Clinical trial NCT02380690: Evaluation of a Peer Coach-Led Intervention to Improve Pain Symptoms
Official title: Evaluation of a Peer Coach-Led Intervention to Improve Pain Symptoms (ECLIPSE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: self-management
peer support
social support
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-03-05
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Brief Pain Inventory (BPI) (Overall Pain Assessment)
timeFrame: 6 months
measure: Brief Pain Inventory (BPI) (Overall Pain Assessment)
timeFrame: 9 months
Secondary outcomes:
measure: Pain Catastrophizing
timeFrame: 6 months
measure: Perceived Social Support
timeFrame: 6 months
measure: Perceived Social Support
timeFrame: 9 months
measure: Self Efficacy
timeFrame: 6 months
measure: Self Efficacy
timeFrame: 9 months
measure: Anxiety
timeFrame: 6 months
measure: Anxiety
timeFrame: 9 months
measure: Depression
timeFrame: 6 months
measure: Depression
timeFrame: 9 months
measure: Pain Catastrophizing
timeFrame: 9 months
measure: Patient Activation
timeFrame: 6 months
measure: Patient Activation
timeFrame: 9 months
measure: General Health Perceptions
timeFrame: 6 months
measure: General Health Perceptions
timeFrame: 9 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Richard L. Roudebush VA Medical Center, Indianapolis, IN
state: Indiana
Study officials:
affiliation: Richard L. Roudebush VA Medical Center, Indianapolis, IN
name: Marianne Sassi Matthias, PhD MS BA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.