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Completed

NCT Number: NCT01748227

IMproving Pain Using Peer RE-inforced Self-management Skills

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peer-Delivered Pain Self-Management

Behavioral

Patients (n=20) were assigned a peer coach to meet with for 4 months to discuss pain self-management.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

    12 items, possible range 12-84 with higher scores indicating higher social support (i.e., better outcomes).

  3. 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.

  4. Pain Centrality Scale

    Time frame: 4 month assessment

    Possible range 10-50. Higher scores indicate higher pain centrality, i.e., worse outcomes.

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Official study title

Improving Pain Using Peer RE-inforced Self-management Skills (IMPPRESS)

Acronym: IMPPRESS

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 12, 2012
Registry last updated
May 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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