A randomized, parallel group, pragmatic comparative-effectiveness trial comparing medication-assisted treatment induction methods in primary care practices: The HOMER study protocol.

Opioid use disorder (OUD) represents a public health crisis in the United States. Medication for opioid use disorder (MOUD) with buprenorphine in primary care is a proven OUD treatment strategy. MOUD induction is when patients begin withdrawal and receive the first doses of buprenorphine. Differences between induction methods might influence short-term stabilization, long-term maintenance, and quality of life. This paper describes the protocol for a study designed to: (1) compare short-term stabilization and long-term maintenance treatment engagement in MOUD in patients receiving office, home, or telehealth induction and (2) identify clinically-relevant practice and patient characteristics associated with successful long-term treatment. The study design is a randomized, parallel group, pragmatic comparative effectiveness trial of three care models of MOUD induction in 100 primary care practices in the United States. Eligible patients are at least 16 years old, have been identified by their clinician as having opioid dependence and would benefit from MOUD. Patients will be randomized to one of three induction comparators: office, home, or telehealth induction. Primary outcomes are buprenorphine medication-taking and illicit opioid use at 30, 90, and 270 days post-induction. Secondary outcomes include quality of life and potential mediators of treatment maintenance (intentions, planning, automaticity). Potential moderators include social determinants of health, substance use history and appeal, and executive function. An intent to treat analysis will assess effects of the interventions on long-term treatment, using general/generalized linear mixed models, adjusted for covariates, for the outcomes analysis. Analysis includes practice- and patient-level random effects for hierarchical/longitudinal data. No large-scale, randomized comparative effectiveness research has compared home induction to office or telehealth MOUD induction on long-term outcomes for patients with OUD seen in primary care settings. The results of this study will offer primary care providers evidence and guidance in selecting the most beneficial induction method(s) for specific patients.

A Unique Model and Workforce to Address Health-Related Social Needs and Health Equity: Regional Health Connectors in Colorado.

Unmet health-related social needs contribute to high morbidity and poor population health. Improving social conditions are likely to reduce health disparities and improve the health of the overall U.S. population. The primary objective of this article is to describe an innovative workforce model, called Regional Health Connectors (RHCs), and how they address health-related social needs in Colorado. This is a program evaluation that analyzed field notes and interview data from 2021-2022. We applied our findings to the framework developed by the National Academies of Sciences, Engineering, and Medicine's (NASEM's) report on strengthening social care integration into health care (2019). We found that RHCs address the following health-related social needs most commonly: food insecurity (n = 18 of 21 regions or 85% of all regions), housing (n = 17 or 81% of all regions), transportation (n = 11 or 52% of all regions), employment opportunities (n = 10 or 48% of all regions), and income/financial assistance (n = 11 or 52% of all regions). RHCs interacted across many sectors to address health-related social needs and provided multiple types of support to primary care practices at the organizational level. Examples of emerging impact of RHCs are described and mapped onto the NASEM framework. Findings from this program evaluation add to the growing landscape of knowledge and importance of detecting and addressing health-related social needs. We conclude that RHCs are a unique and emerging workforce that addresses multiple domains needed to integrate social care into health care.

"We've Really Built Something": Why Family Medicine Program Directors Stay in Their Positions-A Qualitative Study.

Background: Program directors (PDs) are essential to more than 12 000 residency and fellowship programs accredited in the United States. Short PD tenure may affect overall program quality. Reasons why PDs leave the position are multifactorial, and little is known about the reasons why PDs stay in the position. Objective: The authors explored factors related to retention and why family medicine PDs have stayed in their positions long term. Methods: This was a qualitative study of PDs in their roles for 12 or more years drawn from a national sample of family medicine residency PDs. Interviews with semi-structured and structured questions about long-term PD experience were conducted in October and November 2020. Multiple cycles of comparative coding and code network analysis produced constructs describing reasons why some PDs stay in the position long term. Results: Among 17 respondents with a mean tenure of 17.4 years, 3 interrelated constructs consistently emerged that supported PDs: developing the program, support systems, and job rewards. Program development reinforces internal and external support systems and enhances experiencing rewards of the job. Strong support systems enable further program development and job rewards. Conclusions: Family medicine residency PDs who have been in the role 12 or more years continuously work to develop the program, benefit from strong internal and external support systems, and describe many important rewards of the position that help sustain them in the role.

UPSTREAM! Together evaluation results from community efforts to prevent mental, emotional, and behavioral health problems.

Mental, emotional, and behavioral (MEB) health problems are prevalent globally. Despite effective programs that can prevent MEB problems and promote mental health, there has not been widespread adoption. UPSTREAM! Together was a planning project in three Colorado communities. Communities partnered with academic and policy entities to 1) translate evidence about MEB problem prevention into locally-relevant messages and materials and 2) develop long-term plans for broad implementation of interventions to prevent high-priority MEB problems. Community members recognized the need to talk about MEB problems to prevent them. The UPSTREAM! communities localized messages designed to start conversations and sustain attention on preventing MEB problems. The communities understood that prevention takes sustained community attention and advocacy, knowing that important outcomes may be years away. Long-term implementation plans aimed to strengthen families and enhance social connections among youth. Despite community readiness and capacity to implement evidence-based programs, there were few funding opportunities, delaying program implementation and revealing gaps between funding policies and community readiness. This community-engaged experience suggests an achievable approach, acceptable to communities, and worthy of further development and testing. Policies that cultivate and support local expertise may help to increase wider community adoption of evidence-based programs that promote mental health among youth.

Review of transforming teamwork: Cultivating collaborative cultures.

Teams, especially interdisciplinary teams, are now common in integrated care settings. Many behavioral health providers and physicians will work in teams for much of their careers. Transforming Teamwork: Cultivating Collaborative Cultures is a timely publication that aims to help teams improve by offering the rationale and guidance for enhancing teams and teamwork. The book is broadly applicable to organizations that want to learn how to improve teams, including organizations with diverse, interdisciplinary team members. The authors, with backgrounds in education, leadership development, and instruction, provide practical help to leaders and team members to improve their collective efficacy and produce actionable learning. Transforming Teamwork is framed around a "triple helix" of transformational teamwork: psychological safety, constructive conflict, and actionable team learning. The book unpacks the why and how of effective teamwork, providing useful tools and techniques for groups and individuals to apply in real-world settings. Part 1 explores how psychological safety underlies transformative teamwork by allowing for open exchange of different ways of thinking among team members. Part 2 describes the important role of conflict in teamwork and how team members can cultivate productive responses to conflict. Part 3 aims to guide teams past personal biases to carefully ask questions, listen, develop coherent team knowledge, and take action. Proficiency scales throughout the book clearly illustrate what unproductive, productive, and transformative types of teamwork look like. This practical guide satisfactorily provides answers to questions about the why and how of effective teams and teamwork. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Challenges Faced by Rural Primary Care Providers When Caring for COPD Patients in the Western United States.

RATIONALE: Rural chronic obstructive pulmonary disease (COPD) patients have worse outcomes and higher mortality compared with urban patients. Reasons for these disparities likely include challenges to delivery of care that have not been explored. OBJECTIVE: To determine challenges faced by rural primary care providers when caring for COPD patients. METHODS: Rural primary care providers in 7 primarily western states were asked about barriers they experienced when caring for COPD patients. RESULTS: A total of 71 rural primary care medical providers completed the survey, of which 51% were physicians and 49% were advanced practice providers (APPs). A total of 61% used Global Initiative for Chronic Obstructive Lung Disease or American Thoracic Society/European Respiratory Society guidelines as an assessment and treatment resource. The presence of multiple chronic conditions and patient failure to recognize and report symptoms were the greatest barriers to diagnose COPD. A total of 89% of providers used spirometry to diagnose COPD, but only 62% were satisfied with access to spirometry. Despite recommendations, 41% of providers never test for alpha-1 antitrypsin deficiency. A total of 87% were comfortable with their ability to assess symptoms, but only 11% used a guideline-recommended assessment tool. Although most providers were satisfied with their ability to treat symptoms and exacerbations, only 66% were content with their ability to prevent exacerbations. Fewer providers were happy with their access to pulmonologists (55%) or pulmonary rehabilitation (37%). Subgroup analyses revealed differences based on provider type (APP versus physician) and location (Colorado and Kansas versus other states), but not on population or practice size. CONCLUSIONS: Rural providers face significant challenges when caring for COPD patients that should be targeted in future interventions to improve COPD outcomes.

Practice Transformation Support and Patient Engagement to Improve Cardiovascular Care: From EvidenceNOW Southwest (ENSW).

PURPOSE: To improve cardiovascular care through supporting primary care practices' adoption of evidence-based guidelines. STUDY DESIGN: A cluster randomized trial compared two approaches: (1) standard practice support (practice facilitation, practice assessment with feedback, health information technology assistance, and collaborative learning sessions) and (2) standard support plus patient engagement support. METHODS: Primary outcomes were cardiovascular clinical quality measures (CQMs) collected at baseline, 9 months, and 15 months. Implementation of the first 6 "Building Blocks of High-Performing Primary Care" was assessed by practice facilitators at baseline and 3, 6, and 9 months. CQMs from practices not involved in the study served as an external comparison. RESULTS: A total of 211 practices completed baseline surveys. There were no differences by study arm (odds ratio [95% confidence interval]) for aspirin use (1.03 [0.99, 1.06]), blood pressure (0.98 [0.95, 1.01]), cholesterol (0.96 [0.92, 1.00]), and smoking (1.01 [0.96, 1.07]); however, there were significant improvements over time in aspirin use (1.04 [1.01, 1.07]), cholesterol (1.05 [1.03, 1.08]), and smoking (1.03 [1.01, 1.06]), but not blood pressure (1.01 [0.998, 1.03]). Improvement in enrolled practices was greater than external comparison practices across all 4 measures (all P < .05). Implementation improved in both arms for Team-Based Care, Patient-Team Partnership, and Population Management, and improvement was greater in enhanced intervention practices (all P < .05). Leadership and Data-Driven Improvement (P < .05) improved significantly, with no difference by arm. A greater improvement in Building Block implementation was associated with a greater improvement in blood pressure measures (P < .05). CONCLUSIONS: Practice transformation support can assist practices with improving quality of care. Patient engagement in practice transformation can further enhance practices' implementation of aspects of new models of care.

Exemplary Practices in Cardiovascular Care: Results on Clinical Quality Measures from the EvidenceNOW Southwest Cooperative.

BACKGROUND: Identifying characteristics of primary care practices that perform well on cardiovascular clinical quality measures (CQMs) may point to important practice improvement strategies. OBJECTIVE: To identify practice characteristics associated with high performance on four cardiovascular disease CQMs. DESIGN: Longitudinal cohort study among 211 primary care practices in Colorado and New Mexico. Quarterly CQM reports were obtained from 178 (84.4%) practices. There was 100% response rate for baseline practice characteristics and implementation tracking surveys. Follow-up implementation tracking surveys were completed for 80.6% of practices. PARTICIPANTS: Adult patients, staff, and clinicians in family medicine, general internal medicine, and mixed-specialty practices. INTERVENTION: Practices received 9 months of practice facilitation and health information technology support, plus biannual collaborative learning sessions. MAIN MEASURES: This study identified practice characteristics associated with overall highest performance using area under the curve (AUC) analysis on aspirin therapy, blood pressure management, and smoking cessation CQMs. RESULTS: Among 178 practices, 39 were exemplars. Exemplars were more likely to be a Federally Qualified Health Center (69.2% vs 35.3%, p = 0.0006), have an underserved designation (69.2% vs 45.3%, p = 0.0083), and have higher percentage of patients with Medicaid (p < 0.0001). Exemplars reported greater use of cardiovascular disease registries (61.5% vs 29.5%,), standing orders (38.5 vs 22.3%) or electronic health record prompts (84.6% vs 49.6%) (all p < 0.05), were more likely to have medical home recognition (74.4% vs 43.2%, p = 0.0006), and reported greater implementation of building blocks of high-performing primary care: regular quality improvement team meetings (3.0 vs 2.2), patient experience survey (3.1 vs 2.2), and resources for patients to manage their health (3.0 vs 2.3). High improvers (n = 45) showed greater improvement implementing team-based care (32.8 vs 11.7, p = 0.0004) and population management (37.4 vs 20.5, p = 0.0057). CONCLUSIONS: Multiple strategies-registries, prompts and protocols, patient self-management support, and patient-team partnership activities-were associated with delivering high-quality cardiovascular care over time, measured by CQMs. TRIAL REGISTRATION: ClinicalTrials.gov registration: NCT02515578.

