Comparative Effectiveness of Patient-Driven versus Standardized Diabetes Shared Medical Appointments: A Pragmatic Cluster Randomized Trial.

BACKGROUND: Diabetes self-management education and support can be effectively and efficiently delivered in primary care in the form of shared medical appointments (SMAs). Comparative effectiveness of SMA delivery features such as topic choice, multi-disciplinary care teams, and peer mentor involvement is not known. OBJECTIVE: To compare effects of standardized and patient-driven models of diabetes SMAs on patient-level diabetes outcomes. DESIGN: Pragmatic cluster randomized trial. PARTICIPANTS: A total of 1060 adults with type 2 diabetes in 22 primary care practices. INTERVENTIONS: Practice personnel delivered the 6-session Targeted Training in Illness Management (TTIM) curriculum using either standardized (set content delivered by a health educator) or patient-driven SMAs (patient-selected topic order delivered by health educators, behavioral health providers [BHPs], and peer mentors). MAIN MEASURES: Outcomes included self-reported diabetes distress and diabetes self-care behaviors from baseline and follow-up surveys (assessed at 1st and final SMA session), and HbA1c, BMI, and blood pressure from electronic health records. Analyses used descriptive statistics, linear regression, and linear mixed models. KEY RESULTS: Both standardized and patient-driven SMAs effectively improved diabetes distress, self-care behaviors, BMI (- 0.29 on average), and HbA1c (- 0.45% (mmol/mol) on average, 8.3 to 7.8%). Controlling for covariates, there was a small, significant effect of condition on overall diabetes distress in favor of standardized SMAs (F(1,841) = 4.3, p = .04), attributable to significant effects of condition on emotion and regimen distress subscales. There was a small, significant effect of condition on diastolic blood pressure in favor of standardized SMAs (F(1,5199) = 4.50, p = .03). There were no other differences between conditions. CONCLUSIONS: Both SMA models using the TTIM curriculum yielded significant improvement in diabetes distress, self-care, and HbA1c. Patient-driven diabetes SMAs involving BHPs and peer mentors and topic selection did not lead to better clinical or patient-reported outcomes than standardized diabetes SMAs facilitated by a health educator following a set topic order. NIH TRIAL REGISTRY NUMBER: NCT03590041.

Stepped-care to improve mental health outcomes among underserved patients with lung and head and neck cancer.

BACKGROUND: The comparative effectiveness study (ClinicalTrials.gov, NCT03016403) assessed the effects of a stepped-care intervention versus usual care on mental health outcomes, including anxiety, depression, coping self-efficacy, emotional distress (anxiety and depression combined), health-related quality of life (HRQoL), and perceived stress among underserved patients (i.e., low-income, uninsured, underinsured) with lung cancer (LC) and head-and-neck cancer (HNC). METHODS: In a randomized controlled trial, we investigated if 147 patients who received the stepped-care intervention had better mental health outcomes compared to 139 patients who received usual care. Using an intent-to-treat approach, we analyzed outcomes with linear mixed models. RESULTS: For the primary outcomes estimated mean differences (denoted by "Δ"), depression (Δ = 1.75, 95% CI = 0.52, 2.98, p = 0.01) and coping self-efficacy (Δ = -15.24, 95% CI = -26.12, -4.36, p = 0.01) were better for patients who received the intervention compared to patients who received usual care, but anxiety outcomes were not different. For secondary outcomes, emotional distress (Δ = 1.97, 95% CI: 0.68, 3.54, p =< 0.01) and HRQoL (Δ = -4.16 95% CI: -7.45, -0.87, p = 0.01) were better for patients who received the intervention compared to usual care patients, while perceived stress was not different across groups. CONCLUSIONS: The stepped-care intervention influenced depression and coping self-efficacy, important outcomes for patients with acute illnesses like LC and HNC. Although differences in emotional distress met the minimally important differences (MID) previously reported, depression and HRQoL were not above the MID threshold. Our study is among a few to report differences in mental health outcomes for underserved LC and HNC patients after receiving a psychological intervention. GOV IDENTIFIER: NCT03016403.

A Multi-Method Study of Patient Reach and Attendance in a Pragmatic Trial of Diabetes Shared Medical Appointments.

