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BackgroundChoosing candidates for antiseizure medication (ASM) withdrawal in well- controlled epilepsy is challenging. We evaluated 1) the correlation between neurologists’ seizure risk estimation (“clinician predictions”) versus calculated predictions, 2) how viewing calculated predictions influenced recommendations, and 3) barriers to using risk calculation.MethodsWe asked neurologists to predict two-year seizure risk after ASM withdrawal for hypothetical vignettes. We compared withdrawal recommendations ASMs before versus after viewing calculated predictions using generalized linear models.ResultsThree-hundred forty-six responded. There was moderate correlation between clinician and calculated predictions (Spearman coefficient 0.42). Clinician predictions varied widely, e.g., predictions ranged 5%-100% for a two-year seizure-free adult without epileptiform abnormalities. Mean clinician predictions exceeded calculated predictions for vignettes with epileptiform abnormalities (e.g., childhood absence epilepsy: clinician 65%, 95% confidence interval [CI] 57%-74%; calculated 46%) and surgical vignettes (e.g., focal cortical dysplasia six-months seizure-free mean clinician 56%, 95% CI 52%-60%; calculated 28%). Clinicians overestimated the influence of epileptiform EEG findings on withdrawal risk (26%, 95% CI 24%-28%) compared with calculators (14%, 95% 13%-14%). Viewing calculated predictions slightly reduced willingness to withdraw (−0.8/10 change, 95% CI -1.0 to -0.7), particularly without epileptiform abnormalities. The greatest barrier to calculator use was doubting its accuracy (44%).ConclusionsClinicians overestimated the influence of abnormal EEGs particularly for low-risk patients and overestimated risk and the influence of seizure-free duration for surgical patients, compared with calculators. These data may question widespread ordering of EEGs or time-based seizure-free thresholds for surgical patients. Viewing calculated predictions reduced willingness to withdraw particularly without epileptiform abnormalities.What is already known on this topicFor the two-thirds of patients with epilepsy who become seizure-free on antiseizure medications (ASMs), a key question is whether ASMs are necessary indefinitely after attaining seizure-freedom. An individualized post-withdrawal seizure risk calculator exists,[1,2] which has demonstrated moderate external validity, and one 1993 study suggested that viewing results from an older version of such a calculator slightly reduced patients’ willingness to withdraw.What this study addsBefore our study, it was unknown how closely clinicians’ intuitive estimates of post-withdrawal seizure risk (“clinician predictions”) align with model (“calculated”) predictions, and no study had previously evaluated the influence of viewing calculated risk on clinician recommendations. We found 1) moderate correlation between clinician and calculated predictions (Spearman coefficient 0.42), 2) clinician predictions and recommendations varied widely, 3) clinicians tended to overestimate risk compared with calculators for vignettes with epileptiform abnormalities and surgical cases, 4) viewing calculated predictions slightly reduced willingness to withdraw particularly without epileptiform abnormalities, and 5) the greatest endorsed barrier to calculator use was doubting its accuracy.How this study might affect research, practice or policyOur study suggests patient scenarios in which viewing calculator results may be most useful or be most likely to change clinical practice. These data may also question widespread ordering of EEGs or time-based seizure-free thresholds for surgical patients given calculated risk differences were smaller than clinician predictions. We also provide preliminary data guiding future work to improve calculator implementation such as targeting educational efforts to improve knowledge of its development, improving its accuracy, and integrating it into the electronic medical record.

Objective The aim of the current study was to evaluate primary care pediatrician (PCP) adoption of an electronic health record (EHR) documentation tool and their delivery of a behavioral activation (BA) intervention within their routine practice with adolescents who screened positive for depression. Methods We used the RE-AIM framework to describe PCP adoption and implementation of EHR documentation tools and brief evidence-based protocols. Utilization was assessed using a customized toolbar (ie, actions toolbar) via retrospective chart review. A pre-post design was used to measure changes in PCP-reported knowledge, comfort, and feasibility managing depression before and after they were trained. A mixed-effects logistic regression model was used to analyze associations of resource utilization with depression severity. Results PCPs used the actions toolbar to document responses to elevated Patient Health Questionnaire (PHQ-9) scores for 29.80% of encounters. The PCPs utilized the BA protocol for 10.5% of encounters with elevated PHQ-9 scores. Higher depression severity categories were associated with significantly higher odds of utilization relative to mild severity. The training was rated highly acceptable and PCPs reported significant post-training increases in comfort and feasibility. Conclusion This is the first study of its kind to implement and evaluate PCP utilization of an EHR documentation tool aimed to improve delivery of an evidence-based intervention for adolescent depression. Teaching PCPs to implement brief interventions has potential to increase access to evidence-based care; however, large-scale practice change requires an effective implementation strategy that does not increase provider burden and is fully integrated into physician documentation and workflow.

Purpose: The present study examined the feasibility of internet-based cognitive behavioral therapy (iCBT) for home care older adults. Method: A feasibility open trial was conducted with 26 recipients of nonmedical home care with depressive symptoms. When possible, home care workers (HCWs) of older adults ( n = 13) were recruited to provide external support for iCBT usage. Results: The mean therapy sessions completed was 4.7 out of 8, and 86% would recommend the program to others with depressed mood. Participants’ depressive symptoms and anxiety symptoms decreased, whereas their quality of life ratings improved. Discussion: iCBT is a feasible and acceptable treatment modality for home care older adults with depressive symptoms and is potentially effective. Future studies are warranted to refine the existing treatment platform to achieve a better fit between the demands of the program and the needs and capabilities of homebound older adults and to examine treatment effectiveness as a function of HCW support.

Background The Assistant to Lift your Level of activitY (Ally) app is a smartphone application that combines financial incentives with chatbot-guided interventions to encourage users to reach personalized daily step goals. Purpose To evaluate the effects of incentives, weekly planning, and daily self-monitoring prompts that were used as intervention components as part of the Ally app. Methods We conducted an 8 week optimization trial with n = 274 insurees of a health insurance company in Switzerland. At baseline, participants were randomized to different incentive conditions (cash incentives vs. charity incentives vs. no incentives). Over the course of the study, participants were randomized weekly to different planning conditions (action planning vs. coping planning vs. no planning) and daily to receiving or not receiving a self-monitoring prompt. Primary outcome was the achievement of personalized daily step goals. Results Study participants were more active and healthier than the general Swiss population. Daily cash incentives increased step-goal achievement by 8.1%, 95% confidence interval (CI): [2.1, 14.1] and, only in the no-incentive control group, action planning increased step-goal achievement by 5.8%, 95% CI: [1.2, 10.4]. Charity incentives, self-monitoring prompts, and coping planning did not affect physical activity. Engagement with planning interventions and self-monitoring prompts was low and 30% of participants stopped using the app over the course of the study. Conclusions Daily cash incentives increased physical activity in the short term. Planning interventions and self-monitoring prompts require revision before they can be included in future versions of the app. Selection effects and engagement can be important challenges for physical-activity apps. Clinical Trial Information This study was registered on ClinicalTrials.gov, NCT03384550., Users of a physical activity app were more likely to increase their daily activity after receiving cash rewards but not in response to chatbot-guided reminders and planning interventions.

