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

NCT02761733 | Completed Results

• 1 other identifier: CE-12-11-4309
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Mental Disorders

Keywords

Shared Decision Making; Case Management; Decision Aid

Outcome Measures

Primary Outcomes (6)

• Short Form Health Survey-12 (SF-12), Physical Symptoms Subscale

  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.

  Change in scores on the SF-12 from Baseline to 24 month follow-up

• Short Form Health Survey-12 (SF-12) Mental Symptoms

  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.

  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.

• Outcome Rating Scale (ORS)

  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.

  Change in scores on the Outcome Rating Scale from Baseline to 24 month follow-up

• Shared Decision Making Questionnaire

  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.

  Change in scores on the Shared Decision Making Questionnaire from Baseline to 24 month follow-up

• Working Alliance Inventory

  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.

  Change in scores on the Working Alliance Inventory from Baseline to 24 month follow-up

• Communication Satisfaction Questionnaire

  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.

  Change in scores on the Communication Satisfaction Questionnaire from Baseline to 24 month follow-up

Study Arms (2)

mPOWR System

EXPERIMENTAL

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)

Control

NO INTERVENTION

Treatment as usual

Interventions

Moving Patient Outcomes toward Wellness and Recovery (mPOWR) BEHAVIORAL

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.

mPOWR System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Felton Institute: lead
• Patient-Centered Outcomes Research Institute: collaborator
• University of New Mexico: collaborator

Related Publications (8)

• 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.

  PMID: 18341779 BACKGROUND

• 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. doi: 10.1097/00005650-199603000-00003.

  PMID: 8628042 BACKGROUND

• 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. doi: 10.1023/a:1008809610703.

  PMID: 9523497 BACKGROUND

• 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.

  BACKGROUND

• Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter 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.

  PMID: 19879711 BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

• 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. doi: 10.1111/j.1365-2929.2006.02657.x.

  PMID: 17269944 BACKGROUND

MeSH Terms

Conditions

Mental Disorders

Interventions

Salvage Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Limitations and Caveats

Missing responses at baseline and 24 month followups were handled using full-information ML as part of a 2(Tx)x2(Location)x5(Time) mixed-effects ANOVA estimated using SAS PROC MIXED 9.4.

Results Point of Contact

• Title: Joyce Chu (Principal Investigator)
• Organization: Felton Institute & Palo Alto University

jchu@paloaltou.edu

650-814-8376

Study Officials

• Joyce Chu, PhD

  Felton Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: May 4, 2016
• Study Start: September 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: April 26, 2017
• Results First Posted: April 26, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share