Conducting a Pragmatic Trial in Integrated Primary Care: Key Decision Points and Considerations.

Pragmatic trials testing the effectiveness of interventions under "real world" conditions help bridge the research-to-practice gap. Such trial designs are optimal for studying the impact of implementation efforts, such as the effectiveness of integrated behavioral health clinicians in primary care settings. Formal pragmatic trials conducted in integrated primary care settings are uncommon, making it difficult for researchers to anticipate the potential pitfalls associated with balancing scientific rigor with the demands of routine clinical practice. This paper is based on our experience conducting the first phase of a large, multisite, pragmatic clinical trial evaluating the implementation and effectiveness of behavioral health consultants treating patients with chronic pain using a manualized intervention, brief cognitive behavioral therapy for chronic pain (BCBT-CP). The paper highlights key choice points using the PRagmatic-Explanatory Continuum Indicator Summary (PRECIS-2) tool. We discuss the dilemmas of pragmatic research that we faced and offer recommendations for aspiring integrated primary care pragmatic trialists.

Targeting Chronic Pain in Primary Care Settings by Using Behavioral Health Consultants: Methods of a Randomized Pragmatic Trial.

BACKGROUND: Manualized cognitive and behavioral therapies are increasingly used in primary care environments to improve nonpharmacological pain management. The Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP) intervention, recently implemented by the Defense Health Agency for use across the military health system, is a modular, primary care-based treatment program delivered by behavioral health consultants integrated into primary care for patients experiencing chronic pain. Although early data suggest that this intervention improves functioning, it is unclear whether the benefits of BCBT-CP are sustained. The purpose of this paper is to describe the methods of a pragmatic clinical trial designed to test the effect of monthly telehealth booster contacts on treatment retention and long-term clinical outcomes for BCBT-CP treatment, as compared with BCBT-CP without a booster, in 716 Defense Health Agency beneficiaries with chronic pain. DESIGN: A randomized pragmatic clinical trial will be used to examine whether telehealth booster contacts improve outcomes associated with BCBT-CP treatments. Monthly booster contacts will reinforce BCBT-CP concepts and the home practice plan. Outcomes will be assessed 3, 6, 12, and 18 months after the first appointment for BCBT-CP. Focus groups will be conducted to assess the usability, perceived effectiveness, and helpfulness of the booster contacts. SUMMARY: Most individuals with chronic pain are managed in primary care, but few are offered biopsychosocial approaches to care. This pragmatic brief trial will test whether a pragmatic enhancement to routine clinical care, monthly booster contacts, results in sustained functional changes among patients with chronic pain receiving BCBT-CP in primary care.

The Primary Care Behavioral Health (PCBH) Model: An Overview and Operational Definition.

The Primary Care Behavioral Health (PCBH) model is a prominent approach to the integration of behavioral health services into primary care settings. Implementation of the PCBH model has grown over the past two decades, yet research and training efforts have been slowed by inconsistent terminology and lack of a concise, operationalized definition of the model and its key components. This article provides the first concise operationalized definition of the PCBH model, developed from examination of multiple published resources and consultation with nationally recognized PCBH model experts. The definition frames the model as a team-based approach to managing biopsychosocial issues that present in primary care, with the over-arching goal of improving primary care in general. The article provides a description of the key components and strategies used in the model, the rationale for those strategies, a brief comparison of this model to other integration approaches, a focused summary of PCBH model outcomes, and an overview of common challenges to implementing the model.

Military and veteran health behavior research and practice: challenges and opportunities.

There are 2.1 million current military servicemembers and 21 million living veterans in the United States. Although they were healthier upon entering military service compared to the general U.S. population, in the longer term veterans tend to be of equivalent or worse health than civilians. One primary explanation for the veterans' health disparity is poorer health behaviors during or after military service, especially areas of physical activity, nutrition, tobacco, and alcohol. In response, the Department of Defense and Department of Veterans Affairs continue to develop, evaluate, and improve health promotion programs and healthcare services for military and veteran health behavior in an integrated approach. Future research and practice is needed to better understand and promote positive health behavior during key transition periods in the military and veteran life course. Also paramount is implementation and evaluation of existing interventions, programs, and policies across the population using an integrated and person centered approach.

Primary Care Behavioral Health Provider Training: Systematic Development and Implementation in a Large Medical System.