Background Implementation facilitation is an effective strategy to support the implementation of evidence-based practices (EBPs), but our understanding of multilevel strategies and the mechanisms of change within the “black box” of implementation facilitation is limited. This implementation trial seeks to disentangle and evaluate the effects of facilitation strategies that separately target the care team and leadership levels on implementation of a collaborative care model in pediatric primary care. Strategies targeting the provider care team (TEAM) should engage team-level mechanisms, and strategies targeting leaders (LEAD) should engage organizational mechanisms. Methods We will conduct a hybrid type 3 effectiveness–implementation trial in a 2 × 2 factorial design to evaluate the main and interactive effects of TEAM and LEAD and test for mediation and moderation of effects. Twenty-four pediatric primary care practices will receive standard REP training to implement Doctor–Office Collaborative Care (DOCC) and then be randomized to (1) Standard REP only, (2) TEAM, (3) LEAD, or (4) TEAM + LEAD. Implementation outcomes are DOCC service delivery and change in practice-level care management competencies. Clinical outcomes are child symptom severity and quality of life. Discussion This statewide trial is one of the first to test the unique and synergistic effects of implementation strategies targeting care teams and practice leadership. It will advance our knowledge of effective care team and practice-level implementation strategies and mechanisms of change. Findings will support efforts to improve common child behavioral health conditions by optimizing scale-up and sustainment of CCMs in a pediatric patient-centered medical home. Trial registration ClinicalTrials.gov, NCT04946253. Registered June 30, 2021.

Background Life Goals is an evidence-based self-management intervention that assists individuals with bipolar disorder (BD) by aligning BD symptom coping strategies with their personal goals. The intervention can be availed via in-person and telephonic sessions, and it has been recently developed as an individualized, customizable mobile app. Objective We examined the feasibility, usability, and acceptability of the Life Goals self-management app among individuals diagnosed with BD who used the app for up to 6 months. Methods A total of 28 individuals with BD used the Life Goals app on their personal smartphone for 6 months. They completed key clinical outcome measurements of functioning, disability, and psychiatric symptoms at baseline, 3 months, and 6 months, in addition to a poststudy survey about usability and satisfaction. Results Participants used the app for a median of 25 times (IQR 13-65.75), and for a longer time during the first 3 months of the study. The modules on depression and anxiety were the most frequently used, accounting for 35% and 22% of total usage, respectively. Overall, the study participants found the app useful (15/25, 60%) and easy to use (18/25, 72%), and they reported that the screen displayed the material adequately (22/25, 88%). However, less than half of the participants found the app helpful in managing their health (10/25, 40%) or in making progress on their wellness goals (9/25, 36%). Clinical outcomes showed a trend for improvements in mental and physical health and mania-related well-being. Conclusions The Life Goals app showed feasibility of use among individuals with BD. Higher user engagement was observed in the initial 3 months with users interested more frequently in the mood modules than other wellness modules. Participants reported acceptability with the ease of app use and satisfaction with the app user interface, but the app showed low success in encouraging self-management within this small sample. The Life Goals app is a mobile health technology that can provide individuals with serious mental illness with more flexible access to evidence-based treatments.

Background Schools increasingly provide mental health services to students, but often lack access to implementation strategies to support school-based (and school professional [SP]) delivery of evidence-based practices. Given substantial heterogeneity in implementation barriers across schools, development of adaptive implementation strategies that guide which implementation strategies to provide to which schools and when may be necessary to support scale-up. Methods A clustered, sequential, multiple-assignment randomized trial (SMART) of high schools across Michigan was used to inform the development of a school-level adaptive implementation strategy for supporting SP-delivered cognitive behavioral therapy (CBT). All schools were first provided with implementation support informed by Replicating Effective Programs (REP) and then were randomized to add in-person Coaching or not (phase 1). After 8 weeks, schools were assessed for response based on SP-reported frequency of CBT delivered to students and/or barriers reported. Responder schools continued with phase 1 implementation strategies. Slower-responder schools (not providing ≥ 3 CBT components to ≥10 students or >2 organizational barriers identified) were re-randomized to add Facilitation to current support or not (phase 2). The primary aim hypothesis was that SPs at schools receiving the REP + Coaching + Facilitation adaptive implementation strategy would deliver more CBT sessions than SPs at schools receiving REP alone. Secondary aims compared four implementation strategies (Coaching vs no Coaching × Facilitation vs no Facilitation) on CBT sessions delivered, including by type (group, brief and full individual). Analyses used a marginal, weighted least squares approach developed for clustered SMARTs. Results SPs (n = 169) at 94 high schools entered the study. N = 83 schools (88%) were slower-responders after phase 1. Contrary to the primary aim hypothesis, there was no evidence of a significant difference in CBT sessions delivered between REP + Coaching + Facilitation and REP alone (111.4 vs. 121.1 average total CBT sessions; p = 0.63). In secondary analyses, the adaptive strategy that offered REP + Facilitation resulted in the highest average CBT delivery (154.1 sessions) and the non-adaptive strategy offering REP + Coaching the lowest (94.5 sessions). Conclusions The most effective strategy in terms of average SP-reported CBT delivery is the adaptive implementation strategy that (i) begins with REP, (ii) augments with Facilitation for slower-responder schools (schools where SPs identified organizational barriers or struggled to deliver CBT), and (iii) stays the course with REP for responder schools. Trial registration ClinicalTrials.gov, NCT03541317, May 30, 2018.

