- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02183844
A System for Preference Assessment in Mental Health (SPA)
Implementing Patient-Centered Decision Support for Mental Health
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background/Rationale: It is important that individuals with serious mental illness have access to treatments that meet their preferences, and that they make informed choices among alternative treatments. Too often, preferences are not being routinely elicited, nor used to guide which treatments are made available. Schizophrenia is a serious mental illness that is common and produces substantial disability when poorly treated. National treatment guidelines specify that individuals with schizophrenia should receive evidence-based treatments that improve outcomes. For example, obesity is a pressing problem in this population, a side-effect of commonly used medications, and a cause of cardiovascular disease and premature mortality. There are multiple, different psychosocial interventions for weight management that can lead to reduced weight. None are widely used. If individuals' preferences were routinely assessed, then clinicians and managers would know when to make alternative treatments available.
Objectives: This project implements and evaluates a method for routinely assessing the treatment preferences of individuals with schizophrenia. The objectives are to: 1) develop a computerized, kiosk-based system that delivers education regarding treatment options for weight, uses conjoint analysis to elicit preferences, and meets the cognitive needs of individuals with schizophrenia; 2) study the feasibility and acceptability of implementing this method at a mental health clinic; and, 3) evaluate the extent to which this method predicts use of evidence-based weight services, and satisfaction with services at three months.
Methods: This is a prospective evaluation of preferences, treatment use, and satisfaction in individuals with schizophrenia. 94 individuals are enrolled who are overweight and receiving treatment at a busy, urban mental health clinic. These participants use a kiosk system that provides them with education about treatment options, and assesses their preferences regarding alternative treatments for weight. They are then offered a weekly, intensive, evidence-based psychosocial treatment for weight. Research assessments occur at baseline and 3 months. Treatment preferences are analyzed to determine how they relate to use of weight treatment, and satisfaction with treatment.
Significance: People with serious mental illness could benefit from access to effective treatments. Implementing these treatments would be facilitated by routinely collecting information regarding individuals' preferences. If the assessment method in this study is found to be feasible, acceptable, and accurate, it could be used to support implementation of improved care at clinics, medical centers, and community-based programs.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90024
- UCLA Center for Health Services and Society
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosis of schizophrenia
- age 18 or older
- Body Mass Index (BMI) of either 28.0-29.9 and gained 10 pounds in the last 3 months; OR, BMI of 30 or above
- able to provide informed consent
Exclusion Criteria:
- a medical condition for which a weight program is contraindicated
- pregnant and nursing mothers
- attendance at a psychosocial intervention for weight management in the past month
- individuals with legal conservators who manage informed consent
- can not speak English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Psychosocial Weight Intervention
Weekly group intervention for diet and exercise, designed specifically for individuals with serious mental illness and the cognitive deficits that accompany those illnesses
|
Weekly group intervention for diet and exercise, designed specifically for individuals with serious mental illness and the cognitive deficits that accompany those illnesses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Days until using weight services
Time Frame: 3 months
|
Utilization of the weight services offered.
This includes the number of days until starting to use weight services.
This is assessed using information regarding attendance at weight services, and by survey administered by interview.
|
3 months
|
Participant preferences regarding weight services
Time Frame: Baseline
|
Individuals' preferences are assessed regarding different attributes of weight treatments.
These are assessed using computerized conjoint analysis methods.
|
Baseline
|
Satisfaction with the weight services provided
Time Frame: 3 months
|
Satisfaction with the weight services provided.
This is assessed using the Client Satisfaction Questionnaire administered by interview.
|
3 months
|
Number of weight services used
Time Frame: 3 months
|
Utilization of the weight services offered.
This includes the number of weight service sessions attended.
This is assessed using information regarding attendance at weight services, and by survey administered by interview.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility and acceptability of implementing preference assessment
Time Frame: Baseline
|
Feasibility and acceptability of implementing kiosk-based preference assessment at a mental health clinic.
This is assessed using project records, surveys, and semi-structured interview questions assessing whether participants and staff find the program and its components to be advantageous, relevant, simple, easy to use, and beneficial.
|
Baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aspects of the Theory of Planned Behavior
Time Frame: Baseline and 3 months
|
Attitudes, subjective norms, perceived control, and behavioral intentions regarding weight loss.
These are assessed by interview, using scales from the Theory of Planned Behavior.
|
Baseline and 3 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Alexander S Young, MD, MSHS, University of California, Los Angeles
Publications and helpful links
General Publications
- Young AS, Niv N, Chinman M, Dixon L, Eisen SV, Fischer EP, Smith J, Valenstein M, Marder SR, Owen RR. Routine outcomes monitoring to support improving care for schizophrenia: report from the VA Mental Health QUERI. Community Ment Health J. 2011 Apr;47(2):123-35. doi: 10.1007/s10597-010-9328-y. Epub 2010 Jul 25.
- Cohen AN, Chinman MJ, Hamilton AB, Whelan F, Young AS. Using patient-facing kiosks to support quality improvement at mental health clinics. Med Care. 2013 Mar;51(3 Suppl 1):S13-20. doi: 10.1097/MLR.0b013e31827da859.
- Brown AH, Cohen AN, Chinman MJ, Kessler C, Young AS. EQUIP: implementing chronic care principles and applying formative evaluation methods to improve care for schizophrenia: QUERI Series. Implement Sci. 2008 Feb 15;3:9. doi: 10.1186/1748-5908-3-9.
- Chinman M, Young AS, Schell T, Hassell J, Mintz J. Computer-assisted self-assessment in persons with severe mental illness. J Clin Psychiatry. 2004 Oct;65(10):1343-51. doi: 10.4088/jcp.v65n1008.
- Young AS. The client, the clinician, and the computer. Psychiatr Serv. 2010 Jul;61(7):643. doi: 10.1176/ps.2010.61.7.643. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21MH100565 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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