- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04515771
Improving Patient-Provider Communication to Reduce Mental Health Disparities (PARTNER-MH)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46202-2884
- Richard L. Roudebush VA Medical Center, Indianapolis, IN
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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.
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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.
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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.
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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.
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Change from Baseline to 3 months, to 6 months, to 9 months, and to 12 months
|
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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.
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Change from Baseline to 3 months, to 6 months, to 9 months, and to 12 months
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SDM-Q9 PARTNER-MH
Time Frame: Change from Baseline to 3 months, to 6 months, to 9 months, and to 12 months Change
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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.
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Change from Baseline to 3 months, to 6 months, to 9 months, and to 12 months Change
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CollaboRATE (SDM)
Time Frame: Change from Baseline to 3 months, to 6 months, to 9 months, and to 12 months Change
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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).
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Change from Baseline to 3 months, to 6 months, to 9 months, and to 12 months Change
|
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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)
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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.
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Adminstered after completion of the study program (6 months for Active PARTNER-MH and 12 months for Waitlist Control)
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Satisfaction with Services Questionnaire Responses Change
Time Frame: Change from Baseline to 3 months, to 6 months, to 9 months, and to 12 months
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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.
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Change from Baseline to 3 months, to 6 months, to 9 months, and to 12 months
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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.
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Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
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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
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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).
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Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
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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
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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."
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Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
|
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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
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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.
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Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
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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
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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.
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Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
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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
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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.
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Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
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Patient Health Questionnaire (PHQ-9) Change
Time Frame: Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
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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.
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Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
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Perceived Discrimination in Healthcare Responses Change
Time Frame: Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
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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).
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Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
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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
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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.
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Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
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Trust and Satisfaction Survey Responses Change
Time Frame: Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
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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).
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Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Johanne Eliacin, PhD, Richard L. Roudebush VA Medical Center, Indianapolis, IN
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CDX 20-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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