Background and ObjectivesTo describe neurologist practice patterns, challenges, and decision support needs pertaining to withdrawal of antiseizure medications (ASMs) in patients with well-controlled epilepsy.MethodsWe sent an electronic survey to (1) US and (2) European physician members of the American Academy of Neurology and (3) members of EpiCARE, a European Reference Network for rare and complex epilepsies. Analyses included frequencies and percentages, and we showed distributions through histograms and violin plots.ResultsWe sent the survey to 4,923 individuals; 463 consented, 411 passed eligibility questions, and 287 responded to at least 1 of these questions. Most respondents indicated that they might ever consider ASM withdrawal, with respondents treating mostly children being more likely ever to consider withdrawal (e.g., medical monotherapy: children 96% vs adults 81%;p< 0.05). The most important factors when making decisions included seizure probability (83%), consequences of seizures (73%), and driving (74%). The top challenges when making decisions included unclear seizure probability (81%), inadequate guidelines (50%), and difficulty communicating probabilities (45%). Respondents would consider withdrawal after a median of 2-year seizure freedom, but also responded that they would begin withdrawal on average only when the postwithdrawal seizure relapse risk in the coming 2 years was less than 15%–30%. Wide variation existed in the use of words or numbers in respondents' counsel methods, for example, percentages vs frequencies or probability of seizure freedom vs seizure. The most highly rated point-of-care methods to inform providers of calculated risk were Kaplan-Meier curves and showing percentages only, rather than pictographs or text recommendations alone.DiscussionMost surveyed neurologists would consider withdrawing ASMs in seizure-free individuals. Seizure probability was the largest factor driving decisions, yet estimating seizure probabilities was the greatest challenge. Respondents on average indicated that they may withdraw ASM after a minimum seizure-free duration of 2 years, yet also on average were willing to withdraw when seizure risk decreased below 15%–30%, which is lower than most patients' postwithdrawal risk at 2-year seizure freedom and lower than the equivalent even of a first seizure of life. These findings will inform future efforts at developing decision support tools aimed at optimizing ASM withdrawal decisions.

BACKGROUND Implementation strategies are essential for promoting the uptake of evidence-based practices and for patients to receive optimal care. Yet strategies differ substantially in their intensity and feasibility. Lower-intensity strategies (eg, training and technical support) are commonly used but may be insufficient for all clinics. Limited research has examined the comparative effectiveness of augmentations to low-level implementation strategies for nonresponding clinics. OBJECTIVES To compare 2 augmentation strategies for improving uptake of an evidence-based collaborative chronic care model (CCM) on 18-month outcomes for patients with depression at community-based clinics nonresponsive to lower-level implementation support. RESEARCH DESIGN Providers initially received support using a low-level implementation strategy, Replicating Effective Programs (REP). After 6 months, nonresponsive clinics were randomized to add either external facilitation (REP+EF) or external and internal facilitation (REP+EF/IF). MEASURES The primary outcome was patient 12-item short form survey (SF-12) mental health score at month 18. Secondary outcomes were patient health questionnaire (PHQ-9) depression score at month 18 and receipt of the CCM during months 6 through 18. RESULTS Twenty-seven clinics were nonresponsive after 6 months of REP. Thirteen clinics (N=77 patients) were randomized to REP+EF and 14 (N=92) to REP+EF/IF. At 18 months, patients in the REP+EF/IF arm had worse SF-12 [diff, 8.38; 95% confidence interval (CI), 3.59-13.18] and PHQ-9 scores (diff, 1.82; 95% CI, -0.14 to 3.79), and lower odds of CCM receipt (odds ratio, 0.67; 95% CI, 0.30-1.49) than REP+EF patients. CONCLUSIONS Patients at sites receiving the more intensive REP+EF/IF saw less improvement in mood symptoms at 18 months than those receiving REP+EF and were no more likely to receive the CCM. For community-based clinics, EF augmentation may be more feasible than EF/IF for implementing CCMs.

PurposeMood and anxiety disorders affect 20–30 percent of school-age children, contributing to academic failure, substance abuse, and adult psychopathology, with immense social and economic impact. These disorders are treatable, but only a fraction of students in need have access to evidence-based treatment practices (EBPs). Access could be substantially increased if school professionals were trained to identify students at risk and deliver EBPs in the context of school-based support services. However, current training for school professionals is largely ineffective because it lacks follow-up supported practice, an essential element for producing lasting behavioral change. The paper aims to discuss these issues.Design/methodology/approachIn this pilot feasibility study, the authors explored whether a coaching-based implementation strategy could be used to integrate common elements of evidence-based cognitive behavioral therapy (CBT) into schools. The strategy incorporated didactic training in CBT for school professionals followed by coaching from an expert during co-facilitation of CBT groups offered to students.FindingsIn total, 17 school professionals in nine high schools with significant cultural and socioe-conomic diversity participated, serving 105 students. School professionals were assessed for changes in confidence in CBT delivery, frequency of generalized use of CBT skills and attitudes about the utility of CBT for the school setting. Students were assessed for symptom improvement. The school professionals showed increased confidence in, utilization of, and attitudes toward CBT. Student participants showed significant reductions in depression and anxiety symptoms pre- to post-group.Originality/valueThese findings support the feasibility and potential impact of a coaching-based implementation strategy for school settings, as well as student symptom improvement associated with receipt of school-delivered CBT.

BACKGROUND Life Goals is an evidence-based self-management intervention that assists individuals with bipolar disorder (BD) by aligning BD symptom coping strategies with their personal goals. The intervention can be availed via in-person and telephonic sessions, and it has been recently developed as an individualized, customizable mobile app. OBJECTIVE We examined the feasibility, usability, and acceptability of the Life Goals self-management app among individuals diagnosed with BD who used the app for up to 6 months. METHODS A total of 28 individuals with BD used the Life Goals app on their personal smartphone for 6 months. They completed key clinical outcome measurements of functioning, disability, and psychiatric symptoms at baseline, 3 months, and 6 months, in addition to a poststudy survey about usability and satisfaction. RESULTS Participants used the app for a median of 25 times (IQR 13-65.75), and for a longer time during the first 3 months of the study. The modules on depression and anxiety were the most frequently used, accounting for 35% and 22% of total usage, respectively. Overall, the study participants found the app useful (15/25, 60%) and easy to use (18/25, 72%), and they reported that the screen displayed the material adequately (22/25, 88%). However, less than half of the participants found the app helpful in managing their health (10/25, 40%) or in making progress on their wellness goals (9/25, 36%). Clinical outcomes showed a trend for improvements in mental and physical health and mania-related well-being. CONCLUSIONS The Life Goals app showed feasibility of use among individuals with BD. Higher user engagement was observed in the initial 3 months with users interested more frequently in the mood modules than other wellness modules. Participants reported acceptability with the ease of app use and satisfaction with the app user interface, but the app showed low success in encouraging self-management within this small sample. The Life Goals app is a mobile health technology that can provide individuals with serious mental illness with more flexible access to evidence-based treatments.

