Clinical trial NCT02761733: The Effectiveness of a Decision-Support Tool for Adult Consumers With Mental Health Needs and Their Care Managers
Official title: Researching the Effectiveness of a Decision-Support Tool for Adult Consumers With Mental Health Needs and Their Care Managers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorders
Keywords: Shared Decision Making
Case Management
Decision Aid
Lead sponsor: Felton Institute
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: University of New Mexico
First posted: 2016-05-04
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility 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).

Primary outcomes:
measure: Short Form Health Survey-12 (SF-12), Physical Symptoms Subscale
timeFrame: Change in scores on the SF-12 from Baseline to 24 month follow-up
measure: Short Form Health Survey-12 (SF-12) Mental Symptoms
timeFrame: 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.
measure: Outcome Rating Scale (ORS)
timeFrame: Change in scores on the Outcome Rating Scale from Baseline to 24 month follow-up
measure: Shared Decision Making Questionnaire
timeFrame: Change in scores on the Shared Decision Making Questionnaire from Baseline to 24 month follow-up
measure: Working Alliance Inventory
timeFrame: Change in scores on the Working Alliance Inventory from Baseline to 24 month follow-up
measure: Communication Satisfaction Questionnaire
timeFrame: Change in scores on the Communication Satisfaction Questionnaire from Baseline to 24 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Felton Institute
name: Joyce Chu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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