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Pilot of Peers Enhancing Engagement for Pain Services (PEEPS)

Primary Purpose

Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PEEPS
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pain focused on measuring chronic pain, peer support

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Veteran receiving care from VA Connecticut Healthcare System referred to a VA Connecticut Pain Management Team has high-impact chronic pain as defined by the Graded Chronic Pain Scale - Revised willing/able to participate in sessions either in person or via video Exclusion Criteria: moderate to severe cognitive impairment or apparent difficulty communicating with the research staff inability to read or understand English severely impaired hearing or speech that would preclude them from participating in telephone interviews

Sites / Locations

  • VA Connecticut Healthcare System West Haven Campus, West Haven, CTRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

peer specialist

Arm Description

Work with a peer specialist for six 30-minute sessions

Outcomes

Primary Outcome Measures

Feasibility - Number of completers
Number of Veterans who completed at least 3 sessions with the peer specialist
Acceptability
Intervention acceptability as indicated by results of qualitative interviews

Secondary Outcome Measures

Feasibility - Recruiting 24 participants
Ability to recruit 24 participants over the study period
Feasibility - Enrollment of >15% of those invited
An enrollment rate of greater or equal to 15% of those invited to participate
Feasibility - Retention >60%
A retention rate of greater or equal to 60% of enrolled Veterans completing follow-up measures
Acceptability - Quantitative
Intervention acceptability as indicated by a score of 24 or greater on the CSQ-8

Full Information

First Posted
December 16, 2022
Last Updated
May 3, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05681520
Brief Title
Pilot of Peers Enhancing Engagement for Pain Services
Acronym
PEEPS
Official Title
Pilot of Peers Enhancing Engagement for Pain Services
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Chronic non-cancer pain is common among Veterans, and more work is needed to understand how best to support Veterans with chronic pain to improve pain-related function and quality of life. Peer specialists may be valuable resource to support Veterans in pain management. Peer specialists, individuals with lived experience who are hired and trained to work with Veterans, are increasingly being used outside traditional mental health settings. More research is needed to understand how best to train peer specialists to work in new settings and with new presenting problems, such as chronic pain. Peer support to help Veterans improve pain-related function, increase physical activity, and engage in recommended pain care, is especially needed. In this study, the investigators will finalize a peer-led intervention and then pilot it with 24 Veterans with chronic pain in order to establish feasibility and acceptability; results will be used to develop a larger proposal testing the intervention in a randomized trial.
Detailed Description
Background: Chronic pain, and particularly high-impact chronic pain (that is, pain last three months or longer that impacts daily functioning in one or more domains) is a leading cause of disability, often associated with declining functioning, lost days of work, and worsened quality of life. The Veterans Health Administration (VHA) identified both improved pain management and reduced opioid-related harms as national priorities, with an emphasis on improving function and pain-related disability. Peer specialists may be an untapped and valuable resource to support Veterans with chronic pain and enhance the effectiveness of pain treatment. Peer specialists are individuals with lived experience who work with Veterans to encourage patient activation and help patients manage chronic conditions. Peer specialists work in a variety of clinical settings, most commonly mental health clinics, and are well-suited to help patients who are harder to engage in services or those needing more support to promote self-management strategies. Peer support is particularly effective for patients with more severe illnesses or higher levels of distress, and thus may be helpful for Veterans with high-impact chronic pain. Significance: Chronic pain is one of the most common and costly problems among Veterans using VHA healthcare. VHA guidelines for pain management and opioid therapy encourage non-pharmacological pain management strategies (NPMs) and non-opioid medications for chronic pain management. However, NPMs that emphasize improved pain-related function are often underutilized. Addressing pain management and opioid misuse are VHA priorities and this research directly aligns with VHA Rehabilitation Research & Development (RR&D) priorities, including promotion of non-pharmacological activity-based interventions for chronic pain, impacting outcomes such as pain; it also aligns with RR&D's broader goal of maximizing Veteran's function and quality of life. Innovation & Impact: The role of peer specialists in VHA is rapidly expanding beyond traditional mental health settings, leading to an urgent need for additional research to understand how best to use peer specialists' unique skills to enhance care for Veterans in a wider range of settings. No studies to date have evaluated the use of peer specialists to support improvements in pain-related function among Veterans with chronic pain. The current proposal is innovative because it proposes, for the first time, using peer specialists to focus on pain management. If proven effective, this project could pave the way for widespread implementation of peer specialists into new settings where they can support pain management. Specific Aims: The specific aims of this project are to (1) Use intervention mapping (IM) to refine the intervention, Peers Enhancing Engagement for Pain Services (PEEPS) and (2) Pilot test the feasibility and acceptability of PEEPS and collect function-focused outcome measures for use in a rigorous prospective study. Methodology: After refining the intervention protocol using intervention mapping, the investigators propose a single arm pilot trial where the investigators will enroll 24 Veterans with high-impact chronic pain to participate in PEEPS, collecting data at baseline and three-months post baseline. The primary focus will be feasibility and acceptability; the investigators will also collect data on pain-related function, activity (steps walked, using pedometers), and well-being/quality of life. Next Steps/Implementation: These data will inform the development of a larger proposal testing PEEPS in a multicenter randomized controlled trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
chronic pain, peer support