Strategies for Developing and Sustaining Patient and Community Advisory Groups: Lessons from the State Networks of Colorado Ambulatory Practices and Partners (SNOCAP) Consortium of Practice-Based Research Networks.

BACKGROUND: Patient and community engagement is essential to maintain the relevance of practice-based research. Empowered engagement requires going beyond the check box, with advisory groups involved in every aspect of a project. Here, 4 Colorado practice-based research networks (PBRNs) share their advisory group origins, as well as methods for continued engagement and the work that has resulted. METHODS: PBRNs, like communities and practices, vary in form and function. In a 4-part case series, we describe commonalities and differences among advisory groups within the State Networks of Colorado Ambulatory Practices and Partners (SNOCAP), a consortium of PBRNs in Colorado. Three SNOCAP advisory groups are well established, while a fourth is under development. RESULTS: Each case shares ways in which advisory groups have been structured within SNOCAP, including meeting frequency, compensation, and member activities to ensure the design, conduct, analysis, and dissemination of research are grounded in the needs of patients and communities. We share 6 lessons learned regarding membership, relationships, relevance, care and feeding, listening, and showing up. CONCLUSIONS: SNOCAP believes advisory groups are the backbone and guidepost of PBRN work. Patient advisors are an essential and invaluable complement to traditional research when engaged beyond "basic" participation. Best structures for advisory groups depend upon stakeholder needs.

Process for Setting Research Priorities: A Case Study from the State Networks of Colorado Ambulatory Practices and Partners (SNOCAP) Consortium.

PURPOSE: It is important to share processes that practice-based research networks (PBRNs) can implement with PBRN members and partners to determine research topics of priority. Engaging partners at a preproject phase and continuing engagement throughout a project can help address topics of great need and increase meaningfulness at a local level. METHODS: The State Networks of Colorado Ambulatory Practices and Partners (SNOCAP) practice-based research network has a 20-year history of research topic prioritization. Annually, PBRN members and partners come together to set new priorities for SNOCAP to put focus on in the coming years. Methods from these Colorado PBRNs are shared as a framework for other PBRN networks, community and patient partners, and stakeholders to use. RESULTS: Engaging PBRN members and researchers in a bidirectional manner in preproject prioritization helps address current needs and gaps in care and identifies topics that are meaningful and important statewide. SNOCAP shares various approaches and lessons learned, provides guidance to PBRNs wanting to establish priorities, and helps guide groups that want to engage, or engage more deeply with, network members. Priority setting methods, a sample agenda, and resulting SNOCAP projects from the past 5 years of prioritization are shared. CONCLUSIONS: Inquiry on a regular basis is an important step in practice- or community-based research. Getting to the local level to determine and fully address priority needs is not only "the right thing to do," rather, it is essential in true bidirectional work.

Self-management support for chronic disease in primary care: frequency of patient self-management problems and patient reported priorities, and alignment with ultimate behavior goal selection.

