Evaluation of a Peer Coach-Led Intervention to Improve Pain Symptoms (ECLIPSE)

Evaluation of a Peer Coach-Led Intervention to Improve Pain Symptoms (ECLIPSE)

To maximize implementation potential of pain self-management in the VA, alternative delivery methods are needed to provide Veterans with education and support needed to self-manage their pain, without requiring additional resources from healthcare teams. A novel and promising approach is a peer coaching model, in which Veterans with chronic pain who are successfully managing their pain offer information, support, and mentorship to other Veterans with pain.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Peer Coach Assignment

Detailed Description

The investigators' goal is to test the effectiveness of a peer coaching model among Veterans. The investigators are examining feasibility for implementation alongside effectiveness, to shorten the timeline to implementation.

Aim 1 (primary aim): To compare 6-month (primary endpoint) and 9-month (sustained effects) effects of peer-supported chronic pain self-management versus controls on overall pain (intensity and function).

Hypothesis 1: Veterans in the peer support arm will experience reduced overall pain compared to controls.

Aim 2 (secondary aim): To compare 6- and 9-month effects of peer-supported chronic pain self-management versus controls on self-efficacy, social support, pain coping, patient activation, health-related quality of life, and health service utilization.

Hypothesis 2: Veterans in the peer support arm will experience greater self-efficacy, social support, pain coping, patient activation, and health-related quality of life, and lower health service utilization, compared to controls.

Aim 3 (pre-implementation aim): To explore facilitators and barriers to implementation of peer support for chronic pain, intervention costs, and fidelity to the model.

• Study Type: Interventional
• Enrollment (Actual): 215
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202-2884
      • Richard L. Roudebush VA Medical Center, Indianapolis, IN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, or shoulder) for 3 months
• have at least moderate pain severity, defined by pain 5 on a 0 (no pain) to 10 (worst pain imaginable) scale
• indicate willingness to engage in phone or in-person contact on a regular basis with another Veteran

Exclusion Criteria:

• if the electronic medical record indicates a diagnosis of a psychotic disorder (e.g., International Classification of Diseases (ICD) ICD-9 codes 295-295.9 for schizophrenia)
• current substance dependence (e.g., ICD-9 codes 304-304.9)
• severe medical conditions precluding participation (e.g., New York Heart Association Class III or IV heart failure, ICD-9 codes 428-428.9 )
• if the eligibility screener given to prospective participants reveals active suicidal ideation severe hearing or speech impairment
• pending surgery for a musculoskeletal condition (e.g., back surgery)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peer Coach Assignment; Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period.	Behavioral: Peer Coach Assignment; Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.
No Intervention: Control; Veteran participants will attend a 2-hour class in pain "basics" and pain self-management. Veterans will aso be given a set of pamphlets related to pain self-management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Pain Inventory (BPI) (Overall Pain Assessment)	The BPI was developed to assess the severity of pain and the impact of pain on daily functioning, and has been validated in primary care studies. (Range = 0-10, 0 = no pain, 10 = worst pain imaginable)	6 months
Brief Pain Inventory (BPI) (Overall Pain Assessment)	The BPI was developed to assess the severity of pain and the impact of pain on daily functioning, and has been validated in primary care studies. (Range = 0-10, 0 = no pain, 10 = worst pain imaginable)	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Catastrophizing	Pain Catastrophizing Scale, a 13-item scale that assesses catastrophizing - a pain belief that has been found to be a strong predictor of poor treatment response. (Range: 0-52, higher numbers = higher catastrophizing)	6 months
Perceived Social Support	Measures perceptions of social support.(Range: 12-84, higher numbers = higher perceptions of social support)	6 months
Perceived Social Support	Measures perceptions of social support.(Range: 12-84, higher numbers = higher perceptions of social support)	9 months
Self Efficacy	Adapted from the Arthritis Self Efficacy Scale (Range 0-10, higher numbers = higher self efficacy)	6 months
Self Efficacy	Adapted from the Arthritis Self Efficacy Scale (Range 0-10, higher numbers = higher self efficacy)	9 months
Anxiety	GAD-7 (Range 0-21, higher numbers = higher anxiety)	6 months
Anxiety	GAD-7 (Range 0-21, higher numbers = higher anxiety)	9 months
Depression	PHQ-8 (Range: 0-24, higher numbers = higher depression)	6 months
Depression	PHQ-8 (Range: 0-24, higher numbers = higher depression)	9 months
Pain Catastrophizing	Pain Catastrophizing Scale, a 13-item scale that assesses catastrophizing - a pain belief that has been found to be a strong predictor of poor treatment response. (Range: 0-52, higher numbers = higher catastrophizing)	9 months
Patient Activation	Patient Activation Measure (Range: 0-100, higher numbers = higher activation)	6 months
Patient Activation	Patient Activation Measure (Range: 0-100, higher numbers = higher activation)	9 months
General Health Perceptions	SF-36 General Health Perceptions (Range: 0-100, higher numbers = higher health perceptions)	6 months
General Health Perceptions	SF-36 General Health Perceptions (Range: 0-100, higher numbers = higher health perceptions)	9 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Marianne Sassi Matthias, PhD MS BA, Richard L. Roudebush VA Medical Center, Indianapolis, IN

