NCT00677898

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 15, 2008

Completed
1.8 years until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 12, 2014

Completed
Last Updated

April 27, 2015

Status Verified

August 1, 2014

Enrollment Period

2 years

First QC Date

May 9, 2008

Results QC Date

September 5, 2014

Last Update Submit

April 6, 2015

Conditions

SchizophreniaPsychotic Disorders

Keywords

Patient-Centered CareAdverse effectsAntipsychotics

Outcome Measures

Primary Outcomes (6)

  • 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

    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

    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

    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

    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

    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

    1 year

Study Arms (2)

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

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

Behavioral: Written educational materials

Interventions

Patient-centered computerized toolBEHAVIORAL

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

Patient-centered computerized tool
Written educational materialsBEHAVIORAL

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

Written educational materials

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Diagnosis of dementia or other organic brain syndrome or traumatic brain injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

  • 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.

    PMID: 25178383RESULT

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Results Point of Contact

Title
Julie Kreyenbuhl, Pharm.D., Ph.D.
Organization
VA VISN 5 Mental Illness Research, Education and Clinical Center
Julie.Kreyenbuhl@va.gov
410-637-1864

Study Officials

  • Julie Anne Kreyenbuhl, PhD

    Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2008

First Posted

May 15, 2008

Study Start

March 1, 2010

Primary Completion

March 1, 2012

Study Completion

June 1, 2013

Last Updated

April 27, 2015

Results First Posted

September 12, 2014

Record last verified: 2014-08

Locations

US(1)