Little information has been compiled across studies about existing interventions to mitigate issues of medical financial hardship, despite growing interest in health care delivery. The purpose of this qualitative systematic scoping review was to examine content and outcomes of interventions to address medical financial hardship. PRISMA guidelines were applied to present results using PubMed, Scopus, and CINAHL, published between January 1980 and August 2020. Additional studies were identified through reference lists of selected papers. Included studies focused on mitigating medical financial hardship from out-of-pocket (OOP) health care expenses as an intervention strategy with at least 1 evaluation component. Screening 2412 articles identified 339 articles for full-text review, 12 of which met inclusion criteria. Variation was found regarding targets and outcome measurement of intervention. Primary outcomes were in the following categories: financial outcomes (eg, OOP expenses), behavioral outcomes, psychosocial, health care utilization, and health status. No included studies reported significant reduction in OOP expenses, perceptions of financial burden/toxicity, or health status. However, changes were observed for behavioral outcomes (adherence to treatment, patient needs addressed), some psychosocial outcomes (mental health symptoms, perceived support, patient satisfaction), and care utilization such as routine health care. No patterns were observed in the achievement of outcomes across studies based on intensity of intervention. Few rigorous studies exist in this emerging field, and studies have not shown consistent positive effects. Future research should focus on conceptual clarity of the intervention, align outcome measurement and achieve consensus around outcomes, and employ rigorous study designs, measurement, and outcome follow-up.

Importance Real-world surgical practice often lags behind the best scientific evidence. For example, although optimizing comorbidities such as smoking and morbid obesity before ventral and incisional hernia repair improves outcomes, as many as 25% of these patients have a high-risk characteristic at the time of surgery. Implementation strategies may effectively increase use of evidence-based practice. Objective To describe current trends in preoperative optimization among patients undergoing ventral hernia repair, identify barriers to optimization, develop interventions to address these barriers, and then pilot these interventions. Design, setting, and participants This quality improvement study used a retrospective medical record review to identify hospital-level trends in preoperative optimization among patients undergoing ventral and incisional hernia repair. Semistructured interviews with 21 practicing surgeons were conducted to elicit barriers to optimizing high-risk patients before surgery. Next, a task force of experts was convened to develop pragmatic interventions to increase surgeon use of preoperative optimization. Finally, these interventions were piloted at 2 sites to assess acceptability and feasibility. This study was performed from January 1, 2014, to December 31, 2019. Main outcomes and measures The main outcome was rate of referrals for preoperative patient optimization at the 2 pilot sites. Results Among 23 000 patients undergoing ventral hernia repair, the mean (SD) age was 53.9 (14.3) years, and 12 315 (53.5%) were men. Of these, 8786 patients (38.2%) had at least 1 high-risk characteristic at the time of surgery, including 7683 with 1, 1079 with 2, and 24 with 3. At the hospital level, the mean proportion of patients with at least 1 of 3 high-risk characteristics at the time of surgery was 38.2% (95% CI, 38.1%-38.3%). This proportion varied widely from 21.5% (95% CI, 17.6%-25.5%) to 52.8% (95% CI, 43.9%-61.8%) across hospitals. Interviews with surgeons identified 3 major barriers to improving this practice: lost financial opportunity by not offering a patient an operation, lack of surgeon awareness of available resources for optimization, and organizational barriers. A task force therefore developed 3 interventions: a financial incentive to optimize high-risk patients, an educational intervention to make surgeons aware of available optimization resources, and on-site facilitation. These strategies were piloted at 2 sites where preoperative risk optimization referrals increased 860%. Conclusions and relevance This study demonstrates a stepwise process of identifying a practice gap, eliciting barriers that contribute to this gap, using expert consensus and local resources to develop strategies to address these barriers, and piloting these strategies. This implementation strategy can be adopted to diverse settings given that it relies on developing and implementing strategies based on local practice patterns.

OBJECTIVE: To evaluate the comparative effectiveness of external facilitation (EF) vs external + internal facilitation (EF/IF), on uptake of a collaborative chronic care model (CCM) in community practices that were slower to implement under low‐level implementation support. STUDY SETTING: Primary data were collected from 43 community practices in Michigan and Colorado at baseline and for 12 months following randomization. STUDY DESIGN: Sites that failed to meet a pre‐established implementation benchmark after six months of low‐level implementation support were randomized to add either EF or EF/IF support for up to 12 months. Key outcomes were change in number of patients receiving the CCM and number of patients receiving a clinically significant dose of the CCM. Moderators’ analyses further examined whether comparative effectiveness was dependent on prerandomization adoption, number of providers trained or practice size. Facilitation log data were used for exploratory follow‐up analyses. DATA COLLECTION: Sites reported monthly on number of patients that had received the CCM. Facilitation logs were completed by study EF and site IFs and shared with the study team. PRINCIPAL FINDINGS: N = 21 sites were randomized to EF and 22 to EF/IF. Overall, EF/IF practices saw more uptake than EF sites after 12 months (Δ(EF/IF‐EF) = 4.4 patients, 95% CI = 1.87‐6.87). Moderators' analyses, however, revealed that it was only sites with no prerandomization uptake of the CCM (nonadopter sites) that saw significantly more benefit from EF/IF (Δ(EF/IF‐EF) = 9.2 patients, 95% CI: 5.72, 12.63). For sites with prerandomization uptake (adopter sites), EF/IF offered no additional benefit (Δ(EF/IF‐EF) = −0.9; 95% CI: −4.40, 2.60). Number of providers trained and practice size were not significant moderators. CONCLUSIONS: Although stepping up to the more intensive EF/IF did outperform EF overall, its benefit was limited to sites that failed to deliver any CCM under the low‐level strategy. Once one or more providers were delivering the CCM, additional on‐site personnel did not appear to add value to the implementation effort.

BACKGROUND: HeartSteps is an mHealth intervention that encourages regular walking via activity suggestions tailored to the individuals’ current context. PURPOSE: We conducted a micro-randomized trial (MRT) to evaluate the efficacy of HeartSteps’ activity suggestions to optimize the intervention. METHODS: We conducted a 6-week MRT with 44 adults. Contextually tailored suggestions could be delivered up to five times per day at user-selected times. At each of these five times, for each participant on each day of the study, HeartSteps randomized whether to provide an activity suggestion, and, if so, whether to provide a walking or an antisedentary suggestion. We used a centered and weighted least squares method to analyze the effect of suggestions on the 30-min step count following suggestion randomization. RESULTS: Averaging over study days and types of activity suggestions, delivering a suggestion versus no suggestion increased the 30-min step count by 14% (p = .06), 35 additional steps over the 253-step average. The effect was not evenly distributed in time. Providing any type of suggestion versus no suggestion initially increased the step count by 66% (167 steps; p < .01), but this effect diminished over time. Averaging over study days, delivering a walking suggestion versus no suggestion increased the average step count by 24% (59 steps; p = .02). This increase was greater at the start of study (107% or 271 additional steps; p < .01), but decreased over time. Antisedentary suggestions had no detectable effect on the 30-min step count. CONCLUSION: Contextually tailored walking suggestions are a promising way of initiating bouts of walking throughout the day. CLINICAL TRIAL INFORMATION: This study was registered on ClinicalTrials.gov number NCT03225521.