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm pilot study; intervention includes six 30-minute sessions with a peer specialist
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
peer specialist
Arm Type
Experimental
Arm Description
Work with a peer specialist for six 30-minute sessions
Intervention Type
Behavioral
Intervention Name(s)
PEEPS
Other Intervention Name(s)
Peer Specialist Intervention
Intervention Description
Working with a peer specialist for six 30-minute sessions to enhance engagement in pain management approaches/treatments
Primary Outcome Measure Information:
Title
Feasibility - Number of completers
Description
Number of Veterans who completed at least 3 sessions with the peer specialist
Time Frame
through study completion, approximately 18 months
Title
Acceptability
Description
Intervention acceptability as indicated by results of qualitative interviews
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Feasibility - Recruiting 24 participants
Description
Ability to recruit 24 participants over the study period
Time Frame
through study completion, approximately 18 months
Title
Feasibility - Enrollment of >15% of those invited
Description
An enrollment rate of greater or equal to 15% of those invited to participate
Time Frame
through study completion, approximately 18 months
Title
Feasibility - Retention >60%
Description
A retention rate of greater or equal to 60% of enrolled Veterans completing follow-up measures
Time Frame
through study completion, approximately 18 months
Title
Acceptability - Quantitative
Description
Intervention acceptability as indicated by a score of 24 or greater on the CSQ-8
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Pain Interference
Description
Brief Pain Inventory (BPI); we are piloting this measure for use in a future randomized trial. One-point decrease is often considered clinically meaningfully (range 0-10, lower scores are better).
Time Frame
3 months
Title
Physical Function
Description
Steps per day as measured by pedometer; we are piloting this measure for use in a future randomized trial. Improvement indicated by increased average steps per day.
Time Frame
3 months
Title
Well-being
Description
Well-Being Signs tool; we are piloting this three-item measure for use in a future randomized trial (higher scores are better, range 0-10)
Time Frame
3 months
Title
Quality of Life
Description
Health-related quality of life as measured by SF12; we are piloting this measure for use in a future randomized trial (range 0-100, higher scores are better)
Time Frame
3 months
Title
Pain self-management
Description
Modified version of Chronic Pain Coping Inventory (CPCI); we are piloting this measure for use in a future randomized trial. Improvement indicated by increased use of adaptive pain coping skills (items are scored 0 to 7, higher scores better)
Time Frame
3 months
Title
Healthcare engagement
Description
Altarum Consumer Engagement (ACE); we are piloting this measure for use in a future randomized trial. Improvement indicated by more engagement with healthcare (items are scored 1 to 5, high scores better)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veteran receiving care from VA Connecticut Healthcare System referred to a VA Connecticut Pain Management Team has high-impact chronic pain as defined by the Graded Chronic Pain Scale - Revised willing/able to participate in sessions either in person or via video Exclusion Criteria: moderate to severe cognitive impairment or apparent difficulty communicating with the research staff inability to read or understand English severely impaired hearing or speech that would preclude them from participating in telephone interviews
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Edmond, PhD
Phone
(203) 932-5711
Ext
3288
Email
sara.edmond@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer L Snow, MSc
Phone
(203) 932-5711
Email
jennifer.snow1@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Edmond, PhD
Organizational Affiliation
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516-2770
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Edmond, PhD
Phone
203-932-5711
Ext
3288
Email
sara.edmond@va.gov
First Name & Middle Initial & Last Name & Degree
Sara Edmond, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
A de-identified, anonymized dataset will be created and shared. Datasets meeting VA standards for disclosure to the public will be made available within 1 year of publication by contacting the study PI. Prior to distribution, a local privacy officer will certify that all datasets contains no PHI. Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access. Guidance on request and distribution processes will be provided by ORD. Those requesting data will be asked to sign a Letter of Agreement.
IPD Sharing Time Frame
The data will become available within 1 year of publication. The analytical datasets and statistical code used in the publication will be retained for 6 years, in accordance with VA record retention policy.
IPD Sharing Access Criteria
Guidance on request and distribution processes will be provided by ORD. Those requesting data will be asked to sign a Letter of Agreement. De-identified data will be provided after requesters sign a Letter of Agreement detailing the mechanisms by which the data will be kept secure and access restricted to their study team and will state that the recipient will not attempt to identify any individual whose data are included and will not share the data.

Learn more about this trial

Pilot of Peers Enhancing Engagement for Pain Services

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