BACKGROUND: To enable delivery of high quality patient-centered care, as well as to allow primary care health systems to allocate appropriate resources that align with patients' identified self-management problems (SM-Problems) and priorities (SM-Priorities), a practical, systematic method for assessing self-management needs and priorities is needed. In the current report, we present patient reported data generated from Connection to Health (CTH), to identify the frequency of patients' reported SM-Problems and SM-Priorities; and examine the degree of alignment between patient SM-Priorities and the ultimate Patient-Healthcare team member selected Behavioral Goal. METHODS: CTH, an electronic self-management support system, was embedded into the flow of existing primary care visits in 25 primary care clinics and was used to assess patient-reported SM-Problems across 12 areas, patient identified SM-Priorities, and guide the selection of a Patient-Healthcare team member selected Behavioral Goal. SM-Problems included: BMI, diet (fruits and vegetables, salt, fat, sugar sweetened beverages), physical activity, missed medications, tobacco and alcohol use, health-related distress, general life stress, and depression symptoms. Descriptive analyses documented SM-Problems and SM-Priorities, and alignment between SM-Priorities and Goal Selection, followed by mixed models adjusting for clinic. RESULTS: 446 participants with ≥ one chronic diseases (mean age 55.4 ± 12.6; 58.5% female) participated. On average, participants reported experiencing challenges in 7 out of the 12 SM-Problems areas; with the most frequent problems including: BMI, aspects of diet, and physical activity. Patient SM-Priorities were variable across the self-management areas. Patient- Healthcare team member Goal selection aligned well with patient SM-Priorities when patients prioritized weight loss or physical activity, but not in other self-management areas. CONCLUSION: Participants reported experiencing multiple SM-Problems. While patients show great variability in their SM-Priorities, the resulting action plan goals that patients create with their healthcare team member show a lack of diversity, with a disproportionate focus on weight loss and physical activity with missed opportunities for using goal setting to create targeted patient-centered plans focused in other SM-Priority areas. Aggregated results can assist with the identification of high frequency patient SM-Problems and SM-Priority areas, and in turn inform resource allocation to meet patient needs. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT01945918 .

Practice Characteristics Associated with Better Implementation of Patient Self-Management Support.

BACKGROUND: Advanced primary care models emphasize patient-centered care, including self-management support (SMS). This study aimed to promote the translation of SMS into primary care practices and reported on key baseline practice characteristics that may impact SMS implementation. METHODS: Thirty-six practices in Colorado and California participated in the study from December 2013 to March 2017. Practice administrators completed a Practice Information Form describing practice characteristics. Clinicians and staff (n = 716) completed the Practice Culture Assessment and the Patient-Centered Medical Home (PCMH) Monitor. Descriptive statistics were computed to determine practice characteristics related to culture, quality improvement, level of PCMH, and SMS implementation. Field notes and key informant interviews provided contextual details about practices. Iterative qualitative analyses identified important facilitators and barriers and change capabilities around SMS implementation. RESULTS: In bivariate analyses, rural locations, fewer uncontrolled patients with diabetes, higher Medicaid or uninsured populations, underserved designation, and higher level of "PCMHness" were associated with greater reported implementation of patient SMS (all P < .05) at baseline. In the final multilevel model, specialty (FM vs mixed, P = .0081), rural location (P = .0109), and higher percent Medicaid (P < .0001) were associated with greater SMS. Practices described key facilitators (alignment, motivation, a visible champion, supporting infrastructure, and functional quality improvement and care teams) and barriers (no shared vision, no visible champion, siloed infrastructure, competing programs, turnover, and time constraints) to improving SMS delivery. CONCLUSIONS: Careful attention-and action-on key practice characteristics and context may create more favorable initial conditions for practice change efforts to improve SMS in primary care practices.

A Cluster Randomized Trial Comparing Strategies for Translating Self-Management Support into Primary Care Practices.

INTRODUCTION: Self-management support (SMS) is a key factor in diabetes care, but true SMS has not been widely adopted by primary care practices. Interactive behavior-change technology (IBCT) can provide efficient methods for adoption of SMS in primary care. Practice facilitation has been effective in assisting practices in implementing complex evidence-based interventions, such as SMS. This study was designed to study the incremental impact of practice education, the Connection to Health (CTH) IBCT tool, and practice facilitation as approaches to enhance the translation of SMS for patients with diabetes in primary care practices. METHODS: A cluster-randomized trial compared the effectiveness of 3 implementation strategies for enhancing SMS for patients with diabetes in 36 primary care practices: 1) SMS education (SMS-ED); 2) SMS-ED plus CTH availability (CTH); and 3) SMS-ED, CTH availability, plus brief practice facilitation (CTH + PF). Outcomes including hemoglobin A1c (HbA1c) levels and SMS activities were assessed at 18 months post study initiation in a random sample of patients through medical record reviews. RESULTS: A total of 488 patients enrolled in the CTH system (141 CTH, 347 CTH + PF). In the intent-to-treat analysis of patients with medical record reviews, HbA1c slopes did not differ between study arms (CTH vs SMS-ED: P = .2243, CTH + PF vs SMS-ED: P = .8601). However, patients from practices in the CTH + PF arm who used CTH showed significantly improved HbA1c trajectories over time compared with patients from SMS-ED practices (P = .0422). SMS activities were significantly increased in CTH and CTH + PF study arms compared with SMS-ED (CTH vs SMS-ED: P = .0223, CTH + PF vs SMS-ED: P = .0013). The impact of CTH on SMS activities was a significant mediator of the impact of the CTH and CTH + PF interventions on HbA1c. CONCLUSION: An interactive behavior change technology tool such as CTH can increase primary care practice SMS activities and improve patient HbA1c levels. Even brief practice facilitation assists practices in implementing SMS.