Publications and helpful links

General Publications

• Matthias MS, Daggy J, Adams J, Menen T, McCalley S, Kukla M, McGuire AB, Ofner S, Pierce E, Kempf C, Heisler M, Bair MJ. Evaluation of a peer coach-led intervention to improve pain symptoms (ECLIPSE): Rationale, study design, methods, and sample characteristics. Contemp Clin Trials. 2019 Jun;81:71-79. doi: 10.1016/j.cct.2019.04.002. Epub 2019 Apr 2.
• Matthias MS, Hirsh AT, Ofner S, Daggy J. Exploring the Relationships Among Social Support, Patient Activation, and Pain-Related Outcomes. Pain Med. 2022 Apr 8;23(4):676-685. doi: 10.1093/pm/pnab306.
• Shue SA, McGuire AB, Matthias MS. Facilitators and Barriers to Implementation of a Peer Support Intervention for Patients with Chronic Pain: A Qualitative Study. Pain Med. 2019 Jul 1;20(7):1311-1320. doi: 10.1093/pm/pny229.
• Matthias MS, Daggy J, Ofner S, McGuire AB, Kukla M, Bair MJ. Exploring peer coaches' outcomes: Findings from a clinical trial of patients with chronic pain. Patient Educ Couns. 2020 Jul;103(7):1366-1372. doi: 10.1016/j.pec.2020.02.007. Epub 2020 Feb 5.
• Matthias MS, Bair MJ, Ofner S, Heisler M, Kukla M, McGuire AB, Adams J, Kempf C, Pierce E, Menen T, McCalley S, Johnson NL, Daggy J. Peer Support for Self-Management of Chronic Pain: the Evaluation of a Peer Coach-Led Intervention to Improve Pain Symptoms (ECLIPSE) Trial. J Gen Intern Med. 2020 Dec;35(12):3525-3533. doi: 10.1007/s11606-020-06007-6. Epub 2020 Jul 22.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: February 23, 2015
• First Submitted That Met QC Criteria: February 27, 2015
• First Posted (Estimated): March 5, 2015

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: self-management; social support; peer support
• Additional Relevant MeSH Terms: Neurologic Manifestations; Chronic Pain; Pain
• Other Study ID Numbers: IIR 14-070; 1410626162 (Other Identifier: Indiana University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon request, the Research Service will consider requests for the final data sets underlying the publications to be provided to the public. The limited dataset will include de-identified data relevant to the specific request. Independent research groups can view relevant data to evaluate the extent that data sources support conclusions made by authors in published studies as well as observe additional emergent themes and view supplemental details that might not be included in publications.
• IPD Sharing Time Frame: The data will become available once the study team completes all analyses.
• IPD Sharing Access Criteria: The Research Service will evaluate individual requests.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No