Using a Visual Decision Aid (DA) to Facilitate Shared Decision Making (SDM) During Antipsychotic Treatment in Schizophrenia.

VA Nebraska Western Iowa Health Care System1 site in 1 country8 target enrollmentOctober 2010

ConditionsSchizophrenia Schizoaffective Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Schizophrenia
Sponsor: VA Nebraska Western Iowa Health Care System
Enrollment: 8
Locations: 1
Primary Endpoint: Differences in Decisional Conflict scores between the two groups (intervention versus care as usual)
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

We hypothesize that the use of a visual decision aid tool to educate patients regarding potential harm with respect to weight gain with olanzapine versus perphenazine can lead to better shared decision making by patients, increase rates of antipsychotic switches and promote weight loss in overweight patients with schizophrenia/schizoaffective disorder.

Our specific aims are the following:

To investigate the effects of a visual decision aid, versus care as usual, on patients' perceived difficulties in medical decision making regarding switching antipsychotics in overweight veterans with schizophrenia or schizoaffective disorder.
To investigate the effects of a visual decision aid and a shared decision making model on rate of medication switches (from olanzapine to perphenazine) in overweight veterans with schizophrenia or schizoaffective disorder.
To investigate the effects of a visual decision making aid and shared decision making model on BMI in overweight veterans who switch from olanzapine to perphenazine therapy.

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

August 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

VA Nebraska Western Iowa Health Care System

Responsible Party

Principal Investigator

SRIRAM RAMASWAMY

Staff Psychiatrist

VA Nebraska Western Iowa Health Care System

Eligibility Criteria

Inclusion Criteria

•Patients with diagnosis of Schizophrenia or Schizoaffective Disorder as per by their medical record diagnosis.
•Patients currently on olanzapine therapy and BMI \>29.
•Patients treated with olanzapine for greater than or equal to 3 months prior to enrollment.
•Patient would be required to have either attempted dietary, lifestyles modifications and/or participated in weight loss programs.
•Patients with no history of psychiatric hospitalizations in past six months and judged by treating clinician to be suitable for antipsychotic medication switch.
•Patients with adequate decisional capacity to make a choice about participating in this research study.
•Patients, who are able to comprehend and satisfactorily comply with protocol requirements and have an ability to read and write English.
•Patients, who signed the written consent given prior to entering any study procedure.

Exclusion Criteria

•Patients with a history of treatment resistant schizophrenia or past trials with clozapine.
•Patients with a concurrent DSM-IV diagnosis of PTSD as per their medical record.
•Substance Dependence or Abuse (excluding nicotine) within one month prior to the screening visit.
•Patients with a history of non-response, intolerance or hypersensitivity ot perphenazine.
•Subjects with history of treatment of clozapine.
•Patients who based on history of mental status examination have a significant risk of committing suicide.
•Patients who are homicidal or violent and who are in the Investigator's opinion in significant imminent risk of hurting others.
•Female patients who are pregnant, planning to become pregnant, or if of childbearing potential, not using an acceptable method of birth control.
•Patient currently receiving depot neuroleptics.
•Patients with visual impairments.