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The Effectiveness of a Decision-Support Tool for Adult Consumers With Mental Health Needs and Their Care Managers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02761733
Recruitment Status : Completed
First Posted : May 4, 2016
Results First Posted : April 26, 2017
Last Update Posted : April 26, 2017
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
University of New Mexico
Information provided by (Responsible Party):
Felton Institute

Brief Summary:
The primary goal of the proposed study is to investigate the implementation and effectiveness of the mPOWR (Moving Patient-centered Outcomes through Wellness and Recovery) in diverse urban and rural community mental health settings. The study compares patient participation and outcomes using the mPOWR system to a usual care control condition. Four community mental health agencies participate in the research: two in San Francisco (urban) and two in N.M. (rural). One site in each setting serves as the mPOWR implementation site and the other serves as the control site. Service sites were randomly assigned to intervention or usual care conditions. A quasi experimental design was used; only eligible participants were enrolled in the study (e.g., exclusion criteria of moderate to severe cognitive impairment, patient services structured for provision of mPOWR implementation, etc.). The study design will employ repeated quantitative measures to assess change in outcomes within and across conditions over time. Qualitative methods in the form of focus group interviews will also be used to round out the information obtained about patient and provider expectations and experiences. Primary outcomes of interest include: Short Form Health Survey-12 (SF-12; physical and mental health aspects of health and well-being); Outcome Rating Scale (ORS; general well-being, personal well-being, close relationships, and work/school/friend relationships); Shared Decision Making Questionnaire (congruence of patient's and provider's participation in therapeutic decision making and patient's understanding of treatment and treatment options); Working Alliance Inventory (perception of therapeutic alliance); and Satisfaction Questionnaire (communication patterns between physicians and their patients).

Condition or disease Intervention/treatment Phase
Mental Disorders Behavioral: Moving Patient Outcomes toward Wellness and Recovery (mPOWR) Not Applicable

Detailed Description:

Research on the impact of decision-support tools for providers and patients has not included frontline care managers within community mental health settings. In particular, the care management field lacks effective models for integrating results-based and patient-centered care into routine practice with diverse adults with complex mental health and social service needs. For over five years, Family Service Agency of San Francisco (FSA) developed and piloted a mental health decision-support tool entitled the Assessment Diagnostic Evaluation and Planning Tool (ADEPT) for use by patients and front-line providers. The ADEPT was developed by a team of researchers, frontline providers, and FSA patients to collect data and track patient progress over time. Yet, its strong focus on diagnostic screening and excessive length limited its relevance to patients in guiding service decisions. Over the past two years, a team of FSA patients and care managers revised the tool, eliminating its diagnostic component and retaining two measures of quality of life and community living skills that were reviewed and/or adapted by patients to reflect meaningful outcomes in the delivery of services. Decision aids and a communications toolkit were also developed to support the use of shared-decision making (SDM) processes in the provision of services. Together, these instruments and tools make up the Moving Patient Outcomes toward Wellness and Recovery (mPOWR) system. mPOWR ensures that the patient-provider relationship remains focused on patient identified outcomes and use of SDM throughout care. The primary goal of the study is to investigate the implementation and effectiveness of the mPOWR in diverse urban and rural community mental health settings.

FSA has partnered with senior faculty from the University of New Mexico to serve as independent researchers for this study. The study involves four community mental health agencies: two in San Francisco (urban) and two in N.M. (rural). One (randomly chosen) site in each setting serves as the mPOWR implementation site and the other serves as the control site. The study population initially enrolled included 240 (60/site X 4 sites) diverse adults with chronic mental health conditions. The specific aims for this study are: (1) To improve patient and provider participation in shared-decision making and engagement in mental health treatment, to improve [patient] personal Quality of Life, and to improve [patient] access to community/social services; (2) To increase patient understanding of their treatment and of treatment options; to increase their personal treatment progress; (3) To increase patient functionality and sense of perceived support for their therapeutic outcomes.

Primary outcomes of interest include: Short Form Health Survey-12 (SF-12; physical and mental health aspects of health and well-being); Outcome Rating Scale (ORS; general well-being, personal well-being, close relationships, and work/school/friend relationships); Shared Decision Making Questionnaire (congruence of patient's and provider's participation in therapeutic decision making and patient's understanding of treatment and treatment options); Working Alliance Inventory (perception of therapeutic alliance); and Satisfaction Questionnaire (communication patterns between physicians and their patients). Qualitative methods in the form of focus group interviews will also be used to round out the information obtained about patient and provider expectations and experiences. Data will be collected in a time series design.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Researching the Effectiveness of a Decision-Support Tool for Adult Consumers With Mental Health Needs and Their Care Managers
Study Start Date : September 2013
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: mPOWR System
Moving Patient Outcomes toward Wellness and Recovery (mPOWR) consists of an assessment questionnaire and decision support tools which map onto 6 life domains which are measured by the questionnaire.
Behavioral: Moving Patient Outcomes toward Wellness and Recovery (mPOWR)
An mPOWR intervention and toolkit that consists of strategies, prompts, and decision aids designed to foster patient involvement in treatment. The mPOWR intervention includes a questionnaire that assesses quality of life and consumer functioning for use in the development of consumer-centered goals and outcomes within the mPOWR intervention.