Background Depressive and anxiety disorders affect 20–30% of school-age youth, most of whom do not receive adequate services, contributing to poor developmental and academic outcomes. Evidence-based practices (EBPs) such as cognitive behavioral therapy (CBT) can improve outcomes, but numerous barriers limit access among affected youth. Many youth try to access mental health services in schools, but school professionals (SPs: counselors, psychologists, social workers) are rarely trained adequately in CBT methods. Further, SPs face organizational barriers to providing CBT, such as lack of administrative support. Three promising implementation strategies to address barriers to school-based CBT delivery include (1) Replicating Effective Programs (REP), which deploys customized CBT packaging, didactic training in CBT, and technical assistance; (2) coaching, which extends training via live supervision to improve SP competence in CBT delivery; and (3) facilitation, which employs an organizational expert who mentors SPs in strategic thinking to promote self-efficacy in garnering administrative support. REP is a relatively low-intensity/low-cost strategy, whereas coaching and facilitation require additional resources. However, not all schools will require all three strategies. The primary aim of this study is to compare the effectiveness of a school-level adaptive implementation intervention involving REP, coaching, and facilitation versus REP alone on the frequency of CBT delivered to students by SPs and student mental health outcomes. Secondary and exploratory aims examine cost-effectiveness, moderators, and mechanisms of implementation strategies. Methods Using a clustered, sequential multiple-assignment, randomized trial (SMART) design, ≥ 200 SPs from 100 schools across Michigan will be randomized initially to receive REP vs. REP+coaching. After 8 weeks, schools that do not meet a pre-specified implementation benchmark are re-randomized to continue with the initial strategy or to augment with facilitation. Discussion EBPs need to be implemented successfully and efficiently in settings where individuals are most likely to seek care in order to gain large-scale impact on public health. Adaptive implementation interventions hold the promise of providing cost-effective implementation support. This is the first study to test an adaptive implementation of CBT for school-age youth, at a statewide level, delivered by school staff, taking an EBP to large populations with limited mental health care access. Trial registration NCT03541317—Registered on 29 May 2018 on ClinicalTrials.gov PRS Electronic supplementary material The online version of this article (10.1186/s13012-018-0808-8) contains supplementary material, which is available to authorized users.

Background: A national shortage of mental health providers for youth exists in the United States. Implementation support for mental health services in schools, where students are most likely to access care, can help to fill these gaps. Coaching consists of in vivo modeling and support during service delivery and is effective in supporting the implementation of evidence-based practices (EBPs). This implementation report describes the recruitment and training of community providers to become coaches as a part of a modified train-the-trainer model of implementation support. Method: An EBP implementation program, Transforming Research into Action to Improve the Lives of Students (TRAILS), trained community providers in Michigan to increase knowledge of cognitive behavioral therapy (CBT) and position them as coaches in schools. The development of the coach network involved five stages prior to the initiation of a randomized controlled trial: (1) recruitment, (2) a one-day clinical training, (3) 12 weeks of individualized consultation, (4) evaluation, and (5) training in the coaching protocol. Results: A total of 347 individuals attended an initial training, and 187 were paired with a consultant. Eighty-six clinicians from 47 of Michigan's 83 counties successfully became coaches by completing all required elements of training. Coaches showed significant improvements in the use and knowledge of CBT across consultation. Conclusion: Statewide networks of trained mental health professionals can address gaps in mental healthcare for youth. This article demonstrates one strategy for strengthening and leveraging community expertise to support the implementation of EPBs in schools. Plain Language Summary Although youth face many barriers in accessing effective mental health care, schools are one setting where they can more easily receive treatment. Research shows that training and supports are needed for school mental health professionals to provide effective care. Coaching, which involves in vivo support for school mental health professionals, is one helpful strategy. We describe the process of recruiting and training community clinicians to become coaches. The Transforming Research into Action to Improve the Lives of Students (TRAILS) program successfully recruited and trained a network of 86 community clinicians to become coaches. Clinicians attended two day-long trainings and participated in 12 weeks of personalized consultation. Clients to whom these clinicians provided CBT showed significant symptom improvement. Clinicians also reported that they increased their knowledge and use of core CBT strategies, including psychoeducation, exposure, and behavioral activation. Community mental health professionals who are trained as coaches can address gaps in access to care for youth. We demonstrate one strategy for strengthening and leveraging clinicians’ knowledge of CBT to support the school-based implementation of CBT.

Key Points Question Can a low-cost optimization clinic be implemented to successfully manage high-risk patients seeking hernia repair? Findings In this quality improvement study, 1 year after the implementation of a preoperative optimization clinic, 9.1% of high-risk patients became eligible for hernia repair through the optimization of a high-risk characteristic, and the number of emergency surgery events was low. Meaning These findings suggest that this model represents a scalable and sustainable framework for preoperative optimization with the potential to improve the care of patients with hernias., This quality improvement study evaluates the feasibility of a low-cost preoperative optimization clinic that was implemented to improve the care of high-risk patients seeking elective hernia repair., Importance Preoperative optimization is an important clinical strategy for reducing morbidity; however, nearly 25% of persons undergoing elective abdominal hernia repairs are not optimized with respect to weight or substance use. Although the preoperative period represents a unique opportunity to motivate patient health behavior changes, fear of emergent presentation and financial concerns are often cited as clinician barriers to optimization. Objective To evaluate the feasibility of evidence-based patient optimization before surgery by implementing a low-cost preoperative optimization clinic. Design, Setting, and Participants This quality improvement study was conducted 1 year after a preoperative optimization clinic was implemented for high-risk patients seeking elective hernia repair. The median (range) follow-up was 197 (39-378) days. A weekly preoperative optimization clinic was implemented in 2019 at a single academic center. Referral occurred for persons seeking elective hernia repair with a body mass index greater than or equal to 40, age 75 years or older, or active tobacco use. Data analysis was performed from February to July 2020. Exposures Enrolled patients were provided health resources and longitudinal multidisciplinary care. Main Outcomes and Measures The primary outcomes were safety and eligibility for surgery after participating in the optimization clinic. The hypothesis was that the optimization clinic could preoperatively mitigate patient risk factors, without increasing patient risk. Safety was defined as the occurrence of complications during participation in the optimization clinic. The secondary outcome metric centered on the financial impact of implementing the preoperative optimization program. Results Of the 165 patients enrolled in the optimization clinic, most were women (90 patients [54.5%]) and White (145 patients [87.9%]). The mean (SD) age was 59.4 (15.8) years. Patients’ eligibility for the clinic was distributed across high-risk criteria: 37.0% (61 patients) for weight, 26.1% (43 patients) for tobacco use, and 23.6% (39 patients) for age. Overall, 9.1% of persons (15 patients) were successfully optimized for surgery, and tobacco cessation was achieved in 13.8% of smokers (8 patients). The rate of hernia incarceration requiring emergent surgery was 3.0% (5 patients). Economic evaluation found increased operative yield from surgical clinics, with a 58% increase in hernia-attributed relative value units without altering surgeon workflow. Conclusions and Relevance In this quality improvement study, a hernia optimization clinic safely improved management of high-risk patients and increased operative yield for the institution. This represents an opportunity to create sustainable and scalable models that provide longitudinal care and optimize patients to improve outcomes of hernia repair.

