Background Chronic diseases that drive morbidity, mortality, and health care costs are largely influenced by human behavior. Behavioral health conditions such as anxiety, depression, and substance use disorders can often be effectively managed. The majority of patients in need of behavioral health care are seen in primary care, which often has difficulty responding. Some primary care practices are providing integrated behavioral health care (IBH), where primary care and behavioral health providers work together, in one location, using a team-based approach. Research suggests there may be an association between IBH and improved patient outcomes. However, it is often difficult for practices to achieve high levels of integration. The Integrating Behavioral Health and Primary Care study responds to this need by testing the effectiveness of a comprehensive practice-level intervention designed to improve outcomes in patients with multiple chronic medical and behavioral health conditions by increasing the practice’s degree of behavioral health integration. Methods Forty-five primary care practices, with existing onsite behavioral health care, will be recruited for this study. Forty-three practices will be randomized to the intervention or usual care arm, while 2 practices will be considered “Vanguard” (pilot) practices for developing the intervention. The intervention is a 24-month supported practice change process including an online curriculum, a practice redesign and implementation workbook, remote quality improvement coaching services, and an online learning community. Each practice’s degree of behavioral health integration will be measured using the Practice Integration Profile. Approximately 75 patients with both chronic medical and behavioral health conditions from each practice will be asked to complete a series of surveys to measure patient-centered outcomes. Change in practice degree of behavioral health integration and patient-centered outcomes will be compared between the two groups. Practice-level case studies will be conducted to better understand the contextual factors influencing integration. Discussion As primary care practices are encouraged to provide IBH services, evidence-based interventions to increase practice integration will be needed. This study will demonstrate the effectiveness of one such intervention in a pragmatic, real-world setting. Trial registration ClinicalTrials.gov NCT02868983. Registered on August 16, 2016.

BackgroundChronic diseases that drive morbidity, mortality, and health care costs are largely influenced by human behavior. Behavioral health conditions such as anxiety, depression, and substance use disorders can often be effectively managed. The majority of patients in need of behavioral health care are seen in primary care, which often has difficulty responding. Some primary care practices are providing integrated behavioral health care (IBH), where primary care and behavioral health providers work together, in one location, using a team-based approach. Research suggests there may be an association between IBH and improved patient outcomes. However, it is often difficult for practices to achieve high levels of integration. The Integrating Behavioral Health and Primary Care study responds to this need by testing the effectiveness of a comprehensive practice-level intervention designed to improve outcomes in patients with multiple chronic medical and behavioral health conditions by increasing the practice’s degree of behavioral health integration.Methods43 primary care practices, with existing onsite behavioral health care, will be randomized to the intervention or usual care arm. The intervention is a 24-month supported practice change process including an online curriculum, a practice redesign and implementation workbook, remote quality improvement coaching services, and an online learning community. Each practice’s degree of behavioral health integration will be measured using the Practice Integration Profile. Approximately 75 patients with both chronic medical and behavioral health conditions from each practice will be asked to complete a series of surveys to measure patient-centered outcomes. Change in practice degree of behavioral health integration and patient-centered outcomes will be compared between the two groups. Practice-level case studies will be conducted to better understand the contextual factors influencing integration.DiscussionAs primary care practices are encouraged to provide IBH services, evidence-based interventions to increase practice integration will be needed. This study will demonstrate the effectiveness of one such intervention in a pragmatic, real-world setting.Trial registrationClinicalTrials.gov NCT02868983. Registered August 16, 2016. https://clinicaltrials.gov/ct2/show/NCT02868983

Background Engaging patients as partners can influence research, with rewards and deterrents. The authors are researchers and patient co-investigators who collaborated on a comparative effectiveness, randomized controlled study of a structured quality improvement (QI) process to improve behavioral health and primary care integration for people managing multiple chronic conditions (MCC). Patient co-investigators responded to a gap in available resources to support study clinics in partnering with their own patients in QI and co-created the Patient Partner Guide (PPG). Objective Describe the development of the PPG, its use by clinics undertaking the QI project, and research team partnerships. Design Observational report of study intervention component. Participants Diverse patients and family members managing MCC and members of their primary care clinics. Intervention The PPG component of the study intervention is a five-step workbook providing practical tools and resources to sustain partnerships across clinic QI team members, including patient partners. The process of developing the PPG relied on relationship-building tools that were iteratively assessed, practiced, improved, and incorporated into the PPG under the leadership of patient co-investigators. Main Measures Observations related to PPG use and patient partner inclusion in clinic QI; impact on the research team. Key Results Of 20 clinics, 6 engaged patients as full partners on QI teams. Clinics found resistance in partnering and challenges in using the PPG but valued the material and their partners’ contributions. Similarly, engagement of patient co-investigators in research brought a shift in perspective to team members. The PPG is available and was adapted for use by research teams. Conclusions Engagement of patients and other stakeholders in research can be transformative and productive. Building relationships through meaningful work benefits others, and in turn, the research process. This approach can enhance clinical care QI and may result in substantial contributions to the conduct of research. Clinical Trial Registration https://clinicaltrials.gov/ct2/show/NCT02868983

Context: Most patients in need of behavioral health (BH) care are seen in primary care, which often has difficulty responding. Some practices integrate behavioral health care (IBH), with medical and BH providers at the same location, working as a team. However, it is difficult to achieve high levels of integration. Objective: Test the effectiveness of a practice intervention designed to increase BH integration. Study Design: Pragmatic, cluster-randomized controlled trial. Setting: 43 primary care practices with on-site BH services in 13 states. Population: 2,460 adults with multiple chronic medical and behavioral conditions. Intervention: 24-month practice change process including an online curriculum, a practice redesign and implementation workbook, remote quality improvement coaching services, and an online learning community. Outcomes: Primary outcomes were changes in the 8 Patient-Reported Outcomes Measurement Information System (PROMIS-29) domain scores. Secondary outcomes were changes in medication adherence, self-reported healthcare utilization, time lost due to disability, cardiovascular capacity, patient centeredness, provider empathy, and several conditionspecific measures. A sample of practice staff completed the Practice Integration Profile at each time point to estimate the degree of BH integration in that site. Practice-level case studies estimated the typical costs of implementing the intervention. Results: The intervention had no significant effect on any