Skip to content

A Multi-Site Study of Strategies for Implementing Schizophrenia Guidelines

A Multi-Site Study of Strategies for Implementing Schizophrenia Guidelines

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00013000
Enrollment
400
Registered
2001-03-16
Start date
Unknown
Completion date
2000-09-30
Last updated
2015-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

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: 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.

Interventions

BEHAVIORALTest strategy for implementation guideline

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026