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

Mental Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02761733
• Other study ID #: CE-12-11-4309
• Status: Active, not recruiting
• Phase: N/A
• First received: January 20, 2016
• Last updated: May 3, 2016
• Start date: September 2013
• Est. completion date: October 2016

Study information

• Verified date: May 2016
• Source: Felton Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Felton Institute	Patient-Centered Outcomes Research Institute, University of New Mexico

References & Publications (8)

Campbell C, Lockyer J, Laidlaw T, Macleod H. Assessment of a matched-pair instrument to examine doctor-patient communication skills in practising doctors. Med Educ. 2007 Feb;41(2):123-9. — View Citation

Hanson, W., K. Curry, and D. Bandalos, Reliability Generalization of Working Alliance Inventory Scale Scores. Educational and Psychological Measurement, 2002. 62(4): p. 659-673.

Horvath, A. and L. Greenberg, Development and validation of the Working Alliance Inventory. J Counseling Psychology, 1989. 36: p. 223-233.

Johnson JA, Coons SJ. Comparison of the EQ-5D and SF-12 in an adult US sample. Qual Life Res. 1998 Feb;7(2):155-66. — View Citation

Kriston L, Scholl I, Hölzel L, Simon D, Loh A, Härter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30. — View Citation

Larson CO, Schlundt D, Patel K, Beard K, Hargreaves M. Validity of the SF-12 for use in a low-income African American community-based research initiative (REACH 2010). Prev Chronic Dis. 2008 Apr;5(2):A44. Epub 2008 Mar 15. — View Citation

Miller, S., et al., The Outcome Rating Scale: A Preliminary Study of the Reliability, Validity, and Feasibility of a Brief Visual Analog Measure. J Brief Therapy, 2003. 2(2): p. 91-100.

Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Form Health Survey-12 (SF-12)		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.	No
Primary	Outcome Rating Scale (ORS)	The Outcome Rating Scale includes a visual analog scale that records four questions about general well-being, personal well-being, close relationships, and work/school/friend relationships. Analyses will examine treatment progress via change in ORS scores from pre- to post-intervention.	Change in scores on the Outcome Rating Scale from Baseline to 24 month follow-up	No
Primary	Shared Decision Making Questionnaire	The Shared Decision Making Questionnaire includes 9 questions that assess for congruence of patient's and provider's participation in therapeutic decision making and patient's understanding of treatment and treatment options. Analyses will examine change in Shared Decision Making Questionnaire scores from pre- to post-intervention.	Change in scores on the Shared Decision Making Questionnaire from Baseline to 24 month follow-up	No
Primary	Working Alliance Inventory	The Working Alliance Inventory includes 12 items administered to both the patient and provider that measure the perception of therapeutic alliance in a clinical dyad during the process of developing a relationship required for effective psychotherapy. Analyses will examine change in patient- and provider-reported Working Alliance Inventory scores from pre- to post-intervention.	Change in scores on the Working Alliance Inventory from Baseline to 24 month follow-up	No
Primary	Satisfaction Questionnaire	The Satisfaction Questionnaire includes 19 questions that evaluate communication patterns between physicians and their patients. Analyses will examine change in Satisfaction Questionnaire scores from pre- to post-intervention.	Change in scores on the Satisfaction Questionnaire from Baseline to 24 month follow-up	No