Patient-Centered Depression Care for African Americans
Recruitment status was Recruiting
The investigators propose to answer the following research question: Does a multifaceted, culturally tailored intervention that focuses on the specific concerns and preferences of African American patients with depression and their primary care providers improve the processes and outcomes of care for African Americans to a greater degree than a standard state-of-the art depression intervention?
This study will determine whether two new educational programs can improve the care for depression in African Americans. These programs may include visits with a depression case manager and access to educational materials, such as a videotape, a calendar, pamphlets, and books. One program is a standard quality improvement program for depression that has been shown to be effective in most patients. The other program is similar, but has materials that focus more on the patient’s specific culture, beliefs, values, and preferences.
Major Depressive Disorder
Procedure: Standard Quality Improvement
Procedure: Patient-centered Intervention
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Patient-Centered Depression Care for African Americans|
- Compare the effectiveness of a culturally tailored intervention with the effectiveness of a standard intervention by evaluating its impact on patient outcomes (remission of depression, depression symptom level, functional status) at 6 and 12 months.
- Evaluating intervention impact on processes of care (satisfaction of care, guideline concordant care, patient involvement in participatory decision making, communication skills) rated by patients and providers at 6 and 12 months.
|Study Start Date:||March 2004|
|Estimated Study Completion Date:||March 2007|
Several studies document underutilization of outpatient specialty mental health services by African Americans. However, African Americans with depression are just as likely as whites to receive care in primary care settings. Despite their use of primary care services, African American patients are less likely than whites to be recognized as depressed, offered pharmacotherapy, and to initiate or complete pharmacotherapy or psychotherapy for depression. Compared to whites, African American patients express stronger preferences for counseling and more negative attitudes toward antidepressant medication, the most common form of treatment of depression used by primary care physicians. African Americans are also more likely to see depression and its treatment through a spiritual or religious framework. Studies show that African Americans receive less optimal technical and interpersonal health care than whites for many conditions. Depression is a common chronic condition that results in substantial morbidity, functional disability, and resource use. Despite the proven efficacy of pharmacotherapy and psychotherapy for treatment of depression, the gap between research findings and clinical practice is wide for management of depression in primary care. Recent intervention work has shown that quality improvement strategies for depression in primary care are effective. Research also shows that cultural adaptations can improve adherence and retention in care for ethnic minority patients. We have created a patient-centered adaptation that includes many of the components of recent successful quality improvement interventions for depression in primary care. The proposed study compares a standard depression intervention for patients (delivered by a depression case manager) and physicians (review of guidelines and structured mental health consultation) to a patient-centered intervention for patients (incorporates patient activation, individual preferences, and cultural sensitivity) and physicians (incorporates participatory communication skills training with individualized feedback on interactive CD-ROM). Thirty physicians and 250 patients will be randomized to either the standard interventions or the culturally tailored interventions. The main hypothesis is that patients in the patient-centered, culturally tailored intervention group will have higher remission rates from depression and lower levels of depressive symptoms at 12 months than patients in the standard intervention care group. Secondary outcomes will include patient receipt of guideline concordant care, patient and physician satisfaction with care, patient-physician communication behaviors, patient and physician attitudes towards depression, and self-efficacy in managing depression. This study will add to knowledge about how to effectively engage African American patients in care of depression and serve as a prototype of how to incorporate patient-centeredness in programs to reduce racial and ethnic disparities in health care for common conditions.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00243425
|Contact: Bri K Ghods, B.S.||410-522-6500 ext firstname.lastname@example.org|
|United States, Delaware|
|Christiana Care Health Services||Recruiting|
|Wilmington, Delaware, United States, 19803|
|Contact: James M Gill, MD, MPH 302-477-3324 JGill@Christianacare.org|
|Sub-Investigator: James M Gill, MD, MPH|
|United States, Maryland|
|Johns Hopkins Community Phsyicians||Recruiting|
|Baltimore, Maryland, United States, 21211|
|Contact: Gary J Noronha, M.D. 410-338-3421|
|Sub-Investigator: Gary J Noronha, MD|
|Baltimore Medical Systems, Middlesex Health Center||Recruiting|
|Baltimore, Maryland, United States, 21221|
|Contact: Melissa Treola 410-558-4700|
|Baltimore, Maryland, United States, 21215|
|Contact: Robert T Chow, MD 410-601-6856|
|Sub-Investigator: Robert T Chow, MD|
|Johns Hopkins School of Medicine||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Lisa A Cooper, MD, MPH 410-614-3659 email@example.com|
|Principal Investigator: Lisa A Cooper, MD, MPH|
|Principal Investigator:||Lisa A Cooper, MD, MPH||Johns Hopkins University|