IMproving Pain Using Peer RE-inforced Self-management Skills

Chronic Pain Clinical Trial

— IMPPRESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748227
• Other study ID #: RRP 12-438
• Status: Completed
• Phase: N/A
• First received: November 21, 2012
• Last updated: April 27, 2015
• Start date: January 2013
• Est. completion date: December 2013

Study information

• Verified date: April 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Peer-Delivered Pain Self-Management
Patients (n=20) were assigned a peer coach to meet with for 4 months to discuss pain self-management.

Locations

Country	Name	City	State
United States	Richard L. Roudebush VA Medical Center, Indianapolis, IN	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

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, 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 201 — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain/Enjoyment of Life/General Activity	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.	Change from baseline to 4 month assessment	No
Secondary	Pain Catastrophizing Scale	Pain Catastrophizing Scale. 13-item scale. Possible score range 0-52, with lower scores representing improvement.	Baseline and 4 month assessment (final assessment)	No
Secondary	Multidimensional Perceived Social Support Scale (MPSS).	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	No
Secondary	Patient Reported Outcome Measurement System (PROMIS)	Possible scores range 0-100. Higher scores represent higher pain interference. Thus lower scores represent better outcomes.	Change from baseline to 4 month assessment	No
Secondary	Pain Centrality Scale	Possible range 10-50. Higher scores indicate higher pain centrality, i.e., worse outcomes.	4 month assessment	No