Trial Outcomes & Findings for Evaluation of Peer Specialists on VA PACTs (NCT NCT02732600)

NCT ID: NCT02732600

Last Updated: 2023-07-27

Results Overview

The Patient Activation Measure (PAM) is a 13-item survey that measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. It has been shown to be reliable, valid, sensitive to change and correlates with measures of improved self-management. Scores for this outcome range from Zero to One Hundred with higher scores indicating higher levels of patient activation (better outcome).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5616 participants

Primary outcome timeframe

Baseline, 6 months, 1 year

Results posted on

2023-07-27

Participant Flow

numbers of participants is presented at three time points: 1. Baseline 2. 6-months, and 3. 1-year

Unit of analysis: Sites

Participant milestones

Participant milestones
Measure
Standard Implementation
Standard Implementation sites will receive written guidance and limited consultation by the investigators' team.
Facilitated Implementation
Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation. Facilitated Implementation: Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation
Overall Study
STARTED
3525 13
2091 12
Overall Study
Sub-set of Sites Newly Delivering PS Services
899 12
1484 11
Overall Study
Veteran Baseline Veteran (Sub-set of 23 Sites)
118 12
145 11
Overall Study
Veteran 6-months (Sub-set 23 Sites)
70 12
84 11
Overall Study
Veteran 1-year (Sub-set 23 Sites)
54 12
71 11
Overall Study
Peer Specialist Responses at 6-months (All 25 Sites)
12 13
14 12
Overall Study
Peer Specialist Responses at 1-year (All 25 Sites)
5 13
12 12
Overall Study
Supervisor Responses 6-months (All 25 Sites)
10 13
21 12
Overall Study
Supervisor 1-year (All 25 Sites)
6 13
10 12
Overall Study
COMPLETED
100 13
113 12
Overall Study
NOT COMPLETED
3425 0
1978 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

numbers vary across variables due to missing data

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Standard Implementation
n=194 Participants
Standard Implementation sites will receive written guidance and limited consultation by the investigators' team.
Facilitated Implementation
n=221 Participants
Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation. Facilitated Implementation: Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation
Total
n=415 Participants
Total of all reporting groups
Age, Continuous
61.1 years
STANDARD_DEVIATION 10.7 • n=160 Participants • numbers vary across variables due to missing data
61.2 years
STANDARD_DEVIATION 13.8 • n=208 Participants • numbers vary across variables due to missing data
61.2 years
STANDARD_DEVIATION 12.5 • n=368 Participants • numbers vary across variables due to missing data
Sex: Female, Male
Female
28 Participants
n=160 Participants • numbers vary from total due to missing data
17 Participants
n=203 Participants • numbers vary from total due to missing data
45 Participants
n=363 Participants • numbers vary from total due to missing data
Sex: Female, Male
Male
132 Participants
n=160 Participants • numbers vary from total due to missing data
186 Participants
n=203 Participants • numbers vary from total due to missing data
318 Participants
n=363 Participants • numbers vary from total due to missing data
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=152 Participants • numbers vary due to missing data
0 Participants
n=196 Participants • numbers vary due to missing data
0 Participants
n=348 Participants • numbers vary due to missing data
Race (NIH/OMB)
Asian
0 Participants
n=152 Participants • numbers vary due to missing data
0 Participants
n=196 Participants • numbers vary due to missing data
0 Participants
n=348 Participants • numbers vary due to missing data
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=152 Participants • numbers vary due to missing data
0 Participants
n=196 Participants • numbers vary due to missing data
0 Participants
n=348 Participants • numbers vary due to missing data
Race (NIH/OMB)
Black or African American
37 Participants
n=152 Participants • numbers vary due to missing data
64 Participants
n=196 Participants • numbers vary due to missing data
101 Participants
n=348 Participants • numbers vary due to missing data
Race (NIH/OMB)
White
109 Participants
n=152 Participants • numbers vary due to missing data
121 Participants
n=196 Participants • numbers vary due to missing data
230 Participants
n=348 Participants • numbers vary due to missing data
Race (NIH/OMB)
More than one race
0 Participants
n=152 Participants • numbers vary due to missing data
0 Participants
n=196 Participants • numbers vary due to missing data
0 Participants
n=348 Participants • numbers vary due to missing data
Race (NIH/OMB)
Unknown or Not Reported
6 Participants
n=152 Participants • numbers vary due to missing data
11 Participants
n=196 Participants • numbers vary due to missing data
17 Participants
n=348 Participants • numbers vary due to missing data

PRIMARY outcome

Timeframe: Baseline, 6 months, 1 year

Population: Comparison across two conditions on PAM Total Score - PAM Total Score (0-100)

The Patient Activation Measure (PAM) is a 13-item survey that measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. It has been shown to be reliable, valid, sensitive to change and correlates with measures of improved self-management. Scores for this outcome range from Zero to One Hundred with higher scores indicating higher levels of patient activation (better outcome).

Outcome measures

Outcome measures
Measure
Standard Implementation
n=194 Participants
Standard Implementation sites will receive written guidance and limited consultation by the investigators' team.
Facilitated Implementation
n=221 Participants
Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation. Facilitated Implementation: Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation
Patient Activation Measure Change
Baseline-PAM Total
41.0 Score on a scale
Standard Deviation 5.9
41.6 Score on a scale
Standard Deviation 6.2
Patient Activation Measure Change
6-Month-PAM Total
39.9 Score on a scale
Standard Deviation 5.6
40.6 Score on a scale
Standard Deviation 5.7
Patient Activation Measure Change
1-year-PAM Total
39.8 Score on a scale
Standard Deviation 6.2
40.8 Score on a scale
Standard Deviation 5.5

SECONDARY outcome

Timeframe: Baseline, 6 months, 1 year

Population: number of site based leadership and supervisors who responded

The Team Development Measure is a 31 item self-report survey that evaluates the degree to which a team has and uses the components needed for highly effective teamwork including cohesiveness, communication, role clarity, and goals and means clarity. All components min scores are zero % and maximum is 100%; higher percentages mean positive responses.

Outcome measures

Outcome measures
Measure
Standard Implementation
n=21 Participants
Standard Implementation sites will receive written guidance and limited consultation by the investigators' team.
Facilitated Implementation
n=30 Participants
Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation. Facilitated Implementation: Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation
Team Development Measure
Role Clarity Baseline
76.0 units on a scale
Standard Deviation 28.6
84.4 units on a scale
Standard Deviation 16.3
Team Development Measure
Goals Baseline
67.9 units on a scale
Standard Deviation 38.9
82.0 units on a scale
Standard Deviation 29.9
Team Development Measure
Goals 1 year
77.5 units on a scale
Standard Deviation 24.9
87.5 units on a scale
Standard Deviation 17.7
Team Development Measure
Cohesiveness 6 month
89.6 units on a scale
Standard Deviation 21.8
89.1 units on a scale
Standard Deviation 23.5
Team Development Measure
Role Clarity 6 months
77.0 units on a scale
Standard Deviation 31.8
83.2 units on a scale
Standard Deviation 22.3
Team Development Measure
Communication 1 year
80.0 units on a scale
Standard Deviation 32.1
83.2 units on a scale
Standard Deviation 22.9
Team Development Measure
cohesiveness-Baseline
91.1 units on a scale
Standard Deviation 15.5
96.7 units on a scale
Standard Deviation 10.3
Team Development Measure
Communication Baseline
85.0 units on a scale
Standard Deviation 22.4
93.0 units on a scale
Standard Deviation 19.5
Team Development Measure
Communication 6 month
84.7 units on a scale
Standard Deviation 26.9
86.0 units on a scale
Standard Deviation 26.9
Team Development Measure
Goals 6 months
74.8 units on a scale
Standard Deviation 28.6
77.0 units on a scale
Standard Deviation 19.8
Team Development Measure
Cohesiveness 1 year
85.2 units on a scale
Standard Deviation 35.0
94.3 units on a scale
Standard Deviation 13.2
Team Development Measure
Role Clarity 1 year
70.8 units on a scale
Standard Deviation 40.6
82.3 units on a scale
Standard Deviation 21.5

