Decision Aid to Facilitate Shared Decision Making During Treatment in Schizophrenia

NCT01420575 | Terminated

• 1 other identifier: RAM-00730
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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:

1. 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. 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. 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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Schizophrenia; Schizoaffective Disorder; Shared Decision; Decision Aid; Antipsychotic; Weight Gain; Olanzapine; Lexapro; Perphenazine

Outcome Measures

Primary Outcomes (1)

• Differences in Decisional Conflict scores between the two groups (intervention versus care as usual)

  12 weeks

Study Arms (2)

Visual Decision Making Aid

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

Visual Decision Aid and Shared Decision Making Model BEHAVIORAL

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.

Also known as: Zyprexa

Visual Decision Making Aid

Usual Care BEHAVIORAL

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.

Also known as: Zyprexa

Usual Care

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Nebraska Western Iowa Health Care System: lead
• US Department of Veterans Affairs: collaborator
• Nebraska Educational Biomedical Research Association: collaborator

Study Sites (1)

Omaha Veterans Affairs Medical Center

Omaha, Nebraska, 68105, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Weight Gain

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sriram Ramaswamy, M.D.

  Department of Veterans Affairs/NWIHCS

  PRINCIPAL INVESTIGATOR

• Robert Rosenheck, M.D.

  Department of Veterans Affairs/NWIHCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Psychiatrist

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: August 19, 2011
• Study Start: October 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 19, 2012

Record last verified: 2012-09

Locations

US (1)