A Multi-Site Study of Strategies for Implementing Schizophrenia Guidelines - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 14, 2001

Last Updated Date

April 23, 2008

Start Date ^†

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00013000 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

A Multi-Site Study of Strategies for Implementing Schizophrenia Guidelines

Official Title ^†

A Multi-Site Study of Strategies for Implementing Schizophrenia Guidelines

Brief Summary

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.

Detailed Description

Background:

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Schizophrenia

Intervention ^†

Behavioral: Test strategy for implementation guideline

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

400

Completion Date

Primary Completion Date

Eligibility Criteria ^†

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:

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00013000

Responsible Party

Owen, Richard - Principal Investigator, Department of Veterans Affairs

Secondary IDs ^††

Study Sponsor ^†

Department of Veterans Affairs

Collaborators ^††

Investigators ^†

Principal Investigator:

Richard R. Owen, MD

Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock

Information Provided By

Department of Veterans Affairs

Verification Date

September 2000

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.