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.

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.

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.

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.

Change in Patient Outcomes After Augmenting a Low-level Implementation Strategy in Community Practices That Are Slow to Adopt a Collaborative Chronic Care Model: A Cluster Randomized Implementation Trial.

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.

Randomized Controlled Trial of a Collaborative Care Intervention for Mood Disorders by a National Commercial Health Plan.

OBJECTIVE: Few individuals with mood disorders have access to evidence-based collaborative chronic care models (CCMs) because most patients are seen in small-group practices (<20 providers) with limited capacity to deliver CCMs. In this single-blind randomized controlled trial, we determined whether a CCM delivered nationally in a U.S. health plan improved 12-month outcomes among enrollees with mood disorders compared with usual care. METHODS: Aetna insurance enrollees (N=238), mostly females (66.1%) with a mean age of 41.1 years, who were recently hospitalized for unipolar major depression or bipolar disorder provided informed consent, completed baseline assessments, and were randomly assigned to usual care or CCM. The CCM included 10 sessions of the Life Goals self-management program and brief contacts by phone by a care manager to determine symptom status. Primary outcomes were changes over 12 months in depression symptoms (nine-item Patient Health Questionnaire [PHQ-9]) and mental health-related quality of life (Short Form-12). RESULTS: Adjusted mean PHQ-9 scores were lower by 2.34 points (95% confidence level [CL]=-4.18 to -0.50, p=0.01), indicating improved symptoms, and adjusted mean SF-12 mental health scores were higher by 3.21 points (CL=-.97 to 7.38, p=0.10), indicating better quality of life, among participants receiving CCM versus usual care. CONCLUSIONS: Individuals receiving CCM compared with usual care had improved clinical outcomes, although substantial attrition may limit the impact of health plan-level delivery of CCMs. Further research on the use of health plan-level interventions, such as CCMs, as alternatives to practice-based models is warranted.

Adaptive School-based Implementation of CBT (ASIC): clustered-SMART for building an optimized adaptive implementation intervention to improve uptake of mental health interventions in schools.

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.

Organizational culture and climate as moderators of enhanced outreach for persons with serious mental illness: results from a cluster-randomized trial of adaptive implementation strategies.

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.