SchizophreniaNCT00677898
A Patient-Centered Approach to Improve Screening for Side Effects of Second Generation Antipsychotics (SGAs)
A study testing Patient-centered computerized tool and Written educational materials in people with Schizophrenia and Psychotic Disorders, run by US Department of Veterans Affairs at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia, Psychotic Disorders
- What is being tested?
- Patient-centered computerized tool and Written educational materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diagnosis of dementia or other organic brain syndrome or traumatic brain injury
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
About this study
Official title: A Patient-Centered Approach to Improve Screening for Side Effects of SGAs
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.
Read the 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.
- Conditions
- Schizophrenia, Psychotic Disorders
- Being tested
- Patient-centered computerized tool, Written educational materials
- Keywords
- Patient-Centered Care, Adverse effects, Antipsychotics
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-centered computerized toolBehavioural
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 materialsBehavioural
Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening
| Study group | Role | What they receive |
|---|---|---|
| Patient-centered computerized tool | Experimental | 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 Receives: Behavioral: Patient-centered computerized tool |
| Written educational materials | Active comparator | Printed information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening Receives: Behavioral: Written educational materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startMar 2010
- Primary completionMar 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Julie Anne Kreyenbuhl, PhD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677898
- Sponsor's protocol ID
- IIR 07-256
- Status last verified
- Aug 2014
- First submitted
- 9 May 2008
- Last updated
- 27 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.201400131. Epub 2014 Nov 17.
PubMed 25178383
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient-Centered Approach to Improve Screening for Side Effects of SGAs
- ClinicalTrials.gov ID
- NCT00677898
- Acronym / sponsor ID
- IIR 07-256
- Conditions
- Schizophrenia, Psychotic Disorders
- Keywords
- Patient-Centered Care, Adverse effects, Antipsychotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Mar 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 May 2008 (estimated)
- Results
- Posted 12 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient-centered computerized tool | Experimental | Behavioral: Patient-centered computerized toolA 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 | Active comparator | Behavioral: Written educational materialsPrinted information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Diagnosis of dementia or other organic brain syndrome or traumatic brain injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-centered computerized toolA 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 | Behavioural | Patient-centered computerized tool |
| Written educational materialsPrinted information on the metabolic side effects of second-generation antipsychotic medications and general recommendations for screening | Behavioural | Written educational materials |
Primary outcome
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
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
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
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
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
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
Guidelines recommend that triglycerides be evaluated every 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25178383Park 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.201400131. Epub 2014 Nov 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Anne Kreyenbuhl, PhD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-centered computerized tool and Written educational materials in people with Schizophrenia and Psychotic Disorders, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00677898, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2015; AzTrials last refreshed its copy on 31 Oct 2026.