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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00677898
Enrollment
239
Registered
2008-05-15
Start date
2010-03-31
Completion date
2013-06-30
Last updated
2015-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychotic Disorders, Schizophrenia

Keywords

Patient-Centered Care, Adverse effects, Antipsychotics

Brief 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.

Interventions

BEHAVIORALPatient-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

BEHAVIORALWritten educational materials

Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 Index1 yearGuidelines 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 Pressure1 yearGuidelines 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/HbA1c1 yearGuidelines 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 Cholesterol1 yearGuidelines 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 Cholesterol1 yearGuidelines 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: Triglycerides1 yearGuidelines recommend that triglycerides be evaluated every 2 years

Countries

United States

Participant flow

Participants by arm

ArmCount
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
119
Written Educational Materials
Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
120
Total239

Baseline characteristics

CharacteristicPatient-centered Computerized ToolWritten Educational MaterialsTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
8 Participants4 Participants12 Participants
Age, Categorical
Between 18 and 65 years
111 Participants116 Participants227 Participants
Age, Continuous55.1 years
STANDARD_DEVIATION 8
53.5 years
STANDARD_DEVIATION 8.6
54.3 years
STANDARD_DEVIATION 8.3
Region of Enrollment
United States
119 participants120 participants239 participants
Sex: Female, Male
Female
12 Participants14 Participants26 Participants
Sex: Female, Male
Male
107 Participants106 Participants213 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1190 / 120
serious
Total, serious adverse events
2 / 1192 / 120

Outcome results

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

Time frame: 1 year

ArmMeasureValue (MEAN)Dispersion
Patient-centered Computerized ToolPercentage 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/HbA1c97.7 percentage of days in the study periodStandard Deviation 10.7
Written Educational MaterialsPercentage 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/HbA1c96.2 percentage of days in the study periodStandard Deviation 14.8
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

Time frame: 1 year

ArmMeasureValue (MEAN)Dispersion
Patient-centered Computerized ToolPercentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Blood Pressure83.5 percentage of days in the study periodStandard Deviation 21.8
Written Educational MaterialsPercentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Blood Pressure78.5 percentage of days in the study periodStandard Deviation 27.5
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

Time frame: 1 year

ArmMeasureValue (MEAN)Dispersion
Patient-centered Computerized ToolPercentage 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 Index81.4 percentage of days in the study periodStandard Deviation 22.5
Written Educational MaterialsPercentage 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 Index76.1 percentage of days in the study periodStandard Deviation 26.2
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

Time frame: 1 year

ArmMeasureValue (MEAN)Dispersion
Patient-centered Computerized ToolPercentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: HDL Cholesterol94.1 percentage of days in study periodStandard Deviation 16.6
Written Educational MaterialsPercentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: HDL Cholesterol95.2 percentage of days in study periodStandard Deviation 14.3
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

Time frame: 1 year

ArmMeasureValue (MEAN)Dispersion
Patient-centered Computerized ToolPercentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: LDL Cholesterol93.7 percentage of days in study periodStandard Deviation 17
Written Educational MaterialsPercentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: LDL Cholesterol95.1 percentage of days in study periodStandard Deviation 14.3
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

Time frame: 1 year

ArmMeasureValue (MEAN)Dispersion
Patient-centered Computerized ToolPercentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Triglycerides94.1 percentage of days in the study periodStandard Deviation 16.6
Written Educational MaterialsPercentage of Days in the Study Period That a Patient's Screening for Metabolic Side Effects of Second-generation Antipsychotic Medications Adheres to Guidelines: Triglycerides94.5 percentage of days in the study periodStandard Deviation 15.1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026