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A System for Preference Assessment in Mental Health (SPA)

Primary Purpose

Mental Disorders, Schizophrenia, Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychosocial Weight Intervention
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mental Disorders focused on measuring Medical Informatics, Patient-Centered, Healthcare Preferences, Health Education, Quality Improvement, Weight Loss, Personal Satisfaction, Humans, Cognition, Body Weight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA Center for Health Services and Society

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Psychosocial Weight Intervention

Arm Description

Weekly group intervention for diet and exercise, designed specifically for individuals with serious mental illness and the cognitive deficits that accompany those illnesses

Outcomes

Primary Outcome Measures

Days until using weight services
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.
Participant preferences regarding weight services
Individuals' preferences are assessed regarding different attributes of weight treatments. These are assessed using computerized conjoint analysis methods.
Satisfaction with the weight services provided
Satisfaction with the weight services provided. This is assessed using the Client Satisfaction Questionnaire administered by interview.
Number of weight services used
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.

Secondary Outcome Measures

Feasibility and acceptability of implementing preference assessment
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.

Full Information

First Posted
June 30, 2014
Last Updated
November 2, 2017
Sponsor
University of California, Los Angeles
Collaborators
Los Angeles County Department of Public Health, Los Angeles County Department of Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT02183844
Brief Title
A System for Preference Assessment in Mental Health
Acronym
SPA
Official Title
Implementing Patient-Centered Decision Support for Mental Health
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 16, 2014 (Actual)
Primary Completion Date
October 31, 2017 (Actual)
Study Completion Date
October 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Los Angeles County Department of Public Health, Los Angeles County Department of Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders, Schizophrenia, Overweight, Obesity
Keywords
Medical Informatics, Patient-Centered, Healthcare Preferences, Health Education, Quality Improvement, Weight Loss, Personal Satisfaction, Humans, Cognition, Body Weight

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychosocial Weight Intervention
Arm Type
Experimental
Arm Description
Weekly group intervention for diet and exercise, designed specifically for individuals with serious mental illness and the cognitive deficits that accompany those illnesses
Intervention Type
Behavioral
Intervention Name(s)
Psychosocial Weight Intervention
Intervention Description
Weekly group intervention for diet and exercise, designed specifically for individuals with serious mental illness and the cognitive deficits that accompany those illnesses
Primary Outcome Measure Information:
Title
Days until using weight services
Description
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.
Time Frame
3 months
Title
Participant preferences regarding weight services
Description
Individuals' preferences are assessed regarding different attributes of weight treatments. These are assessed using computerized conjoint analysis methods.
Time Frame
Baseline
Title
Satisfaction with the weight services provided
Description
Satisfaction with the weight services provided. This is assessed using the Client Satisfaction Questionnaire administered by interview.
Time Frame
3 months
Title
Number of weight services used
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Feasibility and acceptability of implementing preference assessment
Description
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.
Time Frame
Baseline
Other Pre-specified Outcome Measures:
Title
Aspects of the Theory of Planned Behavior
Description
Attitudes, subjective norms, perceived control, and behavioral intentions regarding weight loss. These are assessed by interview, using scales from the Theory of Planned Behavior.
Time Frame
Baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander S Young, MD, MSHS
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Center for Health Services and Society
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20658320
Citation
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.
Results Reference
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PubMed Identifier
23407006
Citation
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.
Results Reference
background
PubMed Identifier
18279505
Citation
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.
Results Reference
background
PubMed Identifier
15491237
Citation
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.
Results Reference
background
PubMed Identifier
20591993
Citation
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.
Results Reference
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A System for Preference Assessment in Mental Health

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