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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer-Delivered Pain Self-Management
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Pain focused on measuring self-management, peer support, social support

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Richard L. Roudebush VA Medical Center, Indianapolis, IN

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Peer-Coached Pain Self-Management

Arm Description

Participants (n=20) were assigned to a peer coach, who delivered self-management instruction one-on-one over a 4-month period.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain Catastrophizing Scale
Pain Catastrophizing Scale. 13-item scale. Possible score range 0-52, with lower scores representing improvement.
Multidimensional Perceived Social Support Scale (MPSS).
12 items, possible range 12-84 with higher scores indicating higher social support (i.e., better outcomes).
Patient Reported Outcome Measurement System (PROMIS)
Possible scores range 0-100. Higher scores represent higher pain interference. Thus lower scores represent better outcomes.
Pain Centrality Scale
Possible range 10-50. Higher scores indicate higher pain centrality, i.e., worse outcomes.

Full Information

First Posted
November 21, 2012
Last Updated
April 27, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT01748227
Brief Title
IMproving Pain Using Peer RE-inforced Self-management Skills
Acronym
IMPPRESS
Official Title
Improving Pain Using Peer RE-inforced Self-management Skills (IMPPRESS)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
self-management, peer support, social support

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer-Coached Pain Self-Management
Arm Type
Other
Arm Description
Participants (n=20) were assigned to a peer coach, who delivered self-management instruction one-on-one over a 4-month period.
Intervention Type
Behavioral
Intervention Name(s)
Peer-Delivered Pain Self-Management
Intervention Description
Patients (n=20) were assigned a peer coach to meet with for 4 months to discuss pain self-management.
Primary Outcome Measure Information:
Title
Pain/Enjoyment of Life/General Activity
Description
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.
Time Frame
Change from baseline to 4 month assessment
Secondary Outcome Measure Information:
Title
Pain Catastrophizing Scale
Description
Pain Catastrophizing Scale. 13-item scale. Possible score range 0-52, with lower scores representing improvement.
Time Frame
Baseline and 4 month assessment (final assessment)
Title
Multidimensional Perceived Social Support Scale (MPSS).
Description
12 items, possible range 12-84 with higher scores indicating higher social support (i.e., better outcomes).
Time Frame
Baseline and 4 month for Statistical Package for Social Scientists (SPSS) and only 4 month final interview for Working Alliance
Title
Patient Reported Outcome Measurement System (PROMIS)
Description
Possible scores range 0-100. Higher scores represent higher pain interference. Thus lower scores represent better outcomes.
Time Frame
Change from baseline to 4 month assessment
Title
Pain Centrality Scale
Description
Possible range 10-50. Higher scores indicate higher pain centrality, i.e., worse outcomes.
Time Frame
4 month assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Sassi Matthias, PhD MS BA
Organizational Affiliation
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richard L. Roudebush VA Medical Center, Indianapolis, IN
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-2884
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25312858
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
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.
Results Reference
result
PubMed Identifier
28025359
Citation
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.
Results Reference
derived

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IMproving Pain Using Peer RE-inforced Self-management Skills

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