Implementing pharmacist-prescriber collaboration to improve evidence-based anticoagulant use: a randomized trial.

BACKGROUND: Direct oral anticoagulant medications are commonly used to treat or prevent thrombotic conditions, such as pulmonary embolism, deep vein thrombosis, and atrial fibrillation. However, up to 10-15% of patients receiving these medications get unsafe doses based on a patient's kidney or liver function, potential interactions with other medications, and indication for taking the medication. Alert systems may be beneficial for improving evidence-based prescribing, but can be burdensome and are not currently able to provide monitoring after the initial prescription is written. METHODS/DESIGN: This study will improve upon existing alert systems by testing novel medication alerts that encourage collaboration between prescribers (e.g., physicians, nurse practitioners, physician assistants) and expert pharmacists working in anticoagulation clinics. The study will also improve upon the existing alert system by incorporating dynamic long-term monitoring of patient needs and encouraging collaboration between prescribers and expert pharmacists working in anticoagulation clinics. Incorporating state-of-the-art user-centered design principles, prescribing healthcare providers will be randomized to different types of electronic health record medication alerts when a patient has an unsafe anticoagulant prescription. We will identify which alerts are most effective at encouraging evidence-based prescribing and will test moderators to tailor alert delivery to when it is most beneficial. The aims of the project are to (1) determine the effect of notifications targeting existing inappropriate DOAC prescriptions; (2) examine the effect of alerts on newly prescribed inappropriate DOACs; and (3) examine changes in the magnitude of effects over time for both the new prescription alerts and existing prescription notifications for inappropriate DOACs over the 18-month study period. DISCUSSION: Findings from this project will establish a framework for implementing prescriber-pharmacist collaboration for high-risk medications, including anticoagulants. If effectively implemented at the more than 3000 anticoagulation clinics that exist nationally, hundreds of thousands of patients taking direct oral anticoagulants stand to benefit from safer, evidence-based healthcare. TRIALS REGISTRATION: NCT05351749.

Self-administered acupressure for veterans with chronic back pain: Study design and methodology of a type 1 hybrid effectiveness implementation randomized controlled trial.

BACKGROUND: Chronic low back pain is prevalent and disabling in Veterans, but effective pain management is challenging. Clinical practice guidelines emphasize multimodal pain management including evidence-based complementary and integrative health treatments such as acupressure as a first line of care. Unfortunately, the ability to replicate interventions, cost, resources, and limited access are implementation barriers. Self-administered acupressure has shown positive effects on pain and can be practiced anywhere with little to no side effects. METHODS/DESIGN: The aims of this Type 1 hybrid effectiveness implementation randomized controlled trial are 1) to determine effectiveness of a self-administered acupressure protocol at improving pain interference and secondary outcomes of fatigue, sleep quality, and disability in 300 Veterans with chronic low back pain, and 2) evaluate implementation barriers and facilitators to scale-up acupressure utilization within Veterans Health Administration (VHA). Participants randomized to the intervention will receive instruction on acupressure application using an app that facilitates daily practice for 6 weeks. During weeks 6 through 10, participants will discontinue acupressure to determine sustainability of effects. Participants randomized to waitlist control will continue their usual care for pain management and receive study materials at the end of the study period. Outcomes will be collected at baseline and at 6- and 10-weeks post baseline. The primary outcome is pain interference, measured by the PROMIS pain interference scale. Using established frameworks and a mixed methods approach, we will evaluate intervention implementation. DISCUSSION: If acupressure is effective, we will tailor strategies to support implementation in the VHA based on study findings. TRIAL REGISTRATION NUMBER: NCT05423145.

Antiseizure Medication Withdrawal Practice Patterns: A Survey Among Members of the American Academy of Neurology and EpiCARE.

Background and Objectives: To describe neurologist practice patterns, challenges, and decision support needs pertaining to withdrawal of antiseizure medications (ASMs) in patients with well-controlled epilepsy. Methods: We 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. Results: We 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. Discussion: Most 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.

Individual and organizational factors as predictors of early evidence-based practice adoption in Michigan high schools: Baseline data from an implementation trial.

