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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00012766
Other study ID # IIR 95-097
Secondary ID
Status Completed
Phase Phase 2
First received March 14, 2001
Last updated April 6, 2015
Est. completion date March 2001

Study information

Verified date December 2005
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

Most depression treatment takes place in primary care, where the condition continues to be under-detected and under-treated. A collaborative care model derived from chronic illness management theory has been successful in improving care in other managed care settings.


Description:

Background:

Most depression treatment takes place in primary care, where the condition continues to be under-detected and under-treated. A collaborative care model derived from chronic illness management theory has been successful in improving care in other managed care settings.

Objectives:

This effectiveness study adapted collaborative care to the VA primary care setting ("collaborative care") and compared it with consult-liaison care ("CL care").

Methods:

Patients within a VA primary care clinic were randomly assigned by firm to the two interventions.

In collaborative care, existing staff resources were reorganized to form a multidisciplinary mental health specialist team. The team developed a treatment plan based on an initial assessment and suggested the plan to the primary care provider. Primary care providers' treatment efforts were then supported by brief Social Work telephone calls designed to support adherence and monitor symptomatology. Treatment results were systematically reviewed and suggestions for treatment modification were fed back to the primary providers. In CL care, the primary care providers were informed of the diagnosis and study clinicians facilitated referrals to Psychiatry residents in-clinic as requested. Mailed and in-clinic surveys and provider referral were used to recruit 168 collaborative care and 186 CL care patients who met criteria for major depression and/or dysthymia based on structured interview. Patients were excluded only if they required immediate inpatient care, had a pending mental health specialty clinic appointment, or had primary alcohol abuse. Outcome data on the SCL-20 depression symptomatology measure, Veterans SF-36, and Sheehan Disability Scale were collected at baseline, 3 and 9 months. VA utilization and costs of care were analyzed.

Status:

Complete. Final Report submitted June 30, 2001.


Recruitment information / eligibility

Status Completed
Enrollment 360
Est. completion date March 2001
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

Several screening methods including mailed and in-clinic surveys and provider referral were used to recruit 168 team and 188 CL study patients who met criteria for major depression and/or dysthymia based on structured interview. Patients were excluded only if they required immediate inpatient care, had a pending mental health specialty clinic appointment, had primary alcohol abuse, or were too impaired to participate in the screening interview. Outcome data on the SCL-20 depression symptomatology measure, SF-36V, and Sheehan functional impairment measure were collected at baseline, 3 and 9 months.

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Integrated team care


Locations

Country Name City State
United States VA Puget Sound Health Care System Seattle Division, Seattle, WA Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (6)

Felker BL, Hedrick SC, Chaney EF, Liu CF, Heagerty P, Caples H, Lin P, Katon W. Identifying Depressed Patients With a High Risk of Comorbid Anxiety in Primary Care. Prim Care Companion J Clin Psychiatry. 2003 Jun;5(3):104-110. — View Citation

Fischer EP, Marder SR, Smith GR, Owen RR, Rubenstein L, Hedrick SC, Curran GM. Quality Enhancement Research Initiative in Mental Health. Med Care. 2000 Jun;38(6 Suppl 1):I70-81. Review. — View Citation

Hedrick SC, Chaney EF, Felker B, Liu CF, Hasenberg N, Heagerty P, Buchanan J, Bagala R, Greenberg D, Paden G, Fihn SD, Katon W. Effectiveness of collaborative care depression treatment in Veterans' Affairs primary care. J Gen Intern Med. 2003 Jan;18(1):9- — View Citation

Kanter JW, Epler AJ, Chaney EF, Liu CF, Heagerty P, Lin P, Felker B, Hedrick SC. Comparison of 3 Depression Screening Methods and Provider Referral in a Veterans Affairs Primary Care Clinic. Prim Care Companion J Clin Psychiatry. 2003 Dec;5(6):245-250. — View Citation

Lin P, Campbell DG, Chaney EF, Liu CF, Heagerty P, Felker BL, Hedrick SC. The influence of patient preference on depression treatment in primary care. Ann Behav Med. 2005 Oct;30(2):164-73. — View Citation

Liu CF, Hedrick SC, Chaney EF, Heagerty P, Felker B, Hasenberg N, Fihn S, Katon W. Cost-effectiveness of collaborative care for depression in a primary care veteran population. Psychiatr Serv. 2003 May;54(5):698-704. — View Citation

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