Shared medical appointments (SMAs) are an evidence-based approach to diabetes care in primary care settings, yet practices can struggle to ensure participation, especially among racial and ethnic minority and low-income patients. We conducted a multimethod evaluation of reach and attendance in the Invested in Diabetes study of the comparative effectiveness of two SMA delivery models (standardized and patient-driven) in two practice settings (federally qualified health centers [FQHCs] and clinics serving more commercially insured patients). Through this study, 22 practices reached 6.2% of patients with diabetes through SMAs over 3 years, with good attendance for both practice types and both SMA delivery models. FQHCs were especially successful at enrolling underserved populations and improved attendance with virtual SMAs.

Patient perspectives on diabetes shared medical appointments before, during, and after the COVID-19 pandemic.

Context: Shared Medical Appointments for diabetes (SMAs) are an evidence-based strategy improve health outcomes. However, which elements of SMAs are important remain unknown. Invested in Diabetes studied two implementation approaches (standardized [STD] vs. patient-driven [PTD]), using a curriculum focused on mental health and skill building in addition to diabetes self-management. Objective: To understand patient experiences and preferences, including care team and peer mentor involvement, and how teaching style affected satisfaction. Those completing SMAs after the COVID pandemic began discussed their experience with virtual SMAs. Study Design: Semi-structured interviews, conducted between 2019-21. Setting: 21 primary care practices in Colorado and Kansas. Population: Patients with type 2 diabetes who attended SMAs at participating sites. Outcome Measures: Transcripts were analyzed using qualitative thematic analysis (data triangulation and a constant comparative technique). Results: Forty-one patients from 14 participating clinics agreed to participate (25 STD, 16 PTD). All patients completed their 6-class cohort. Both newly diagnosed patients and those living with diabetes for longer found classes useful. Patients generally enjoyed the content, with nutrition favored most. Opinion on mental health topics and skill building varied, but overall deemed valuable. The social aspect of SMAs was seen as the biggest benefit. However, the peer mentor role (PTD only) was not always appreciated. Patient topic order selection and behavioral health as part of the care team (PTD only) were viewed as helpful but not necessary, though guest lecturers were supported by all. Facilitators were mostly seen as supportive and their teaching style agreeable, which contributed considerably to positive experiences. Those who did virtual SMAs had mostly positive views. The format allowed continuation of care that may have been halted due to the pandemic, let people with busy schedules to participate, and in some instances made sharing easier to do. Some would still have preferred an in-person class. Conclusions: Patients found SMAs beneficial, favoring classic diabetes self-management topics over mental health and skill building. The peer mentor role was not always well received, likely due to variations in the peer mentor. Teaching style was very important to satisfaction, and all patients wanted guest speakers with varied expertise. A virtual format was acceptable. .

Protocol refinement for a diabetes pragmatic trial using the PRECIS-2 framework.

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

Pilot Randomized Controlled Trial of Web-Delivered Acceptance and Commitment Therapy Versus Smokefree.gov for Smokers With Bipolar Disorder.

INTRODUCTION: Smokers with bipolar disorder (BD) are less successful at quitting than the general population. In this study, we evaluated in a pilot randomized controlled trial a novel, targeted, web-based intervention for smokers with BD based on acceptance and commitment therapy (ACT) and designed for reach and disseminability. AIMS AND METHODS: Daily smokers (n = 51) with bipolar I or II disorder were recruited from four US sites and randomly assigned to one of two web-based smoking cessation interventions-ACT-based WebQuit Plus (n = 25) or Smokefree.gov (n = 26) over a 10-week treatment period. All participants received nicotine patch for 8 weeks. Key outcomes were trial design feasibility, intervention acceptability, and cessation at end of treatment and 1-month follow-up. RESULTS: We screened 119 to enroll 51 participants (target sample size = 60) over 24 months. The most common reason for ineligibility was the inability to attend study appointments. Retention was 73% at end of treatment and 80% at follow-up, with no differences by arm. The mean number of logins was twice as high for WebQuit Plus (10.3 vs. 5.3). The usefulness of program skills was rated higher for WebQuit Plus (75% vs. 29%). Biochemically confirmed, 7-day abstinence at end of treatment was 12% in WebQuit Plus versus 8% in Smokefree.gov (odds ratio = 1.46, 95% confidence interval = 0.21 to 9.97). At follow-up, abstinence rates were 8% in both arms. CONCLUSIONS: Trial design produced favorable retention rates, although alternative recruitment methods will be needed for a larger trial. At end of treatment, acceptability and estimated effect size of WebQuit Plus relative to Smokefree.gov were promising and support continued program refinement and evaluation. IMPLICATIONS: In this first randomized controlled trial of a targeted intervention for smokers with BD, we found that the ACT-based WebQuit Plus intervention, delivered in combination with the nicotine patch, had promising acceptability and cessation outcomes relative to Smokefree.gov. The observed signals for acceptability and cessation suggest that the WebQuit Plus program should be refined based on participant feedback and evaluated in a larger trial. Feasibility findings from this study also provide direction for refining trial procedures to enhance the recruitment of smokers with BD.