Recruiting Primary Care Practices for Research: Reflections and Reminders.

BACKGROUND: Recruiting primary care practices for research projects has always required carefully tended relationships, a compelling message, and good timing. Recruiting practices to participate in practice transformation research trials may take more and different efforts. We reflect on practice recruitment for a recently-concluded trial of a diabetes self-management support system in 2 states and 36 practices. METHODS: Iterative qualitative analysis of field notes, semistructured clinician and staff interviews, and meeting notes from a 2-state, cluster-randomized trial that aimed to improve self-management support for patients with type 2 diabetes mellitus. RESULTS: Although all 36 enrolled practices finished the study, fully recruiting practices early on took considerable effort, yielding 2 primary lessons: 1) practice-based research networks (PBRNs) must recruit more stakeholders at more levels, at the clinic, in the system, and across roles; and 2) practice recruitment is a process and may take longer than expected with unplanned turnover of key contacts. Adjusting our recruitment strategies required: helping with communication efforts in practices; aligning our study message according to stakeholders' interests; allowing for minor adaptations at the practice-level to align with critical practice workflows, staffing, and resources; re-engaging with clinical leadership over time; and identifying a "backup" champion due to turnover. CONCLUSIONS: When undertaking a pragmatic clinical trial requiring substantial practice change in a PBRN setting across a large number of practices, it is important that PBRN leaders develop a comprehensive strategy to identify and engage a broad group of stakeholders within each practice, understand their needs and priorities around research, and design and implement a structured communications strategy to maintain engagement throughout every phase of the project.

A protocol for a cluster randomized trial comparing strategies for translating self-management support into primary care practices.

BACKGROUND: Advanced primary care models emphasize patient-centered care, including self-management support (SMS), but the effective use of SMS for patients with type 2 diabetes (T2DM) remains a challenge. Interactive behavior-change technology (IBCT) can facilitate the adoption of SMS interventions. To meet the need for effective SMS intervention, we have developed Connection to Health (CTH), a comprehensive, evidence-based SMS program that enhances interactions between primary care clinicians and patients to resolve self-management problems and improve outcomes. Uptake and maintenance of programs such as CTH in primary care have been limited by the inability of practices to adapt and implement program components into their culture, patient flow, and work processes. Practice facilitation has been shown to be effective in helping practices make the changes required for optimal program implementation. The proposed research is designed to promote the translation of SMS into primary care practices for patients with T2DM by combining two promising lines of research, specifically, (a) testing the effectiveness of CTH in diverse primary-care practices, and (b) evaluating the impact of practice facilitation to enhance implementation of the intervention. METHODS: A three-arm, cluster-randomized trial will evaluate three discrete strategies for implementing SMS for patients with T2DM in diverse primary care practices. Practices will be randomly assigned to receive and implement the CTH program, the CTH program plus practice facilitation, or a SMS academic detailing educational intervention. Through this design, we will compare the effectiveness, adoption and implementation of these three SMS practice implementation strategies. Primary effectiveness outcomes including lab values and evidence of SMS will be abstracted from medical records covering baseline through 18 months post-baseline. Data from CTH assessments and action plans completed by patients enrolled in CTH will be used to evaluate practice implementation of CTH and the impact of CTH participation. Qualitative data including field notes from encounters with the practices and interviews of practice personnel will be analyzed to assess practice implementation of SMS. DISCUSSION: This study will provide important information on the implementation of SMS in primary care, the effectiveness of an IBCT tool such as CTH, and the use of practice facilitation to assist implementation. TRIAL REGISTRATION: Registered with ClinicalTrials.gov - ClinicalTrials.gov ID: NCT01945918 , date 08/27/2013. Modifications have been updated.