SECONDARY outcome

Timeframe: 6 months, 1 year

Population: 6 months and 1 year

The Peer Fidelity Measure assesses: a) peer specialist services and b) peer specialist implementation. The first part has 5 domains of peer services critical to the VA's peer support model (e.g., being a role model that recovery is possible; share personal recovery story). The second has 7 domains of implementation factors shown to either help or hinder PS deployment (e.g., role clarity, support for PS at higher organizational levels, regular supervision). Each domain has 1-2 questions (responses ranging from 1= not at all through 5=Very much with higher scores indicating higher fidelity. Min Value=1 and Max value =5. The Peer Fidelity Measure will be administered to both Peer Specialists and their supervisors. Analyses looked at discrepancies (difference in difference) between Peer Specialists and their Supervisors at each time point. Min discrepancy score is -4 and Max discrepancy score is 4. (calculated as Peer Specialist minus Peer Supervisor score)

Outcome measures

Outcome measures
Measure
Standard Implementation
n=8 Participants
Standard Implementation sites will receive written guidance and limited consultation by the investigators' team.
Facilitated Implementation
n=19 Participants
Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation. Facilitated Implementation: Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation
Peer Fidelity Measure
Peer Specialist as Liaison 6-mo
-0.1 units on a scale
Standard Deviation 1.2
1.1 units on a scale
Standard Deviation 1.4
Peer Fidelity Measure
Provides Info on Services 6 mo
-0.1 units on a scale
Standard Deviation 1.1
0.7 units on a scale
Standard Deviation 0.8
Peer Fidelity Measure
Symptoms and Medications 6-mo
0.2 units on a scale
Standard Deviation 2.2
1.0 units on a scale
Standard Deviation 2.0
Peer Fidelity Measure
Training and Preparation 6-mo
0.1 units on a scale
Standard Deviation 1.1
0.4 units on a scale
Standard Deviation 1.6
Peer Fidelity Measure
Teams Integration and Relationships 6-mo
-0.4 units on a scale
Standard Deviation 1.3
0.5 units on a scale
Standard Deviation 1.5
Peer Fidelity Measure
Role Clarity 6-mo
-0.3 units on a scale
Standard Deviation 1.2
0.2 units on a scale
Standard Deviation 1.3
Peer Fidelity Measure
Core PS functions 1-yr
0.7 units on a scale
Standard Deviation 0.5
-0.1 units on a scale
Standard Deviation 0.41
Peer Fidelity Measure
Peer Specialist as Liaison 1 year
0.8 units on a scale
Standard Deviation 1.1
-0.2 units on a scale
Standard Deviation 0.6
Peer Fidelity Measure
Core Peer Specialist 6-moFunctions
0.3 units on a scale
Standard Deviation 0.3
0.7 units on a scale
Standard Deviation 1.1
Peer Fidelity Measure
Collaborate-Promoting Health 6-mo
0.2 units on a scale
Standard Deviation 0.7
0.7 units on a scale
Standard Deviation 1.2
Peer Fidelity Measure
Leadership Support 6-mo
0.01 units on a scale
Standard Deviation 1.2
-0.2 units on a scale
Standard Deviation 0.8
Peer Fidelity Measure
Fits to Experience and Needs 6-mo
-0.4 units on a scale
Standard Deviation 1.6
-0.4 units on a scale
Standard Deviation 2.1
Peer Fidelity Measure
Resources 6-mo
-0.1 units on a scale
Standard Deviation 1.2
0.7 units on a scale
Standard Deviation 1.6
Peer Fidelity Measure
Performance Reviews 6-mo
-0.1 units on a scale
Standard Deviation 1.2
-0.1 units on a scale
Standard Deviation 2.3
Peer Fidelity Measure
Collaborate on Promoting Health 1 year
0.7 units on a scale
Standard Deviation 0.1
-0.01 units on a scale
Standard Deviation 0.6
Peer Fidelity Measure
provides info on services 1 year
0.0 units on a scale
Standard Deviation 0.0
-0.2 units on a scale
Standard Deviation 0.5
Peer Fidelity Measure
Symptoms and Medication 1 year
0.8 units on a scale
Standard Deviation 2.5
-0.1 units on a scale
Standard Deviation 2.1
Peer Fidelity Measure
Training and Preparation 1 year
0.5 units on a scale
Standard Deviation 1.2
-0.4 units on a scale
Standard Deviation 1.1
Peer Fidelity Measure
Team Integration and relationships 1 year
1.1 units on a scale
Standard Deviation 0.4
-0.2 units on a scale
Standard Deviation 0.5
Peer Fidelity Measure
Leadership Support 1 year
2.5 units on a scale
Standard Deviation 0.7
0.1 units on a scale
Standard Deviation 1.1
Peer Fidelity Measure
Fit to experience and need 1 year
0.0 units on a scale
Standard Deviation 2.8
-0.3 units on a scale
Standard Deviation 0.8
Peer Fidelity Measure
Role Clarity 1 year
1.3 units on a scale
Standard Deviation 1.1
-0.2 units on a scale
Standard Deviation 0.9
Peer Fidelity Measure
Resources
-0.5 units on a scale
Standard Deviation 1.4
-0.3 units on a scale
Standard Deviation 0.5
Peer Fidelity Measure
Performance Review 1 year
0.8 units on a scale
Standard Deviation 0.4
-0.7 units on a scale
Standard Deviation 2.2

