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Patient-Centered Depression Care for African Americans

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by Agency for Healthcare Research and Quality (AHRQ).
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Aetna, Inc.
Information provided by:
Agency for Healthcare Research and Quality (AHRQ)
ClinicalTrials.gov Identifier:
NCT00243425
First received: October 21, 2005
Last updated: NA
Last verified: October 2005
History: No changes posted
  Purpose

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.


Condition Intervention
Major Depressive Disorder
Procedure: Standard Quality Improvement
Procedure: Patient-centered Intervention

Study Type: Interventional
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

Further study details as provided by Agency for Healthcare Research and Quality (AHRQ):

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 250
Study Start Date: March 2004
Estimated Study Completion Date: March 2007
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have experienced two weeks or more of depressed mood/ loss of interest in the past year
  • Patients who have experienced one week or more of depressed mood or loss of interest in the past month
  • Self defined race or ethnicity African American
  • Able to give written consent

Exclusion Criteria:

  • Current alcohol or drug abuse
  • History of mania
  • Grief reaction or bereavement within the past 2 months
  • Pregnancy
  • Life expectancy less than 1 year
  • Non English speaking
  • Current specialty mental health care (at least 2 visits in past 6 weeks and appt scheduled in future
  • Plan to change health care or primary care Provider in next 12 months
  • Active suicidal thoughts and plans
  • Residing in US for less than 5 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243425

Contacts
Contact: Bri K Ghods, B.S. 410-522-6500 ext 263 bghods@jhmi.edu

Locations
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
Baltimore Medical Systems, Middlesex Health Center Recruiting
Baltimore, Maryland, United States, 21221
Contact: Melissa Treola    410-558-4700      
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         
Johns Hopkins School of Medicine Recruiting
Baltimore, Maryland, United States, 21287
Contact: Lisa A Cooper, MD, MPH    410-614-3659    lisa.cooper@jhmi.edu   
Principal Investigator: Lisa A Cooper, MD, MPH         
Sinai Hospital Recruiting
Baltimore, Maryland, United States, 21215
Contact: Robert T Chow, MD    410-601-6856      
Sub-Investigator: Robert T Chow, MD         
Sponsors and Collaborators
Aetna, Inc.
Investigators
Principal Investigator: Lisa A Cooper, MD, MPH Johns Hopkins University
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00243425     History of Changes
Other Study ID Numbers: R01HS013645
Study First Received: October 21, 2005
Last Updated: October 21, 2005
Health Authority: United States: Federal Government

Keywords provided by Agency for Healthcare Research and Quality (AHRQ):
Major Depressive Disorder;
African Americans;
Disparities;
Quality Improvement;
Patient Centered Care;
Primary Care;
Patient-Physician Relationship;

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 20, 2014