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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01748227
First received: November 21, 2012
Last updated: April 27, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention
Chronic Pain
Behavioral: Peer-Delivered Pain Self-Management

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Improving Pain Using Peer RE-inforced Self-management Skills (IMPPRESS)

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Pain/Enjoyment of Life/General Activity [ Time Frame: Change from baseline to 4 month assessment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 4 month assessment (final assessment) ] [ Designated as safety issue: No ]
    Pain Catastrophizing Scale. 13-item scale. Possible score range 0-52, with lower scores representing improvement.

  • 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 ] [ Designated as safety issue: No ]
    12 items, possible range 12-84 with higher scores indicating higher social support (i.e., better outcomes).

  • Patient Reported Outcome Measurement System (PROMIS) [ Time Frame: Change from baseline to 4 month assessment ] [ Designated as safety issue: No ]
    Possible scores range 0-100. Higher scores represent higher pain interference. Thus lower scores represent better outcomes.

  • Pain Centrality Scale [ Time Frame: 4 month assessment ] [ Designated as safety issue: No ]
    Possible range 10-50. Higher scores indicate higher pain centrality, i.e., worse outcomes.


Enrollment: 20
Study Start Date: January 2013
Study Completion Date: December 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748227

Locations
United States, Indiana
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States, 46202-2884
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Marianne Sassi Matthias, PhD MS BA Richard L. Roudebush VA Medical Center, Indianapolis, IN
  More Information

Publications:
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 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.

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01748227     History of Changes
Other Study ID Numbers: RRP 12-438 
Study First Received: November 21, 2012
Results First Received: December 11, 2014
Last Updated: April 27, 2015
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
self-management
peer support
social support

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on December 06, 2016