PolytraumaNCT01193686
Peer Visitation for OEF/OIF Veterans
A study testing Peer Visitation in people with Polytrauma and Blast Injuries, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polytrauma, Blast Injuries
- What is being tested?
- Peer Visitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 14Show fewer
- 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
Who cannot join
- Not an OEF/OIF Veteran
- Under age 18
- Non English Speaking
- Psychiatrically at risk (i.e., uncontrolled psychotic symptoms, active substance abuse or dependence)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
About this study
Official title: Evaluating a Peer Visitor Program for OIF/OEF Veterans With Polytrauma
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.
Read the 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.
- Conditions
- Polytrauma, Blast Injuries
- Being tested
- Peer Visitation
- Medical subject headings
- Multiple Trauma, Blast Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer VisitationOther
Trained Volunteers will visit OEF/OIF Veterans with Polytrauma Injuries to provide support.
| Study group | Role | What they receive |
|---|---|---|
| Peer Visitation Training (Peer Mentor) | Experimental | Veteran Peer Visitors participated in a 2-day training program and then provide at 1-5 visits to at least 2 recipients. Receives: Other: Peer Visitation |
| Peer Visitation | Experimental | Veterans who received at least one visit from a Veteran Peer Visitor. Receives: Other: Peer Visitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Traumatic Growth Inventory
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.
Measured: Upon completion of study requirements (i.e., visits)
Secondary outcomes (4)
Patient Health Questionnaire-9 (Depression Screen)
9-item depression screen with possible response options ranging from 9-36, with higher numbers indicating greater depression symptom severity.
Measured: Upon completion of visits.
Post-Traumatic Stress Disorder Checklist- Military Version (PCL-M)
Measures PTSD symptoms. Possible scores range from 19-95, with higher scores indicating greater symptom severity.
Measured: Upon study completion.
Patient Activation Measure
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.
Measured: Post- Participation
General Anger Level
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.
Measured: Post- Participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PolytraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Rhonda M. Williams, PhD, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193686
- Sponsor's protocol ID
- RRP 09-134
- Status last verified
- Oct 2014
- First submitted
- 31 Aug 2010
- Last updated
- 28 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Williams RM, Bambara J, Turner AP. A scoping study of one-to-one peer mentorship interventions and recommendations for application with Veterans with postdeployment syndrome. J Head Trauma Rehabil. 2012 Jul-Aug;27(4):261-73. doi: 10.1097/HTR.0b013e3182585cb6.
PubMed 22767074
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Peer Visitor Program for OIF/OEF Veterans With Polytrauma
- ClinicalTrials.gov ID
- NCT01193686
- Acronym / sponsor ID
- RRP 09-134
- Conditions
- Polytrauma, Blast Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Nov 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 2 Sep 2010 (estimated)
- Results
- Posted 5 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Visitation Training (Peer Mentor) | Experimental | Other: Peer VisitationVeteran Peer Visitors participated in a 2-day training program and then provide at 1-5 visits to at least 2 recipients. |
| Peer Visitation | Experimental | Other: Peer VisitationVeterans who received at least one visit from a Veteran Peer Visitor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- eligibility will be determined using a combination of self-assessment, clinician recommendation, and Voluntary Services screening
- eligibility will be determined by the referring clinical team and the Research Nurse
- 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
Key exclusion criteria (4 listed)
- Not an OEF/OIF Veteran
- Under age 18
- Non English Speaking
- Psychiatrically at risk (i.e., uncontrolled psychotic symptoms, active substance abuse or dependence)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer VisitationTrained Volunteers will visit OEF/OIF Veterans with Polytrauma Injuries to provide support. | Other | Peer Visitation, Peer Visitation Training (Peer Mentor) |
Primary outcome
Post Traumatic Growth Inventory
Time frame: 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.
4 secondary outcomes
Patient Health Questionnaire-9 (Depression Screen)
Time frame: Upon completion of visits.
Post-Traumatic Stress Disorder Checklist- Military Version (PCL-M)
Time frame: Upon study completion.
Patient Activation Measure
Time frame: Post- Participation
General Anger Level
Time frame: Post- Participation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22767074Williams RM, Bambara J, Turner AP. A scoping study of one-to-one peer mentorship interventions and recommendations for application with Veterans with postdeployment syndrome. J Head Trauma Rehabil. 2012 Jul-Aug;27(4):261-73. doi: 10.1097/HTR.0b013e3182585cb6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rhonda M. Williams, PhD principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Visitation in people with Polytrauma and Blast Injuries, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Traumatic Growth Inventory (time frame: Upon completion of study requirements (i.e., visits)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01193686, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.