Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013000
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2001-03-14
Brief Title:
A Multi-Site Study of Strategies for Implementing Schizophrenia Guidelines
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
A Multi-Site Study of Strategies for Implementing Schizophrenia Guidelines
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None