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Clinical Trials/NCT04515771
NCT04515771CompletedNot Applicable

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

VA Office of Research and Development1 site in 1 country50 target enrollmentStarted: August 17, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Patient Activation Measure- Mental Health (PAM-MH)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

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.

Intervention: PARTNER-MH (Behavioral)

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.

Intervention: PARTNER-MH (Behavioral)

Outcomes

Primary Outcomes

Patient Activation Measure- Mental Health (PAM-MH)

Time Frame: Change from Baseline to 6 months

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.

Altarum Consumer Engagement (ACE) Change

Time Frame: Change from Baseline to 6 months

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.

SDM-Q9 PARTNER-MH

Time Frame: Change from Baseline to 6 months

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.

Peer Coaching Experience Satisfaction Questionnaire

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

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).

Trust and Satisfaction Survey Responses Change

Time Frame: Change from Baseline to 6 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. 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.

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (1)

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