Background The just-in-time adaptive intervention (JITAI) is an intervention design aiming to provide the right type/amount of support, at the right time, by adapting to an individual’s changing internal and contextual state. The availability of increasingly powerful mobile and sensing technologies underpins the use of JITAIs to support health behavior, as in such a setting an individual’s state can change rapidly, unexpectedly, and in his/her natural environment. Purpose Despite the increasing use and appeal of JITAIs, a major gap exists between the growing technological capabilities for delivering JITAIs and research on the development and evaluation of these interventions. Many JITAIs have been developed with minimal use of empirical evidence, theory, or accepted treatment guidelines. Here, we take an essential first step towards bridging this gap. Methods Building on health behavior theories and the extant literature on JITAIs, we clarify the scientific motivation for JITAIs, define their fundamental components, and highlight design principles related to these components. Examples of JITAIs from various domains of health behavior research are used for illustration. Conclusions As we enter a new era of technological capacity for delivering JITAIs, it is critical that researchers develop sophisticated and nuanced health behavior theories capable of guiding the construction of such interventions. Particular attention has to be given to better understanding the implications of providing timely and ecologically sound support for intervention adherence and retention

BackgroundRecent efforts to reduce patient infection rates emphasise the importance of safety culture. However, little evidence exists linking measures of safety culture and infection rates, in part because of the difficulty of collecting both safety culture and infection data from a large number of nursing homes.ObjectiveTo examine the association between nursing home safety culture, measured with the Nursing Home Survey on Patient Safety Culture (NHSOPS), and catheter-associated urinary tract infection rates (CAUTI) using data from a recent national collaborative for preventing healthcare-associated infections in nursing homes.MethodsIn this prospective cohort study of nursing homes, facility staff completed the NHSOPS at intervention start and 11 months later. National Healthcare Safety Network-defined CAUTI rates were collected monthly for 1 year. Negative binomial models examined CAUTI rates as a function of both initial and time-varying facility-aggregated NHSOPS components, adjusted for facility characteristics.ResultsStaff from 196 participating nursing homes completed the NHSOPS and reported CAUTI rates monthly. Nursing homes saw a 52% reduction in CAUTI rates over the intervention period. Seven of 13 NHSOPS measures saw improvements, with the largest improvements for ‘Management Support for Resident Safety’ (3.7 percentage point increase in facility-level per cent positive response, on average) and ‘Communication Openness’ (2.5 percentage points). However, these increases were statistically insignificant, and multivariate models did not find significant association between CAUTI rates and initial or over-time NHSOPS domains.ConclusionsThis large national collaborative of nursing homes saw declining CAUTI rates as well as improvements in several NHSOPS domains. However, no association was found between initial or over-time NHSOPS scores and CAUTI rates.

RESEARCH OBJECTIVE: Implementation scientists generally acknowledge that low‐level implementation support will not suffice supporting adoption of evidence‐based practices (EBPs), but little work has examined the best way to step up support for sites that are slow to implement. Facilitation, that is, interactive strategic thinking support for providers to encourage uptake of EBPs, is often identified as a key component of successful implementation. Several models of facilitation, of varying intensity, have been operationalized, notably models involving external facilitation (EF) versus those combining external with internal facilitation (EF/IF). Relative to EF, IF is thought to better embed the EBP into the practice setting and encourage transformational rather than transactional change. However, few studies have examined whether EF/IF improves uptake of evidence‐based practices relative to EF alone, and/or whether certain sites benefit most from IF. This study examines the comparative effectiveness of EF vs. EF/IF on uptake of an evidence‐based collaborative care model (CCM) at sites not responsive to low‐level implementation support. STUDY DESIGN: Providers at participating sites received training and technical support to implement a CCM using the Replicating Effective Programs (REP) implementation strategy. After 6 months, nonresponding sites (

This pilot study examined the feasibility of delivering internet-based cognitive behavioral therapy (iCBT) to homebound older adults with symptoms of depression who are recipients of non-medical home care. A feasibility open trial was conducted in the homes of homecare older adults (n=26). When possible, home care workers (HCWs) of older adults (n=13) were recruited to provide external support for iCBT usage. In cases where consistent assistance from the same HCW was not feasible, participants were given the choice of working on the program on their own (n=7) or receiving assistance from a research assistant (RA) (n=6). The mean therapy sessions completed was 4.7 out of 8 total sessions. The mean satisfaction rating was 7.7 (SD=2.9) and 86% would recommend the program to others with depressed mood. Significant reductions in depressive symptoms and anxiety symptoms and improvement on a quality of life measure were observed at post-test. The RA-supported group tended to have the best adherence, satisfaction, and reduction in depressive symptoms, followed closely by the HCW-supported group. The self-guided group had the lowest adherence, satisfaction, and symptom reduction. iCBT is a feasible and acceptable treatment modality for homebound older adults with depressive symptoms and potentially effective. Data from the participant exit interviews suggest a need for refining the existing treatment platform to better meet the needs and capabilities of homebound older adults. Future studies are warranted to examine treatment effectiveness as a function of HCW support.