A Community Engagement Method to Design Patient Engagement Materials for Cardiovascular Health.

PURPOSE: EvidenceNOW Southwest is a cluster-randomized trial evaluating the differential impact on cardiovascular disease (CVD) care of engaging patients and communities in practice transformation in addition to standard practice facilitation support. The trial included development of locally tailored CVD patient engagement materials through Boot Camp Translation (BCT), a community engagement process that occurred before practice recruitment but after cluster randomization. METHODS: We introduce a cluster randomization method performed before recruitment of small to medium-size primary care practices in Colorado and New Mexico, which allowed for balanced study arms while minimizing contamination. Engagement materials for the enhanced study arm were developed by means of BCT, which included community members, practice members, and public health professionals from (1) metropolitan Denver, (2) rural northeast Colorado, (3) Albuquerque, and (4) rural southeast New Mexico. Outcome measures were messages and materials from BCTs and population characteristics of study arms after using geographic-based covariate constrained randomization. RESULTS: The 4 BCTs' messages and materials developed by the BCT groups uniquely reflected each community and ranged from family or spiritual values to early prevention or adding relevance to CVD risk. The geographic-based covariate of a cluster randomization method constrained randomization-assigned regions to study arms, allowing BCTs to precede practice recruitment, reduce contamination, and balance populations. CONCLUSIONS: Cluster-randomized trials with community-based interventions present study design and implementation challenges. The BCTs elicited unique contextual messages and materials, suggesting that interventions designed to help primary care practices decrease CVD risk may not be one size fits all.

Impact of a Boot Camp Translation Intervention on Self-Management Support in Primary Care: A Report From the INSTTEPP Trial and Meta-LARC Consortium.

PURPOSE: Self-management support (SMS) is a pillar of the well-established chronic care model and a key component of improving outcomes for patients with chronic illnesses. The Implementing Networks' Self-management Tools Through Engaging Patients and Practices (INSTTEPP) trial sought to determine whether a boot camp translation process could assist small to medium-sized primary care practices with care managers implement SMS tools. METHODS: INSTTEPP used a stepped-wedge design across 16 practices from 4 practice-based research networks over 12 months. Each network completed a 2-month boot camp translation for creating SMS tools with 16 participants (2 patients, a clinician, and a care manager from each of 4 practices) and subsequent implementation. Outcome measures for patients were the Patient Activation Measure (PAM), self-rated health, and Patient Assessment of Chronic Illness Care (PACIC) process-of-care items at baseline, 1 and 2 months. Clinician Support for Patient Activation Measure (CS-PAM) and theory of planned behavior outcomes were assessed at 5 points over 10 months for clinicians and staff. RESULTS: A total of 297 patients and 89 practice staff and clinicians completed surveys during the study. Over successive 2-month sampling periods, intervention patients experienced greater improvement in PACIC process of care and self-rated health compared to control patients (P<0.0001 and P=0.0273, respectively). PAM (P=0.3515), CS-PAM (P=0.7464), and theory of planned behavior outcomes (P>0.10 for all) were not significantly different. CONCLUSIONS: Significant effects on process of care and self-rated health are evidence that the boot camp translation intervention impacted SMS. A larger trial with a typical 6-month boot camp intervention may show significant effects on other outcomes.

Implementing Community-Created Self-Management Support Tools in Primary Care Practices: Multimethod Analysis From the INSTTEPP Study.

