An interventional study of PARTNER-MH in Healthcare Disparities and Mental Health, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research
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.
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To be eligible:
Exclusion Criteria:
Not eligible if:
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
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
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Change from Baseline to 6 months
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 mental and physical functioning. The VR-12 uses five-point ordinal response choices and provides two scores: the Physical Component Summary Score and the Mental Health Summary Score, ranging from 0 to 100. VR-12 scores are standardized using a T-score metric with a mean of 50 and a standard deviation of 10. The scores are compared to the population average, measured in standard deviations. The United States population average PCS and MCS are 50 points each. The United States population standard deviation is 10 points. Higher scores indicate better self-reported health. Lower VR-12 MCS scores indicate worse psychological distress/functioning. Clinically significant scores vary based on the condition or disease population.
Time frame: Change from Baseline to 6 months
Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) Change
The Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) is 5-item scale rated on a 10-point Likert scale ranging from 1 (not confident at all) to 10 (very confident) and the total score, which is the sum of all item ratings, range from 0 (minimum) to 50 (maximum). Higher scores indicate higher levels of self-efficacy. There is no subscale.
Time frame: Change from Baseline to 6 months
Working Alliance Inventory Short-Revised (WAI-SR) Change
Working Alliance Inventory -Short Revised (WAI-SR) evaluates key aspects of the therapeutic alliance between patients and their mental health providers. It includes 12 items rated on a 5-point Likert scale ranging from 1= seldom to 5= always. The WAI-SR has 3 subscales: The Goal, Task, and Bond subscales each have 4 items and scores ranging from 4 to 20. For research purposes, use of the overall mean scores of the WAI-SR rather than its subscales have been recommended. The scale total scores range from 12 (minimum) to 60 (maximum). Higher scores indicate higher level of working alliance. There is no cut off score for this scale.
Time frame: Change from Baseline to 6 months
UCLA Loneliness Scale (ULS-6) Change
The UCLA Loneliness Scale Short Form, (ULS-6), is a 6-item scale that assesses loneliness and is rated on a 4-point Likert Scale, ranging from 1=never to 4= often. The scale has a total summed score ranging from 6 (minimum) to 24 (maximum), with higher scores indicate higher level of loneliness.
Time frame: Change from Baseline to 6 months
Patient Health Questionnaire (PHQ-9) Change
Measure Description: Patient Health Questionnaire (PHQ-9) measures severity of depressive symptoms. It includes 9 items, ranging in scores from 0 to 27. Higher scores indicate more severe symptoms of depression.
Time frame: Change from Baseline to 6 months
Lubben Social Network Scale-6
The Lubben Social Network Scale (LSNS-6) is a self-report measure consisting of 6 items, rated on a 6-point Likert scale ranging 0 to 5. The total score is the sum of all 6 items ranging from 0 to 30. A score of 12 indicates at risk of social isolation and scores less than 12 indicate social isolation.
Time frame: change in scores from baseline to 6 months
Perceived Discrimination in Healthcare Responses
Measure Description: Respondents are asked to rate their experiences on a 5-point Likert-type scale, with answers ranging from 0 (never) to 4 (always). Higher scores indicate more frequent experiences of discrimination in healthcare.
Time frame: Change in score from baseline to 6 months
| Milestone | Active PARTNER-MH | Waitlist Control |
|---|---|---|
| Started | 30 | 20 |
| Completed | 18 | 18 |
| Not completed | 12 | 2 |
| Withdrew: Lost to follow-up | 9 | 1 |
| Withdrew: Withdrawal by subject | 3 | 1 |
| Milestone | Active PARTNER-MH | Waitlist Control |
|---|---|---|
| Started | 0 | 12 |
| Completed | 0 | 7 |
| Not completed | 0 | 5 |
| Withdrew: Lost to follow-up | 0 | 5 |
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.
| score on a scale | Active PARTNER-MH | Waitlist Control |
|---|---|---|
| Patient Activation Measure- Mental Health (PAM-MH) | 5.7 ± 16.5 | 9.1 ± 11.7 |
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.
| score on a scale | Active PARTNER-MH | Waitlist Control |
|---|---|---|
| Altarum Consumer Engagement (ACE) Change | 5.5 ± 11.5 | 2.9 ± 10.4 |
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.