Background: Smartphones enable the implementation of just-in-time adaptive interventions (JITAIs) that tailor the delivery of health interventions over time to user- and time-varying context characteristics. Ideally, JITAIs include effective intervention components, and delivery tailoring is based on effective moderators of intervention effects. Using machine learning techniques to infer each user’s context from smartphone sensor data is a promising approach to further enhance tailoring. Objective: The primary objective of this study is to quantify main effects, interactions, and moderators of 3 intervention components of a smartphone-based intervention for physical activity. The secondary objective is the exploration of participants’ states of receptivity, that is, situations in which participants are more likely to react to intervention notifications through collection of smartphone sensor data. Methods: In 2017, we developed the Assistant to Lift your Level of activitY (Ally), a chatbot-based mobile health intervention for increasing physical activity that utilizes incentives, planning, and self-monitoring prompts to help participants meet personalized step goals. We used a microrandomized trial design to meet the study objectives. Insurees of a large Swiss insurance company were invited to use the Ally app over a 12-day baseline and a 6-week intervention period. Upon enrollment, participants were randomly allocated to either a financial incentive, a charity incentive, or a no incentive condition. Over the course of the intervention period, participants were repeatedly randomized on a daily basis to either receive prompts that support self-monitoring or not and on a weekly basis to receive 1 of 2 planning interventions or no planning. Participants completed a Web-based questionnaire at baseline and postintervention follow-up. Results: Data collection was completed in January 2018. In total, 274 insurees (mean age 41.73 years; 57.7% [158/274] female) enrolled in the study and installed the Ally app on their smartphones. Main reasons for declining participation were having an incompatible smartphone (37/191, 19.4%) and collection of sensor data (35/191, 18.3%). Step data are available for 227 (82.8%, 227/274) participants, and smartphone sensor data are available for 247 (90.1%, 247/274) participants. Conclusions: This study describes the evidence-based development of a JITAI for increasing physical activity. If components prove to be efficacious, they will be included in a revised version of the app that offers scalable promotion of physical activity at low cost., JMIR Research Protocols, 8 (1), ISSN:1929-0748

To (1) compare the 2015 hospital grades reported on Medicare's Hospital Compare website for heart failure (HF) and acute myocardial infarction (AMI) readmissions with the HF- and AMI-specific scores for excess readmissions used to assess Medicare readmission penalties and (2) assess how often hospitals were penalized for excess readmissions in only 1 or 2 conditions, given that hospitals received a penalty impacting all Medicare payments based on an overall readmission score calculated from 5 conditions (HF, AMI, pneumonia, chronic obstructive pulmonary disease, and total hip/knee arthroplasty).Retrospective secondary data analysis.Descriptive analyses of hospital-specific, condition-specific grades and excess readmission scores and hospital-level penalties downloaded from Hospital Compare.Of the 2956 hospitals that had publicly reported HF grades on Hospital Compare, 91.9% (2717) were graded as "no different" than the national rate for HF readmissions, which included 48.6% that were scored as having excessive HF admissions, and 87% received an overall readmission penalty. Of 120 (4.1%) hospitals graded as "better" than the national rate for HF, none were scored as having excessive HF readmissions and 50% were penalized. AMI data yielded similar results. Among 2591 hospitals penalized for overall readmissions, 26.6% had only 1 condition with excess readmissions and 27.5% had 2 conditions.Many hospitals with an HF and AMI readmission grade of "no different" than the national rate on Hospital Compare received penalties for excessive readmissions under the Hospital Readmissions Reduction Program. The value signal to consumers and hospitals communicated by grades and penalties is therefore weakened because the methods applied to the same hospital data produce conflicting messages of "average grades" yet "bad enough for penalty."

There is a growing interest in leveraging the prevalence of mobile technology to improve health by delivering momentary, contextualized interventions to individuals' smartphones. A just-in-time adaptive intervention (JITAI) adjusts to an individual's changing state and/or context to provide the right treatment, at the right time, in the right place. Micro-randomized trials (MRTs) allow for the collection of data which aid in the construction of an optimized JITAI by sequentially randomizing participants to different treatment options at each of many decision points throughout the study. Often, this data is collected passively using a mobile phone. To assess the causal effect of treatment on a near-term outcome, care must be taken when designing the data collection system to ensure it is of appropriately high quality. Here, we make several recommendations for collecting and managing data from an MRT. We provide advice on selecting which features to collect and when, choosing between "agents" to implement randomization, identifying sources of missing data, and overcoming other novel challenges. The recommendations are informed by our experience with HeartSteps, an MRT designed to test the effects of an intervention aimed at increasing physical activity in sedentary adults. We also provide a checklist which can be used in designing a data collection system so that scientists can focus more on their questions of interest, and less on cleaning data., Author accepted manuscript

Chart-based surveillance reviews indicate that the incidence of hospital-acquired pressure ulcers (HAPUs) declined 23 percent during 2010-14, equating to an estimated savings of $1 billion during that period. Yet it remains unclear whether the administrative data used to implement three Medicare value-based purchasing programs that target HAPUs indicate similar improvements, and how success varied by HAPU severity. These programs measure and penalize only for more severe ulcers (stage 3 or 4 or unstageable), which are much more costly than less severe cases (stage 1 or 2). We assessed HAPU incidence, severity, and trends using administrative data for 2009-14 from three states. The HAPU incidence we found was approximately one-twentieth of that found in chart-based surveillance review data. HAPU incidence in administrative data declined, but 96 percent of the change was due to a decline in the incidence of less severe HAPUs. Transitioning from administrative data to chart-based surveillance review to measure HAPUs (mirroring changes that have already been made in reporting hospital-acquired infections) and accounting for HAPU severity could improve the validity of HAPU measures for assessing the clinical and financial impact of value-based purchasing interventions.

Background Organizational culture and climate are considered key factors in implementation efforts but have not been examined as moderators of implementation strategy comparative effectiveness. We investigated organizational culture and climate as moderators of comparative effectiveness of two sequences of implementation strategies (Immediate vs. Delayed Enhanced Replicating Effective Programs [REP]) combining Standard REP and REP enhanced with facilitation on implementation of an outreach program for Veterans with serious mental illness lost to care at Veterans Health Administration (VA) facilities nationwide. Methods This study is a secondary analysis of the cluster-randomized Re-Engage implementation trial that assigned 3075 patients at 89 VA facilities to either the Immediate or Delayed Enhanced REP sequences. We hypothesized that sites with stronger entrepreneurial culture, task, or relational climate would benefit more from Enhanced REP than Standard REP. Veteran- and site-level data from the Re-Engage trial were combined with site-aggregated measures of entrepreneurial culture and task and relational climate from the 2012 VA All Employee Survey. Longitudinal mixed-effects logistic models examined whether the comparative effectiveness of the Immediate vs. Delayed Enhanced REP sequences were moderated by culture or climate measures at 6 and 12 months post-randomization. Three Veteran-level outcomes related to the engagement with the VA system were assessed: updated documentation, attempted contact by coordinator, and completed contact. Results For updated documentation and attempted contact, Veterans at sites with higher entrepreneurial culture and task climate scores benefitted more from Enhanced REP compared to Standard REP than Veterans at sites with lower scores. Few culture or climate moderation effects were detected for the comparative effectiveness of the full sequences of implementation strategies. Conclusions Implementation strategy effectiveness is highly intertwined with contextual factors, and implementation practitioners may use knowledge of contextual moderation to tailor strategy deployment. We found that facilitation strategies provided with Enhanced REP were more effective at improving uptake of a mental health outreach program at sites with stronger entrepreneurial culture and task climate; Veterans at sites with lower levels of these measures saw more similar improvement under Standard and Enhanced REP. Within resource-constrained systems, practitioners may choose to target more intensive implementation strategies to sites that will most benefit from them. Trial registration ISRCTN: ISRCTN21059161. Date registered: April 11, 2013. Electronic supplementary material The online version of this article (10.1186/s13012-018-0787-9) contains supplementary material, which is available to authorized users.

