IMproving Pain Using Peer RE-inforced Self-management Skills

NCT ID: NCT01748227

Last Updated: 2015-05-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

Peer-Delivered Pain Self-Management

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Peer-Delivered Pain Self-Management

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marianne Sassi Matthias, PhD MS BA

Role: PRINCIPAL_INVESTIGATOR

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 25312858 (View on PubMed)

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.

Reference Type RESULT

Matthias MS, McGuire AB, Kukla ME, Daggy J, Myers L, Bair MJ. Effectiveness of a brief peer support intervention for veterans with chronic pain. [Abstract]. Journal of general internal medicine. 2014 Apr 16; 29(1):80.

Reference Type RESULT

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.

Reference Type DERIVED
PMID: 28025359 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RRP 12-438

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effective Screening for Pain Study
NCT01816763 COMPLETED NA