Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00677898
First received: May 9, 2008
Last updated: April 6, 2015
Last verified: August 2014
  Purpose
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.

Condition Intervention
Schizophrenia
Psychotic Disorders
Behavioral: Patient-centered computerized tool
Behavioral: Written educational materials

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Patient-Centered Approach to Improve Screening for Side Effects of SGAs

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Guidelines recommend that body mass index be evaluated every 3 months

  • 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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Guidelines recommend that blood pressure be evaluated every 3 months

  • 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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Guidelines recommend that blood glucose/HbA1c be evaluated every 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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Guidelines recommend that LDL cholesterol be evaluated every 2 years

  • 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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Guidelines recommend that HDL cholesterol be evaluated every 2 years

  • 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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Guidelines recommend that triglycerides be evaluated every 2 years


Enrollment: 239
Study Start Date: March 2010
Study Completion Date: June 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Active Comparator: Written educational materials
Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
Behavioral: Written educational materials
Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677898

Locations
United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Julie Anne Kreyenbuhl, PhD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00677898     History of Changes
Other Study ID Numbers: IIR 07-256 
Study First Received: May 9, 2008
Results First Received: September 5, 2014
Last Updated: April 6, 2015
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
Patient-Centered Care
Adverse effects
Antipsychotics

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 28, 2016