Background Peripherally inserted central catheters (PICCs) are associated with upper extremity-deep vein thrombosis (DVT). However, patterns, risk factors and treatment associated with this event remain poorly defined. Objective To determine patterns, risk factors and treatment related to PICC-DVT in hospitalized patients. Design, Setting & Patients Between 2012–2013, consecutive cases of ultrasound-confirmed, symptomatic PICC-DVT were identified. For each case, at least two contemporaneous controls were identified and matched by age and gender. Patient- and device-specific data were obtained through electronic-medical records. Using variables selected a priori, multivariable logistic regression models were fit to the outcome of PICC-DVT, comparing cases to controls. Results 909 adult hospitalized patients (268 cases, 641 controls) were included in the study. Indications for PICC placement included long-term intravenous antibiotic therapy (n = 447; 49.1%), in-hospital venous access for blood draws or infusion of medications (n = 342; 44.2%), and total parenteral nutrition (n = 120; 6.7%). Patients with PICC-DVT were more likely to have a history of venous thromboembolism (OR 1.70, 95% CI = 1.02-2.82) or have undergone surgery while the PICC was in situ (OR 2.17, 95%CI = 1.17-4.01 for surgeries longer than two hours). Treatment for PICC-DVT varied and included heparin bridging, low molecular weight heparin only and device removal only; the average duration of treatment also varied across these groups. Compared to 4-Fr PICCs, 5- and 6-Fr PICCs were associated with greater risk of DVT (OR 2.74, 95%CI = 0.75-10.09 and OR 7.40 95%CI = 1.94-28.16, respectively). Patients who received both aspirin and statins were less likely to develop PICC-DVT than those that received neither treatment (OR 0.31, 95%CI = 0.16-0.61). Receipt of pharmacological DVT prophylaxis during hospitalization showed a non-significant trend towards reduction in risk of PICC-DVT (OR = 0.72, 95%CI = 0.48-1.08). Conclusion Several factors appear associated with PICC-DVT. While some of these characteristics may be non-modifiable, future studies that target potentially modifiable variables to prevent this adverse outcome would be welcomed.

Voluntary Leapfrog Safe Practices Score (SPS) measures were among the first public reports of hospital performance. Recently, Medicare's Hospital Compare website has reported compulsory measures. Leapfrog's Hospital Safety Score (HSS) grades incorporate SPS and Medicare measures. We evaluate associations between Leapfrog SPS and Medicare measures, and the impact of SPS on HSS grades. Using 2013 hospital data, we linked Leapfrog HSS data with central line-associated bloodstream infection (CLABSI) and catheter-associated urinary tract infection (CAUTI) standardized infection ratios (SIRs), and Hospital Readmission and Hospital-Acquired Condition (HAC) Reduction Program penalties incorporating 2013 performance. For SPS-providing hospitals, we used linear and logistic regression models to predict CLABSI/CAUTI SIRs and penalties as a function of SPS. For hospitals not reporting SPS, we simulated change in HSS grades after imputing a range of SPS. In total, 1089 hospitals reported SPS; >50% self-reported perfect scores for all but 1 measure. No SPS measures were associated with SIRs. One SPS (feedback) was associated with lower odds of HAC penalization (odds ratio, 0.86; 95% confidence interval, 0.76-0.97). Among hospitals not reporting SPS (N=1080), 98% and 54% saw grades decline by 1+ letters with first and 10th percentile SPS imputed, respectively; 49% and 54% saw grades improve by 1+ letter with median and highest SPS imputed. Voluntary Leapfrog SPS measures skew toward positive self-report and bear little association with compulsory Medicare outcomes and penalties. SPS significantly impacts HSS grades, particularly when lower SPS is reported. With increasing compulsory reporting, Leapfrog SPS seems limited for comparing hospital performance.

Policy is a powerful motivator of clinical change, but implementation success can depend on organizational characteristics. This article used validated measures of organizational resources, culture, and climate to predict uptake of a nationwide Veteran's Health Administration (VA) policy aimed at implementing Re-Engage, a brief care management program that reestablishes contact with veterans with serious mental illness lost to care. Patient care databases were used to identify 2738 veterans lost to care. Local recovery coordinators (LRCs) were to update disposition for 2738 veterans at 158 VA facilities and, as appropriate, facilitate a return to care. Multivariable regression was used to assess organizational culture and climate as predictors of early policy compliance (via LRC presence) and uptake at 6 months. Higher composite climate and culture scores were associated with higher odds of having a designated LRC but were not predictive of higher uptake. Sites with LRCs had significantly higher rates of updated documentation than sites without LRCs.

Implementation science is focused on maximizing the adoption, appropriate use, and sustainability of effective clinical practices in real world clinical settings. Many implementation science questions can be feasibly answered by fully experimental designs, typically in the form of randomized controlled trials (RCTs). Implementation-focused RCTs, however, usually differ from traditional efficacy- or effectiveness-oriented RCTs on key parameters. Other implementation science questions are more suited to quasi-experimental designs, which are intended to estimate the effect of an intervention in the absence of randomization. These designs include pre-post designs with a non-equivalent control group, interrupted time series (ITS), and stepped wedges, the last of which require all participants to receive the intervention, but in a staggered fashion. In this article we review the use of experimental designs in implementation science, including recent methodological advances for implementation studies. We also review the use of quasi-experimental designs in implementation science, and discuss the strengths and weaknesses of these approaches. This article is therefore meant to be a practical guide for researchers who are interested in selecting the most appropriate study design to answer relevant implementation science questions, and thereby increase the rate at which effective clinical practices are adopted, spread, and sustained.