- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00013000
A Multi-Site Study of Strategies for Implementing Schizophrenia Guidelines
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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District of Columbia
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Washington, District of Columbia, 미국, 20422
- Washington DC VA Medical Center, Washington, DC
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Louisiana
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New Orleans, Louisiana, 미국, 70112
- Southeast Louisiana Veterans Health Care System, New Orleans, LA
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Maryland
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Tuscaloosa, Maryland, 미국, 35404
- Tuscaloosa VA Medical Center, Tuscaloosa, AL
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Texas
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Dallas, Texas, 미국, 75216
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
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Houston, Texas, 미국, 77030
- Michael E. DeBakey VA Medical Center, Houston, TX
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San Antonio, Texas, 미국, 78229
- South Texas Health Care System, San Antonio, TX
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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:
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
다른: 팔 1
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Richard R. Owen, MD, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CPG 97-027
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