SECONDARY outcome

Timeframe: Baseline, 6 months, 1 year

Population: Veterans responding to survey

The Satisfaction Index-Mental Health is a 12-item, unidimensional measure of patient satisfaction with care. It has been used with Veteran populations and has been shown to be valid, reliable, and sensitive to change in a sample of Veterans with mental illnesses being treated in primary care settings. It will be administered to Veterans who receive care from the Peer Specialists involved in the project. Minimum score is 12 and the maximum score is 72; higher scores mean more satisfaction.

Outcome measures

Outcome measures
Measure
Standard Implementation
n=194 Participants
Standard Implementation sites will receive written guidance and limited consultation by the investigators' team.
Facilitated Implementation
n=221 Participants
Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation. Facilitated Implementation: Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation
The Satisfaction Index-Mental Health
Baseline
47.7 units on a scale
Standard Deviation 12.1
51.3 units on a scale
Standard Deviation 11.5
The Satisfaction Index-Mental Health
6-months
49.7 units on a scale
Standard Deviation 12.7
52.3 units on a scale
Standard Deviation 12.6
The Satisfaction Index-Mental Health
1-year
50.6 units on a scale
Standard Deviation 13.0
51.2 units on a scale
Standard Deviation 13.6

SECONDARY outcome

Timeframe: one year, across two years

Population: Unique Veteran encounters

This adjusted workload variables took into consideration both the employment period (many PSs did not start immediately or may have left prior to the end of the 2 years) and weekly hours worked (varying from one hour to 40 hours per week). Visits during each PS's employment period were divided by the total number of hours worked, then multiplied by 40 to calculate adjusted values for operationalization above. Because this variable was significantly skewed, we used a log transformation to improve their distributional properties. Differences between intervention conditions were then compared with a series of Analyses of Covariance models with age, gender and race as covariates. Since these variables are measured at the PS level, the covariates were the average across the Veterans sesn by each PS (mean age, percent White and percent male). N's are number of Veterans

Outcome measures

Outcome measures
Measure
Standard Implementation
n=899 Participants
Standard Implementation sites will receive written guidance and limited consultation by the investigators' team.
Facilitated Implementation
n=1 Participants
Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation. Facilitated Implementation: Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation
Number of Unique Veterans Seen (Adjusted for Employment Period and Hours Worked Per Week)
1st year
1.3 count of Veterans
Standard Deviation 1.3
4.8 count of Veterans
Standard Deviation 6.1
Number of Unique Veterans Seen (Adjusted for Employment Period and Hours Worked Per Week)
across both years
5.8 count of Veterans
Standard Deviation 8.5
6.0 count of Veterans
Standard Deviation 5.8

