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Patient-Centered Depression Care for African Americans

Primary Purpose

Major Depressive Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Quality Improvement
Patient-centered Intervention
Sponsored by
Agency for Healthcare Research and Quality (AHRQ)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder;, African Americans;, Disparities;, Quality Improvement;, Patient Centered Care;, Primary Care;, Patient-Physician Relationship;

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Christiana Care Health ServicesRecruiting
  • Johns Hopkins Community PhsyiciansRecruiting
  • Sinai HospitalRecruiting
  • Baltimore Medical Systems, Middlesex Health CenterRecruiting
  • Johns Hopkins School of MedicineRecruiting

Outcomes

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.

Full Information

First Posted
October 21, 2005
Last Updated
October 21, 2005
Sponsor
Agency for Healthcare Research and Quality (AHRQ)
Collaborators
Aetna, Inc., National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00243425
Brief Title
Patient-Centered Depression Care for African Americans
Official Title
Patient-Centered Depression Care for African Americans
Study Type
Interventional

2. Study Status

Record Verification Date
October 2005
Overall Recruitment Status
Unknown status
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Agency for Healthcare Research and Quality (AHRQ)
Collaborators
Aetna, Inc., National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder;, African Americans;, Disparities;, Quality Improvement;, Patient Centered Care;, Primary Care;, Patient-Physician Relationship;

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Standard Quality Improvement
Intervention Type
Procedure
Intervention Name(s)
Patient-centered Intervention
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bri K Ghods, B.S.
Phone
410-522-6500
Ext
263
Email
bghods@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa A Cooper, MD, MPH
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christiana Care Health Services
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James M Gill, MD, MPH
Phone
302-477-3324
Email
JGill@Christianacare.org
First Name & Middle Initial & Last Name & Degree
James M Gill, MD, MPH
Facility Name
Johns Hopkins Community Phsyicians
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary J Noronha, M.D.
Phone
410-338-3421
First Name & Middle Initial & Last Name & Degree
Gary J Noronha, MD
Facility Name
Sinai Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert T Chow, MD
Phone
410-601-6856
First Name & Middle Initial & Last Name & Degree
Robert T Chow, MD
Facility Name
Baltimore Medical Systems, Middlesex Health Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21221
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Treola
Phone
410-558-4700
Facility Name
Johns Hopkins School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa A Cooper, MD, MPH
Phone
410-614-3659
Email
lisa.cooper@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Lisa A Cooper, MD, MPH

12. IPD Sharing Statement

Citations:
PubMed Identifier
2646486
Citation
Kaplan SH, Greenfield S, Ware JE Jr. Assessing the effects of physician-patient interactions on the outcomes of chronic disease. Med Care. 1989 Mar;27(3 Suppl):S110-27. doi: 10.1097/00005650-198903001-00010. Erratum In: Med Care 1989 Jul;27(7):679.
Results Reference
background
PubMed Identifier
9002500
Citation
Roter DL, Stewart M, Putnam SM, Lipkin M Jr, Stiles W, Inui TS. Communication patterns of primary care physicians. JAMA. 1997 Jan 22-29;277(4):350-6.
Results Reference
background
PubMed Identifier
8637945
Citation
Gallo JJ, Marino S, Ford D, Anthony JC. Filters on the pathway to mental health care, II. Sociodemographic factors. Psychol Med. 1995 Nov;25(6):1149-60. doi: 10.1017/s0033291700033122.
Results Reference
background
PubMed Identifier
8277799
Citation
Cooper-Patrick L, Crum RM, Ford DE. Characteristics of patients with major depression who received care in general medical and specialty mental health settings. Med Care. 1994 Jan;32(1):15-24. doi: 10.1097/00005650-199401000-00002.
Results Reference
background
PubMed Identifier
10524370
Citation
Cooper-Patrick L, Gallo JJ, Powe NR, Steinwachs DM, Eaton WW, Ford DE. Mental health service utilization by African Americans and Whites: the Baltimore Epidemiologic Catchment Area Follow-Up. Med Care. 1999 Oct;37(10):1034-45. doi: 10.1097/00005650-199910000-00007.
Results Reference
background
PubMed Identifier
12665712
Citation
Cooper LA, Gonzales JJ, Gallo JJ, Rost KM, Meredith LS, Rubenstein LV, Wang NY, Ford DE. The acceptability of treatment for depression among African-American, Hispanic, and white primary care patients. Med Care. 2003 Apr;41(4):479-89. doi: 10.1097/01.MLR.0000053228.58042.E4.
Results Reference
background
PubMed Identifier
14644893
Citation
Cooper LA, Roter DL, Johnson RL, Ford DE, Steinwachs DM, Powe NR. Patient-centered communication, ratings of care, and concordance of patient and physician race. Ann Intern Med. 2003 Dec 2;139(11):907-15. doi: 10.7326/0003-4819-139-11-200312020-00009.
Results Reference
background
PubMed Identifier
9229282
Citation
Cooper-Patrick L, Powe NR, Jenckes MW, Gonzales JJ, Levine DM, Ford DE. Identification of patient attitudes and preferences regarding treatment of depression. J Gen Intern Med. 1997 Jul;12(7):431-8. doi: 10.1046/j.1525-1497.1997.00075.x.
Results Reference
background
PubMed Identifier
20178624
Citation
Cooper LA, Ford DE, Ghods BK, Roter DL, Primm AB, Larson SM, Gill JM, Noronha GJ, Shaya EK, Wang NY. 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. Implement Sci. 2010 Feb 23;5:18. doi: 10.1186/1748-5908-5-18.
Results Reference
derived

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Patient-Centered Depression Care for African Americans

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