NCT04515771

Brief Summary

The purpose of this study was to develop and pilot test an intervention to reduce mental health disparities for racially and ethnically minoritized Veterans receiving outpatient VA mental health services. The program was delivered by trained VA peer navigators. The specific aims of the program were to enhance navigation of mental health services, increase patient engagement, and improve patient-provider communication. Study participants were randomized into one of two study groups, which determined when they received the study intervention. Regardless of study group, participants had 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 were 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 received. Some participants also completed an interview to discuss their experience in the program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

August 17, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2022

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

August 1, 2024

Enrollment Period

1.7 years

First QC Date

August 12, 2020

Results QC Date

April 20, 2023

Last Update Submit

August 13, 2024

Conditions

Keywords

Social Determinants of HealthMinority HealthVeterans HealthPatient ParticipationPatient NavigationMental Health Services

Outcome Measures

Primary Outcomes (5)

  • Patient Activation Measure- Mental Health (PAM-MH)

    Measure Description: The PAM-MH is a 13-item questionnaire that measures an individual's perceived ability to manage illness and health behaviors. The questions are rated on a 4-point Likert-type scale (1= strongly disagree, 2=disagree, 3=agree, 4=strongly agree). Scores are then converted using Rasch analysis to a 100-point scale. Raw scores range from 13 to 52 and converted activation scores range from 0-100. Higher activation scores indicate higher level of patient activation.

    Change from Baseline to 6 months

  • Altarum Consumer Engagement (ACE) Change

    The ACE is administered as a 5-level Likert scale. The subscale scores range from 5 to 25, and the total engagement score is computed by adding the 3 subscale scores and multiplying the sum by 4/3 to obtain a possible range score of 20 to 100. Higher scores represent higher patient engagement.

    Change from Baseline to 6 months

  • SDM-Q9 PARTNER-MH

    The SDM-Q9 PARTNER-MH was adapted from Braddock et al.'s SDM-Q-9 informed decision-making scale. The original, validated scale, the SDM-Q-9, has 9 items measured on a 6-point Likert Scale, ranging from 0=completely disagree to 5=completely agree. The total score is calculated by summing the scores of the nine items, range from 0 to 45. A higher score indicates a greater level of perceived SDM.

    Change from Baseline to 6 months

  • Peer Coaching Experience Satisfaction Questionnaire

    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. Only participants in active PARTNER-MH were administered this questionnaire. This questionnaire was developed for the study. Question 1: Overall, how satisfied are you with PARTNER-MH program? Question 2: How satisfied are you with your assigned peer. Answers are rated on a Likert scale ranging from 1 (very satisfied) to 5 (very dissatisfied).

    Administered after completion of the study program (6 months for Active PARTNER-MH )

  • Trust and Satisfaction Survey Responses Change

    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. Items are rated on a scale ranging from 1 (strongly disagree) to 5 (strongly agree). The survey yields final scores ranging from 5 (minimum) to 25 (maximum) with higher scores representing greater trust and satisfaction. No subscale.

    Change from Baseline to 6 months

Secondary Outcomes (5)

  • Veteran's RAND 12-item Health Survey (VR-12) Change

    Change from Baseline to 6 months

  • Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) Change

    Change from Baseline to 6 months

  • Working Alliance Inventory Short-Revised (WAI-SR) Change

    Change from Baseline to 6 months

  • UCLA Loneliness Scale (ULS-6) Change

    Change from Baseline to 6 months

  • Patient Health Questionnaire (PHQ-9) Change

    Change from Baseline to 6 months

Other Outcomes (2)

  • Lubben Social Network Scale-6

    change in scores from baseline to 6 months

  • Perceived Discrimination in Healthcare Responses

    Change in score from baseline to 6 months

Study Arms (2)

Active PARTNER-MH

EXPERIMENTAL

Participants in this arm received the intervention immediately after study enrollment. They continued to receive usual mental health services in addition to intervention.

Behavioral: PARTNER-MH

Waitlist Control

OTHER

The waitlist control arm participants received usual mental health services. They were offered to receive the intervention after the 6-month wait period.

Behavioral: PARTNER-MH

Interventions

PARTNER-MHBEHAVIORAL

The study intervention consisted of a 6-month, manualized, peer-led navigation program. It involved assessing and addressing patients' unmet social needs and barriers to care, delivery of peer support services, navigation to VA mental health services, and psychoeducation.

Active PARTNER-MHWaitlist Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be eligible:
  • Must be a Veteran belonging to a racial/ethnic minoritized 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

You may not qualify if:

  • Not eligible if:
  • Is a Veteran not belonging to a racial/ethnic minoritized 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

Related Publications (3)

  • Eliacin J, Matthias MS, Cameron KA, Burgess DJ. Veterans' views of PARTNER-MH, a peer-led patient navigation intervention, to improve patient engagement in care and patient-clinician communication: A qualitative study. Patient Educ Couns. 2023 Sep;114:107847. doi: 10.1016/j.pec.2023.107847. Epub 2023 Jun 13.

  • Eliacin J, Burgess D, Rollins AL, Patterson S, Damush T, Bair MJ, Salyers MP, Spoont M, Chinman M, Slaven JE, Matthias MS. Outcomes of a peer-led navigation program, PARTNER-MH, for racially minoritized Veterans receiving mental health services: a pilot randomized controlled trial to assess feasibility and acceptability. Transl Behav Med. 2023 Sep 12;13(9):710-721. doi: 10.1093/tbm/ibad027.

  • Eliacin J, Burgess DJ, Rollins AL, Patterson S, Damush T, Bair MJ, Salyers MP, Spoont M, Slaven JE, O'Connor C, Walker K, Zou DS, Austin E, Akins J, Miller J, Chinman M, Matthias MS. Proactive, Recovery-Oriented Treatment Navigation to Engage Racially Diverse Veterans in Mental Healthcare (PARTNER-MH), a Peer-Led Patient Navigation Intervention for Racially and Ethnically Minoritized Veterans in Veterans Health Administration Mental Health Services: Protocol for a Mixed Methods Randomized Controlled Feasibility Study. JMIR Res Protoc. 2022 Sep 6;11(9):e37712. doi: 10.2196/37712.

MeSH Terms

Conditions

Psychological Well-BeingPatient Participation

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Limitations and Caveats

The study had some limitations that should be considered. The study was conducted with a small sample at one VHA site. It was not powered to detect significant changes. Therefore, findings should be interpreted with caution. The retention rate in the study was also moderate and differed by study group. Future evaluation of PARTNER-MH should also examine outcomes over a longer period to assess patients' health services utilization and engagement in mental health treatment.

Results Point of Contact

Title
Dr. Johanne Eliacin
Organization
Richard L. Roudebush VA Medical Center

Study Officials

  • Johanne Eliacin, PhD

    Richard L. Roudebush VA Medical Center, Indianapolis, IN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: The study consisted of two groups, an active treatment group and a waitlist control group. Participants randomized to the active treatment group received the peer-administered intervention program for 6 months and then were followed for 3 months after completion of the program. The waitlist control group received the peer-administered intervention program for 6 months following a 6-month waiting period.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2020

First Posted

August 17, 2020

Study Start

August 17, 2020

Primary Completion

April 15, 2022

Study Completion

April 15, 2022

Last Updated

September 19, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Data will become available 6 months after publication.
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.

Locations