Developing a Regional Distributed Data Network for Surveillance of Chronic Health Conditions: The Colorado Health Observation Regional Data Service.

Electronic health records (EHRs) provide an alternative to traditional public health surveillance surveys and administrative data for measuring the prevalence and impact of chronic health conditions in populations. As the infrastructure for secondary use of EHR data improves, many stakeholders are poised to benefit from data partnerships for regional access to information. Electronic health records can be transformed into a common data model that facilitates data sharing across multiple organizations and allows data to be used for surveillance. The Colorado Health Observation Regional Data Service, a regional distributed data network, has assembled diverse data partnerships, flexible infrastructure, and transparent governance practices to better understand the health of communities through EHR-based, public health surveillance. This article describes attributes of regional distributed data networks using EHR data and the history and design of Colorado Health Observation Regional Data Service as an emerging public health surveillance tool for chronic health conditions. Colorado Health Observation Regional Data Service and our experience may serve as a model for other regions interested in similar surveillance efforts. While benefits from EHR-based surveillance are described, a number of technology, partnership, and value proposition challenges remain.

Long-Term Clinical Outcomes from a Randomized Controlled Trial of Two Implementation Strategies to Promote Collaborative Care Attendance in Community Practices.

This randomized controlled implementation study compared the effectiveness of a standard versus enhanced version of the replicating effective programs (REP) implementation strategy to improve the uptake of the life goals-collaborative care model (LG-CC) for bipolar disorder. Seven community-based practices (384 patient participants) were randomized to standard (manual/training) or enhanced REP (customized manual/training/facilitation) to promote LG-CC implementation. Participants from enhanced REP sites had no significant changes in primary outcomes (improved quality of life, reduced functioning or mood symptoms) by 24 months. Further research is needed to determine whether implementation strategies can lead to sustained, improved participant outcomes in addition to program uptake.

Integrated Behavioral Health Implementation and Training in Primary Care: A Practice-Based Research Network Study.

INTRODUCTION: Integrating behavioral health services into primary care has a strong evidence base, but how primary care training programs incorporate integrated behavioral health (IBH) into care delivery and training has not been well described. The goal of this study was to evaluate factors related to successful IBH implementation in family medicine (FM) residency programs and assess perspectives and attitudes on IBH among program leaders. METHODS: FM residency programs, all which are required to provide IBH training, were recruited from the American Academy of Family Physicians National Research Network. After completing eligibility screening that included the Integrated Practice Assessment Tool (IPAT) questionnaire, 14 training programs were included. Selected practices identified 3 staff in key roles to be interviewed: medical director or similar, behavioral health professional (BHP), and chief medical officer or similar. RESULTS: Forty-one individuals from 14 FM training programs were interviewed. IPAT scores ranged from 4 (Close Collaboration Onsite) to 6 (Full Collaboration). Screening, outcome tracking, and treatment differed among and within practices. Use of curricula and trainee experience also varied with little standardization. Most participants described similar approaches to communication and collaboration between primary care clinicians and BHPs and believed that IBH should be standard practice. Participants reported space, staff, and billing support as critical for sustainability. CONCLUSIONS: Delivery and training experiences in IBH varied widely despite recognition of the value and benefits to patients and care delivery processes. Standardizing resources and training and simplifying and assuring reimbursement for services may promote sustainable and high quality IBH implementation.

Integrated Behavioral Health Adaptations During the COVID-19 Pandemic.

