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| Sponsored by: |
Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00013000 |
Purpose
Schizophrenia, a chronic psychiatric disorder, is the second most frequent VA discharge diagnosis. Medication management practices for schizophrenia often are not guideline-concordant and place patients at risk for adverse outcomes. This project tests a new strategy to standard implementation for VHA Schizophrenia Guidelines.
| Condition | Intervention |
|---|---|
|
Schizophrenia |
Behavioral: Test strategy for implementation guideline |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Multi-Site Study of Strategies for Implementing Schizophrenia Guidelines |
| Estimated Enrollment: | 400 |
| Arms | Assigned Interventions |
|---|---|
| 1 | Behavioral: Test strategy for implementation guideline |
Background:
Schizophrenia, a chronic psychiatric disorder, is the second most frequent VA discharge diagnosis. Medication management practices for schizophrenia often are not guideline-concordant and place patients at risk for adverse outcomes. This project tests a new strategy to standard implementation for VHA Schizophrenia Guidelines.
Objectives:
Research objectives are: (1) to compare the effectiveness of a conceptually-based, enhanced intervention to that of a basic educational strategy with regard to improving guideline adherence and patient compliance; (2) to compare the effectiveness of the two strategies with regard to improving symptom and side effect outcomes; (3) to determine the effect of the enhanced intervention on service utilization for acute exacerbations of schizophrenia; (4) to determine the extent to which guideline-concordant medication management improves patient outcomes; and (5) to examine providers� knowledge of and attitudes toward guidelines.
Methods:
Thirteen VA sites were considered for the study, and VistA data were extracted to assess baseline guideline performance. Seven sites were selected and received basic education about schizophrenia guidelines. Three of these sites were randomly selected to receive the enhanced intervention, employing a nurse coordinator to promote providers' guideline adherence and patients' treatment adherence. Subjects with an acute exacerbation of schizophrenia were enrolled and were interviewed at baseline and six months using the Positive and Negative Syndrome Scale, the Schizophrenia Outcomes Module, and the Barnes Akathisia Scale. Data on guideline adherence were collected from medical records and VistA files. When data collection is completed, analyses will be conducted to determine the effectiveness of the enhanced intervention with regard to improving guideline adherence and patient outcomes.
Status:
The project is ongoing. To date, 401 subjects have been enrolled in the intervention study. The rate of completed follow-up assessments to date is 86 percent.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1. Subjects must have a diagnosis of schizophrenia. 2. Subjects must have been admitted to an inpatient psychiatry unit or seen in an ambulatory care clinic or the Emergency Room at a study site for symptoms of acute exacerbation. 3. Must be able to provide informed consent themselves or informed consent by a guardian.
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| Tuscaloosa VAMC | |
| Tuscaloosa, Alabama, United States, 35405 | |
| United States, Arkansas | |
| Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock | |
| No. Little Rock, Arkansas, United States, 72114-1706 | |
| United States, District of Columbia | |
| VA Medical Center | |
| Washington, District of Columbia, United States, 20422 | |
| United States, Louisiana | |
| VA Medical Center | |
| New Orleans, Louisiana, United States, 70112-1262 | |
| United States, Maryland | |
| VA Maryland Health Care System | |
| Perry Point, Maryland, United States, 21902 | |
| VA Maryland Health Care System | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Texas | |
| VA South Texas Health Care System HSR&D COE | |
| San Antonio, Texas, United States, 78229-5700 | |
| VA North Texas Health Care System | |
| Dallas, Texas, United States, 75216 | |
| Houston VA Medical Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Richard R. Owen, MD | Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock |
More Information
| Responsible Party: | Department of Veterans Affairs ( Owen, Richard - Principal Investigator ) |
| Study ID Numbers: | CPG 97-027 |
| Study First Received: | March 14, 2001 |
| Last Updated: | April 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00013000 History of Changes |
| Health Authority: | United States: Federal Government |
|
Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
|
Schizophrenia Mental Disorders Schizophrenia and Disorders with Psychotic Features |