Schizophrenia Clinical Trial
Official title:
A Patient-Centered Approach to Improve Screening for Side Effects of SGAs
The purpose of this study is to determine if individuals with serious mental illnesses exposed to a patient-centered computerized tool versus printed educational materials have higher rates of screening for the metabolic side effects of second-generation antipsychotic medications and different patterns of communication with their prescribers about screening.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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