INTRODUCTION: COVID-19 pandemic lockdowns threatened standard components of integrated behavioral health (IBH) such as in-person communication across care teams, screening, and assessment. Restrictions also exacerbated pre-existing challenges to behavioral health (BH) access. METHODS: Semistructured interviews were completed with clinicians from family medicine residency programs on the impact of the pandemic on IBH care delivery along with adaptations employed by care teams to ameliorate disruption. RESULTS: Participants (n = 41) from 14 family medicine residency programs described the rapid shift to virtual care, creating challenges for IBH delivery and increased demand for BH services. With patients and care team members at home, virtual warm handoffs and increased attention to communication were necessary. Screening and measurement were more difficult, and referrals to appropriate services were challenging due to higher demand. Tele-BH facilitated continued access to BH services but was associated with logistic challenges. Participants described adaptations to stay connected with patients and care teams and discussed the need to increase capacity for both in-person and virtual care. DISCUSSION: Most practices modified their workflows to use tele-BH as COVID-19 cases increased. Participants shared key learnings for successful implementation of tele-BH that could be applied in future health care crises. CONCLUSION: Practices adapted readily to challenges posed by pandemic restrictions and their ability to sustain key elements of IBH during the COVID-19 pandemic demonstrates innovation in maintaining access when in-person care is not possible, informing strategies applicable to other scenarios.

Pilot randomized trial of a cross-diagnosis collaborative care program for patients with mood disorders.

OBJECTIVES: Chronic care models improved outcomes for persons with mental disorders but to date have primarily been tested for single diagnoses (e.g. unipolar depression). We report findings from a pilot multisite randomized controlled trial of a cross-diagnosis care model for patients with mood disorders. METHODS: Patients (N = 60) seen in one of four primary care or mental health clinics affiliated with the National Network of Depression Centers were randomized to receive a mood disorder care model, Life Goals Collaborative Care (LGCC, N = 29) or usual care (N = 31). LGCC consisted of five group self-management sessions focused on mood symptom coping and health behavior change strategies followed by monthly patient and provider care management contacts for up to 6 months. Outcomes at 3 and 6 months included mood symptoms (Patient Health Questionnaire-PHQ-9, Internal State Scale-well-being, Generalized Anxiety Disorder scale) and health-related quality of life. RESULTS: Of the 60 enrolled, the mean age was 46.2 (SD = 13.2), 73.3% were female, 16.7% were non-white, and 36.8% had a bipolar disorder diagnosis. LGCC was associated with greater likelihood of depressive symptom remission in 6 months (respectively, 50% versus 19% had a PHQ-9 score ≤9 and 50% reduction in PHQ-9 score, P = .04) and improved well-being (ß = 2.66, P ≤ .01, Cohen's D = 0.43). CONCLUSIONS: LGCC may improve outcomes for patients regardless of mood diagnosis, potentially providing a feasible and generalizable chronic care model for routine practice settings.

Delivering diabetes shared medical appointments in primary care: early and mid-program adaptations and implications for successful implementation.

BACKGROUND: Self-management is essential for good outcomes in type 2 diabetes and patients often benefit from self-management education. Shared medical appointments (SMAs) can increase self-efficacy for self management but are difficult for some primary care practices to implement. Understanding how practices adapt processes and delivery of SMAs for patients with type 2 diabetes may provide helpful strategies for other practices interested in implementing SMAs. METHODS: The Invested in Diabetes study was a pragmatic cluster-randomized, comparative effectiveness trial designed to compare two different models of diabetes SMAs delivered in primary care. We used a multi-method approach guided by the FRAME to assess practices' experience with implementation, including any planned and unplanned adaptations. Data sources included interviews, practice observations and field notes from practice facilitator check-ins. RESULTS: Several findings were identified from the data: 1) Modifications and adaptations are common in implementation of SMAs, 2) while most adaptations were fidelity-consistent supporting the core components of the intervention conditions as designed, some were not, 3) Adaptations were perceived to be necessary to help SMAs meet patient and practice needs and overcome implementation challenges, and 4) Content changes in the sessions were often planned and enacted to better address the contextual circumstances such as patient needs and culture. DISCUSSION: Implementing SMAs in primary care can be challenging and adaptations of both implementation processes and content and delivery of SMAS for patients with type 2 diabetes were common in the Invested in Diabetes study. Recognizing the need for adaptations based on practice context prior to implementation may help improve fit and success with SMAs, but care needs to be given to ensure that adaptations do not weaken the impact of the intervention. Practices may be able to assess what might need to adapted for them to be successful prior to implementation but likely will continue to adapt after implementation. CONCLUSION: Adaptations were common in the Invested in Diabetes study. Practices may benefit from understanding common challenges in implementing SMAs and adapting processes and delivery based on their own context. TRIAL REGISTRATION: This trial is registered on clinicaltrials.gov under Trial number NCT03590041, posted 18/07/2018.

