Decision Aid to Facilitate Shared Decision Making During Treatment in Schizophrenia
|ClinicalTrials.gov Identifier: NCT01420575|
Recruitment Status : Terminated (Low enrollment rate.)
First Posted : August 19, 2011
Last Update Posted : September 19, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder||Behavioral: Visual Decision Aid and Shared Decision Making Model Behavioral: Usual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Using a Visual Decision Aid (DA) to Facilitate Shared Decision Making (SDM) During Antipsychotic Treatment in Schizophrenia.|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
Experimental: Visual Decision Making Aid
Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower overweight patients with schizophrenia/schizoaffective disorder and help them efficiently arrive at a treatment decision that can be successfully implemented.
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.
Other Name: Zyprexa
Active Comparator: Usual Care
Usual care reflects the standard of care in psychiatry. Psychiatrists will recommend treatment for overweight patients with schizophrenia on olanzapine who have failed to lose weight despite life style and dietary modifications. They may recommend switching to a comparable antipsychotic with a lower incidence of weight gain.
Behavioral: 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.
Other Name: Zyprexa
- Differences in Decisional Conflict scores between the two groups (intervention versus care as usual) [ Time Frame: 12 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420575
|United States, Nebraska|
|Omaha Veterans Affairs Medical Center|
|Omaha, Nebraska, United States, 68105|
|Principal Investigator:||Sriram Ramaswamy, M.D.||Department of Veterans Affairs/NWIHCS|
|Principal Investigator:||Robert Rosenheck, M.D.||Department of Veterans Affairs/NWIHCS|