PURPOSE: With one-half of Americans projected to be living with at least one chronic condition before 2020, enhancing patient self-management support (SMS) may improve health-related behaviors and clinical outcomes. Routine SMS implementation in primary care settings is difficult. Little is known about the practice conditions required for successful implementation of SMS tools. METHODS: Four primary care practice-based research networks (PBRNs) recruited 16 practices to participate in a boot camp translation process to adapt patient-centered SMS tools. Boot camp translation sessions were held over a 2-month period with 2 patients, a clinician, and a care manager from each practice. Qualitative case comparison and qualitative comparative analysis were used to examine practice conditions needed to implement SMS tools. The Consolidated Framework for Implementation Research guided data collection and analysis. RESULTS: Four different practice conditions affected the implementation of new SMS tools: functional practice organization; system that enables innovation and change; presence of a visible, activated champion; and synergy and alignment of SMS changes with other work. Qualitative comparative analysis suggested that it was necessary to have an enabling system, a visible champion, and synergy for a practice to at least minimally implement the SMS tools. Sufficiency testing, however, failed to show robust consistency to satisfactorily explain conditions required to implement new SMS tools. CONCLUSIONS: To implement tailored self-management support tools relatively rapidly, the minimum necessary conditions include a system that enables innovation and change, presence of a visible champion, and alignment of SMS changes with other work; yet, these alone are insufficient to ensure successful implementation.

How to Translate Self-Management Support Tools Into Clinical Practice: A Report From the INSTTEPP Trial and Meta-LARC Consortium.

PURPOSE: Patient self-management is an inevitable part of the work of being a patient, and self-management support (SMS) has become increasingly important in chronic disease management. However, the majority of SMS resources available in the Agency for Healthcare Research and Quality SMS Resource Library were developed without explicit collaboration between clinicians and patients. METHODS: Translation of SMS tools derived from the library into primary care practices occurred utilizing boot camp translation in four different practice-based research networks (PBRNs). The typical model of boot camp translation was adapted for the purpose of the Implementing Networks' Self-management Tools Through Engaging Patients and Practices (INSTTEPP) study to develop SMS tools for implementation in the participating practices. Clinicians, clinic staff members, and patients were involved throughout the translation process. Existing resources from the SMS library were reviewed and adapted by each boot camp translation group to create tools unique to the patients in each network. RESULTS: There was no preexisting resource within the library that was deemed suitable for implementation without modification. Each network adapted tools from the SMS library to create different products. Common themes emerged from each network's translation process that highlighted the importance of patient engagement in the translation process. Boot camp translation, in conjunction with PBRNs, can be implemented to adapt SMS tools for implementation in member practices. CONCLUSIONS: Boot camp translation with a combination of practices and patients can be implemented to facilitate a process of local adaptation that improves the local applicability of SMS tools in primary care clinics.

Adapting Boot Camp Translation Methods to Engage Clinician/Patient Research Teams Within Practice-Based Research Networks: A Report From the INSTTEPP Trial and Meta-LARC Consortium.

PURPOSE: Boot camp translation is a proven process to engage community members and health professionals in translating and disseminating evidence-based "best practices" models for health prevention and chronic illness care. Primary care practice improvement studies, particularly involving patient-driven change, as seen with self-management support (SMS), require engaged practice teams that include patients. Models of engagement such as boot camp translation may be effective. METHODS: Four geographically dispersed practice-based research networks (PBRNs) from the Meta-LARC consortium engaged 16 practices to form SMS implementation teams involving a clinician, care manager, and 2 patients in each team. Our study adapted the boot camp translation model to engage the implementation teams in describing patient SMS, studying the Agency for Healthcare Research and Quality's SMS Resource Library, and adapting and implementing self-management tools at each practice site. Testimonials and quotes were collected across the 4 PBRNs through a facilitated brainstorming discussion and consensus model at each PBRN kickoff meeting to address the focused question, "What do patients want and need in order to self-manage their chronic illnesses?" RESULTS: Testimonials collected across the 4 PBRNs and participation levels indicated there was a high degree of engagement in the boot camp translation process across the PBRNs and the practices. Each PBRN developed themes expressed by patients and the practices regarding what patients want and need to self-manage their illnesses. Each practice selected, adapted, and implemented an SMS tool. CONCLUSIONS: Results suggest that adapted boot camp translation was effective in guiding multiple practices to implement self-management support tools for the INSTTEPP trial. Additional study of the adapted boot camp translation process in practice quality improvement and practice redesign studies is needed.