Exploring digital cognitive behavioural therapy for insomnia in an early intervention in psychosis service - A study protocol for an initial feasibility study with process evaluation.

AIM: Early psychosis may be a critical time at which clinical trajectories are still evolving, and sleep interventions hold promise to improve outcomes at this stage. Although cognitive behavioural therapy (CBT) for insomnia shows promise in psychosis, there has been limited evaluation of delivery within current care. This study aims to evaluate the feasibility and acceptability of providing fully-automated digital CBT for insomnia (CBT-I) within an early intervention in psychosis service. METHODS: We will conduct a single-arm feasibility trial within an early psychosis intervention service, and up to 40 individuals experiencing a first episode of psychosis and with evidence of insomnia can be enrolled (May 2021 - August 2022). Additional service user inclusion criteria are capacity to consent and access to a suitable technological device to access digital CBT. Participants will be offered access to a fully-automated digital CBT-I program (Sleepio) delivered using web and/or mobile app. The study comprises pre- and post- intervention questionnaire assessments and interviews with service users and staff to provide initial outcome signals. RESULTS: Quantitative questionnaire data will be analysed descriptively, alongside rates of eligibility, consent, uptake and completion. Qualitative data will be analysed using thematic analysis. Results will be used to develop a logic model describing feasibility and implementation. CONCLUSIONS: From this study, we hope to better understand how to deliver digital CBT for insomnia within an early intervention in psychosis service. This study will help inform further research, including how best to support staff in using Sleepio, and inform the design of subsequent trials in this area.

Tobacco use in youth with mental illnesses.

Despite an abundance of literature documenting the prevalence and dangers of youth tobacco use, there is a relative dearth of literature in the area of effective cessation treatments for youth (Fiore et al. in Clinical tobacco guideline: treating tobacco use and dependence, 2008). Additionally, although it has been widely accepted that mental illness is highly correlated with tobacco use and dependence, little research has been done to support prevention and cessation efforts for youth with mental illnesses. This paper summarizes the literature on tobacco use and cessation in youth, with a focus on describing the existing knowledge base for youth with mental illnesses.

The Psychosocial Needs of Patients Participating in Diabetes Shared Medical Appointments.

BACKGROUND: Patient reported outcomes (PROs) for diabetes are self-reported and often give insight into outcomes important to people with diabetes. Federally Qualified Health Centers (FQHCs) see patients who may have higher levels of diabetes distress and lower levels of self-care behaviors. METHODS: The Invested in Diabetes study is a comparative effectiveness trial of diabetes Shared Medical Appointments (SMAs) in FQHCs and non-FQHC settings. PROs measure outcomes including validated measures on diabetes distress. SETTING AND PARTICIPANTS: 616 people from 22 practices completed PROs prior to SMAs. At FQHCs, participants were younger (average 57.7 years vs 66.9 years, p < 0.0001), more likely to be female (36.8% vs 46.1%, p = 0.02), and fewer spoke English (72.7% vs 99.6%, p < 0.0001). RESULTS: At FQHCs, diabetes distress was higher (2.1 vs 1.8, P = .02), more people were current smokers (14.3% vs 4.7%, P = .0002), on insulin (48.9% vs 22.3%, P < .0001) and reported food insecurity (52.7% vs 26.2%, P < .0001). After controlling for sociodemographic factors, these differences were nonsignificant. CONCLUSIONS: Higher numbers of patients at FQHCs report diabetes distress and food insecurity compared with patients in non-FQHC settings, indicating that patient social circumstances need to be considered as part of program implementation.

Methods for capturing and analyzing adaptations: implications for implementation research.

