Improving Patient-Provider Communication to Reduce Mental Health Disparities (PARTNER-MH)

April 20, 2022 updated by: VA Office of Research and Development

Improving Patient-provider Communication to Reduce Mental Health Disparities (CDA 16-153)

The purpose of this study is to develop a program to reduce mental health disparities for racial and ethnic minority Veterans. The research program is led by VA peer navigators who are trained specifically to deliver the study intervention. The specific aims of the program are to enhance navigation of mental health services, increase patient engagement, and improve patient-provider communication.

Study participants will be randomized into one of two study groups, which will determine when they receive the study intervention. Regardless of study group, participants will have the opportunity to receive services in addition to their regular mental health treatment (either immediately after enrollment into the study or after a 6-month waiting period).

Participants will be asked to complete study questionnaires at different timepoints throughout the study to assess their overall satisfaction with the study program and the mental health services that they receive. Participants will also complete an interview to discuss their experience in the study program.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Indiana
      • Indianapolis, Indiana, United States, 46202-2884
        • Richard L. Roudebush VA Medical Center, Indianapolis, IN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

To be eligible:

  • Must be a Veteran belonging to a racial/ethnic minority group
  • Must be actively receiving mental health care in the Outpatient Mental Health Clinic at Veteran Health Indiana (Richard L. Roudebush VA Medical Center)
  • Must have started receiving mental health care as a new patient in the Outpatient Mental Health within 12 months prior to enrollment into the study

Exclusion Criteria:

Not eligible if:

  • Is a Veteran not belonging to a racial/ethnic minority group
  • Not actively receiving mental health care in the Outpatient Mental Health Clinic at Veteran Health Indiana (Richard L. Roudebush VA Medical Center)
  • Started receiving mental health care as a new patient in the Outpatient Mental Health outside of the 12-month window

