Peer Visitation for OEF/OIF Veterans

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01193686
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 19
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

The goal of this study was to train OIF/OIF Veterans with multiple injuries to be Peer Visitors, i.e., Volunteers who visit more recently OIF/OEF Veterans and provide support. We evaluated the effectiveness of the training, and any benefits that Volunteer Peer Visitors and the Recipients of Peer Visitors experienced as a result of participating in Peer Visitation.

Condition or Disease	Intervention/Treatment	Phase
Polytrauma; Blast Injuries	Other: Peer Visitation	N/A

Detailed Description

Peer visitation (PV) provides individuals newly dealing with a particular injury/ illness with an opportunity to interact with a peer who has successfully managed a similar condition. Interaction with a successful role model can provide credible social support and information, increase self-efficacy and teach coping strategies, which in turn can engender hope and motivation to engage in treatment and use active coping strategies. In spite of the widespread clinical availability of PV programs, the amount and type of training and clinical/organizational varies widely, and empirical support for their efficacy is limited. The main objective of this project is to test the feasibility of implementing a PV program for OEF/OIF veterans with war-related polytrauma.

The proposed study represented a unique opportunity to evaluate three important aspects of peer visitation among OEF/OIF Veterans. Our three hypotheses were: H 1: Veteran Peer Visitors (VPVs) who complete the training will demonstrate successful acquisition of efficacy, knowledge and skills as measured by: (1) pre- and post-tests administered before and after the training; (2) trainer evaluations upon completion of the training, (3) self-evaluation of at least two actual peer visits, and (4) evaluation by two individuals who receive peer visits. H2: VPVs who complete the study will demonstrate increased self-care, improved mood, and increased post-traumatic growth compared to pre-training baseline measures. H 3: Veterans who receive a visit from a VPV will endorse improvement in one or more of the following areas: stress, self-efficacy, activation, mood, ability to make meaning of their experiences, and knowledge of coping options.

We used a mixed-methods study to evaluate the feasibility of PV training materials developed in a previous grant to certify 12-18 Veteran Peer Visitors (VPVs). In a prior project, the proposed research team developed the training materials to be tested in this feasibility study, including screening tools to identify appropriate candidates for VPV training, an Instructor manual and a Veteran PV workbook.

Two types of participants: Veteran Peer Visitors and Recipients of VPVs were recruited via the Polytrauma Network Site in VISN 20 (Seattle). VPVs were nominated by a clinician to participate and, if enrolled, will undergo 2-day training and will be required to pass a test upon completion of training. Training included a VA Voluntary Services background check, and orientation to the VHA and VA privacy policies. VPVs became official VA volunteers. Each certified VPV was required to provide 1-5 visits to at least two Veterans. Both VPVs and recipients of VPV completed surveys at baseline and upon study completion.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Evaluating a Peer Visitor Program for OIF/OEF Veterans With Polytrauma
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Peer Visitation Training (Peer Mentor) Veteran Peer Visitors participated in a 2-day training program and then provide at 1-5 visits to at least 2 recipients.	Other: Peer Visitation; Trained Volunteers will visit OEF/OIF Veterans with Polytrauma Injuries to provide support.
Experimental: Peer Visitation Veterans who received at least one visit from a Veteran Peer Visitor.	Other: Peer Visitation; Trained Volunteers will visit OEF/OIF Veterans with Polytrauma Injuries to provide support.

Outcome Measures

Primary Outcome Measures

1. Post Traumatic Growth Inventory [Upon completion of study requirements (i.e., visits)]

   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.

Secondary Outcome Measures

1. Patient Health Questionnaire-9 (Depression Screen) [Upon completion of visits.]

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

2. Post-Traumatic Stress Disorder Checklist- Military Version (PCL-M) [Upon study completion.]

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

3. Patient Activation Measure [Post- Participation]

   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.

4. General Anger Level [Post- Participation]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

For Peer Visitors:

• eligibility will be determined using a combination of self-assessment, clinician recommendation, and Voluntary Services screening

For participants who are interested in receiving a peer visitor:

• eligibility will be determined by the referring clinical team and the Research Nurse

Peer Visitors:

To be eligible to participate in the study as a potential Veteran Peer Visitor, Veterans must complete several screening steps. A Veteran must be nominated by a clinician from the Center for Polytrauma Care (CPC) Clinical Team, or they must nominate themselves for the project and seek endorsement from a clinician on the CPC team. To be nominated or endorsed by a clinician, the Veteran must have been observed by the clinical team member to demonstrate the following specific behaviors and characteristics:

• Reliable and organized about keeping appointments (80% adherence or better)

• Demonstrate excellent insight into own treatment goals, progress, barriers, treatment rationale

• Not demonstrate any "high-risk" behaviors in the previous 12 months, including suicidal ideation or intent, inpatient psychiatric treatment (other than planned, voluntary admission to Evaluation and Brief Treatment Unit), active substance abuse or dependence, uncontrolled psychotic symptoms (e.g., hallucinations, delusions), felonies.

• Evidence of good social support (i.e., clinician aware of supportive relationships)

• Engaged in meaningful life goals and activities (e.g., work, school, volunteering, parenting, recreation, church)

• Able to pass background check for Voluntary Services

• Must be English Speaking

• Able to complete pen and paper surveys

Exclusion Criteria:

• Not an OEF/OIF Veteran

• Under age 18

• Non English Speaking

• Psychiatrically at risk (i.e., uncontrolled psychotic symptoms, active substance abuse or dependence)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington	United States	98108

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

• Principal Investigator: Rhonda M. Williams, PhD, VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT01193686
• Other Study ID Numbers: RRP 09-134
• First Posted: Sep 2, 2010
• Last Update Posted: Apr 28, 2015
• Last Verified: Oct 1, 2014

• Additional relevant MeSH terms: Multiple Trauma; Blast Injuries

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	Veteran Peer Visitors	Recipients of PV
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	15	9
Completed Baseline Assessment	15	9
Completed Mentor Training	9	0
Completed Visits and Final Assessment	8	8
COMPLETED	8	8
NOT COMPLETED	7	1

Baseline Characteristics

Arm/Group Title	Veteran Peer Visitors	Recipients of Peer Visitors	Total
Arm/Group Description	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.	Veterans who seved in Operation Iraqi Freedom or Operation Enduring Freedom, sustained polytrauma injuries, and were initiating rehabilitation therapies.	Total of all reporting groups
Overall Participants	14	8	22
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	34.1	36.5	35
Sex: Female, Male (Count of Participants)
Female	1 7.1%	1 12.5%	2 9.1%
Male	13 92.9%	7 87.5%	20 90.9%
Patient Health Questionnaire-9 (units on a scale) [Mean (Full Range) ]
Mean (Full Range) [units on a scale]	12	27.4	18.2
Self-Reported Anger (units on a scale) [Mean (Full Range) ]
Mean (Full Range) [units on a scale]	NA	28.5	NA
PTSD check-list (PCL) Military Version (units on a scale) [Mean (Full Range) ]
Mean (Full Range) [units on a scale]	34	68	56
Patient Activation (units on a scale) [Mean (Full Range) ]
Mean (Full Range) [units on a scale]	NA	39	NA
Post Traumatic Growth Inventory (units on a scale) [Mean (Full Range) ]
Mean (Full Range) [units on a scale]	64.6	NA	NA

Outcome Measures

1. Primary Outcome

Title	Post Traumatic Growth Inventory
Description	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.
Time Frame	Upon completion of study requirements (i.e., visits)

Outcome Measure Data

Analysis Population Description

This measure was only administered to Veteran Peer Visitors.

Arm/Group Title	Veteran Peer Visitors	Recipients of PV
Arm/Group Description	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.
Measure Participants	8	0
Mean (Full Range) [units on a scale]	67.4

2. Secondary Outcome

Title	Patient Health Questionnaire-9 (Depression Screen)
Description	9-item depression screen with possible response options ranging from 9-36, with higher numbers indicating greater depression symptom severity.
Time Frame	Upon completion of visits.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Veteran Peer Visitors	Recipients of PV
Arm/Group Description
Measure Participants	8	9
Mean (Full Range) [units on a scale]	19.4	23.6

3. Secondary Outcome

Title	Post-Traumatic Stress Disorder Checklist- Military Version (PCL-M)
Description	Measures PTSD symptoms. Possible scores range from 19-95, with higher scores indicating greater symptom severity.
Time Frame	Upon study completion.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Veteran Peer Visitors	Recipients of PV
Arm/Group Description
Measure Participants	8	9
Mean (Full Range) [units on a scale]	44.7	53.7

4. Secondary Outcome

Title	Patient Activation Measure
Description	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.
Time Frame	Post- Participation

Outcome Measure Data

Analysis Population Description

This measure was only administered to Recipients of Peer Visitation.

Arm/Group Title	Veteran Peer Visitors	Recipients of PV
Arm/Group Description
Measure Participants	0	9
Mean (Full Range) [units on a scale]	38

5. Secondary Outcome

Title	General Anger Level
Description	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.
Time Frame	Post- Participation

Outcome Measure Data

Analysis Population Description

This measure was only administered to Recipients of Peer Visits.

Arm/Group Title	Veteran Peer Visitors	Recipients of PV
Arm/Group Description
Measure Participants	0	9
Mean (Full Range) [units on a scale]	24.8

Adverse Events

Time Frame	1 year
Arm/Group Title	Veteran Peer Visitors		Recipients of Veteran Peer Visitation
Arm/Group Description	Veteran Peer Visitors (VPV) who participated in a 2-day training program and then provided at 1-5 visits to at least 2 recipients. All Peer Visitors had served in Operation Iraqi Freedom or Operation Enduring Freedom, sustained polytrauma injuries, and successfully completed rehabilitation.		Veterans of Operation Enduring Freedom or Operation Iraqi Freedom who sustained polytrauma (i.e., mutiple systems involved) injuries.
All Cause Mortality
	Veteran Peer Visitors		Recipients of Veteran Peer Visitation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Veteran Peer Visitors		Recipients of Veteran Peer Visitation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/9 (0%)
Other (Not Including Serious) Adverse Events
	Veteran Peer Visitors		Recipients of Veteran Peer Visitation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/9 (0%)

Limitations/Caveats

We had great difficulty recruiting Recipients of Peer Visitors, i.e., Veterans who wished to receive mentorship from our trained peer visitors. This rendered our sample size too small for planned analyses.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.