- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: 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
|
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
|
Comparador Ativo: Written educational materials
Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
|
Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
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
Prazo: 1 year
|
Guidelines recommend that body mass index be evaluated every 3 months
|
1 year
|
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
Prazo: 1 year
|
Guidelines recommend that blood pressure be evaluated every 3 months
|
1 year
|
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
Prazo: 1 year
|
Guidelines recommend that blood glucose/HbA1c be evaluated every year
|
1 year
|
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
Prazo: 1 year
|
Guidelines recommend that LDL cholesterol be evaluated every 2 years
|
1 year
|
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
Prazo: 1 year
|
Guidelines recommend that HDL cholesterol be evaluated every 2 years
|
1 year
|
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
Prazo: 1 year
|
Guidelines recommend that triglycerides be evaluated every 2 years
|
1 year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Julie Anne Kreyenbuhl, PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IIR 07-256
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .