Clinical Trial: Improving Outcomes of Depression in Primary Care

This study has been completed.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs

Purpose

This study is a randomized, controlled trial of a collaborative treatment intervention, Depression Decision Support (DDS). To equip providers with the knowledge and skills necessary to make best use of DDS, providers entering both arms of the study will receive the MacArthur Depression Education Program (DEP). DEP is a previously tested workshop designed to improve providers’ treatment of depressed patients. Providers in the intervention group will receive DEP followed by DDS, while control providers will receive DEP followed by usual care support. Providers in the DDS intervention group will receive serial reports of depression severity scores and pharmacy and appointment data for their patients enrolled in the study. The DDS team (psychiatrist and nurse) will review this same information, and make initial recommendations to providers. The DDS nurse will make one telephone contact with each intervention patient early in treatment. Additional time and effort expended by the DDS team will be targeted towards patients not showing improvement in depression severity.

The primary objective of this study is to determine the impact of a low-intensity care management program on outcomes of patients with major depression in the primary care setting. Secondary objectives of the study are to determine: 1) the extent to which primary care providers adhere to VA Major Depression Treatment Guidelines; and 2) the extent to which the care management intervention impacts measures of utilization.

Forty-four staff providers and 400 patients at VA clinic sites in the Portland VA will participate. After stratification by discipline and site, providers will be randomized into one of two groups. One group will receive DDS while the other receives usual care (including an on-site mental health team). Patients will be clustered by provider to receive intervention or usual care based on provider assignment. Potential subjects will be contacted by telephone to complete brief screening questionnaires. Patients will be included in the study if they have Patient Health Questionnaire Depression (PHQ) scores >10. There will be no restrictions by age or sex. Patients will be excluded if they have psychotic symptoms, dementia, serious suicidal ideation, very severe depression (PHQ-D >25), or have been treated by mental health clinicians within the previous six months. Patients meeting eligibility criteria will meet in-person or via videoconferencing with research assistants for initial interviews. The intervention will last 12 months.

Depression symptom severity (SCL-20 score) and health related quality of life (SF-36V) at 6- and 12-months will be primary outcomes. Secondary outcomes will be measures of VA healthcare utilization, and provider adherence to VA Major Depression Guidelines. The primary analysis will be a comparison of the DDS versus usual care groups using a nested analysis of variance (ANOVA), with patients nested within provider.

Condition Treatment or Intervention
Depression
 Behavior: Collaborative Care - Depression Decision Support (DDS)

MedlinePlus related topics:  Depression

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Further Study Details: 
Primary Outcomes: Depression symptom severity (SCL-20 score) and health related quality of life (SF-36V) at 6- and 12-months
Secondary Outcomes: Measures of VA healthcare utilization, and provider adherence to VA Major Depression Guidelines
Expected Total Enrollment:  400

Study start: January 2002;  Study completion: December 2004

Eligibility

Genders Eligible for Study:  Both

Criteria

  • Veterans treated in primary care with depression

Location Information


Oregon
      Portland Medical Center, Portland,  Oregon,  97207,  United States

      Portland VA Medical Center, Portland,  Oregon,  97207,  United States

      VA Medical Center, Portland,  Oregon,  97201,  United States

More Information

Publications

Dobscha SK, Anderson TA, Hoffman WF, Winterbottom LM, Turner EH, Snodgrass LS, Hauser P. Strategies to decrease costs of prescribing selective serotonin reuptake inhibitors at a VA Medical Center. Psychiatr Serv. 2003 Feb;54(2):195-200.

Dobscha SK, Gerrity MS, Corson K, Bahr A, Cuilwik NM. Measuring adherence to depression treatment guidelines in a VA primary care clinic. Gen Hosp Psychiatry. 2003 Jul-Aug;25(4):230-7.

Study ID Numbers:  MHI 20-020
Record last reviewed:  March 2005
Last Updated:  March 16, 2005
Record first received:  March 16, 2005
ClinicalTrials.gov Identifier:  NCT00105833
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005