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active PARTNER-MH
The Active PARTNER-MH arm will test the intervention program starting immediately after enrollment in the study. Participants enrolled into this arm will continue to receive normal mental health services in addition to the peer-administered intervention.
The study intervention consists of a peer navigation program developed by the study team. The navigation program focuses on navigating VA mental health services, as well as patient engagement in mental health services and patient-provider communication. The intervention will last for 6 months, during which the participant will commit to regularly meeting with their peer specialist (interventionist). Peer navigation sessions will be guided by the specific aims of the study program, but in a way that is tailored to the participants' specific needs.
Other: Waitlist Control
The Waitlist Control arm will test the intervention program after a waiting period of 6-months following enrollment into the study. During the 6-month waiting period, participants in this arm will continue to receive normal mental health services.
The study intervention consists of a peer navigation program developed by the study team. The navigation program focuses on navigating VA mental health services, as well as patient engagement in mental health services and patient-provider communication. The intervention will last for 6 months, during which the participant will commit to regularly meeting with their peer specialist (interventionist). Peer navigation sessions will be guided by the specific aims of the study program, but in a way that is tailored to the participants' specific needs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Activation Measure- Mental Health (PAM-MH) Change
Time Frame: Change from Baseline to 3 months, to 6 months, to 9 months, and to 12 months
Patient Activation Measure -Mental Health (PAM-MH) is a 13-item scale assessing patient knowledge, skills, and confidence for self-management. The questions are rated on a 4-point Likert-type scale.
Change from Baseline to 3 months, to 6 months, to 9 months, and to 12 months
Altarum Consumer Engagement (ACE) Change
Time Frame: Change from Baseline to 3 months, to 6 months, to 9 months, and to 12 months
Patient Activation Measure- Altarum Consumer Engagement (ACE) is a 12-item scale assessing patient knowledge, skills, and confidence in using the health care system. The questions are rated on a 4-point Likert-type scale.
Change from Baseline to 3 months, to 6 months, to 9 months, and to 12 months
SDM-Q9 PARTNER-MH
Time Frame: Change from Baseline to 3 months, to 6 months, to 9 months, and to 12 months Change
The SDM-Q9 PARTNER-MH was adapted from Braddock et al.'s informed decision-making scale. The measure is made up of three different sections: the first captures a brief description of the respondent's most recent mental health care appointment along with the decisions that were made during that appointment; the second assesses the extent to which shared decision-making occurred in the appointment (rating nine statements from completely disagree (1) to completely agree (6)); and the third looks at the respondent's attitudes about share decision-making during the appointment.
Change from Baseline to 3 months, to 6 months, to 9 months, and to 12 months Change
CollaboRATE (SDM)
Time Frame: Change from Baseline to 3 months, to 6 months, to 9 months, and to 12 months Change
The CollaboRATE measure is a 3-item scale assessing participant efforts to engage in shared decision making during their most recent mental health appointment. The questions are rated on a 10-point Likert-type scale, ranging from 0 (no effort was made) to 10 (every effort was made).
Change from Baseline to 3 months, to 6 months, to 9 months, and to 12 months Change
Peer Coaching Experience Satisfaction Questionnaire Change
Time Frame: Adminstered after completion of the study program (6 months for Active PARTNER-MH and 12 months for Waitlist Control)
Peer Coaching Experience Satisfaction Questionnaire is designed to collect feedback on a respondent's overall experience with a peer coach at the end of a 6-month period. The questionnaire explores topics such as number of contacts with the peer as well as satisfaction with the peer contacts and relationship with the peer.
Adminstered after completion of the study program (6 months for Active PARTNER-MH and 12 months for Waitlist Control)
Satisfaction with Services Questionnaire Responses Change
Time Frame: Change from Baseline to 3 months, to 6 months, to 9 months, and to 12 months
Satisfaction with Services questionnaire is a 13-item survey assessing a respondent's perceptions of their experience with the services that have been provided to them during the study. 11 items are rated on a 3-point Likert type scale, with answers ranging from 1 (not at all) to 3 (very). Two additional items are open answer and ask respondents to describe what they liked the most and least about the services received.
Change from Baseline to 3 months, to 6 months, to 9 months, and to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Veteran's RAND 12-item Health Survey (VR-12) Change
Time Frame: Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
The Veterans Rand 12-item Health Survey (VR-12) is a 12-item scale that assesses Veterans' report of health-related quality of life. It measures eight components: physical functioning, social functioning, role limitations due to physical and emotional problems, mental health, energy and vitality, bodily pain, and general perception of health. The VR-12 uses no/yes, and yes, all the time response options.
Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) Change
Time Frame: Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) measures patients' self-efficacy in obtaining medical information and attention to their chief health concern from a physician. It consists of 5 items, scored on a Likert scale ranging from 1 (not confident at all) to 5 (very confident).
Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
Working Alliance Inventory Short-Revised (WAI-SR) Change
Time Frame: Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
Working Alliance Inventory Short-Revised (WAI-SR) assesses the degree of collaboration and connection patients believe they have with their providers. The WAI-SR is a 12-item self-report measure and is scored on a 7-point Likert-type scale ranging from 1 (never) to 7 (always). Questions on the scale include "I am confident in Dr. X's ability to help me," and "Dr. X and I are working on mutually agreed-upon goals."
Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
Consumer Assessment of Health Care Providers and Systems (CAHPS) Clinician and Group Survey Change
Time Frame: Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
Consumer Assessment of Health Care Providers and Systems (CAHPS) Clinician and Group Survey: The survey was developed by the Agency for HealthCare Research and Quality and is used to measure patient satisfaction with VA services as part of the SAIL facility performance measures. It assesses 5 core categories: 1) access to care; 2) patient-provider communication; 3) care coordination; 4) respect from staff; and 5) patient's ratings of their provider. Responses to the survey are measured on a 4-point Likert scale.
Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
UCLA 6 Item Loneliness Scale (UCLA) Change
Time Frame: Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
UCLA 6 Item Loneliness Scale (UCLA) is a 6-item clinician-administered scale which measures three dimensions of loneliness: relational connectedness, social connectedness, and self-perceived isolation. The dimensions are rated on a scale ranging from hardly ever to often.
Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
Pain Management Collaboratory (PMC) Coronavirus Pandemic (COVID-19) Measure Change
Time Frame: Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
This survey asks about potential impacts that the coronavirus pandemic may have had on an individual's ability to get healthcare, find social support, their finances, ability to meet basic needs, and their mental and emotional well-being. The survey also asks about the individual's experience with the coronavirus. Respondents are asked to think about their experiences over the past 3 months and rate the degree to which they have been impacted.
Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
Patient Health Questionnaire (PHQ-9) Change
Time Frame: Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
Patient Health Questionnaire (PHQ-9) is a 9-item scale assessing the experience and severity of depression symptoms over the last 2 weeks. Respondents are asked to rate their experience of symptoms from not experiencing them at all to experiencing them nearly every day.
Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
Perceived Discrimination in Healthcare Responses Change
Time Frame: Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
Perceived Discrimination in Healthcare questionnaire is a 7-item scale which assesses a respondent's perception of experiences based on their racial background. Respondents are asked to rate their experiences on a 5-point Likert type scale, with answers ranging from 0 (never) to 4 (always).
Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
Lubben Social Network Scale- 6 (LSNS-6) Change
Time Frame: Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
Lubben Social Network Scale (LSNS) is a self-report measure of social engagement including family and friends. There are two versions of the scale; the 6-item scale and the 12-item scale. For this protocol, we will be using the 6-item scale. Each survey item is scored on a 6 point likert-like scale, from 0 to 5, with lower scores indicating less social engagement and higher score indicating more social engagement. The overall score of the measure is found by calculating the sum of all items.
Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
Trust and Satisfaction Survey Responses Change
Time Frame: Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
The Trust and Satisfaction Survey is a 5-item scale which assess a respondent's degree of trust toward the VA, VA mental health care services, and the study program. Respondents are asked to rate how much they agree with each of the 5 items (from 1 (strongly disagree) to 5 (strongly agree).
Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Johanne Eliacin, PhD, Richard L. Roudebush VA Medical Center, Indianapolis, IN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2020

