An interventional study of Patient-centered computerized tool and Written educational materials in Schizophrenia and Psychotic Disorders, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-04-27.
Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Health services research
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 239 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
Behavioral: Written educational materials
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
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
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
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
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
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
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
| Milestone | Patient-centered Computerized Tool | Written Educational Materials |
|---|---|---|
| Started | 119 | 120 |
| Completed | 99 | 102 |
| Not completed | 20 | 18 |
Guidelines recommend that body mass index be evaluated every 3 months
| percentage of days in the study period | Patient-centered Computerized Tool | Written Educational Materials |
|---|---|---|
| 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 | 81.4 ± 22.5 | 76.1 ± 26.2 |
Guidelines recommend that blood pressure be evaluated every 3 months
| percentage of days in the study period | Patient-centered Computerized Tool | Written Educational Materials |
|---|---|---|
| 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 | 83.5 ± 21.8 | 78.5 ± 27.5 |
Guidelines recommend that blood glucose/HbA1c be evaluated every year
| percentage of days in the study period | Patient-centered Computerized Tool | Written Educational Materials |
|---|---|---|
| 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 | 97.7 ± 10.7 | 96.2 ± 14.8 |
Guidelines recommend that LDL cholesterol be evaluated every 2 years
| percentage of days in study period | Patient-centered Computerized Tool | Written Educational Materials |
|---|---|---|
| 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 | 93.7 ± 17.0 | 95.1 ± 14.3 |
Guidelines recommend that HDL cholesterol be evaluated every 2 years
| percentage of days in study period | Patient-centered Computerized Tool | Written Educational Materials |
|---|---|---|
| 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 | 94.1 ± 16.6 | 95.2 ± 14.3 |
Guidelines recommend that triglycerides be evaluated every 2 years
| percentage of days in the study period | Patient-centered Computerized Tool | Written Educational Materials |
|---|---|---|
| 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 | 94.1 ± 16.6 | 94.5 ± 15.1 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patient-centered Computerized Tool | — | 2/119 (1.7%) | 0/119 (0%) |
| Written Educational Materials | — | 2/120 (1.7%) | 0/120 (0%) |
| Event | Patient-centered Computerized Tool | Written Educational Materials |
|---|---|---|
| DeathGeneral disorders | 2/119 | 2/120 |
| Psychiatric hospitalizationPsychiatric disorders | 0/119 | 1/120 |
| Age, Continuous(years) | Patient-centered Computerized Tool | Written Educational Materials | Total |
|---|---|---|---|
| Mean | 55.1 ± 8.0 | 53.5 ± 8.6 | 54.3 ± 8.3 |
| Age, Categorical(Participants) | Patient-centered Computerized Tool | Written Educational Materials | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 111 | 116 | 227 |
| >=65 years | 8 | 4 | 12 |
| Sex: Female, Male(Participants) | Patient-centered Computerized Tool | Written Educational Materials | Total |
|---|---|---|---|
| Female | 12 | 14 | 26 |
| Male | 107 | 106 | 213 |
| Region of Enrollment(participants) | Patient-centered Computerized Tool | Written Educational Materials | Total |
|---|---|---|---|
| United States | 119 | 120 | 239 |
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US Department of Veterans Affairs