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.

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.

Interleukin-6 and body mass index, tobacco use, and sleep in gynecologic cancers.

OBJECTIVE: Elevated body mass index (BMI), tobacco use, and sleep disturbance are common health concerns among women with gynecologic cancers. The extent to which these factors are associated with systemic inflammation in gynecologic cancers is unknown. This is a significant literature gap given that (a) chronic, systemic inflammation may mediate relationships between behavioral health factors and cancer outcomes; and (b) elevated BMI, tobacco use, and sleep disturbances can be modified via behavioral interventions. This study examined Interleukin-6 (IL-6) relations with BMI, tobacco use history, and sleep disturbances in patients undergoing surgery for suspected gynecologic cancer. METHOD: Participants were 100 women (M age = 58.42 years, SD = 10.62 years) undergoing surgery for suspected gynecologic cancer. Smoking history was determined by participant self-report. Sleep quality/disturbance was assessed via the Pittsburgh Sleep Quality Index. BMI was abstracted from electronic health records. Presurgical serum IL-6 concentrations were determined using Enzyme-Linked Immunosorbent Assay. RESULTS: Controlling for the cancer type and stage, regression analyses revealed higher BMI, ß = 0.258, p = .007, and former/current smoking status, ß = 0.181, p = .046, were associated with higher IL-6. IL-6 did not differ between former and current smokers, ß = 0.008, p = .927. Global sleep quality, sleep latency, and sleep efficiency were not associated with IL-6. CONCLUSIONS: Higher BMI and any history of tobacco use predicted higher IL-6 among women undergoing surgery for suspected gynecologic cancers. Cognitive-behavioral interventions targeting primary and secondary obesity and tobacco use prevention may reduce systemic inflammation and optimize cancer outcomes in this population. (PsycINFO Database Record (c) 2019 APA, all rights reserved).