Clinical trial NCT00013000: A Multi-Site Study of Strategies for Implementing Schizophrenia Guidelines
Official title: A Multi-Site Study of Strategies for Implementing Schizophrenia Guidelines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-03-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington DC VA Medical Center, Washington, DC
state: District of Columbia
city: New Orleans
country: United States
facility: Southeast Louisiana Veterans Health Care System, New Orleans, LA
state: Louisiana
city: Tuscaloosa
country: United States
facility: Tuscaloosa VA Medical Center, Tuscaloosa, AL
state: Maryland
city: Dallas
country: United States
facility: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
city: San Antonio
country: United States
facility: South Texas Health Care System, San Antonio, TX
state: Texas
Study officials:
affiliation: Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
name: Richard R. Owen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hamilton J, Guthrie E, Creed F, Thompson D, Tomenson B, Bennett R, Moriarty K, Stephens W, Liston R. A randomized controlled trial of psychotherapy in patients with chronic functional dyspepsia. Gastroenterology. 2000 Sep;119(3):661-9. doi: 10.1053/gast.2000.16493.
citation: Owen RR, Hudson T, Thrush C, Thapa P, Armitage T, Landes RD. The effectiveness of guideline implementation strategies on improving antipsychotic medication management for schizophrenia. Med Care. 2008 Jul;46(7):686-91. doi: 10.1097/MLR.0b013e3181653d43.