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Enhancing Mental Health Care by Scientifically Matching Patients to Providers' Strengths

This study is currently recruiting participants.
Verified November 2017 by University of Massachusetts, Amherst
Sponsor:
ClinicalTrials.gov Identifier:
NCT02990000
First Posted: December 12, 2016
Last Update Posted: November 17, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Patient-Centered Outcomes Research Institute
University at Albany
Psychological and Behavioral Consultants
Outcome Referrals
Information provided by (Responsible Party):
University of Massachusetts, Amherst
  Purpose

Research has shown that mental health care (MHC) providers differ significantly in their ability to help patients. In addition, providers demonstrate different patterns of effectiveness across symptom and functioning domains. For example, some providers are reliably effective in treating numerous patients and problem domains, others are reliably effective in some domains (e.g., depression, substance abuse) yet appear to struggle in others (e.g., anxiety, social functioning), and some are reliably ineffective, or even harmful, across patients and domains. Knowledge of these provider differences is based largely on patient-reported outcomes collected in routine MHC settings.

Unfortunately, provider performance information is not systematically used to refer or assign a particular patient to a scientifically based best-matched provider. MHC systems continue to rely on random or purely pragmatic case assignment and referral, which significantly "waters down" the odds of a patient being assigned/referred to a high performing provider in the patient's area(s) of need, and increases the risk of being assigned/referred to a provider who may have a track record of ineffectiveness. This research aims to solve the existing non-patient-centered provider-matching problem.

Specifically, the investigators aim to demonstrate the comparative effectiveness of a scientifically-based patient-provider match system compared to status quo pragmatic case assignment. The investigators expect in the scientific match group significantly better treatment outcomes (e.g., symptoms, quality of life) and higher patient satisfaction with treatment. The investigators also expect to demonstrate feasibility of implementing a scientific match process in a community MHC system and broad dissemination of the easily replicated scientific match technology in diverse health care settings. The importance of this work for patients cannot be understated. Far too many patients struggle to find the right provider, which unnecessarily prolongs suffering and promotes health care system inefficiency. A scientific match system based on routine outcome data uses patient-generated information to direct this patient to this provider in this setting. In addition, when based on multidimensional assessment, it allows a wide variety of patient-centered outcomes to be represented (e.g., symptom domains, functioning domains, quality of life).


Condition Intervention
Mental Illness Behavioral: Scientific Match

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Health Services Research
Official Title: Enhancing Mental Health Care by Scientifically Matching Patients to Providers' Strengths

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Amherst:

Primary Outcome Measures:
  • Treatment Outcome Package (TOP; Kraus, Seligman, & Jordan, 2005) [ Time Frame: Up to 36 months ]
    The TOP-CS consists of 58 items assessing 12 symptom and functional (including strengths) domains (risk-adjusted for case mix variables assessed via 37 items on the companion TOP-CM, such as divorce, job loss, comorbidity): work functioning, sexual functioning, social conflict, depression, panic (somatic anxiety), psychosis, suicidal ideation, violence, mania, sleep, substance abuse, and quality of life. Global symptom severity is assessed by summing all items or by averaging the z-scores (i.e., standard deviation units relative to the general population mean) across each of the 12 clinical scales. Domain-specific symptom severity is quantified as the individual z-scores for each clinical scale using general population means and standard deviations for the conversion.


Secondary Outcome Measures:
  • Symptom Checklist-10 (SCL-10; Rosen, Drescher, Moos, & Gusman, 1999) [ Time Frame: Up to 36 months ]
    To evaluate outcome with an index separate from the TOP (to test convergence and enhance the validity of any between condition effects), we will also assess global distress with the Symptom Checklist-10 (SCL-10; Rosen, Drescher, Moos, & Gusman, 1999), a 10-item, well validated and widely used self-report inventory that assesses psychological wellbeing.

  • Existential Isolation Scale (EIS; Pinel et al., 2014). [ Time Frame: Up to 36 months ]
    To assess this isolation subtype, participants will complete the EIS, a six-item scale that requires participants to rate the extent to which they agree with items such as "I often have the same reactions to things as other people around me do" (reverse-coded) and "Other people usually do not understand my experiences" and "People often have the same 'take' or perspective on things that I do" (reverse-coded). Participants respond using a 7-point scale. The EIS has high internal consistency, and has been validated extensively (Pinel et al., 2014).

