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

Chronic Pain Clinical Trial

— ECLIPSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02380690
• Other study ID #: IIR 14-070
• Secondary ID: 1410626162
• Status: Completed
• Phase: N/A
• Start date: May 1, 2015
• Est. completion date: August 1, 2019

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain
• Pain

Intervention

Behavioral:
• Peer Coach Assignment
Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.

Locations

Country	Name	City	State
United States	Richard L. Roudebush VA Medical Center, Indianapolis, IN	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (4)

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 — View 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 character — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Perceived Social Support	Measures perceptions of social support.(Range: 12-84, higher numbers = higher perceptions of social support)	6 months
Secondary	Perceived Social Support	Measures perceptions of social support.(Range: 12-84, higher numbers = higher perceptions of social support)	9 months
Secondary	Self Efficacy	Adapted from the Arthritis Self Efficacy Scale (Range 0-10, higher numbers = higher self efficacy)	6 months
Secondary	Self Efficacy	Adapted from the Arthritis Self Efficacy Scale (Range 0-10, higher numbers = higher self efficacy)	9 months
Secondary	Anxiety	GAD-7 (Range 0-21, higher numbers = higher anxiety)	6 months
Secondary	Anxiety	GAD-7 (Range 0-21, higher numbers = higher anxiety)	9 months
Secondary	Depression	PHQ-8 (Range: 0-24, higher numbers = higher depression)	6 months
Secondary	Depression	PHQ-8 (Range: 0-24, higher numbers = higher depression)	9 months
Secondary	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
Secondary	Patient Activation	Patient Activation Measure (Range: 0-100, higher numbers = higher activation)	6 months
Secondary	Patient Activation	Patient Activation Measure (Range: 0-100, higher numbers = higher activation)	9 months
Secondary	General Health Perceptions	SF-36 General Health Perceptions (Range: 0-100, higher numbers = higher health perceptions)	6 months
Secondary	General Health Perceptions	SF-36 General Health Perceptions (Range: 0-100, higher numbers = higher health perceptions)	9 months