A Patient-Centered Approach to Improve Screening for Side Effects of Second Generation Antipsychotics (SGAs)

Schizophrenia Clinical Trial

Official title:

A Patient-Centered Approach to Improve Screening for Side Effects of SGAs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00677898
• Other study ID #: IIR 07-256
• Status: Completed
• Phase: N/A
• First received: May 9, 2008
• Last updated: April 6, 2015
• Start date: March 2010
• Est. completion date: June 2013

Study information

• Verified date: August 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: June 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Intervention

Behavioral:
• 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
• Written educational materials
Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Park SG, Derman M, Dixon LB, Brown CH, Klingaman EA, Fang LJ, Medoff DR, Kreyenbuhl J. Factors associated with shared decision-making preferences among veterans with serious mental illness. Psychiatr Serv. 2014 Dec 1;65(12):1409-13. doi: 10.1176/appi.ps.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Guidelines recommend that body mass index be evaluated every 3 months	1 year	No
Primary	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	Guidelines recommend that blood pressure be evaluated every 3 months	1 year	No
Primary	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	Guidelines recommend that blood glucose/HbA1c be evaluated every year	1 year	No
Primary	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	Guidelines recommend that LDL cholesterol be evaluated every 2 years	1 year	No
Primary	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	Guidelines recommend that HDL cholesterol be evaluated every 2 years	1 year	No
Primary	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	Guidelines recommend that triglycerides be evaluated every 2 years	1 year	No