Background: Adolescents increasingly access mental health services in schools. School mental health professionals (SPs; school counselors, social workers, etc.) can offer evidence-based mental health practices (EBPs) in schools, which may address access gaps and improve clinical outcomes. Although some studies have assessed factors associated with EBP adoption in schools, additional research focusing on SP- and school-level factors is warranted to support EBP implementation as SPs' mental health delivery grows. Methods: Baseline data were collected from SPs at Michigan high schools participating in a statewide trial to implement SP-delivered cognitive behavioral therapy (CBT) to students. Models examined factors associated with attitudes about EBPs, implementation climate, and implementation leadership, and their associations with CBT knowledge, training attendance, and pre-training CBT delivery. Results: One hundred ninety-eight SPs at 107 schools (87%) completed a baseline survey. The mean Evidence-Based Practice Attitude Scale (EBPAS) total score was 2.9, and school-aggregated mean scores of the Implementation Climate Scale (ICS) and Implementation Leadership Scale (ILS) were 1.83 and 1.77, respectively, all on a scale ranging from 0 (low) to 4 (high). ICS and ILS scores were lower than typically reported in clinical settings, while EBPAS scores were higher. School characteristics were not significantly associated with EBPAS, ICS, or ILS scores, but scores did differ by SP role. Higher EBPAS scores were associated with more CBT knowledge (average marginal effect for 1 SD change [AME] = 0.15 points) and a higher probability of training completion (AME = 8 percentage points). Higher ICS scores were associated with a higher probability of pre-training CBT delivery (AME = 6 percentage points), and higher ILS scores were associated with higher probability of training completion (AME = 10 percentage points). Conclusions: Our findings suggest that SPs' attitudes toward EBPs and organizational support were positively associated with early signs of implementation success. As schools increasingly fill the adolescent mental healthcare access gap, efforts to strengthen both provider attitudes toward EBP and strategic organizational factors supporting EBP delivery will be key to encouraging EBP uptake in schools. Plain Language Summary: Schools are an important setting in which adolescents receive mental healthcare. We need to better understand how to implement evidence-based practices (EBPs) in this setting to improve student mental health. This study examined the attitudes and perceptions of school professionals (SPs) as key contributors to the implementation of a particular EBP, the delivery of cognitive behavioral therapy (CBT) in schools. The study found that implementation climate and leadership scores in participating schools were lower than scores typically reported in clinical settings, while scores for SP attitudes about EBP adoption were higher than typical scores in clinical settings. Results further suggest that SPs with more positive attitudes toward EBPs are more knowledgeable of CBT and more likely to complete a 1-day CBT training. We also found that higher implementation climate scores were associated with SPs reporting pre-training CBT delivery (although this association was not statistically significant), and more implementation leadership was associated with SPs completing the CBT training. These findings suggest that SP attitudes toward EBPs and organizational support in schools are positively associated with early signs of implementation success. Early, low-intensity efforts to (1) improve SP attitudes about mental health EBPs, and (2) increase schools' support for implementation may scaffold more intensive implementation efforts in schools down the road.

Antiseizure medication withdrawal risk estimation and recommendations: A survey of American Academy of Neurology and EpiCARE members.

OBJECTIVE: Choosing candidates for antiseizure medication (ASM) withdrawal in well-controlled epilepsy is challenging. We evaluated (a) the correlation between neurologists' seizure risk estimation ("clinician predictions") vs calculated predictions, (b) how viewing calculated predictions influenced recommendations, and (c) barriers to using risk calculation. METHODS: We asked US and European neurologists to predict 2-year seizure risk after ASM withdrawal for hypothetical vignettes. We compared ASM withdrawal recommendations before vs after viewing calculated predictions, using generalized linear models. RESULTS: Three-hundred and forty-six neurologists responded. There was moderate correlation between clinician and calculated predictions (Spearman coefficient 0.42). Clinician predictions varied widely, for example, predictions ranged 5%-100% for a 2-year seizure-free adult without epileptiform abnormalities. Mean clinician predictions exceeded calculated predictions for vignettes with epileptiform abnormalities (eg, childhood absence epilepsy: clinician 65%, 95% confidence interval [CI] 57%-74%; calculated 46%) and surgical vignettes (eg, focal cortical dysplasia 6-month 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 for vignettes without epileptiform abnormalities. The greatest barrier to calculator use was doubting its accuracy (44%). SIGNIFICANCE: Clinicians 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.

A Community-Engaged Process for Adapting a Cardiovascular Health Intervention for Persons with Serious Mental Illness.

Introduction: People with serious mental illness experience grave disparities in cardiovascular disease risk factors. To promote scale-up of effective cardiovascular disease risk reduction interventions from clinical trials, it is important to involve end-users in adapting interventions to fit the needs of community-based settings. Objective: We describe a novel, theory-informed process of garnering community input to adapt IDEAL Goals, an evidence-based intervention for improving cardiovascular disease risk factors in persons with serious mental illness. Setting: Outpatient community mental health programs in Maryland and Michigan implementing behavioral health homes, which provide enhanced support to people living with both physical and mental illnesses. Participants: Clinicians, frontline staff, and administrators from community mental health organizations and persons with serious mental illness. Methods: Our approach to community engagement is based on the Replicating Effective Programs (REP) framework. During the REP preimplementation phase, we used 2 community engagement activities: (1) a "needs assessment" to identify anticipated implementation barriers and facilitators, and (2) "community working groups" to collaboratively engage with end-users in adapting the intervention and implementation strategies. Main Findings: We used the Stakeholder Engagement Reporting Questionnaire to describe our processes for conducting a needs assessment, involving site-level surveys (N=26) and individual interviews (N=94), and convening a series of community working groups with clinicians and staff (mean, 24 per meeting) and persons with serious mental illness (mean, 8 per meeting). Conclusions: By specifying the nature and extent of our community engagement activities, we aim to contribute to the evidence base of how to better integrate and measure community-engaged processes in the adaptation of evidence-based interventions.

Digital mental health interventions for chronic serious mental illness: Findings from a qualitative study on usability and scale-up of the Life Goals app for bipolar disorder.

The Life Goals (LG) application is an evidence-based self-management tool intended to help individuals with bipolar disorder (BD) by aligning symptom coping strategies with personal goals. The program has traditionally been offered in-person or via the web, but has recently been translated into an individualized, customizable mobile intervention to improve access to care and reduce provider burden. The LG app previously showed acceptability with ease of use and satisfaction with user interface, but less success in encouraging self-management. To better understand patient needs, our team conducted semi-structured interviews with 18 individuals with BD who used the LG app for 6 months. These interviews also investigated participant interest in sharing LG app data with their provider through an online dashboard. Using affinity mapping, a collaborative, qualitative data analysis technique, our team identified emerging common themes in the interviews. Through this process, team members identified 494 pieces of salient information from interviews that were mapped and translated into three main findings: (1) many participants found Mood Monitoring and LG modules helpful/interesting and stated the app overall had positive impacts on their mental health, (2) some components of the app were too rudimentary or impersonal to be beneficial, and (3) feedback was mixed regarding future implementation of an LG provider dashboard, with some participants seeing potential positive impacts and others hesitating due to perceived efficacy and privacy concerns. These findings can help researchers improve app-based interventions for individuals with BD by increasing app usage and improving care overall.

Primary aim results of a clustered SMART for developing a school-level, adaptive implementation strategy to support CBT delivery at high schools in Michigan.

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.

Care team and practice-level implementation strategies to optimize pediatric collaborative care: study protocol for a cluster-randomized hybrid type III trial.

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.

Developing a statewide network of coaches to support youth access to evidence-based practices.

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.

The Life Goals Self-Management Mobile App for Bipolar Disorder: Consumer Feasibility, Usability, and Acceptability Study.

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.

A Roadmap to Inform the Implementation of Evidence-Based Collaborative Care Interventions in Communities: Insights From the Michigan Mental Health Integration Partnership.

