCT04302675.

Shared decision making (SDM) is not widely practiced in routine care due to a variety of organizational, provider, patient, and contextual factors. This article explores how implementation science—which encourages attention to the multilevel contextual factors that influence the adoption, implementation, and sustainment of health care practices—can provide useful insights for increasing SDM use in routine practice. We engaged with stakeholders representing different organizations and geographic locations over three phases: 1) multidisciplinary workgroup meeting comprising researchers and clinicians ( n = 11); 2) survey among a purposive sample of 47 patient advocates, clinicians, health care system leaders, funders, policymakers, and researchers; and 3) working session among diverse stakeholders ( n = 30). The workgroup meeting identified priorities for action and research, which included targeting multiple audiences and levels, shifting culture toward valuing and supporting SDM, and considering contextual factors influencing SDM implementation. Survey respondents provided recommendations for increasing adoption, implementation, and maintenance of SDM in practice including providing tools to support SDM, obtaining stakeholders’ involvement, and raising awareness of the importance of SDM. Stakeholders in the working session provided recommendations on the design of a guide for implementation of SDM in clinical settings, strategies to disseminate educational curricula on SDM, and strategies to influence policies to increase SDM use. These specific recommendations serve as a call to action to pursuing specific promising strategies aimed at increasing SDM use in practice and enhance understanding of the perspectives of diverse stakeholders at multiple levels from an implementation science perspective that appear fruitful for further study and application.

Physical activity (PA) is a cornerstone of treatment for type 2 diabetes mellitus (T2D). Among other benefits, regular PA improves physical function which can prevent institutionalization. However, effective PA interventions are not widely adopted in primary care. Our recent systematic review identified an effective PA intervention for adults with T2D that was nearly pragmatic enough for use in primary care. However, it still required adaptation to fit clinic work flows and to be reimbursed by insurance. After adapting the intervention (Be ACTIVE) to address these issues, we hypothesized Be ACTIVE would improve PA and physical function relative to randomized controls. This pragmatic pilot trial randomized adults with T2D to 12 weeks of Be ACTIVE (6 telephone behavioral counseling sessions + PA tracking (FitBit©); 3 primary care visits to teach strength exercises + monitor safety) vs. enhanced usual care (3 self-management mailings). At baseline and post-intervention, we assessed PA with Actigraph© accelerometers (steps/week) and physical function by a timed 400-meter walk (sec) and the Short Physical Performance Battery (SPPB, 0-12 scale). To date, we have completed assessments for 15 participants (n=8 Be ACTIVE, n=7 controls). Pre-post PA increased by 19.8% in the Be ACTIVE group (+5122 ± 10steps/week; data shown as mean ± SE) and decreased by 15.9% in controls (-3122 ± 1233 steps/week). SPPB scores increased by a clinically important >1-point difference in the Be ACTIVE group (+1.1 ± 0.2), and were stable in controls (+0.3 ± 0.1). The 400-meter walk time improved by 10.3% in Be ACTIVE participants (-38.3 ± 6.6 sec) and declined by 5.4% in controls (+17.3 ± 6.4 sec). Be ACTIVE is a reimbursable intervention delivered by primary care staff. Strong pilot data support that Be ACTIVE improves PA/physical function. If our data remain promising at trial completion, the next step towards broader dissemination will be to test Be ACTIVE in multiple clinical settings. Disclosure A.G. Huebschmann: Research Support; Self; Merck &Co., Inc..I.M. Leavitt: None.R. Glasgow: None.J.G. Regensteiner: None.A.L. Dunn: None.

Background Many health outcomes and implementation science studies have demonstrated the importance of tailoring evidence-based care interventions to local context to improve fit. By adapting to local culture, history, resources, characteristics, and priorities, interventions are more likely to lead to improved outcomes. However, it is unclear how best to adapt evidence-based programs and promising innovations. There are few guides or examples of how to best categorize or assess healthcare adaptations, and even fewer that are brief and practical for use by non-researchers. Materials and methods This paper describes the importance and potential of assessing adaptations before, during, and after the implementation of health systems interventions. We present a promising multi-level and multi-method approach developed and being applied across four different health systems interventions. Finally, we discuss implications and opportunities for future research. Results The four case studies are diverse in the conditions addressed, interventions, and implementation strategies. They include two nurse coordinator-based transition of care interventions, a data and training-driven multimodal pain management project, and a cardiovascular patient-reported outcomes project, all of which are using audit and feedback. We used the same modified adaptation framework to document changes made to the interventions and implementation strategies. To create the modified framework, we started with the adaptation and modification model developed by Stirman and colleagues and expanded it by adding concepts from the RE-AIM framework. Our assessments address the intuitive domains of Who, How, When, What, and Why to classify and organize adaptations. For each case study, we discuss how the modified framework was operationalized, the multiple methods used to collect data, results to date and approaches utilized for data analysis. These methods include a real-time tracking system and structured interviews at key times during the intervention. We provide descriptive data on the types and categories of adaptations made and discuss lessons learned. Conclusions The multi-method approaches demonstrate utility across diverse health systems interventions. The modified adaptations model adequately captures adaptations across the various projects and content areas. We recommend systematic documentation of adaptations in future clinical and public health research, and have made our assessment materials publicly available.

