N/A
N=239
A Patient-Centered Approach to Improve Screening for Side Effects of Second Generation Antipsychotics (SGAs)
Schizophrenia · Psychotic Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00677898 ↗Enrolled (actual)
239
Serious AEs
1.7%
Results posted
Sep 2014
Primary outcome: 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 — 81.4; 76.1 percentage of days in the study period
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patient-centered computerized tool (Behavioral); Written educational materials (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
81.4; 76.1 | — |
| 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 |
83.5; 78.5 | — |
| 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: Blood Glucose/HbA1c |
97.7; 96.2 | — |
| 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: LDL Cholesterol |
93.7; 95.1 | — |
| 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 |
94.1; 95.2 | — |
| 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: Triglycerides |
94.1; 94.5 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00677898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.