- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01748227
IMproving Pain Using Peer RE-inforced Self-management Skills (IMPPRESS)
Improving Pain Using Peer RE-inforced Self-management Skills (IMPPRESS)
The overall purpose of this pilot study is to conduct a formative evaluation of (veteran)peer delivery of a chronic pain self-management program to veterans with chronic musculoskeletal pain.
Our specific aims are as follows:
Aim 1: Evaluate the feasibility of identifying, recruiting, training, and retaining veteran peers to implement a self-management program for chronic pain.
Aim 2: Identify facilitators and barriers to peer-delivery of a chronic pain self-management program.
Aim 3: Convene an expert panel to review the results of Aims 1 and 2, help to interpret the results, and plan next steps.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a one-arm pilot study with a pretest/posttest design. Thus, participants' (n=20) baseline scores were compared to their final outcome assessment scores (i.e., change scores.) There was no control group.
This study is an intervention using peer coaches to deliver pain self-management instruction to patients. Peer coaches thus delivered the intervention and underwent a 3-hour training session prior to initiation of the study. Because peers served as intervention facilitators and not as recipients of the intervention, this study was not focused on peer outcomes.
Patients (n=20) attended a 2-hour didactic session led by the study nurse. Then patients were assigned a peer (2 patients per peer). Patients met with their peers for 4 months to discuss pain self-management with the guidance of a study manual. Peers were asked to contact patients a minimum of bi-weekly via telephone or in-person.
Peers reviewed each of the topic areas covered in the self-management manual. Peers reviewed a different topic each session, ask if the patient has questions, and discuss his or her personal experience with the topic being covered during that session. Modeling what the nurse care manager has done in prior studies, peers worked with patients to help them to set goals and to evaluate whether these goals are realistic. A new goal was set at each session, with the peer following up on the previous goals with the patient, whether they were accomplished, and if not, possible courses of action (e.g., modifying the goal or offering other advice to accomplish the goal). Throughout these sessions peers were encouraged to draw on their own experiences and how they personally overcame obstacles and handled setbacks and frustrations. Peers did not advise on or discuss medications or medical questions with patients.
Participating patients (n=20) were given outcome assessments at baseline and at 4-month follow-up.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46202-2884
- Richard L. Roudebush VA Medical Center, Indianapolis, IN
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Peers will be eligible if they have chronic musculoskeletal pain and have completed a pain self-management program from any of these chronic pain trials:
- Stepped Care for Depression and Musculoskeletal Pain (SCAMP)
- Evaluation of Stepped Care for Chronic Pain in Iraq and Afghanistan Veterans (ESCAPE)
- CAre Management for the Effective use of Opioids (CAMEO)
- Or participants of the VA Pain School or VA Pain program
- Peers may also be recommended by their primary care providers at the VA
- Eligible patients must have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, or shoulder) that has persisted for 3 months
- And have pain of at least moderate intensity as defined by a Brief Pain Inventory score 5
Exclusion Criteria:
- Patients will be excluded if they have active suicidal ideation
- Have been hospitalized for psychiatric or substance abuse reasons in the last 6 months pending back surgery
- Current substance dependence
- Severe medical conditions (e.g., New York Heart Association Class III or IV heart failure) that precludes participation
- Or severe hearing or speech impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Peer-Coached Pain Self-Management
Participants (n=20) were assigned to a peer coach, who delivered self-management instruction one-on-one over a 4-month period.
|
Patients (n=20) were assigned a peer coach to meet with for 4 months to discuss pain self-management.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain/Enjoyment of Life/General Activity
Time Frame: Change from baseline to 4 month assessment
|
3-item version of the Brief Pain Inventory.
Possible range: 0-30.
0=no pain/interference, 30=maximum pain/interference.
Thus lower values represent a better outcome.
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Change from baseline to 4 month assessment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Catastrophizing Scale
Time Frame: Baseline and 4 month assessment (final assessment)
|
Pain Catastrophizing Scale.
13-item scale.
Possible score range 0-52, with lower scores representing improvement.
|
Baseline and 4 month assessment (final assessment)
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Multidimensional Perceived Social Support Scale (MPSS).
Time Frame: Baseline and 4 month for Statistical Package for Social Scientists (SPSS) and only 4 month final interview for Working Alliance
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12 items, possible range 12-84 with higher scores indicating higher social support (i.e., better outcomes).
|
Baseline and 4 month for Statistical Package for Social Scientists (SPSS) and only 4 month final interview for Working Alliance
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Patient Reported Outcome Measurement System (PROMIS)
Time Frame: Change from baseline to 4 month assessment
|
Possible scores range 0-100.
Higher scores represent higher pain interference.
Thus lower scores represent better outcomes.
|
Change from baseline to 4 month assessment
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Pain Centrality Scale
Time Frame: 4 month assessment
|
Possible range 10-50.
Higher scores indicate higher pain centrality, i.e., worse outcomes.
|
4 month assessment
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Collaborators and Investigators
Publications and helpful links
General Publications
- Matthias MS, McGuire AB, Kukla M, Daggy J, Myers LJ, Bair MJ. A brief peer support intervention for veterans with chronic musculoskeletal pain: a pilot study of feasibility and effectiveness. Pain Med. 2015 Jan;16(1):81-7. doi: 10.1111/pme.12571. Epub 2014 Oct 14.
- Matthias MS, Kukla ME, McGuire AB, Bair MJ. Peer support for chronic pain self-management: A qualitative study of peer coaches' experiences. [Abstract]. Journal of general internal medicine. 2014 Apr 16; 29(1):169-170.
- Matthias MS, Kukla M, McGuire AB, Bair MJ. How Do Patients with Chronic Pain Benefit from a Peer-Supported Pain Self-Management Intervention? A Qualitative Investigation. Pain Med. 2016 Dec;17(12):2247-2255. doi: 10.1093/pm/pnw138. Epub 2016 Jul 8.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RRP 12-438
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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