BACKGROUND: Interventions are often adapted; some adaptations may provoke more favorable outcomes, whereas some may not. A better understanding of the adaptations and their intended goals may elucidate which adaptations produce better outcomes. Improved methods are needed to better capture and characterize the impact of intervention adaptations. METHODS: We used multiple data collection and analytic methods to characterize adaptations made by practices participating in a hybrid effectiveness-implementation study of a complex, multicomponent diabetes intervention. Data collection methods to identify adaptations included interviews, observations, and facilitator sessions resulting in transcripts, templated notes, and field notes. Adaptations gleaned from these sources were reduced and combined; then, their components were cataloged according to the framework for reporting adaptations and modifications to evidence-based interventions (FRAME). Analytic methods to characterize adaptations included a co-occurrence table, statistically based k-means clustering, and a taxonomic analysis. RESULTS: We found that (1) different data collection methods elicited more overall adaptations, (2) multiple data collection methods provided understanding of the components of and reasons for adaptation, and (3) analytic methods revealed ways that adaptation components cluster together in unique patterns producing adaptation "types." These types may be useful for understanding how the "who, what, how, and why" of adaptations may fit together and for analyzing with outcome data to determine if the adaptations produce more favorable outcomes rather than by adaptation components individually. CONCLUSION: Adaptations were prevalent and discoverable through different methods. Enhancing methods to describe adaptations may better illuminate what works in providing improved intervention fit within context. TRIAL REGISTRATION: This trial is registered on clinicaltrials.gov under Trial number NCT03590041 , posted July 18, 2018.

Smoking reduction for persons with mental illnesses: 6-month results from community-based interventions.

Persons with mental illnesses use tobacco at significantly higher and heavier rates than the general population, and suffer greater tobacco- related morbidity and mortality. However, there are few existing tobacco cessation interventions for these individuals. This study examined two tobacco cessation interventions, a telephonic quitline intervention (counseling and nicotine replacement therapy) and a community-based group counseling intervention with adults currently receiving community mental health services. At 6-month follow-up, both groups demonstrated significantly reduced tobacco use, but participants who received both quitline services and the group counseling intervention were significantly more likely to have a 50% tobacco use reduction. Across groups, the overall intent-to-treat cessation rate was 7%. Tobacco dependence, depression symptoms, and psychotic symptoms decreased significantly for all treatment groups, while health and mental health functioning increased. Findings suggest that common community tobacco cessation services are effective for this population.

Training Primary Care Practitioners about Integrated Behavioral Health: How Integrated is the Training?

Integrating behavioral health into primary care has shown promise in extending access to evidence-based care to the underserved while demonstrating increasing benefits in outcomes and in the practice environment as the level of integration increases. Primary care trainees must be ready for the increase in mental health and substance abuse treatment needs during and after the COVID-19 pandemic. To maximize primary care trainee skill building and leverage adult learning theories, training programs should involve something like apprenticeship rather than being didactic. In fully integrated behavioral health primary care settings, there should be behavioral health resources either on site or available virtually to meet patients' multiple biopsychosocial needs and to support primary care trainees. The level of integration of these programs can be evaluated via the Integrated Practice Assessment tool (IPAT) to assess gaps in structural components and to identify needed resources for fully integrated care settings that provide the optimal training environment. Future assessment of integrated care training is discussed.

Adapting Diabetes Shared Medical Appointments to Fit Context for Practice-Based Research (PBR).

INTRODUCTION: Complex behavioral interventions such as diabetes shared medical appointments (SMAs) should be tested in pragmatic trials. Partnerships between dissemination and implementation scientists and practice-based research networks can support adaptation and implementation to ensure such interventions fit the context. This article describes adaptations to and implementation of the Targeted Training in Illness Management (TTIM) intervention to fit the primary care diabetes context. METHODS: The Invested in Diabetes pragmatic trial engaged 22 practice-based research network practices to compare 2 models of diabetes SMAs, based on TTIM. We used surveys, interviews, and observation to assess practice contextual factors, such as practice size, location, payer mix, change and work culture, motivation to participate, and clinical and administrative capacity. The enhanced Replicating Effective Programs framework was used to guide adaptations to TTIM and implementation in participating practices. RESULTS: Practices varied in size and patient demographics. All practices had integrated behavioral health, but limited health educators or prescribing providers. Adaptations to SMA delivery accommodated the need for flexibility in personnel and reduced scheduling burden. Adaptations to TTIM content were designed to fit general primary care diabetes and Spanish-speaking patients. CONCLUSION: Enhanced Replicating Effective Programs is a useful process framework for adaptation, implementation, and testing of diabetes SMAs in primary care. Adapting intervention content, delivery, and training to fit context can help ensure pragmatic trials have both internal and external validity. Attention to intervention fit to context can support continued practice engagement in research and sustainability of evidence-based interventions.