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.

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.

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.

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.

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.

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.

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.

Correction to: The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments.

After publication of our article [1] the authors have notified us that the title for Figure 1 was incorrectly captioned.

The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments.

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

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.

RE-AIM in the Real World: Use of the RE-AIM Framework for Program Planning and Evaluation in Clinical and Community Settings.

Background: The RE-AIM framework has been widely used in health research but it is unclear the extent to which this framework is also used for planning and evaluating health-related programs in clinical and community settings. Our objective was to evaluate how RE-AIM is used in the "real-world" and identify opportunities for improving use outside of research contexts. Methods: We used purposive and snowball sampling to identify clinical and community health programs that used RE-AIM for planning and/or evaluation. Recruitment methods included surveys with email follow-up to funders, implementers, and RE-AIM working group members. We identified 17 programs and conducted structured in-depth interviews with key informants (n = 18). Across RE-AIM dimensions, respondents described motivations, uses, and measures; rated understandability and usefulness; discussed benefits and challenges, strategies to overcome challenges, and resources used. We used descriptive statistics for quantitative ratings, and content analysis for qualitative data. Results: Program content areas included chronic disease management and prevention, healthy aging, mental health, or multiple, often behavioral health-related topics. During planning, most programs considered reach (n = 9), adoption (n = 11), and implementation (n = 12) while effectiveness (n = 7) and maintenance (n = 6) were considered less frequently. In contrast, most programs evaluated all RE-AIM dimensions, ranging from 13 programs assessing maintenance to 15 programs assessing implementation and effectiveness. On five-point scales, all RE-AIM dimensions were rated as easy to understand (Overall M = 4.7 ± 0.5), but obtaining data was rated as somewhat challenging (Overall M = 3.4 ± 0.9). Implementation was the most frequently used dimension to inform program design (M = 4.7 ± 0.6) relative to the other dimensions (3.0-3.9). All dimensions were considered similarly important for decision-making (average M = 4.1 ± 1.4), with the exception of maintenance (M = 3.4 ± 1.7). Qualitative corresponded to the quantitative findings in that RE-AIM was reported to be a practical, easy to understand, and well-established implementation science framework. Challenges included understanding differences among RE-AIM dimensions and data acquisition. Valuable resources included the RE-AIM website and collaborating with an expert. Discussion: RE-AIM is an efficient framework for planning and evaluation of clinical and community-based projects. It provides structure to systematically evaluate health program impact. Programs found planning for and assessing maintenance difficult, providing opportunities for further refinement.

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.

Integrating primary care and behavioral health with four special populations: Children with special needs, people with serious mental illness, refugees, and deaf people.

Special patient populations can present unique opportunities and challenges to integrating primary care and behavioral health services. This article focuses on four special populations: children with special needs, persons with severe and persistent mental illness, refugees, and deaf people who communicate via sign language. The current state of primary care and behavioral health collaboration regarding each of these four populations is examined via Doherty, McDaniel, and Baird's (1996) five-level collaboration model. The section on children with special needs offers contrasting case studies that highlight the consequences of effective versus ineffective service integration. The challenges and potential benefits of service integration for the severely mentally ill are examined via description of PRICARe (Promoting Resources for Integrated Care and Recovery), a model program in Colorado. The discussion regarding a refugee population focuses on service integration needs and emerging collaborative models as well as ways in which refugee mental health research can be improved. The section on deaf individuals examines how sign language users are typically marginalized in health care settings and offers suggestions for improving the health care experiences and outcomes of deaf persons. A well-integrated model program for deaf persons in Austria is described. All four of these special populations will benefit from further integration of primary care and mental health services.

Smoking cessation behaviors among persons with psychiatric diagnoses: results from a population-level state survey.

BACKGROUND: Persons with psychiatric illnesses are disproportionally affected by tobacco use, smoking at rates at least twice that of other adults. Intentions to quit are known to be high in this population, but population-level cessation behaviors and attitudes by mental health (MH) diagnosis are not well known. METHODS: A population-level survey was conducted in 2008 to examine state-level tobacco attitudes and behaviors in Colorado. Respondents were eligible for the study if they had non-missing values for smoking status (n=14,118). Weighted descriptive and multivariate analyses were conducted of smoking prevalence, cessation behaviors, and attitudes toward cessation by MH status and specific diagnosis. RESULTS: Among respondents with MH diagnoses, smoking was twice as prevalent as among respondents without an MH diagnosis, adjusted for demographic characteristics (adjusted odds ratio 2.2, 95% confidence interval 1.6-3.1). Compared to smokers without an MH diagnosis, those with MH diagnoses were more likely to attempt quitting (58.7% vs. 44.4%, p<0.05), use nicotine replacement therapy more often, and succeed in quitting at similar rates. Smokers with anxiety/PTSD were less likely to quit successfully compared those with other MH diagnoses (0.7% vs. 11.9%, p=0.03). CONCLUSIONS: This population-level analysis found that smokers with mental illness are more likely than those without mental illness to attempt quitting and to use cessation treatment at similar rates, but those with anxiety are less likely to achieve short-term abstinence. Additional approaches are needed for smokers with mental illness in order to reach and sustain long-term abstinence from smoking.

Evaluating Depression Care Management in a Community Setting: Main Outcomes for a Medicaid HMO Population with Multiple Medical and Psychiatric Comorbidities.

The authors describe the implementation of a depression care management (DCM) program at Colorado Access, a public sector health plan, and describe the program's clinical and system outcomes for members with chronic medical conditions. High medical risk, high cost Medicaid health plan members were identified and systematically screened for depression. A total of 370 members enrolled in the DCM program. Longitudinal analyses revealed significantly reduced depression severity scores at 3, 6, and 12 months after intervention as compared to baseline depression scores. At 12 months, 56% of enrollees in the DCM program had either a 50% reduction in PHQ-9 scores or a PHQ-9 score < 10. Longitudinal economic analyses comparing 12 months before and after intervention revealed a significant but modest increase in ER visits, outpatient office visits, and overall medical and pharmacy costs when adjusted for months enrolled in DCM. Limitations and recommendations for the integrated depression care management are discussed.

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.

Colorado access' enhanced care management for high-cost, high-need Medicaid members: preliminary outcomes and lessons learned.

Colorado Access, a nonprofit health plan, collaborated with the Center for Health Care Strategies and the State of Colorado Department of Health Care Policy Financing, to develop, implement, and evaluate a care management services pilot program focused on improving the quality of care and decreasing the cost of care for the highest cost, highest need Medicaid recipients. Colorado Access' preliminary internal evaluation demonstrated decreases in hospitalizations and emergency department utilization and increases in primary care ambulatory visits and member satisfaction. Qualitative analyses informed program implementation. Implementation lessons learned are discussed.