SECONDARY outcome

Timeframe: across both years

Population: Number of Visits per Veteran

See Variable 5 above for details about adjustment. Since this variable this is a Veteran level variable, a General Linear Mixed Model (GSLMM) was used with PS specified as a random effect and Veteran age, race and gender. N's are number of Veterans

Outcome measures

Outcome measures
Measure
Standard Implementation
n=899 Participants
Standard Implementation sites will receive written guidance and limited consultation by the investigators' team.
Facilitated Implementation
n=1 Participants
Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation. Facilitated Implementation: Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation
Average Number of Visits Per Veteran Per Peer Specialist-Adjusted (Across Both Years)
2.2 Count of Visits
Standard Deviation 3.0
3.2 Count of Visits
Standard Deviation 5.6

SECONDARY outcome

Timeframe: one year and across both years

Population: Services Provided by each Peer Specialist

This adjusted workload variables took into consideration both the employment period (many PSs did not start immediately or may have left prior to the end of the 2 years) and weekly hours worked (varying from one hour to 40 hours per week). Visits during each PS's employment period were divided by the total number of hours worked, then multiplied by 40 to calculate adjusted values for operationalization above. Because this variable was significantly skewed, we used a log transformation to improve their distributional properties. Differences between intervention conditions were then compared with a series of Analyses of Covariance models with age, gender and race as covariates. Since these variables are measured at the PS level, the covariates were the average across the Veterans sesn by each PS (mean age, percent White and percent male). N's are number of Veterans

Outcome measures

Outcome measures
Measure
Standard Implementation
n=899 Participants
Standard Implementation sites will receive written guidance and limited consultation by the investigators' team.
Facilitated Implementation
n=1 Participants
Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation. Facilitated Implementation: Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation
Average Total Number of Services Provided-Adjusted (First Year Only and Across Both Years)
1st Year Only
2.7 Count of services
Standard Deviation 2.7
8.4 Count of services
Standard Deviation 8.7
Average Total Number of Services Provided-Adjusted (First Year Only and Across Both Years)
Across Both Years
9.8 Count of services
Standard Deviation 8.7
12.4 Count of services
Standard Deviation 8.7

SECONDARY outcome

Timeframe: variable from baseline to time of first service delivered by Peer Specialists

This variable represents count of days from time study at each site started (baseline) until first service was delivered.

Outcome measures

Outcome measures
Measure
Standard Implementation
n=16 Participants
Standard Implementation sites will receive written guidance and limited consultation by the investigators' team.
Facilitated Implementation
n=21 Participants
Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation. Facilitated Implementation: Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation
Time to First Service
188.2 Number of Days
Standard Deviation 123.4
88.7 Number of Days
Standard Deviation 65.0

SECONDARY outcome

Timeframe: 1st year only

Population: number of visits per Veteran

See Variable 5 above for details about adjustment. Since this variable this is a Veteran level variable, a General Linear Mixed Model (GSLMM) was used with PS specified as a random effect and Veteran age, race and gender. N's are number of Veterans

Outcome measures

Outcome measures
Measure
Standard Implementation
n=459 Participants
Standard Implementation sites will receive written guidance and limited consultation by the investigators' team.
Facilitated Implementation
n=767 Participants
Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation. Facilitated Implementation: Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation
Average Number of Visits Per Veteran Per Peer Specialist-Adjusted (First Year Only)
2.0 Count of Visits
Standard Deviation 2.1
2.6 Count of Visits
Standard Deviation 3.6

Adverse Events

Standard Implementation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Facilitated Implementation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Richard Goldberg

VISN 5 Mental Illness Research, Education, and Clinical Center

Phone: 410-637-1851

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place