Primary Completion (Actual)

April 15, 2022

Study Completion (Actual)

April 15, 2022

Study Registration Dates

First Submitted

August 12, 2020

First Submitted That Met QC Criteria

August 14, 2020

First Posted (Actual)

August 17, 2020

Study Record Updates

Last Update Posted (Actual)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 20, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Final research datasets underlying all publications reporting results of VA research can be made available, upon FOIA request. Upon request, a limited dataset will be made available for other researchers for the purposes of validation of findings. The limited dataset will include de-identified data relevant to the specific request. Independent research groups can view relevant data to evaluate the extent that data sources support conclusions made by authors in published studies as well as observe additional emergent findings and view supplemental details that might not be included in publications.

IPD Sharing Time Frame

Data will become available 6 months after publication.

IPD Sharing Access Criteria

Upon request, the Research Service will consider requests for the final data sets underlying the publications to be provided to the public. These requests for access will be reviewed by the Richard L Roudebush VA Medical Center R&D Committee and Associate Chief of Staff (ACOS) and addressed within a reasonable timeframe. Final data may have variable formats and will be converted to a uniform format, when allowable. No PHI or VASI, if any, will be shared after publication, unless approved by the facility Privacy Officer for a FOIA request. Data sets will be de-identified and anonymized and VASI removed per FOIA. Only authorized research personnel as approved by the ACOS in agreement with the PI, will have access to the data. Data will be securely stored on a VA Research network drive behind the VA firewall. The project will have an assigned secure space for storage on the network drive to protect compartmentalized housing of data to include raw data, working data, and final data sets.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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