| units on a scale | Active PARTNER-MH | Waitlist Control |
|---|---|---|
| SDM-Q9 PARTNER-MH | 1.9 ± 13.5 | 1.3 ± 7.1 |
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).
| participants | Active PARTNER-MH |
|---|---|
| Question 1 Very satisified | 6 |
| Question 1 Satisified | 4 |
| Question 1 Neutral | 2 |
| Question 1 Dissatisfied | 1 |
| Question 1 Very dissatisfied | 1 |
| Question 2 Very satisfied | 11 |
| Question 2 Satisfied | 1 |
| Question 2 Neutral | 1 |
| Question 2 Dissatisfied | 1 |
| Question 2 Very dissatisfied | 0 |
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.
| score on a scale | Active PARTNER-MH | Waitlist Control |
|---|---|---|
| Trust the VA | 0.05 ± 0.85 | -0.13 ± 0.83 |
| Trust the Mental Health Clinic | 0.03 ± 0.69 | -0.03 ± 0.65 |
| Would recommend MH clinic | 0.16 ± 0.87 | -0.19 ± 0.64 |
| Satisfied with the care I received at MH clinic | 0.24 ± 0.72 | -0.53 ± 0.72 |
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 mental and physical functioning. The VR-12 uses five-point ordinal response choices and provides two scores: the Physical Component Summary Score and the Mental Health Summary Score, ranging from 0 to 100. VR-12 scores are standardized using a T-score metric with a mean of 50 and a standard deviation of 10. The scores are compared to the population average, measured in standard deviations. The United States population average PCS and MCS are 50 points each. The United States population standard deviation is 10 points. Higher scores indicate better self-reported health. Lower VR-12 MCS scores indicate worse psychological distress/functioning. Clinically significant scores vary based on the condition or disease population.
| score on a scale | Active PARTNER-MH | Waitlist Control |
|---|---|---|
| VR-12 Physical Function | -4.4 ± 6.8 | -0.3 ± 7.8 |
| VR-12 Mental Function | 8.3 ± 6.5 | -2.8 ± 6.8 |
The Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) is 5-item scale rated on a 10-point Likert scale ranging from 1 (not confident at all) to 10 (very confident) and the total score, which is the sum of all item ratings, range from 0 (minimum) to 50 (maximum). Higher scores indicate higher levels of self-efficacy. There is no subscale.
| score on a scale | Active PARTNER-MH | Waitlist Control |
|---|---|---|
| Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) Change | 6.5 ± 11.5 | 1.2 ± 10.2 |
Working Alliance Inventory -Short Revised (WAI-SR) evaluates key aspects of the therapeutic alliance between patients and their mental health providers. It includes 12 items rated on a 5-point Likert scale ranging from 1= seldom to 5= always. The WAI-SR has 3 subscales: The Goal, Task, and Bond subscales each have 4 items and scores ranging from 4 to 20. For research purposes, use of the overall mean scores of the WAI-SR rather than its subscales have been recommended. The scale total scores range from 12 (minimum) to 60 (maximum). Higher scores indicate higher level of working alliance. There is no cut off score for this scale.
| score on a scale | Active PARTNER-MH | Waitlist Control |
|---|---|---|
| BOND subscale | 0.7 ± 3.4 | 0.7 ± 3.6 |
| GOAL subscale | 1.6 ± 5.7 | 1.6 ± 4.0 |
| TASK Subscale | 1.4 ± 2.7 | 0.7 ± 5.5 |
| Summed scores | 3.8 ± 9.9 | 2.9 ± 10.9 |
The UCLA Loneliness Scale Short Form, (ULS-6), is a 6-item scale that assesses loneliness and is rated on a 4-point Likert Scale, ranging from 1=never to 4= often. The scale has a total summed score ranging from 6 (minimum) to 24 (maximum), with higher scores indicate higher level of loneliness.
| units on a scale | Active PARTNER-MH | Waitlist Control |
|---|---|---|
| UCLA Loneliness Scale (ULS-6) Change | -0.6 ± 4.1 | -0.3 ± 3.9 |
Measure Description: Patient Health Questionnaire (PHQ-9) measures severity of depressive symptoms. It includes 9 items, ranging in scores from 0 to 27. Higher scores indicate more severe symptoms of depression.
| units on a scale | Active PARTNER-MH | Waitlist Control |
|---|---|---|
| Patient Health Questionnaire (PHQ-9) Change | -3.6 ± 6.7 | 0.1 ± 5.2 |
The Lubben Social Network Scale (LSNS-6) is a self-report measure consisting of 6 items, rated on a 6-point Likert scale ranging 0 to 5. The total score is the sum of all 6 items ranging from 0 to 30. A score of 12 indicates at risk of social isolation and scores less than 12 indicate social isolation.
| score on a scale | Active PARTNER-MH | Waitlist Control |
|---|---|---|
| Lubben Social Network Scale-6 | 6.3 ± 7.0 | 0.0 ± 2.6 |
Measure Description: Respondents are asked to rate their experiences on a 5-point Likert-type scale, with answers ranging from 0 (never) to 4 (always). Higher scores indicate more frequent experiences of discrimination in healthcare.
| score on a scale | Active PARTNER-MH | Waitlist Control |
|---|---|---|
| Perceived Discrimination in Healthcare Responses | -1.9 ± 5.3 | -1.6 ± 4.5 |
CollaboRATE consists of 3-items, each scored on a scale of 0-9. Scores range from 0-100. Higher scores indicate more shared decision.
| score on a scale | Active PARTNER-MH | Waitlist Control |
|---|---|---|
| CollaboRATE | 1.8 ± 8.8 | 0.4 ± 6.0 |
Collected over Adverse events were monitored and assessed from the time of study entry at baseline until the end of study participation at 6 months (primary endpoint), or 12 months for those who were in the waitlist control arm and opted to receive the intervention.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active PARTNER-MH | 0/30 (0%) | 0/30 (0%) | 1/30 (3.3%) |
| Waitlist Control | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Event | Active PARTNER-MH | Waitlist Control |
|---|---|---|
| non-serious adverse eventPsychiatric disorders | 1/30 | 0/20 |
| Age, Categorical(Participants) | Active PARTNER-MH | Waitlist Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 28 | 20 | 48 |
| >=65 years | 2 | 0 | 2 |
| Sex: Female, Male(Participants) | Active PARTNER-MH | Waitlist Control | Total |
|---|---|---|---|
| Female | 8 | 11 | 19 |
| Male | 22 | 9 | 31 |
| Race/Ethnicity, Customized(Participants) | Active PARTNER-MH | Waitlist Control | Total |
|---|---|---|---|
| White (Hispanic) | 3 | 0 | 3 |
| Black | 20 | 15 | 35 |
| Asian | 0 | 1 | 1 |
| Other | 2 | 3 | 5 |
| Multiracial | 5 | 1 | 6 |
| Hispanic | 4 | 2 | 6 |
| Region of Enrollment(Participants) | Active PARTNER-MH | Waitlist Control | Total |
|---|---|---|---|
| United States | 30 | 20 | 50 |
| Altarum Consumer Engagement (ACE)(units on a scale) | Active PARTNER-MH | Waitlist Control | Total |
|---|---|---|---|
| ACE Commitment subscale | 13.7 ± 4.7 | 13.6 ± 5.9 | 13.7 ± 5.2 |
| ACE Informed Choice Subscale | 10.6 ± 4.8 | 10.4 ± 5.4 | 10.5 ± 5.0 |
| ACE Navigation Subscale | 15.5 ± 4.4 | 14.8 ± 2.8 | 15.2 ± 3.8 |
| Patient Activation Measure (PAM-MH)(units on a scale) | Active PARTNER-MH | Waitlist Control | Total |
|---|---|---|---|
| Mean | 51.5 ± 11.3 | 49.6 ± 11.8 | 51.5 ± 11.3 |
| Shared-Decision-Making-9 (SDM-Q-9)(units on a scale) | Active PARTNER-MH | Waitlist Control | Total |
|---|---|---|---|
| Mean | 25.8 ± 9.1 | 28.3 ± 9.7 | 26.8 ± 9.4 |
| Communication Self-Efficacy (PEPPI-5)(units on a scale) | Active PARTNER-MH | Waitlist Control | Total |
|---|---|---|---|
| Mean | 35.2 ± 10.6 | 36.4 ± 11.4 | 35.7 ± 10.8 |
9 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Study protocol, Csr
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