Integrating Behavioral Health and Primary Care (IBH-PC) to improve patient-centered outcomes in adults with multiple chronic medical and behavioral health conditions: study protocol for a pragmatic cluster-randomized control trial
Authors: Crocker Abigail M. , Kessler Rodger , van Eeghen Constance , Bonnell Levi N. , Breshears Ryan E. , Callas Peter , Clifton Jessica , Elder William , Fox Chet , Frisbie Sylvie , Hitt Juvena , Jewiss Jennifer , Kathol Roger , Clark/Keefe Kelly , O’Rourke-Lavoie Jennifer , Leibowitz George S. , Macchi C. R. , McGovern Mark , Mollis Brenda , Mullin Daniel J. , Nagykaldi Zsolt , Natkin Lisa Watts , Pace Wilson , Pinckney Richard G. , Pomeroy Douglas , Pond Alexander , Postupack Rachel , Reynolds Paula , Rose Gail L. , Scholle Sarah Hudson , Sieber William J. , Stancin Terry , Stange Kurt C. , Stephens Kari A. , Teng Kathryn , Waddell Elizabeth Needham , Littenberg Benjamin 
Published: March 2021

Abstract
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.