A cluster randomized trial of standard quality improvement versus patient-centered interventions to enhance depression care for African Americans in the primary care setting: study protocol NCT00243425

Abstract

BackgroundSeveral studies document disparities in access to care and quality of care for depression for African Americans. Research suggests that patient attitudes and clinician communication behaviors may contribute to these disparities. Evidence links patient-centered care to improvements in mental health outcomes; therefore, quality improvement interventions that enhance this dimension of care are promising strategies to improve treatment and outcomes of depression among African Americans. This paper describes the design of the BRIDGE (Blacks Receiving Interventions for Depression and Gaining Empowerment) Study. The goal of the study is to compare the effectiveness of two interventions for African-American patients with depression--a standard quality improvement program and a patient-centered quality improvement program. The main hypothesis is that patients in the patient-centered group will have a greater reduction in their depression symptoms, higher rates of depression remission, and greater improvements in mental health functioning at six, twelve, and eighteen months than patients in the standard group. The study also examines patient ratings of care and receipt of guideline-concordant treatment for depression.Methods/DesignA total of 36 primary care clinicians and 132 of their African-American patients with major depressive disorder were recruited into a cluster randomized trial. The study uses intent-to-treat analyses to compare the effectiveness of standard quality improvement interventions (academic detailing about depression guidelines for clinicians and disease-oriented care management for their patients) and patient-centered quality improvement interventions (communication skills training to enhance participatory decision-making for clinicians and care management focused on explanatory models, socio-cultural barriers, and treatment preferences for their patients) for improving outcomes over 12 months of follow-up.DiscussionThe BRIDGE Study includes clinicians and African-American patients in under-resourced community-based practices who have not been well-represented in clinical trials to improve depression care. The patient-centered and culturally targeted approach to depression care is a relatively new one that has not been tested in most previous studies. The study will provide evidence about whether patient-centered accommodations improve quality of care and outcomes to a greater extent than standard quality improvement strategies for African Americans with depression.Trial RegistrationClinicalTrials.gov NCT00243425

Comparative Effectiveness of Standard versus Patient‐Centered Collaborative Care Interventions for Depression among African Americans in Primary Care Settings: The BRIDGE Study

“…Specifically, the trial was designed to have adequate power to confirm a between‐group difference of 3.6‐point in reduction of CES‐D score over 12 months with 250 patients enrolled (Cooper et al. ). With the sample size we have and parameter values derived from our observed data, the estimation precision for difference in mean CES‐D score reduction from baseline to 12 months between groups would be ±5.3 points.…”

“…Further details of the trial and methods have been described elsewhere (Cooper et al. ) (http://ClinicalTrials.gov NCT00243425). The trial was approved by the Institutional Review Boards of Johns Hopkins and MedStar Health.…”

“…Telephone interviews to measure patients’ depression status, use of health services and experiences of care, and reactions to the interventions at 6 and 12 months of follow‐up are described in detail elsewhere (Cooper et al. ). During the time of this study, new evidence was generated regarding the need for longer follow‐up to show improvements in functional outcomes and reduction in disparities in depression outcomes (Wells et al.…”

A comparison of health behaviors between African Americans with spinal cord injury and those in the general population

“…Although African Americans are less likely to have an alcohol use disorder than whites, among persons with a mood disorder, African Americans are significantly more likely to abuse alcohol than whites (Kennedy, & Rogers, 2000). Prior studies suggest these disparities may exist because of poor diagnosis, treatment, and access to care for mental health disorders among African Americans (Chen, & Rizzo, 2010;Cooper et al, 2010;Graves et al, 2011).…”

Protocol for the ROSE sustainment (ROSES) study, a sequential multiple assignment randomized trial to determine the minimum necessary intervention to maintain a postpartum depression prevention program in prenatal clinics serving low-income women

“…In addition, the ROSES Study is the first implementation study of a PPD prevention intervention in outpatient clinics providing prenatal care. In fact, virtually no interventions that prevent any mental health problem among adults without requiring the use of mental health clinicians have been the subject of implementation research in outpatient medical settings [ 37 ].…”