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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Peer Coach Assignment


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peer Coach Assignment<br>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<br>* Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.<br>|
| No Intervention: Control<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self-management, peer support, social support