Clinical trial NCT01420575: 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
Overall status: TERMINATED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Schizophrenia
Schizoaffective Disorder
Shared Decision
Decision Aid
Antipsychotic
Weight Gain
Olanzapine
Lexapro
Perphenazine
Lead sponsor: VA Nebraska Western Iowa Health Care System
Sponsor class: FED
Collaborators: name: US Department of Veterans Affairs
name: Nebraska Educational Biomedical Research Association
First posted: 2011-08-19
Enrollment: 8
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.


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.

Primary outcomes:
measure: Differences in Decisional Conflict scores between the two groups (intervention versus care as usual)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Omaha Veterans Affairs Medical Center
state: Nebraska
Study officials:
affiliation: Department of Veterans Affairs/NWIHCS
name: Sriram Ramaswamy, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Veterans Affairs/NWIHCS
name: Robert Rosenheck, M.D.
role: PRINCIPAL_INVESTIGATOR
References: