Trial Outcomes & Findings for Improving Patient-Provider Communication to Reduce Mental Health Disparities (NCT NCT04515771)
NCT ID: NCT04515771
Last Updated: 2024-09-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Change from Baseline to 6 months
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Active PARTNER-MH
Participants in this arm received the intervention immediately after study enrollment. They continued to receive usual mental health services in addition to intervention.
PARTNER-MH was a 6-month, manualized intervention delivered by VA peer support specialists/navigators. The intervention involved assessing and addressing patients' barriers to care and unmet social needs. It also included navigation to VA mental health services, provision of peer support and psychoeducation to increase patients' engagement in mental health services and to improve their communication with mental health clinicians.
|
Waitlist Control
During the 6-month waiting period, participants in this arm received usual mental health services. They had the option to receive the intervention after the wait period.
|
|---|---|---|
|
Period 1: 6 Month Randomized Period
STARTED
|
30
|
20
|
|
Period 1: 6 Month Randomized Period
COMPLETED
|
18
|
18
|
|
Period 1: 6 Month Randomized Period
NOT COMPLETED
|
12
|
2
|
|
Period 2. 6 Month Waitlist Crossover
STARTED
|
0
|
12
|
|
Period 2. 6 Month Waitlist Crossover
COMPLETED
|
0
|
7
|
|
Period 2. 6 Month Waitlist Crossover
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
| Measure |
Active PARTNER-MH
Participants in this arm received the intervention immediately after study enrollment. They continued to receive usual mental health services in addition to intervention.
PARTNER-MH was a 6-month, manualized intervention delivered by VA peer support specialists/navigators. The intervention involved assessing and addressing patients' barriers to care and unmet social needs. It also included navigation to VA mental health services, provision of peer support and psychoeducation to increase patients' engagement in mental health services and to improve their communication with mental health clinicians.
|
Waitlist Control
During the 6-month waiting period, participants in this arm received usual mental health services. They had the option to receive the intervention after the wait period.
|
|---|---|---|
|
Period 1: 6 Month Randomized Period
Lost to Follow-up
|
9
|
1
|
|
Period 1: 6 Month Randomized Period
Withdrawal by Subject
|
3
|
1
|
|
Period 2. 6 Month Waitlist Crossover
Lost to Follow-up
|
0
|
5
|
Baseline Characteristics
This measure was added later in the study as an exploratory measure.
Baseline characteristics by cohort
| Measure |
Active PARTNER-MH
n=30 Participants
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.
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.
|
Waitlist Control
n=20 Participants
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.
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.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=50 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=30 Participants
|
20 Participants
n=20 Participants
|
48 Participants
n=50 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=30 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=50 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=30 Participants
|
11 Participants
n=20 Participants
|
19 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=30 Participants
|
9 Participants
n=20 Participants
|
31 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
White (Hispanic)
|
3 Participants
n=30 Participants
|
0 Participants
n=20 Participants
|
3 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Black
|
20 Participants
n=30 Participants
|
15 Participants
n=20 Participants
|
35 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=30 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=30 Participants
|
3 Participants
n=20 Participants
|
5 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
5 Participants
n=30 Participants
|
1 Participants
n=20 Participants
|
6 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=30 Participants
|
2 Participants
n=20 Participants
|
6 Participants
n=50 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=30 Participants
|
20 Participants
n=20 Participants
|
50 Participants
n=50 Participants
|
|
Altarum Consumer Engagement (ACE)
ACE Commitment subscale
|
13.7 units on a scale
STANDARD_DEVIATION 4.7 • n=30 Participants
|
13.6 units on a scale
STANDARD_DEVIATION 5.9 • n=20 Participants
|
13.7 units on a scale
STANDARD_DEVIATION 5.2 • n=50 Participants
|
|
Altarum Consumer Engagement (ACE)
ACE Informed Choice Subscale
|
10.6 units on a scale
STANDARD_DEVIATION 4.8 • n=30 Participants
|
10.4 units on a scale
STANDARD_DEVIATION 5.4 • n=20 Participants
|
10.5 units on a scale
STANDARD_DEVIATION 5.0 • n=50 Participants
|
|
Altarum Consumer Engagement (ACE)
ACE Navigation Subscale
|
15.5 units on a scale
STANDARD_DEVIATION 4.4 • n=30 Participants
|
14.8 units on a scale
STANDARD_DEVIATION 2.8 • n=20 Participants
|
15.2 units on a scale
STANDARD_DEVIATION 3.8 • n=50 Participants
|
|
Patient Activation Measure (PAM-MH)
|
51.5 units on a scale
STANDARD_DEVIATION 11.3 • n=30 Participants
|
49.6 units on a scale
STANDARD_DEVIATION 11.8 • n=20 Participants
|
51.5 units on a scale
STANDARD_DEVIATION 11.3 • n=50 Participants
|
|
Shared-Decision-Making-9 (SDM-Q-9)
|
25.8 units on a scale
STANDARD_DEVIATION 9.1 • n=30 Participants
|
28.3 units on a scale
STANDARD_DEVIATION 9.7 • n=20 Participants
|
26.8 units on a scale
STANDARD_DEVIATION 9.4 • n=50 Participants
|
|
Communication Self-Efficacy (PEPPI-5)
|
35.2 units on a scale
STANDARD_DEVIATION 10.6 • n=30 Participants
|
36.4 units on a scale
STANDARD_DEVIATION 11.4 • n=20 Participants
|
35.7 units on a scale
STANDARD_DEVIATION 10.8 • n=50 Participants
|
|
Patient Health Questionnaire (PHQ-9)
|
14.9 units on a scale
STANDARD_DEVIATION 6.4 • n=30 Participants
|
11.5 units on a scale
STANDARD_DEVIATION 6.3 • n=20 Participants
|
13.6 units on a scale
STANDARD_DEVIATION 6.5 • n=50 Participants
|
|
UCLA 6 Item Loneliness Scale (ULS-6)
|
17.1 units on a scale
STANDARD_DEVIATION 4.2 • n=30 Participants
|
14.8 units on a scale
STANDARD_DEVIATION 6.3 • n=20 Participants
|
16.2 units on a scale
STANDARD_DEVIATION 5.2 • n=50 Participants
|
|
Working Alliance Inventory (WAI-SR)
BOND subscale
|
13.5 units on a scale
STANDARD_DEVIATION 5.7 • n=30 Participants
|
15.1 units on a scale
STANDARD_DEVIATION 4.4 • n=20 Participants
|
14.1 units on a scale
STANDARD_DEVIATION 5.2 • n=50 Participants
|
|
Working Alliance Inventory (WAI-SR)
Goal subscale
|
12.7 units on a scale
STANDARD_DEVIATION 6.2 • n=30 Participants
|
14.8 units on a scale
STANDARD_DEVIATION 4.1 • n=20 Participants
|
13.5 units on a scale
STANDARD_DEVIATION 5.5 • n=50 Participants
|
|
Working Alliance Inventory (WAI-SR)
Task subscale
|
11.8 units on a scale
STANDARD_DEVIATION 4.9 • n=30 Participants
|
12.8 units on a scale
STANDARD_DEVIATION 4.5 • n=20 Participants
|
12.2 units on a scale
STANDARD_DEVIATION 4.7 • n=50 Participants
|
|
Working Alliance Inventory (WAI-SR)
Total WAI-SR scores
|
38.0 units on a scale
STANDARD_DEVIATION 15.4 • n=30 Participants
|
42.6 units on a scale
STANDARD_DEVIATION 11.9 • n=20 Participants
|
39.8 units on a scale
STANDARD_DEVIATION 14.2 • n=50 Participants
|
|
VR-12 Physical Function
|
42 units on a scale. T-score
STANDARD_DEVIATION 7.2 • n=30 Participants
|
42 units on a scale. T-score
STANDARD_DEVIATION 8.8 • n=20 Participants
|
42 units on a scale. T-score
STANDARD_DEVIATION 7.7 • n=50 Participants
|
|
VR-12 Mental Function
|
31 units on a scale. T-score
STANDARD_DEVIATION 9.2 • n=30 Participants
|
35 units on a scale. T-score
STANDARD_DEVIATION 5.8 • n=20 Participants
|
32 units on a scale. T-score
STANDARD_DEVIATION 8.2 • n=50 Participants
|
|
Perceived Discrimination in Healthcare Questionnaire
|
1.1 units on a scale
STANDARD_DEVIATION 0.8 • n=30 Participants
|
0.9 units on a scale
STANDARD_DEVIATION 0.8 • n=20 Participants
|
1.0 units on a scale
STANDARD_DEVIATION 0.8 • n=50 Participants
|
|
CollaboRATE
|
73.5 units on a scale
STANDARD_DEVIATION 28.3 • n=30 Participants
|
81.0 units on a scale
STANDARD_DEVIATION 26.0 • n=20 Participants
|
76.5 units on a scale
STANDARD_DEVIATION 27.4 • n=50 Participants
|
|
Lubben Social Network Scale LSNS-6
|
14.2 units on a scale
STANDARD_DEVIATION 7.1 • n=6 Participants • This measure was added later in the study as an exploratory measure.
|
15.7 units on a scale
STANDARD_DEVIATION 0.6 • n=3 Participants • This measure was added later in the study as an exploratory measure.
|
14.7 units on a scale
STANDARD_DEVIATION 5.7 • n=9 Participants • This measure was added later in the study as an exploratory measure.
|
|
Consumer Assessment of Health Care Providers and Systems
Domain 1
|
8.8 units on a scale. Average score.
STANDARD_DEVIATION 2.9 • n=30 Participants
|
8.8 units on a scale. Average score.
STANDARD_DEVIATION 3.0 • n=20 Participants
|
8.8 units on a scale. Average score.
STANDARD_DEVIATION 2.9 • n=50 Participants
|
|
Consumer Assessment of Health Care Providers and Systems
Domain 2
|
14.4 units on a scale. Average score.
STANDARD_DEVIATION 2.1 • n=30 Participants
|
12.9 units on a scale. Average score.
STANDARD_DEVIATION 2.7 • n=20 Participants
|
13.8 units on a scale. Average score.
STANDARD_DEVIATION 2.4 • n=50 Participants
|
|
Consumer Assessment of Health Care Providers and Systems
Domain 3
|
9.6 units on a scale. Average score.
STANDARD_DEVIATION 2.5 • n=30 Participants
|
9.2 units on a scale. Average score.
STANDARD_DEVIATION 2.4 • n=20 Participants
|
9.4 units on a scale. Average score.
STANDARD_DEVIATION 2.4 • n=50 Participants
|
|
Consumer Assessment of Health Care Providers and Systems
Domain 4
|
7.3 units on a scale. Average score.
STANDARD_DEVIATION 1.0 • n=30 Participants
|
7.4 units on a scale. Average score.
STANDARD_DEVIATION 1.2 • n=20 Participants
|
7.3 units on a scale. Average score.
STANDARD_DEVIATION 1.0 • n=50 Participants
|
|
Consumer Assessment of Health Care Providers and Systems
Domain 5
|
8.4 units on a scale. Average score.
STANDARD_DEVIATION 1.8 • n=30 Participants
|
7.2 units on a scale. Average score.
STANDARD_DEVIATION 2.3 • n=20 Participants
|
7.9 units on a scale. Average score.
STANDARD_DEVIATION 2.1 • n=50 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to 6 monthsMeasure 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.
Outcome measures
| Measure |
Active PARTNER-MH
n=18 Participants
Participants in this arm received the intervention immediately after study enrollment. They continued to receive usual mental health services in addition to intervention.
PARTNER-MH was a 6-month, manualized intervention delivered by VA peer support specialists/navigators. The intervention involved assessing and addressing patients' barriers to care and unmet social needs. It also included navigation to VA mental health services, provision of peer support and psychoeducation to increase patients' engagement in mental health services and to improve their communication with mental health clinicians.
|
Waitlist Control
n=18 Participants
During the 6-month wait period, participants in this arm received usual mental health services. They had the option to receive the intervention after the wait period.
|
|---|---|---|
|
Patient Activation Measure- Mental Health (PAM-MH)
|
5.7 score on a scale
Standard Deviation 16.5
|
9.1 score on a scale
Standard Deviation 11.7
|
PRIMARY outcome
Timeframe: Change from Baseline to 6 monthsThe 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.
Outcome measures
| Measure |
Active PARTNER-MH
n=18 Participants
Participants in this arm received the intervention immediately after study enrollment. They continued to receive usual mental health services in addition to intervention.
PARTNER-MH was a 6-month, manualized intervention delivered by VA peer support specialists/navigators. The intervention involved assessing and addressing patients' barriers to care and unmet social needs. It also included navigation to VA mental health services, provision of peer support and psychoeducation to increase patients' engagement in mental health services and to improve their communication with mental health clinicians.
|
Waitlist Control
n=18 Participants
During the 6-month wait period, participants in this arm received usual mental health services. They had the option to receive the intervention after the wait period.
|
|---|---|---|
|
Altarum Consumer Engagement (ACE) Change
|
5.5 score on a scale
Standard Deviation 11.5
|
2.9 score on a scale
Standard Deviation 10.4
|
PRIMARY outcome
Timeframe: Change from Baseline to 6 monthsThe 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.
Outcome measures
| Measure |
Active PARTNER-MH
n=18 Participants
Participants in this arm received the intervention immediately after study enrollment. They continued to receive usual mental health services in addition to intervention.
PARTNER-MH was a 6-month, manualized intervention delivered by VA peer support specialists/navigators. The intervention involved assessing and addressing patients' barriers to care and unmet social needs. It also included navigation to VA mental health services, provision of peer support and psychoeducation to increase patients' engagement in mental health services and to improve their communication with mental health clinicians.
|
Waitlist Control
n=18 Participants
During the 6-month wait period, participants in this arm received usual mental health services. They had the option to receive the intervention after the wait period.
|
|---|---|---|
|
SDM-Q9 PARTNER-MH
|
1.9 units on a scale
Standard Deviation 13.5
|
1.3 units on a scale
Standard Deviation 7.1
|
PRIMARY outcome
Timeframe: Administered after completion of the study program (6 months for Active PARTNER-MH )Population: Only 14 participants answered the question.
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).
Outcome measures
| Measure |
Active PARTNER-MH
n=14 Participants
Participants in this arm received the intervention immediately after study enrollment. They continued to receive usual mental health services in addition to intervention.
PARTNER-MH was a 6-month, manualized intervention delivered by VA peer support specialists/navigators. The intervention involved assessing and addressing patients' barriers to care and unmet social needs. It also included navigation to VA mental health services, provision of peer support and psychoeducation to increase patients' engagement in mental health services and to improve their communication with mental health clinicians.
|
Waitlist Control
During the 6-month wait period, participants in this arm received usual mental health services. They had the option to receive the intervention after the wait period.
|
|---|---|---|
|
Peer Coaching Experience Satisfaction Questionnaire
Question 2 Very satisfied
|
11 participants
|
—
|
|
Peer Coaching Experience Satisfaction Questionnaire
Question 1 Very dissatisfied
|
1 participants
|
—
|
|
Peer Coaching Experience Satisfaction Questionnaire
Question 1 Very satisified
|
6 participants
|
—
|
|
Peer Coaching Experience Satisfaction Questionnaire
Question 1 Satisified
|
4 participants
|
—
|
|
Peer Coaching Experience Satisfaction Questionnaire
Question 1 Neutral
|
2 participants
|
—
|
|
Peer Coaching Experience Satisfaction Questionnaire
Question 1 Dissatisfied
|
1 participants
|
—
|
|
Peer Coaching Experience Satisfaction Questionnaire
Question 2 Satisfied
|
1 participants
|
—
|
|
Peer Coaching Experience Satisfaction Questionnaire
Question 2 Neutral
|
1 participants
|
—
|
|
Peer Coaching Experience Satisfaction Questionnaire
Question 2 Dissatisfied
|
1 participants
|
—
|
|
Peer Coaching Experience Satisfaction Questionnaire
Question 2 Very dissatisfied
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: Change from Baseline to 6 monthsThe 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.
Outcome measures
| Measure |
Active PARTNER-MH
n=18 Participants
Participants in this arm received the intervention immediately after study enrollment. They continued to receive usual mental health services in addition to intervention.
PARTNER-MH was a 6-month, manualized intervention delivered by VA peer support specialists/navigators. The intervention involved assessing and addressing patients' barriers to care and unmet social needs. It also included navigation to VA mental health services, provision of peer support and psychoeducation to increase patients' engagement in mental health services and to improve their communication with mental health clinicians.
|
Waitlist Control
n=18 Participants
During the 6-month wait period, participants in this arm received usual mental health services. They had the option to receive the intervention after the wait period.
|
|---|---|---|
|
Trust and Satisfaction Survey Responses Change
Would recommend MH clinic
|
0.16 score on a scale
Standard Deviation 0.87
|
-0.19 score on a scale
Standard Deviation 0.64
|
|
Trust and Satisfaction Survey Responses Change
Trust the VA
|
0.05 score on a scale
Standard Deviation 0.85
|
-0.13 score on a scale
Standard Deviation 0.83
|
|
Trust and Satisfaction Survey Responses Change
Trust the Mental Health Clinic
|
0.03 score on a scale
Standard Deviation 0.69
|
-0.03 score on a scale
Standard Deviation 0.65
|
|
Trust and Satisfaction Survey Responses Change
Satisfied with the care I received at MH clinic
|
0.24 score on a scale
Standard Deviation 0.72
|
-0.53 score on a scale
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 monthsThe 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.
Outcome measures
| Measure |
Active PARTNER-MH
n=18 Participants
Participants in this arm received the intervention immediately after study enrollment. They continued to receive usual mental health services in addition to intervention.
PARTNER-MH was a 6-month, manualized intervention delivered by VA peer support specialists/navigators. The intervention involved assessing and addressing patients' barriers to care and unmet social needs. It also included navigation to VA mental health services, provision of peer support and psychoeducation to increase patients' engagement in mental health services and to improve their communication with mental health clinicians.
|
Waitlist Control
n=18 Participants
During the 6-month wait period, participants in this arm received usual mental health services. They had the option to receive the intervention after the wait period.
|
|---|---|---|
|
Veteran's RAND 12-item Health Survey (VR-12) Change
VR-12 Mental Function
|
8.3 score on a scale
Standard Deviation 6.5
|
-2.8 score on a scale
Standard Deviation 6.8
|
|
Veteran's RAND 12-item Health Survey (VR-12) Change
VR-12 Physical Function
|
-4.4 score on a scale
Standard Deviation 6.8
|
-0.3 score on a scale
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 monthsThe 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.
Outcome measures
| Measure |
Active PARTNER-MH
n=18 Participants
Participants in this arm received the intervention immediately after study enrollment. They continued to receive usual mental health services in addition to intervention.
PARTNER-MH was a 6-month, manualized intervention delivered by VA peer support specialists/navigators. The intervention involved assessing and addressing patients' barriers to care and unmet social needs. It also included navigation to VA mental health services, provision of peer support and psychoeducation to increase patients' engagement in mental health services and to improve their communication with mental health clinicians.
|
Waitlist Control
n=18 Participants
During the 6-month wait period, participants in this arm received usual mental health services. They had the option to receive the intervention after the wait period.
|
|---|---|---|
|
Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) Change
|
6.5 score on a scale
Standard Deviation 11.5
|
1.2 score on a scale
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 monthsWorking 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.
Outcome measures
| Measure |
Active PARTNER-MH
n=18 Participants
Participants in this arm received the intervention immediately after study enrollment. They continued to receive usual mental health services in addition to intervention.
PARTNER-MH was a 6-month, manualized intervention delivered by VA peer support specialists/navigators. The intervention involved assessing and addressing patients' barriers to care and unmet social needs. It also included navigation to VA mental health services, provision of peer support and psychoeducation to increase patients' engagement in mental health services and to improve their communication with mental health clinicians.
|
Waitlist Control
n=18 Participants
During the 6-month wait period, participants in this arm received usual mental health services. They had the option to receive the intervention after the wait period.
|
|---|---|---|
|
Working Alliance Inventory Short-Revised (WAI-SR) Change
BOND subscale
|
0.7 score on a scale
Standard Deviation 3.4
|
0.7 score on a scale
Standard Deviation 3.6
|
|
Working Alliance Inventory Short-Revised (WAI-SR) Change
GOAL subscale
|
1.6 score on a scale
Standard Deviation 5.7
|
1.6 score on a scale
Standard Deviation 4.0
|
|
Working Alliance Inventory Short-Revised (WAI-SR) Change
TASK Subscale
|
1.4 score on a scale
Standard Deviation 2.7
|
0.7 score on a scale
Standard Deviation 5.5
|
|
Working Alliance Inventory Short-Revised (WAI-SR) Change
Summed scores
|
3.8 score on a scale
Standard Deviation 9.9
|
2.9 score on a scale
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 monthsThe 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.
Outcome measures
| Measure |
Active PARTNER-MH
n=18 Participants
Participants in this arm received the intervention immediately after study enrollment. They continued to receive usual mental health services in addition to intervention.
PARTNER-MH was a 6-month, manualized intervention delivered by VA peer support specialists/navigators. The intervention involved assessing and addressing patients' barriers to care and unmet social needs. It also included navigation to VA mental health services, provision of peer support and psychoeducation to increase patients' engagement in mental health services and to improve their communication with mental health clinicians.
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Waitlist Control
n=18 Participants
During the 6-month wait period, participants in this arm received usual mental health services. They had the option to receive the intervention after the wait period.
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|---|---|---|
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UCLA Loneliness Scale (ULS-6) Change
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-0.6 units on a scale
Standard Deviation 4.1
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-0.3 units on a scale
Standard Deviation 3.9
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SECONDARY outcome
Timeframe: Change from Baseline to 6 monthsMeasure 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.
Outcome measures
| Measure |
Active PARTNER-MH
n=18 Participants
Participants in this arm received the intervention immediately after study enrollment. They continued to receive usual mental health services in addition to intervention.
PARTNER-MH was a 6-month, manualized intervention delivered by VA peer support specialists/navigators. The intervention involved assessing and addressing patients' barriers to care and unmet social needs. It also included navigation to VA mental health services, provision of peer support and psychoeducation to increase patients' engagement in mental health services and to improve their communication with mental health clinicians.
|
Waitlist Control
n=18 Participants
During the 6-month wait period, participants in this arm received usual mental health services. They had the option to receive the intervention after the wait period.
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|---|---|---|
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Patient Health Questionnaire (PHQ-9) Change
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-3.6 units on a scale
Standard Deviation 6.7
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0.1 units on a scale
Standard Deviation 5.2
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OTHER_PRE_SPECIFIED outcome
Timeframe: change in scores from baseline to 6 monthsPopulation: Include changes in scores for patients from baseline to 6-months. This measure was added later as an exploratory measure. Only a few participants completed it.
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.
Outcome measures
| Measure |
Active PARTNER-MH
n=6 Participants
Participants in this arm received the intervention immediately after study enrollment. They continued to receive usual mental health services in addition to intervention.
PARTNER-MH was a 6-month, manualized intervention delivered by VA peer support specialists/navigators. The intervention involved assessing and addressing patients' barriers to care and unmet social needs. It also included navigation to VA mental health services, provision of peer support and psychoeducation to increase patients' engagement in mental health services and to improve their communication with mental health clinicians.
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Waitlist Control
n=3 Participants
During the 6-month wait period, participants in this arm received usual mental health services. They had the option to receive the intervention after the wait period.
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|---|---|---|
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Lubben Social Network Scale-6
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6.3 score on a scale
Standard Deviation 7.0
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0.0 score on a scale
Standard Deviation 2.6
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OTHER_PRE_SPECIFIED outcome
Timeframe: Change in score from baseline to 6 monthsMeasure 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.
Outcome measures
| Measure |
Active PARTNER-MH
n=18 Participants
Participants in this arm received the intervention immediately after study enrollment. They continued to receive usual mental health services in addition to intervention.
PARTNER-MH was a 6-month, manualized intervention delivered by VA peer support specialists/navigators. The intervention involved assessing and addressing patients' barriers to care and unmet social needs. It also included navigation to VA mental health services, provision of peer support and psychoeducation to increase patients' engagement in mental health services and to improve their communication with mental health clinicians.
|
Waitlist Control
n=18 Participants
During the 6-month wait period, participants in this arm received usual mental health services. They had the option to receive the intervention after the wait period.
|
|---|---|---|
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Perceived Discrimination in Healthcare Responses
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-1.9 score on a scale
Standard Deviation 5.3
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-1.6 score on a scale
Standard Deviation 4.5
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POST_HOC outcome
Timeframe: Change in score from baseline to 6-monthsCollaboRATE consists of 3-items, each scored on a scale of 0-9. Scores range from 0-100. Higher scores indicate more shared decision.
Outcome measures
| Measure |
Active PARTNER-MH
n=18 Participants
Participants in this arm received the intervention immediately after study enrollment. They continued to receive usual mental health services in addition to intervention.
PARTNER-MH was a 6-month, manualized intervention delivered by VA peer support specialists/navigators. The intervention involved assessing and addressing patients' barriers to care and unmet social needs. It also included navigation to VA mental health services, provision of peer support and psychoeducation to increase patients' engagement in mental health services and to improve their communication with mental health clinicians.
|
Waitlist Control
n=18 Participants
During the 6-month wait period, participants in this arm received usual mental health services. They had the option to receive the intervention after the wait period.
|
|---|---|---|
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CollaboRATE
|
1.8 score on a scale
Standard Deviation 8.8
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0.4 score on a scale
Standard Deviation 6.0
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Adverse Events
Active PARTNER-MH
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Waitlist Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active PARTNER-MH
n=30 participants at risk
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.
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.
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Waitlist Control
n=20 participants at risk
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.
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.
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|---|---|---|
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Psychiatric disorders
non-serious adverse event
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3.3%
1/30 • Number of events 1 • 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.
|
0.00%
0/20 • 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.
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Additional Information
Dr. Johanne Eliacin
Richard L. Roudebush VA Medical Center
Phone: 317-988-5000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place