Major Depressive DisorderNCT00243425
Patient-Centered Depression Care for African Americans
A study testing Standard Quality Improvement and Patient-centered Intervention in people with Major Depressive Disorder, run by Agency for Healthcare Research and Quality (AHRQ) at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Standard Quality Improvement and Patient-centered Intervention
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2004to Mar 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Johns Hopkins Community Phsyicians
Baltimore, Maryland, 21211
Gary J Noronha, M.D., 410-338-3421
Gary J Noronha, MD
- Recruiting
Sinai Hospital
Baltimore, Maryland, 21215
Robert T Chow, MD, 410-601-6856
Robert T Chow, MD
- Recruiting
Baltimore Medical Systems, Middlesex Health Center
Baltimore, Maryland, 21221
Melissa Treola, 410-558-4700
- Recruiting
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
Lisa A Cooper, MD, MPH, 410-614-3659, lisa.cooper@jhmi.edu
Lisa A Cooper, MD, MPH
- Recruiting
Christiana Care Health Services
Wilmington, Delaware, 19803
James M Gill, MD, MPH, 302-477-3324, JGill@Christianacare.org
James M Gill, MD, MPH
About this study
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Standard Quality Improvement, Patient-centered Intervention
- Keywords
- Major Depressive Disorder;, African Americans;, Disparities;, Quality Improvement;, Patient Centered Care;, Primary Care;, Patient-Physician Relationship;
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Quality ImprovementProcedure or surgery
Patient-centered InterventionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2005 (estimated)
- Study startMar 2004
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)
- Sponsor type
- US federal agency
- Collaborators
- Aetna, Inc., National Institute of Mental Health (NIMH)
- Investigators
- Lisa A Cooper, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243425
- Sponsor's protocol ID
- R01HS013645
- Status last verified
- Oct 2005
- First submitted
- 21 Oct 2005
- Last updated
- 24 Oct 2005
- Results posted
- No
Publications
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.
PubMed 2646486Roter 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.
PubMed 9002500Gallo 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.
PubMed 8637945Cooper-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.
PubMed 8277799Cooper-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.
PubMed 10524370Cooper 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.
PubMed 12665712Cooper 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.
PubMed 14644893Cooper-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.
PubMed 9229282Cooper 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.
PubMed 20178624
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Depression Care for African Americans
- ClinicalTrials.gov ID
- NCT00243425
- Acronym / sponsor ID
- R01HS013645
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder;, African Americans;, Disparities;, Quality Improvement;, Patient Centered Care;, Primary Care;, Patient-Physician Relationship;
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)US federal agency
- Collaborators
- Aetna, Inc., National Institute of Mental Health (NIMH)
- Study start
- Mar 2004
- Study completion
- Mar 2007
- First posted
- 24 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Current alcohol or drug abuse
- History of mania
- Grief reaction or bereavement within the past 2 months
- Pregnancy
- Life expectancy less than 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Quality Improvement | Procedure or surgery | – |
| Patient-centered Intervention | Procedure or surgery | – |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2005.
- Background: PubMed 2646486Kaplan 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.
- Background: PubMed 9002500Roter 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.
- Background: PubMed 8637945Gallo 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.
- Background: PubMed 8277799Cooper-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.
- Background: PubMed 10524370Cooper-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.
- Background: PubMed 12665712Cooper 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.
- Background: PubMed 14644893Cooper 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.
- Background: PubMed 9229282Cooper-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.
- Derived from this study: PubMed 20178624Cooper 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa A Cooper, MD, MPH principal investigator
Johns Hopkins University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Quality Improvement and Patient-centered Intervention in people with Major Depressive Disorder, run by Agency for Healthcare Research and Quality (AHRQ) at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bri K Ghods, B.S. (410-522-6500 ext. 263, bghods@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00243425, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2005.