Back to resultsDecision Aid to Facilitate Shared Decision Making During Treatment in Schizophrenia
Primary Purpose
Schizophrenia, Schizoaffective Disorder
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Visual Decision Aid and Shared Decision Making Model
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Schizoaffective Disorder, Shared Decision, Decision Aid, Antipsychotic, Weight Gain, Olanzapine, Lexapro, Perphenazine
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 >29.9.
- 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.
Sites / Locations
- Omaha Veterans Affairs Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Visual Decision Making Aid
Usual Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Differences in Decisional Conflict scores between the two groups (intervention versus care as usual)
Secondary Outcome Measures
Full Information
NCT ID
NCT01420575
First Posted
August 18, 2011
Last Updated
September 17, 2012
Sponsor
VA Nebraska Western Iowa Health Care System
Collaborators
US Department of Veterans Affairs, Nebraska Educational Biomedical Research Association
1. Study Identification
Unique Protocol Identification Number
NCT01420575
Brief Title
Decision Aid to Facilitate Shared Decision Making During Treatment in Schizophrenia
Official Title
Using a Visual Decision Aid (DA) to Facilitate Shared Decision Making (SDM) During Antipsychotic Treatment in Schizophrenia.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment rate.
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Nebraska Western Iowa Health Care System
Collaborators
US Department of Veterans Affairs, Nebraska Educational Biomedical Research Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Schizophrenia, Schizoaffective Disorder, Shared Decision, Decision Aid, Antipsychotic, Weight Gain, Olanzapine, Lexapro, Perphenazine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Visual Decision Making Aid
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Visual Decision Aid and Shared Decision Making Model
Other Intervention Name(s)
Zyprexa
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Other Intervention Name(s)
Zyprexa
Intervention Description
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.
Primary Outcome Measure Information:
Title
Differences in Decisional Conflict scores between the two groups (intervention versus care as usual)
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 >29.9.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sriram Ramaswamy, M.D.
Organizational Affiliation
Department of Veterans Affairs/NWIHCS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Rosenheck, M.D.
Organizational Affiliation
Department of Veterans Affairs/NWIHCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Omaha Veterans Affairs Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Decision Aid to Facilitate Shared Decision Making During Treatment in Schizophrenia
We'll reach out to this number within 24 hrs