- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00677898
A Patient-Centered Approach to Improve Screening for Side Effects of Second Generation Antipsychotics (SGAs)
A Patient-Centered Approach to Improve Screening for Side Effects of SGAs
Přehled studie
Postavení
Podmínky
Detailní popis
Project Background/Rationale: Second-generation antipsychotic (SGA) medications are widely used to treat psychotic disorders but are associated with metabolic side effects such as weight gain, glucose dysregulation, and hyperlipidemia that may contribute to the high rates of cardiovascular disease observed in individuals with serious mental illness (SMI). Adherence to guidelines for regular screening for the metabolic side effects of SGAs is inadequate. Patient-centered care, characterized by an effective partnership between clinicians and patients that promotes active participation by patients in their own care, improves health outcomes and satisfaction in the general population. In order to increase rates of screening for the metabolic side effects of SGAs, we propose to design a patient-centered computerized tool that provides veterans with SMI with personalized health information on how well their care adheres to screening recommendations. The computerized tool will use principles shown to enhance usability in persons with cognitive impairments.
Project Objectives: The objectives of this study are to determine the effect of exposure to a patient-centered computerized tool compared to enhanced treatment as usual (e-TAU) on: (1) rates of screening for and identification of health problems associated with the metabolic side effects of SGAs; (2) patterns of patient-centered communication around screening for metabolic side effects and VA patients' self-efficacy in communicating with their psychiatrists about screening; (3) VA patients' preferences for obtaining health information and participating in decision-making about screening; and (4) VA patients' perceptions of their psychiatrists' participatory decision-making styles around screening.
Project Methods: A total of 240 veterans with psychotic disorders prescribed SGAs and in regular contact with their prescribing clinicians in outpatient mental health clinics in the VA Maryland Health Care System will be recruited for this randomized controlled trial. Half of participants will be randomly assigned to the intervention condition in which they will view a brief computer program that provides personalized health information on adherence to guidelines for screening of metabolic side effects that is designed to facilitate discussion with psychiatrists about appropriate screening. The other half of participants will receive enhanced treatment-as-usual (e-TAU) consisting of printed information on the metabolic side effects of SGAs and general recommendations for screening. Participants will be exposed to the intervention or e-TAU up to 3 times immediately prior to a visit with their prescriber over the one-year study period. Rates of screening for the metabolic side effects of SGAs will be obtained from patients' computerized medical records. A single prescriber visit for each participant will be audiotaped and coded with the Roter Interaction Analysis System (RIAS) to characterize patterns of patient-clinician communication around screening for metabolic side effects. Baseline and 12-month follow-up interview assessments with veterans will be used to acquire information on self-efficacy, their preferences for obtaining health information and participating in decisions regarding side effect screening, and important covariates such as severity of psychiatric illness.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Maryland
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Baltimore, Maryland, Spojené státy, 21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Agreement obtained from the treating clinician that the patient is clinically stable enough to participate in the study and can be contacted for recruitment
- Agreement obtained from treating clinician to have a single visit with the patient audio taped
- Patient age 18-70 years
- Diagnosis of a psychotic disorder (schizophrenia, affective psychosis, major depression with psychotic features)
- Currently prescribed any SGA medication (aripiprazole, clozapine, olanzapine, quetiapine, risperidone, ziprasidone) by a clinician in a VA Maryland Healthcare System (VAMHCS) mental health clinic
- Had at least two outpatient visits with the prescribing clinician in the past year - Decisional capacity to provide informed consent
- Ability to read at a 4th grade reading level
Exclusion Criteria:
- Diagnosis of dementia or other organic brain syndrome or traumatic brain injury
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Patient-centered computerized tool
A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
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A brief computer program that provides personalized health information to patients prescribed second-generation antipsychotic medications on adherence to guidelines for screening of metabolic side effects
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Aktivní komparátor: Written educational materials
Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
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Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Body Mass Index
Časové okno: 1 year
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Guidelines recommend that body mass index be evaluated every 3 months
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1 year
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Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Blood Pressure
Časové okno: 1 year
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Guidelines recommend that blood pressure be evaluated every 3 months
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1 year
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Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Blood Glucose/HbA1c
Časové okno: 1 year
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Guidelines recommend that blood glucose/HbA1c be evaluated every year
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1 year
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Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: LDL Cholesterol
Časové okno: 1 year
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Guidelines recommend that LDL cholesterol be evaluated every 2 years
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1 year
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Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: HDL Cholesterol
Časové okno: 1 year
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Guidelines recommend that HDL cholesterol be evaluated every 2 years
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1 year
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Percentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Triglycerides
Časové okno: 1 year
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Guidelines recommend that triglycerides be evaluated every 2 years
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1 year
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Julie Anne Kreyenbuhl, PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- IIR 07-256
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Klinické studie na Patient-centered computerized tool
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Walter Reed National Military Medical CenterUniversity of Wisconsin, MilwaukeeDokončenoHypertenze | Kardiovaskulární onemocnění | Diabetes Mellitus | Osteoartróza | Chronické onemocnění | Hyperlipidémie | COPDSpojené státy