The expansion of integrated, collaborative, behavioral health services in primary care requires a trained behavioral health workforce with specific competencies to deliver effective, evidence-informed, team-based care. Most behavioral health providers do not have training or experience working as primary care behavioral health consultants (BHCs), and require structured training to function effectively in this role. This article discusses one such training program developed to meet the needs of a large healthcare system initiating widespread implementation of the primary care behavioral health model of service delivery. It details the Department of Defense's experience in developing its extensive BHC training program, including challenges of addressing personnel selection and hiring issues, selecting a model for training, developing and implementing a phased training curriculum, and improving the training over time to address identified gaps. Future directions for training improvements and lessons learned in a large healthcare system are discussed.

Tipping points in the Department of Defense's experience with psychologists in primary care.

Psychologists played a crucial role in the successful implementation of integrated behavioral health care services in Department of Defense (DoD) primary care clinics. On the front lines of policy development, training programs, clinical care, and program evaluations, psychologists successfully promoted integrated care as a core component of the DoD patient-centered medical home. We review the development of integrated care and discuss the roles of psychologists in the DoD to provide an exemplar of the impact psychologists can have on the implementation and sustainment of integrated care.

Primary care behavioral health: ethical issues in military settings.

The rapid expansion of integrated behavioral health care in primary care medical settings introduces a number of ethical challenges faced by teams of health professionals from different disciplines. As military health care settings have increasingly implemented primary care behavioral health models of service delivery, distinct ethical dilemmas have emerged. This article examines two of these ethical issues, competence and multiple relationships, through presentation of clinical scenarios in military integrated primary care settings. Relevant professional ethical guidelines for psychologists, social workers, and physicians are examined. Recommendations for the ethical practice of primary care behavioral health, as well as suggestions for future development of professional ethical guidelines, are discussed.

Provider practices in the primary care behavioral health (PCBH) model: an initial examination in the Veterans Health Administration and United States Air Force.

The goals of this study were to identify characteristics of both behavioral health providers (BHPs) and the patients seen in a primary care behavioral health (PCBH) model of service delivery using prospective data obtained from BHPs. A secondary objective was to explore similarities and differences between these variables within the Veterans Health Administration (VHA) and United States Air Force (USAF) primary care clinics. A total of 159 VHA and 23 USAF BHPs, representing almost every state in the United States, completed the study, yielding data from 403 patient appointments. BHPs completed a web-based questionnaire that assessed BHP and setting characteristics, and a separate questionnaire after each patient seen on one day of clinical service. Data demonstrated that there are many similarities between the VHA and USAF BHPs and practices. Both systems tend to use well-trained psychologists as BHPs, had systems that support the BHP being in close proximity to the primary care providers, and have seamless operational elements (i.e., shared record, one waiting room, same-day appointments, and administrative support for BHPs). Comorbid anxiety and depression was the most common presenting problem in both systems, but overall rates were higher in VHA clinics, and patients were significantly more likely to meet diagnostic criteria for mental health conditions. This study provides the first systematic, prospective examination of BHPs and practices within a PCBH model of service delivery in two large health systems with well over 5 years of experience with behavioral health integration. Many elements of the PCBH model were implemented in a manner consistent with the model, although some variability exists within both settings. These data can help guide future implementation and training efforts.

Body image and tobacco cessation: relationships with weight concerns and intention to resume tobacco use.

Concern about weight gain after tobacco cessation is a potential barrier to quitting tobacco. Few studies, however, have examined the role of body image in cessation-related weight concerns and anticipated relapse. This study investigated relationships between current body image dissatisfaction, anticipated body image dissatisfaction (discrepancy between anticipated post-cessation body shape and desired body shape), cessation-related weight concerns, and intention to resume tobacco with weight gain. Body image dissatisfaction was significantly related to cessation-related weight concerns. Participants who reported current dissatisfaction with their body image were 2.6 times more likely to intend to resume tobacco use with cessation-related weight gain than those with no body image dissatisfaction. Individuals with anticipated body image dissatisfaction were 3.4 times more likely to intend to resume tobacco compared to individuals with no anticipated body image dissatisfaction. Women and normal weight individuals with anticipated body image dissatisfaction appear to be at particularly high risk for intending to relapse. Results suggest that tobacco cessation interventions may need to target concerns about body image as well as weight gain.

A prospective analysis of eating disorder risk factors: drive for thinness, depressed mood, maladaptive cognitions, and ineffectiveness.

This study examined whether elevations on four variables (drive for thinness, depressed mood, maladaptive cognitions, and ineffectiveness) were related to increased severity of eating disorder symptoms over a 4-year prospective interval in a sample of female undergraduates (N=80). Results indicated that initial scores on the four variables were related to severity of anorexic and bulimic symptoms 4 years later. Examination of each variable individually indicated that anorexia and bulimia may have different risk pathways, and that initial maladaptive cognitions and drive for thinness scores were more related to later eating disorder symptoms than were depressed mood or ineffectiveness.