  • Inventory of Interpersonal Problems-32 (IIP-32; Horowitz, Alden, Wiggins, & Pincus, 2000) [ Time Frame: Up to 36 months ]
    To assess interpersonal problems, participants will complete the 32-item circumplex version of the Inventory of Interpersonal Problems (IIP-32). This widely used instrument reflects interpersonal inhibitions and excesses, with each item rated on a 5-point scale. Higher total scores indicate more interpersonal problems. The IIP-32 also has 8 subscales (Domineering, Vindictive, Intrusive, Cold, Socially Inhibited, Nonassertive, Overly Accommodating, and Self-Sacrificing) that comprise a circumplex of problematic interpersonal behavior around the main interpersonal dimensions of affiliation and control. Like the original measure (Horowitz, Rosenberg, Baer, Ureno, & Villansenor, 1988), the IIP-32 has evidenced good psychometric properties.

  • Working Alliance Inventory—Short Form, patient version (WAI-SF-P; Tracey, & Kokotovic, 1989) [ Time Frame: Up to 36 months ]
    The WAI is the most widely used alliance measure, assessing patient-therapist agreement on the goals and tasks of treatment, and the quality of their relational bond. This 12-item short form, assessing these dimensions from the patient's perspective, has demonstrated sound psychometric properties.

  • Credibility/Expectancy Scale (CEQ; Devilly, & Borkovec, 2000) [ Time Frame: Up to 36 months ]
    The CEQ is the most widely used and psychometrically sound measure of the patient's perceived logicalness of a given treatment and expectation for the personal efficacy of that treatment.


Estimated Enrollment: 308
Study Start Date: December 2016
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Pragmatic Match
Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a pragmatically matched provider (control group)
Experimental: Scientific Match
Randomly assigned, by a case-assigning administrator, to naturalistic treatment with a scientifically matched provider (experimental group)
Behavioral: Scientific Match
Consecutive consenting patients at each site will be randomly assigned to condition. The project coordinator, unaware of therapist baseline performance, will generate the randomization sequences using an online random generator. Therapists will be crossed—that is, some of their cases will be matched, while others will be non-matched. Within condition, patients will be assigned sequentially to the site-specific therapists until therapists reach their study quota. In the low probability event that there is no therapist meeting minimal match criteria for a patient in the match condition, that patient will be removed from the study protocol (though will, of course, still receive treatment) and replaced with the next patient where a match does exist (this will also be carefully tracked).

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult men and women (age 18-65)
  • Largely referred by Atrius primary care and obstetrics/gynecology for triage and treatment through Atrius's behavioral health specialty practice.
  • Has an Atrius primary care physician (PCP).
  • Willingness to be randomized to condition and to complete a few study-specific measures.
  • Most likely that the sample will be predominated by the following diagnoses: complex mood, trauma, and anxiety disorders, eating disorders, simple schizophrenia, borderline personality disorder, substance abuse, and insomnia.

Exclusion Criteria:

  • Patients who are not the primary, informed decision-maker for their care
  • Adults over age 65 years
  Contacts and Locations
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): NCT02990000


Contacts
Contact: Michael J Constantino, PhD 4135451388 mconstantino@psych.umass.edu
Contact: James F Boswell, PhD 5184423402 jboswell@albany.edu

Locations
United States, Massachusetts
University of Massachusetts Amherst Recruiting
Amherst, Massachusetts, United States, 01003
Contact: Michael Constantino, PhD    413-545-1388    mconstantino@psych.umass.edu   
Sponsors and Collaborators
University of Massachusetts, Amherst
Patient-Centered Outcomes Research Institute
University at Albany
Psychological and Behavioral Consultants
Outcome Referrals
Investigators
Principal Investigator: Michael J Constantino, PhD University of Massachusetts, Amherst
Principal Investigator: James F Boswell, PhD University at Albany, SUNY
Principal Investigator: David R Kraus, PhD Outcome Referrals
Principal Investigator: Thomas P Swales, PhD Psychological and Behavioral Consultants
  More Information

Additional Information:
Responsible Party: University of Massachusetts, Amherst
ClinicalTrials.gov Identifier: NCT02990000     History of Changes
Other Study ID Numbers: HIS-1503-28573
First Submitted: November 29, 2016
First Posted: December 12, 2016
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Awardees are expected to maintain the Full Data Package at their own institution for a period of at least seven (7) years following acceptance by PCORI of the final research report. During this period, PCORI may notify awardee of PCORI's intent to provide funds for sharing the Full Data Package either through an established repository or directly to a third party requestor. Reasons for such notification may include PCORI's estimation of high importance of and interest in study findings, request(s) from external researchers for data access, or the Awardee's expressed interest in sharing the data.

Additional relevant MeSH terms:
Mental Disorders