The RE-AIM Framework is a planning and evaluation model that has been used in a variety of settings to address various programmatic, environmental, and policy innovations for improving population health. In addition to the broad application and diverse use of the framework, there are lessons learned and recommendations for the future use of the framework across clinical, community, and corporate settings. The purposes of this article are to: (A) provide a brief overview of the RE-AIM Framework and its pragmatic use for planning and evaluation; (B) offer recommendations to facilitate the application of RE-AIM in clinical, community, and corporate settings; and (C) share perspectives and lessons learned about employing RE-AIM dimensions in the planning, implementation, and evaluation phases within these different settings. In this article, we demonstrate how the RE-AIM concepts and elements within each dimension can be applied by researchers and practitioners in diverse settings, among diverse populations and for diverse health topics. ACL SUSTAIN for Better Health and Health Care for Older Adults [90CS0065-01]; Great Plains IDEA CTR [U54 GM115458-01]; IMPlementation to Achieve Clinical Transformation (IMPACT): the Colorado Training Program from the NIH [K12 HL137862] The authors would like to acknowledge all members of the National Working Group on RE-AIM Planning and Evaluation Framework (www.re-aim.org). The authors would also like to acknowledge funding support for author contributions: MO and MS contributions supported through ACL SUSTAIN for Better Health and Health Care for Older Adults 90CS0065-01. PE contributions supported by Great Plains IDEA CTR U54 GM115458-01. RE contributions partially supported by IMPlementation to Achieve Clinical Transformation (IMPACT): the Colorado Training Program from the NIH K12 HL137862.

The RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) planning and evaluation framework has been applied broadly, but users often have difficulty in applying the model because of data collection needs across multiple domains and sources. Questions in the more common “who, what, where, how, when, and why” format may be an effective guide to ensure that individual participants, organization staff, and the perspectives of the setting are considered in planning and evaluation. Such a format can also help users in typical community and clinical settings to identify which outcomes are most valued and to focus limited measurement resources. Translations of RE-AIM that are easy to understand and apply are needed for application in real-world community and clinical settings where research and evaluation resources are limited. The purpose of this article is to provide simplified, pragmatic, user-centered and stakeholder-centered recommendations to increase the use of RE-AIM in community and clinical settings and in translational research.

Background: The United States spends significantly more money on healthcare per capita than any other country. However, health outcomes in the United States tend to be poorer than for other wealthy countries. Among a number of contributors to this imbalance, the United States uses many expensive services that may not affect health outcomes. The science of dissemination and implementation emphasizes uptake of evidence-based tests and interventions in clinical or public health practice. If based on research in atypical settings or findings about single endpoints rather than overall mortality, morbidity, and quality of life, deployment may fail to meet expectations. Nevertheless, rapid deployment of innovation is typically emphasized. An alternative goal for dissemination and implementation science is the systematic removal of services that are not supported by evidence.

Scale-up and spread of evidence-based practices is one of the most important challenges facing health care. We tested whether a statewide initiative, Depression Improvement Across Minnesota-Offering a New Direction (DIAMOND), to implement the collaborative care model for depression in 75 primary care clinics resulted in patient outcome improvements corresponding to those reported in randomized controlled trials.Health plans provided a new monthly payment to participating clinics after a 6-month intensive training program with ongoing data submission, networking, and consultation. Implementation was staggered, with 5 sequences of 10 to 40 clinics every 6 months. Payers provided weekly contact information for members from participating clinics who were filling antidepressant prescriptions, and we conducted baseline and 6-month surveys of 1,578 patients about their care and outcomes.There were 466 patients in DIAMOND clinics who received usual care before implementation (UCB), 559 who received usual care in DIAMOND clinics after implementation (UCA), 245 who received DIAMOND care after implementation (DCA), and 308 who received usual care in comparison clinics (UC). Patients who received DIAMOND care after implementation reported more collaborative care depression services than the 3 comparison groups (10.9 vs 6.4-6.7, on a scale of 0 of 14, where higher numbers indicate more services; P.001) and more satisfaction with their care (4.0 vs 3.4 on a scale 1 to 5, in which higher scores indicate higher satisfaction; P ≤.001). Depression remission rates, however, were not significantly different among the 4 groups (36.4% DCA vs 35.8% UCB, 35.0% UCA, 33.9% UC; P = .94).Despite the incentive of a supporting payment change and intensive training and support for clinics volunteering to participate, no difference in depression outcomes was documented. Specific unmeasured actions present in trials but not present in these clinics may be critical for successful outcome improvement.

This study compared the clinical outcomes following mini-open rotator cuff repair (MORCR) between early mobilisation and usual care, involving initial immobilisation. In total, 189 patients with radiologically-confirmed full-thickness rotator cuff tears underwent MORCR and were randomised to either early mobilisation (n = 97) or standard rehabilitation (n = 92) groups. Patients were assessed at six weeks and three, six, 12 and 24 months post-operatively. Six-week range of movement comparisons demonstrated significantly increased abduction (p = 0.002) and scapular plane elevation (p = 0.006) in the early mobilisation group, an effect which was not detectable at three months (p > 0.51) or afterwards. At 24 months post-operatively, patients who performed pain-free, early active mobilisation for activities of daily living showed no difference in clinical outcomes from patients immobilised for six weeks following MORCR. We suggest that the choice of rehabilitation regime following MORCR may be left to the discretion of the patient and the treating surgeon. Cite this article: Bone Joint J 2015;97-B:1257–63.

Objective To determine the effectiveness of an individually-targeted Internet-based intervention with monetary incentives (INCENT) at reducing weight of overweight and obese employees when compared to a less-intensive intervention (Livin’ My Weigh [LMW]) 6-months after program initiation.