A Patient-Centered Approach to Improve Screening for Side Effects of Second Generation Antipsychotics (SGAs)
Condition: Schizophrenia; Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Patient-centered computerized tool; Written educational materials
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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; Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Patient-Centered Care; Adverse effects; Antipsychotics