Decision Aid to Facilitate Shared Decision Making During Treatment in Schizophrenia
NCT ID: NCT01420575
Last Updated: 2012-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
8 participants
INTERVENTIONAL
2010-10-31
2012-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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 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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
19 Years
65 Years
FEMALE
No
Sponsors
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US Department of Veterans Affairs
FED
Nebraska Educational Biomedical Research Association
UNKNOWN
VA Nebraska Western Iowa Health Care System
FED
Responsible Party
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SRIRAM RAMASWAMY
Staff Psychiatrist
Principal Investigators
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Sriram Ramaswamy, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Veterans Affairs/NWIHCS
Robert Rosenheck, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Veterans Affairs/NWIHCS
Locations
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Omaha Veterans Affairs Medical Center
Omaha, Nebraska, United States
Countries
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Other Identifiers
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RAM-00730
Identifier Type: -
Identifier Source: org_study_id