No Intervention: Control
Treatment as usual



Primary Outcome Measures :
  1. Short Form Health Survey-12 (SF-12), Physical Symptoms Subscale [ Time Frame: Change in scores on the SF-12 from Baseline to 24 month follow-up ]
    The physical health subscale (PCS-12; Physical Component Summary) of the SF-12 (Health Survey Short Form-12) was utilized in the current study to assess physical aspects of health and well-being48. The measure includes twelve questions asking about overall health, limitations from health conditions, physical health, emotional well-being and daily activities, and feelings over the past four weeks, utilizing variable Likert scale response choice options. The aggregate PCS subscale score of the SF-12 is calculated utilizing norm-based scoring with a weighted sum (Ware, Kosinski, & Keller, 1995). PCS scores in the present study ranged from 13.2 to 65.6, with higher values indicating better physical health.

  2. Short Form Health Survey-12 (SF-12) Mental Symptoms [ Time Frame: Change in scores on the SF-12 from Baseline to 24 month follow-up Description: The Health Survey Short Form-12 (SF-12) includes 12 items that assess for physical and mental aspects of health and well-being. ]
    The mental health subscale (MCS-12; Mental Component Summary) of the SF-12 (Health Survey Short Form-12) was utilized in the current study to assess mental aspects of health and well-being48. The measure includes twelve questions asking about overall health, limitations from health conditions, physical health, emotional well-being and daily activities, and feelings over the past four weeks, utilizing variable Likert scale response choice options. The physical health subscale of the SF-12 was utilized as a key client functioning outcome in the current study. The aggregate MCS subscale score of the SF-12 is calculated utilizing norm-based scoring with a weighted sum (Ware, Kosinski, & Keller, 1995). MCS scores in the present study ranged from 9.6 to 72.0, with higher values indicating better physical health.

  3. Outcome Rating Scale (ORS) [ Time Frame: Change in scores on the Outcome Rating Scale from Baseline to 24 month follow-up ]
    The Outcome Rating Scale (ORS) was utilized as a repeated measure of general therapy outcomes and quality of life changes during the course of therapy. The Outcome Rating Scale includes a visual analog scale (a horizontal line on which the participants marks how well they are doing within the last week from low to high) that records four questions about general well-being, personal well-being, close relationships, and work/school/friend relationships. Physical marks for each of four domains on the visual analog scale are measured by research team members with a ruler and converted to a score from 1 to 100. The four items are then averaged for an overall therapy outcome score. The total averaged ORS score ranges from 1 to 100, with higher scores indicating a better outcome. Analyses will examine treatment progress via change in ORS scores from pre- to post-intervention.

  4. Shared Decision Making Questionnaire [ Time Frame: Change in scores on the Shared Decision Making Questionnaire from Baseline to 24 month follow-up ]
    A 6-item modified version of the Shared Decision Making Questionnaire (SDM-Q-9) 46 was utilized to assess client reports about the degree to which their provider involved them in understanding and making a treatment decision. Examples items included "My provider discussed the advantages and disadvantages of options and strategies" or "My provider helped me understand all the information" measured on a 6-point scale (completely disagree, strongly disagree, somewhat disagree, somewhat agree, strongly agree, and completely agree). The total average score ranges from 1 to 6 with higher scores indicating a better outcome of greater shared decision making. Analyses will examine change in Shared Decision Making Questionnaire scores from pre- to post-intervention.

  5. Working Alliance Inventory [ Time Frame: Change in scores on the Working Alliance Inventory from Baseline to 24 month follow-up ]
    The Working Alliance Inventory measures the perception of therapeutic alliance in a clinical dyad during the process of developing a relationship required for effective psychotherapy. The current study utilized the client version of the Working Alliance Inventory included 7 items measured on a 7-point scale (never, rarely, occasionally, sometimes, often, very often, always). Example items included "I am confident in my provider's ability to help me" and "My provider and I trust one another." The Working Alliance Inventory total average score ranges from 1 to 7, with high scores indicating a more positive outcome. Analyses will examine change in patient-reported Working Alliance Inventory scores from pre- to post-intervention.

  6. Communication Satisfaction Questionnaire [ Time Frame: Change in scores on the Communication Satisfaction Questionnaire from Baseline to 24 month follow-up ]
    Communication satisfaction was measured utilizing a modified version of a 19-item measure of communication patterns between physicians and their clients (Campbell et al., 2007). Thirteen items focusing on the client's satisfaction with communication with their provider and their engagement in treatment were measured on a 7-point scale (strongly agree, agree, agree somewhat, undecided, disagree somewhat, disagree, strongly disagree). Example items included "My provider checks to be sure that I understand everything" or "My provider involves me in decisions as much as I want." Total average scores range from 1 to 7 with higher scores indicating better communication satisfaction. Analyses will examine change in Satisfaction Questionnaire scores from pre- to post-intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women over the age of 18 who are receiving mental health services.

Exclusion Criteria:

Temporary Exclusion:

  • Disruptive, aggressive, or severely disorganized behaviors;
  • Visibly intoxicated or under the influence of illicit drugs.

General Exclusion:

  • Moderate to severe cognitive impairment;
  • Developmental disability that precludes comprehension;
  • Language issues: Intervention is only offered in English and Chinese;
  • Patient services structured for provision of mPOWR implementation (e.g., not in and out of inpatient or crisis stabilization services).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02761733


Sponsors and Collaborators
Felton Institute
Patient-Centered Outcomes Research Institute
University of New Mexico
Investigators
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Principal Investigator: Joyce Chu, PhD Felton Institute
Publications:
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Responsible Party: Felton Institute
ClinicalTrials.gov Identifier: NCT02761733    
Other Study ID Numbers: CE-12-11-4309
First Posted: May 4, 2016    Key Record Dates
Results First Posted: April 26, 2017
Last Update Posted: April 26, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Felton Institute:
Shared Decision Making
Case Management
Decision Aid
Additional relevant MeSH terms:
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Mental Disorders