Decision Aid to Facilitate Shared Decision Making During Treatment in Schizophrenia

This study has been terminated.
(Low enrollment rate.)
Sponsor:
Collaborators:
New England MIRECC
Nebraska Educational Biomedical Research Association
Information provided by (Responsible Party):
SRIRAM RAMASWAMY, VA Nebraska Western Iowa Health Care System
ClinicalTrials.gov Identifier:
NCT01420575
First received: August 18, 2011
Last updated: September 17, 2012
Last verified: September 2012
  Purpose

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.

Condition Intervention
Schizophrenia
Schizoaffective Disorder
Behavioral: Visual Decision Aid and Shared Decision Making Model
Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Using a Visual Decision Aid (DA) to Facilitate Shared Decision Making (SDM) During Antipsychotic Treatment in Schizophrenia.

Resource links provided by NLM:


Further study details as provided by VA Nebraska Western Iowa Health Care System:

Primary Outcome Measures:
  • Differences in Decisional Conflict scores between the two groups (intervention versus care as usual) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: October 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420575

Locations
United States, Nebraska
Omaha Veterans Affairs Medical Center
Omaha, Nebraska, United States, 68105
Sponsors and Collaborators
VA Nebraska Western Iowa Health Care System
New England MIRECC
Nebraska Educational Biomedical Research Association
Investigators
Principal Investigator: Sriram Ramaswamy, M.D. Department of Veterans Affairs/NWIHCS
Principal Investigator: Robert Rosenheck, M.D. Department of Veterans Affairs/NWIHCS
  More Information

No publications provided

Responsible Party: SRIRAM RAMASWAMY, Staff Psychiatrist, VA Nebraska Western Iowa Health Care System
ClinicalTrials.gov Identifier: NCT01420575     History of Changes
Other Study ID Numbers: RAM-00730
Study First Received: August 18, 2011
Last Updated: September 17, 2012
Health Authority: United States: Federal Government

Keywords provided by VA Nebraska Western Iowa Health Care System:
Schizophrenia
Schizoaffective Disorder
Shared Decision
Decision Aid
Antipsychotic
Weight Gain
Olanzapine
Lexapro
Perphenazine

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Olanzapine
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on September 18, 2014