Trial Outcomes & Findings for Peer Visitation for OEF/OIF Veterans (NCT NCT01193686)

Results Overview

Administered only to Peer Visitors, possible range 0-105, with higher scores indicating greater post-traumatic growth. Post-traumatic growth includes emotional changes such as noticing a stronger sense of self, deepened relationships, increased sense of gratitude or appreciation for life, increased spirituality.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Upon completion of study requirements (i.e., visits)

Results posted on

2015-04-28

Participant Flow

Both types of study participants were recruited from Veterans who were seen in Polytrauma Clinics at the Polytrauma Network Site. Both types of participants were referred by clinicians based on their clinical knowledge of whether this intervention seemed indicated; Recipients could also self-refer based on printed information.

400 Veterans were considered by the interdisciplinary polytrauma team as candidates for PV training. Of these, 29 (7%) were nominated. Of these, 14 (48%) were not enrolled: 6 (21%) due to time or travel restrictions, 6 (21%) could not be reached, and 2 (6%) because they had either been injured too recently or not participated in enough therapies.

Participant milestones

Participant milestones
Measure	Veteran Peer Visitors Of the 15 (52%) PV who enrolled in the study and completed the baseline assessment, 4 (27%) withdrew prior to PV training due to moving out of state (3) or schedule limitations (n=1). One was removed from the study by investigators due to discovery of invalid reporting.	Recipients of PV 9 Veterans receiving care at a Polytrauma Network Site (of over 300 seen during the study period) expressed interest in meeting with a Veteran Peer Mentor. Of these 8 completed visits and all study requirements. One withdrew for non-study-related reasons.
Overall Study STARTED	15	9
Overall Study Completed Baseline Assessment	15	9
Overall Study Completed Mentor Training	9	0
Overall Study Completed Visits and Final Assessment	8	8
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	7	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Veteran Peer Visitors Of the 15 (52%) PV who enrolled in the study and completed the baseline assessment, 4 (27%) withdrew prior to PV training due to moving out of state (3) or schedule limitations (n=1). One was removed from the study by investigators due to discovery of invalid reporting.	Recipients of PV 9 Veterans receiving care at a Polytrauma Network Site (of over 300 seen during the study period) expressed interest in meeting with a Veteran Peer Mentor. Of these 8 completed visits and all study requirements. One withdrew for non-study-related reasons.
Overall Study Withdrawal by Subject	4	1
Overall Study Removed by Investigators; unable to matc	3	0

Baseline Characteristics

Peer Visitation for OEF/OIF Veterans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Veteran Peer Visitors n=14 Participants Veterans who seved in Operation Iraqi Freedom or Operation Enduring Freedom, sustained polytrauma injuries, and successfully completed rehabiliation were recruited for training as peer mentors.	Recipients of Peer Visitors n=8 Participants Veterans who seved in Operation Iraqi Freedom or Operation Enduring Freedom, sustained polytrauma injuries, and were initiating rehabilitation therapies.	Total n=22 Participants Total of all reporting groups
Age, Continuous	34.1 years n=93 Participants	36.5 years n=4 Participants	35 years n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Sex: Female, Male Male	13 Participants n=93 Participants	7 Participants n=4 Participants	20 Participants n=27 Participants
Patient Health Questionnaire-9	12 units on a scale n=93 Participants	27.4 units on a scale n=4 Participants	18.2 units on a scale n=27 Participants
Self-Reported Anger	NA units on a scale n=93 Participants	28.5 units on a scale n=4 Participants	NA units on a scale n=27 Participants
PTSD check-list (PCL) Military Version	34 units on a scale n=93 Participants	68 units on a scale n=4 Participants	56 units on a scale n=27 Participants
Patient Activation	NA units on a scale n=93 Participants	39 units on a scale n=4 Participants	NA units on a scale n=27 Participants
Post Traumatic Growth Inventory	64.6 units on a scale n=93 Participants	NA units on a scale n=4 Participants	NA units on a scale n=27 Participants

PRIMARY outcome

Timeframe: Upon completion of study requirements (i.e., visits)

Population: This measure was only administered to Veteran Peer Visitors.

Administered only to Peer Visitors, possible range 0-105, with higher scores indicating greater post-traumatic growth. Post-traumatic growth includes emotional changes such as noticing a stronger sense of self, deepened relationships, increased sense of gratitude or appreciation for life, increased spirituality.

Outcome measures

Outcome measures
Measure	Veteran Peer Visitors n=8 Participants	Recipients of PV 9 Veterans receiving care at a Polytrauma Network Site (of over 300 seen during the study period) expressed interest in meeting with a Veteran Peer Mentor. Of these 8 completed visits and all study requirements. One withdrew for non-study-related reasons.
Post Traumatic Growth Inventory	67.4 units on a scale Interval 21.0 to 90.0	—

SECONDARY outcome

Timeframe: Upon completion of visits.

9-item depression screen with possible response options ranging from 9-36, with higher numbers indicating greater depression symptom severity.

Outcome measures

Outcome measures
Measure	Veteran Peer Visitors n=8 Participants	Recipients of PV n=9 Participants 9 Veterans receiving care at a Polytrauma Network Site (of over 300 seen during the study period) expressed interest in meeting with a Veteran Peer Mentor. Of these 8 completed visits and all study requirements. One withdrew for non-study-related reasons.
Patient Health Questionnaire-9 (Depression Screen)	19.4 units on a scale Interval 13.0 to 30.0	23.6 units on a scale Interval 19.0 to 30.0

SECONDARY outcome

Timeframe: Upon study completion.

Measures PTSD symptoms. Possible scores range from 19-95, with higher scores indicating greater symptom severity.

Outcome measures

Outcome measures
Measure	Veteran Peer Visitors n=8 Participants	Recipients of PV n=9 Participants 9 Veterans receiving care at a Polytrauma Network Site (of over 300 seen during the study period) expressed interest in meeting with a Veteran Peer Mentor. Of these 8 completed visits and all study requirements. One withdrew for non-study-related reasons.
Post-Traumatic Stress Disorder Checklist- Military Version (PCL-M)	44.7 units on a scale Interval 23.0 to 76.0	53.7 units on a scale Interval 42.0 to 73.0

SECONDARY outcome

Timeframe: Post- Participation

Population: This measure was only administered to Recipients of Peer Visitation.

Measures participante self-efficacy, knowledge of and engagement in health care. Possible scores range from 13-52 with higher scores indicating greater efficacy/knowledge/engagement.

Outcome measures

Outcome measures
Measure	Veteran Peer Visitors	Recipients of PV n=9 Participants 9 Veterans receiving care at a Polytrauma Network Site (of over 300 seen during the study period) expressed interest in meeting with a Veteran Peer Mentor. Of these 8 completed visits and all study requirements. One withdrew for non-study-related reasons.
Patient Activation Measure	—	38 units on a scale Interval 33.0 to 41.0

SECONDARY outcome

Timeframe: Post- Participation

Population: This measure was only administered to Recipients of Peer Visits.

5-item scale developed for this study. Assesses level of perceived experienced anger in the past month. Possible scores range from 5-35 with higher scores indicating greater levels of anger.

Outcome measures

Outcome measures
Measure	Veteran Peer Visitors	Recipients of PV n=9 Participants 9 Veterans receiving care at a Polytrauma Network Site (of over 300 seen during the study period) expressed interest in meeting with a Veteran Peer Mentor. Of these 8 completed visits and all study requirements. One withdrew for non-study-related reasons.
General Anger Level	—	24.8 units on a scale Interval 16.0 to 35.0

Adverse Events

Veteran Peer Visitors

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Recipients of Veteran Peer Visitation

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

Rhonda Williams, Ph.D.

VA Puget Sound Health Care System

Phone: 206-277-6290

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place