A System for Preference Assessment in Mental Health (SPA)

November 2, 2017 updated by: Alexander S. Young, MD MSHS, University of California, Los Angeles

Implementing Patient-Centered Decision Support for Mental Health

It is important that individuals with serious mental illness make informed choices among alternative healthcare treatments based on their preferences. However, at present, individuals' preferences are often not being elicited, nor used to guide which treatments are made available. In this pilot project, the investigators implement and evaluate a computerized method for assessing treatment preferences of individuals with schizophrenia. The investigators use weight management treatments for this initial test of the system. If this assessment method is found to predict treatment use and satisfaction, it can be used to guide implementation of treatments that improve outcomes while meeting individuals' preferences.

Study Overview

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

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90024
        • UCLA Center for Health Services and Society

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. diagnosis of schizophrenia
  2. age 18 or older
  3. 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
  4. able to provide informed consent

Exclusion Criteria:

  1. a medical condition for which a weight program is contraindicated
  2. pregnant and nursing mothers
  3. attendance at a psychosocial intervention for weight management in the past month
  4. individuals with legal conservators who manage informed consent
  5. can not speak English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alexander S Young, MD, MSHS, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2014

Primary Completion (Actual)

October 31, 2017

Study Completion (Actual)

October 31, 2017

Study Registration Dates

First Submitted

June 30, 2014

First Submitted That Met QC Criteria

July 2, 2014

First Posted (Estimate)

July 8, 2014

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 2, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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