- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00013000
A Multi-Site Study of Strategies for Implementing Schizophrenia Guidelines
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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District of Columbia
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Washington, District of Columbia, Verenigde Staten, 20422
- Washington DC VA Medical Center, Washington, DC
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Louisiana
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New Orleans, Louisiana, Verenigde Staten, 70112
- Southeast Louisiana Veterans Health Care System, New Orleans, LA
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Maryland
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Tuscaloosa, Maryland, Verenigde Staten, 35404
- Tuscaloosa VA Medical Center, Tuscaloosa, AL
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Texas
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Dallas, Texas, Verenigde Staten, 75216
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
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Houston, Texas, Verenigde Staten, 77030
- Michael E. DeBakey VA Medical Center, Houston, TX
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San Antonio, Texas, Verenigde Staten, 78229
- South Texas Health Care System, San Antonio, TX
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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:
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Ander: Arm 1
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Richard R. Owen, MD, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CPG 97-027
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