Improving Patient-Provider Communication to Reduce Mental Health Disparities

Mental Health Clinical Trial

— PARTNER-MH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04515771
• Other study ID #: CDX 20-003
• Status: Completed
• Phase: N/A
• Start date: August 17, 2020
• Est. completion date: April 15, 2022

Study information

• Verified date: April 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 15, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthcare Disparities
• Mental Health

Intervention

Behavioral:
• PARTNER-MH
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.

Locations

Country	Name	City	State
United States	Richard L. Roudebush VA Medical Center, Indianapolis, IN	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Activation Measure- Mental Health (PAM-MH) Change	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
Primary	Altarum Consumer Engagement (ACE) Change	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
Primary	SDM-Q9 PARTNER-MH	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
Primary	CollaboRATE (SDM)	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
Primary	Peer Coaching Experience Satisfaction Questionnaire Change	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)
Primary	Satisfaction with Services Questionnaire Responses Change	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	Veteran's RAND 12-item Health Survey (VR-12) Change	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
Secondary	Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) Change	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
Secondary	Working Alliance Inventory Short-Revised (WAI-SR) Change	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
Secondary	Consumer Assessment of Health Care Providers and Systems (CAHPS) Clinician and Group Survey Change	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
Secondary	UCLA 6 Item Loneliness Scale (UCLA) Change	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
Secondary	Pain Management Collaboratory (PMC) Coronavirus Pandemic (COVID-19) Measure Change	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
Secondary	Patient Health Questionnaire (PHQ-9) Change	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
Secondary	Perceived Discrimination in Healthcare Responses Change	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
Secondary	Lubben Social Network Scale- 6 (LSNS-6) Change	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
Secondary	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 (from 1 (strongly disagree) to 5 (strongly agree).	Change from Baseline, to 3 months, to 6 months, to 9 months, and to 12 months