Trial Outcomes & Findings for Aligning Resources to Care for Homeless Veterans (NCT NCT01550757)
NCT ID: NCT01550757
Last Updated: 2017-10-11
Results Overview
A primary outcome for this study is non-acute emergency department visits.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
382 participants
Primary outcome timeframe
Two years.
Results posted on
2017-10-11
Participant Flow
Participant milestones
| Measure |
Arm 1: Normal PACT Clinical Care
Normal Patient Aligned Care Team Clinical Care
|
Arm 2: Normal PACT Clinical Care + Embedded Peer Mentor
Normal PACT Clinical Care + Embedded Peer Mentor
Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research.
|
Arm 3: Normal Homeless Oriented PACT Clinical Care
Normal Homeless Oriented Patient Aligned Care Team Clinical Care
|
Arm 4: Normal Homeless Oriented PACT Clinical Care + Embedded
Normal Homeless Oriented PACT Clinical Care + Embedded Peer Mentor
Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
56
|
52
|
130
|
144
|
|
Overall Study
COMPLETED
|
33
|
38
|
85
|
90
|
|
Overall Study
NOT COMPLETED
|
23
|
14
|
45
|
54
|
Reasons for withdrawal
| Measure |
Arm 1: Normal PACT Clinical Care
Normal Patient Aligned Care Team Clinical Care
|
Arm 2: Normal PACT Clinical Care + Embedded Peer Mentor
Normal PACT Clinical Care + Embedded Peer Mentor
Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research.
|
Arm 3: Normal Homeless Oriented PACT Clinical Care
Normal Homeless Oriented Patient Aligned Care Team Clinical Care
|
Arm 4: Normal Homeless Oriented PACT Clinical Care + Embedded
Normal Homeless Oriented PACT Clinical Care + Embedded Peer Mentor
Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
21
|
14
|
42
|
53
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
3
|
1
|
Baseline Characteristics
Aligning Resources to Care for Homeless Veterans
Baseline characteristics by cohort
| Measure |
Arm 1: Normal PACT Clinical Care
n=56 Participants
Normal Patient Aligned Care Team Clinical Care
|
Arm 2: Normal PACT Clinical Care + Embedded Peer Mentor
n=52 Participants
Normal PACT Clinical Care + Embedded Peer Mentor
Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research.
|
Arm 3: Normal Homeless Oriented PACT Clinical Care
n=130 Participants
Normal Homeless Oriented Patient Aligned Care Team Clinical Care
|
Arm 4: Normal Homeless Oriented PACT Clinical Care + Embedded
n=144 Participants
Normal Homeless Oriented PACT Clinical Care + Embedded Peer Mentor
Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research.
|
Total
n=382 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
50.3 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
51.2 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
52.6 years
STANDARD_DEVIATION 9.4 • n=4 Participants
|
52.2 years
STANDARD_DEVIATION 1.8 • n=21 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
130 Participants
n=4 Participants
|
351 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
138 Participants
n=4 Participants
|
366 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
51 participants
n=7 Participants
|
128 participants
n=5 Participants
|
138 participants
n=4 Participants
|
366 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Two years.Population: Veterans enrolled in the study based on the type of care they received at VA and then randomized to receive a peer or not.
A primary outcome for this study is non-acute emergency department visits.
Outcome measures
| Measure |
Arm 1: Normal PACT Clinical Care
n=56 Participants
Normal Patient Aligned Care Team Clinical Care
|
Arm 2: Normal PACT Clinical Care + Embedded Peer Mentor
n=52 Participants
Normal PACT Clinical Care + Embedded Peer Mentor
Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research.
|
Arm 3: Normal Homeless Oriented PACT Clinical Care
n=130 Participants
Normal Homeless Oriented Patient Aligned Care Team Clinical Care
|
Arm 4: Normal Homeless Oriented PACT Clinical Care + Embedded
n=144 Participants
Normal Homeless Oriented PACT Clinical Care + Embedded Peer Mentor
Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research.
|
|---|---|---|---|---|
|
A Primary Outcome for This Study is the Number of Non-acute Emergency Department Visits.
|
1.1 number of visits
Standard Deviation 1.6
|
0.8 number of visits
Standard Deviation 2.3
|
0.7 number of visits
Standard Deviation 1.2
|
1.0 number of visits
Standard Deviation 1.7
|
Adverse Events
Arm 1: Normal PACT Clinical Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Arm 2: Normal PACT Clinical Care + Embedded Peer Mentor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3: Normal Homeless Oriented PACT Clinical Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Arm 4: Normal Homeless Oriented PACT Clinical Care + Embedded
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place