SchizophreniaNCT01420575
Decision Aid to Facilitate Shared Decision Making During Treatment in Schizophrenia
A study testing Visual Decision Aid and Shared Decision Making Model in people with Schizophrenia and Schizoaffective Disorder, run by VA Nebraska Western Iowa Health Care System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 65 years, women only
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Visual Decision Aid and Shared Decision Making Model
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Omaha Veterans Affairs Medical Center
Omaha, Nebraska, 68105
About this study
Official title: Using a Visual Decision Aid (DA) to Facilitate Shared Decision Making (SDM) During Antipsychotic Treatment in Schizophrenia.
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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Visual Decision Aid and Shared Decision Making Model, Usual Care
- Keywords
- Schizophrenia, Schizoaffective Disorder, Shared Decision, Decision Aid, Antipsychotic, Weight Gain, Olanzapine, Lexapro, Perphenazine
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Decision Aid and Shared Decision Making ModelBehavioural
Also called Zyprexa
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 CareBehavioural
Also called Zyprexa
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Decisional Conflict scores between the two groups (intervention versus care as usual)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startOct 2010
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Low enrollment rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Nebraska Western Iowa Health Care System
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs, Nebraska Educational Biomedical Research Association
- Responsible party
- Principal investigator, SRIRAM RAMASWAMY, VA Nebraska Western Iowa Health Care System
- Investigators
- Sriram Ramaswamy, M.D., Principal investigator, Department of Veterans Affairs/NWIHCSRobert Rosenheck, M.D., Principal investigator, Department of Veterans Affairs/NWIHCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420575
- Sponsor's protocol ID
- RAM-00730
- Status last verified
- Sep 2012
- First submitted
- 18 Aug 2011
- Last updated
- 19 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Visual Decision Aid (DA) to Facilitate Shared Decision Making (SDM) During Antipsychotic Treatment in Schizophrenia.
- ClinicalTrials.gov ID
- NCT01420575
- Acronym / sponsor ID
- RAM-00730
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Schizophrenia, Schizoaffective Disorder, Shared Decision, Decision Aid, Antipsychotic, Weight Gain, Olanzapine, Lexapro
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment rate.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- VA Nebraska Western Iowa Health Care SystemUS federal agency
- Collaborators
- US Department of Veterans Affairs, Nebraska Educational Biomedical Research Association
- Study start
- Oct 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 19 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual Decision Making Aid | Experimental | Behavioral: Visual Decision Aid and Shared Decision Making ModelShared 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 | Active comparator | Behavioral: Usual CareUsual 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. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual Decision Aid and Shared Decision Making ModelAlso: ZyprexaVisual 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. | Behavioural | Visual Decision Making Aid |
| Usual CareAlso: ZyprexaUsual 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. | Behavioural | Usual Care |
Primary outcome
Differences in Decisional Conflict scores between the two groups (intervention versus care as usual)
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Low enrollment rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sriram Ramaswamy, M.D. principal investigator
Department of Veterans Affairs/NWIHCS
Robert Rosenheck, M.D. principal investigator
Department of Veterans Affairs/NWIHCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Decision Aid and Shared Decision Making Model in people with Schizophrenia and Schizoaffective Disorder, run by VA Nebraska Western Iowa Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low enrollment rate.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Decisional Conflict scores between the two groups (intervention versus care as usual) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2012.