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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01748227
First received: November 21, 2012
Last updated: March 12, 2014
Last verified: March 2014
  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: 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 Department of Veterans Affairs:

Primary Outcome Measures:
  • Pain severity [ Time Frame: Change from baseline to 4 month assessment ] [ Designated as safety issue: No ]
    This will be measured by the Brief Pain Inventory (3 items)


Secondary Outcome Measures:
  • Pain beliefs and coping measured by the Pain Catastrophizing Scale (10 items) and Centrality of Pain Scale (10 items) [ Time Frame: Baseline and 4 month assessment (final assessment) ] [ Designated as safety issue: No ]
  • Social Support and Relationships measured by the Multidimensional Scale of Perceived Social Support (12 items) and the Working Alliance Inventory (12 items) [ Time Frame: Baseline and 4 month for SPSS and only 4 month final interview for Working Alliance ] [ Designated as safety issue: No ]
  • Pain interference [ Time Frame: Change from baseline to 4 month assessment ] [ Designated as safety issue: No ]
    This will be measured by the PROMIS pain measures (12 items)

  • Relationships [ Time Frame: 4 month assessment ] [ Designated as safety issue: No ]
    Measured by the Working Alliance measure (12 items)


Estimated Enrollment: 45
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
Pain Self-Management
Training of (veteran) peers to deliver pain self-management materials to veterans with chronic pain
Behavioral: Pain Self-Management
Training of veteran peers to deliver pain self-management material to veterans with chronic pain. Veteran peers will then be assigned 2 patients with chronic pain to work with over the next 4 months on pain self-management.

Detailed Description:

Peer training will consist of 2 core components: 1) How to deliver the pain self-management curriculum; and 2) Peer-support competencies (i.e., "how to be a peer"). After initial training, research personnel will remain in regular contact with peers to answer questions, troubleshoot problems, and facilitate mutual support among peers. Peers will meet as a group with the psychologist for bi-weekly peer supervision either in-person or via teleconference.

The self-management program will be delivered in two phases. Phase 1 will be a 2-hour didactic session led by the study nurse and will parallel the content described for the peers. The pain self-management manual developed for our earlier studies will be used and distributed to the patients. Phase 2 will be additional sessions delivered by peers, over a 4-month period. At the end of the Phase 1 session, the peers will meet their assigned patients. Peers will be assigned 2 patients, and pairings will be made with input from the study nurse and psychologist, with patients and peers being age- and gender-matched to the extent possible.

After their initial face-to-face meeting, peers will be asked to keep in regular contact with patients over a 4-month period. Specifically, peers will contact patients a minimum of bi-weekly via telephone or in-person.

Peers will be asked to review each of the topic areas covered in the self-management manual. Peers will review 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 will work with patients to help them to set goals and to evaluate whether these goals are realistic. A new goal will be 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 will be encouraged to draw on their own experiences and how they personally overcame obstacles and handled setbacks and frustrations. Peers will not advise on or discuss medications or medical questions with patients. If such questions come up, peers will instruct patients to contact their PCPs.

  Eligibility

Ages Eligible for Study:   18 Years and older
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 Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, United States, 46202-2884
Sponsors and Collaborators
Investigators
Principal Investigator: Marianne Sassi Matthias, PhD MS BA Richard Roudebush VA Medical Center, Indianapolis
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01748227     History of Changes
Other Study ID Numbers: RRP 12-438
Study First Received: November 21, 2012
Last Updated: March 12, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
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 August 28, 2014