Background: Despite increasing calls for further spread of evidence-based collaborative care interventions (EBIs) in community-based settings, practitioner-driven efforts are often stymied by a lack of experience in addressing barriers to community-based implementation, especially for those not familiar with implementation science. The Michigan Mental Health Integration Partnership (MIP) is a statewide initiative that funds projects that support implementation and uptake of EBIs in community-based settings. MIP also provides an in situ implementation laboratory for understanding barriers to the uptake of EBIs across a variety of settings. We report findings from a statewide qualitative study of practitioners involved in MIP projects to garner their perspectives of best practices in the implementation of EBIs. Methods: Twenty-eight semi-structured interviews of practitioners and researchers from six MIP Projects were conducted with individuals implementing various MIP EBI projects across Michigan, including stakeholders from project teams, implementation sites, and the State of Michigan, to identify common barriers, challenges, and implementation strategies deployed by the project teams, with the purpose of informing a set of implementation steps and milestones. Results: Stakeholders identified a number of barriers to and strategies for success, including the need for tailoring program deployment and implementation to specific site needs, development of web-based tools for facilitating program implementation, and the importance of upper-level administration buy-in. Findings informed our resultant community-based Implementation Roadmap, which identifies critical steps across three implementation phases-pre-implementation, implementation, and sustainability-for implementation practitioners to use in their EBI implementation efforts. Conclusion: Implementation practitioners interested in community-based EBI implementation often lack access to operationalized implementation "steps" or "best practices" that can facilitate successful uptake and evaluation. Our community-informed MIP Implementation Roadmap, offering generalized steps for reaching successful implementation, uses experiences from a diverse set of MIP teams to guide practitioners through the practices necessary for scaling up EBIs in community-based settings over pre-implementation, implementation and sustainability phases.

A Scoping Review of Behavioral Interventions Addressing Medical Financial Hardship.

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.

Cost-effectiveness of the Adaptive Implementation of Effective Programs Trial (ADEPT): approaches to adopting implementation strategies.

BACKGROUND: Theory-based methods to support the uptake of evidence-based practices (EBPs) are critical to improving mental health outcomes. Implementation strategy costs can be substantial, and few have been rigorously evaluated. The purpose of this study is to conduct a cost-effectiveness analysis to identify the most cost-effective approach to deploying implementation strategies to enhance the uptake of Life Goals, a mental health EBP. METHODS: We used data from a previously conducted randomized trial to compare the cost-effectiveness of Replicating Effective Programs (REP) combined with external and/or internal facilitation among sites non-responsive to REP. REP is a low-level strategy that includes EBP packaging, training, and technical assistance. External facilitation (EF) involves external expert support, and internal facilitation (IF) augments EF with protected time for internal staff to support EBP implementation. We developed a decision tree to assess 1-year costs and outcomes for four implementation strategies: (1) REP only, (2) REP+EF, (3) REP+EF add IF if needed, (4) REP+EF/IF. The analysis used a 1-year time horizon and assumed a health payer perspective. Our outcome was quality-adjusted life years (QALYs). The economic outcome was the incremental cost-effectiveness ratio (ICER). We conducted deterministic and probabilistic sensitivity analysis (PSA). RESULTS: Our results indicate that REP+EF add IF is the most cost-effective option with an ICER of $593/QALY. The REP+EF/IF and REP+EF only conditions are dominated (i.e., more expensive and less effective than comparators). One-way sensitivity analyses indicate that results are sensitive to utilities for REP+EF and REP+EF add IF. The PSA results indicate that REP+EF, add IF is the optimal strategy in 30% of iterations at the threshold of $100,000/QALY. CONCLUSIONS: Our results suggest that the most cost-effective implementation support begins with a less intensive, less costly strategy initially and increases as needed to enhance EBP uptake. Using this approach, implementation support resources can be judiciously allocated to those clinics that would most benefit. Our results were not robust to changes in the utility measure. Research is needed that incorporates robust and relevant utilities in implementation studies to determine the most cost-effective strategies. This study advances economic evaluation of implementation by assessing costs and utilities across multiple implementation strategy combinations. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02151331 , 05/30/2014.

Comparative effectiveness of external vs blended facilitation on collaborative care model implementation in slow-implementer community practices.

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 (ΔEF/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 (ΔEF/IF-EF  = 9.2 patients, 95% CI: 5.72, 12.63). For sites with prerandomization uptake (adopter sites), EF/IF offered no additional benefit (ΔEF/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.

Which Components of a Smartphone Walking App Help Users to Reach Personalized Step Goals? Results From an Optimization Trial.

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.

Experimental and quasi-experimental designs in implementation research.

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.

Practical Considerations for Data Collection and Management in Mobile Health Micro-randomized Trials.

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.