Decision Aid to Facilitate Shared Decision Making During Treatment in Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01420575
• Other study ID #: RAM-00730
• Status: Terminated
• Phase: N/A
• First received: August 18, 2011
• Last updated: September 17, 2012
• Start date: October 2010
• Est. completion date: August 2012

Study information

• Verified date: September 2012
• Source: VA Nebraska Western Iowa Health Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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:

1. 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.

2. 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.

3. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with diagnosis of Schizophrenia or Schizoaffective Disorder as per by their medical record diagnosis.

• Patients currently on olanzapine therapy and BMI >29.9.

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• Visual Decision Aid and Shared Decision Making Model
Visual aid is a graph showing the average weight of patients who take olanzapine versus perphenazine over the course of 18 months. A script explaining the information on the graph, accompanies the graph. Patient may decide to stay on current dose of olanzapine, or be tapered off and prescribed a dose of perphenazine based on current symptoms and tolerability. Perphenazine (4-8mg ORALLY 3 times a day) will be used.
• Usual Care
Usual care is standard clinical discussion and advice from a psychiatrist. Patient may decide to stay on current dose of olanzapine, or be tapered off and prescribed a dose of perphenazine based on current symptoms and tolerability. Perphenazine (4-8mg ORALLY 3 times a day) will be used.

Locations

Country	Name	City	State
United States	Omaha Veterans Affairs Medical Center	Omaha	Nebraska

Sponsors (3)

Lead Sponsor	Collaborator
VA Nebraska Western Iowa Health Care System	Nebraska Educational Biomedical Research Association, New England MIRECC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in Decisional Conflict scores between the two groups (intervention versus care as usual)		12 weeks	No