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RecruitingNCT06091202

Tele-Collaborative Outreach to Rural Patients With Chronic Pain

Tele-Collaborative Outreach to Rural Patients With Chronic Pain: The CORPs Trial

Status
Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
608 (estimated)
Sponsor
Oregon Health and Science University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a randomized controlled trial comparing the effectiveness of a remotely delivered collaborative care intervention for chronic pain versus a minimally enhanced control group. The specific aims of the study are: (1) compare the effectiveness of tele-collaborative pain care vs. minimally enhanced usual care to improve pain interference over 12 months of follow-up, and (2) oversample women and rural veterans of minoritized race/ethnicity to test heterogeneity of treatment effects across birth sex and race/ethnicity.

Detailed description

The CORPs trial is a multisite pragmatic effectiveness trial taking place at four geographically diverse VA sites. The CORPs trial will assess the effectiveness of a nurse-led tele-collaborative pain care intervention (CORPs) compared to a one-time education session with a nurse (minimally enhanced usual care, or MEUC) at improving pain and health outcomes for Veterans living in rural areas. This study focuses on management of pain with non-medication services and therapies. Veterans who enroll will participate for 12-months and will be randomized to one of 2 groups: 1) CORPs (with access to a nurse by phone/video for the duration of the study), or 2) One-time education session with the nurse by phone/video to review resources for pain. All participants complete research assessments at the start of the study, and at 3-, 6-, 9-, and 12-months by phone.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCORPs InterventionParticipants will be randomly assigned to the intervention or to the comparator arm. The follow-up period is 12 months. The primary outcome is a change in pain interference. After the baseline assessment, participants will complete a masked telephone assessments with research staff at 3-, 6-, 9-, and 12-months. A subset of individuals may be invited to participate in a qualitative interview at 12-month follow-up.
BEHAVIORALMinimally Enhanced Usual Care (MEUC)Participants will be randomly assigned to the intervention or to the comparator arm. The follow-up period is 12 months. The primary outcome is a change in pain interference. After the baseline assessment, participants will complete a masked telephone assessments with research staff at 3-, 6-, 9-, and 12-months. A subset of individuals may be invited to participate in a qualitative interview at 12-month follow-up.

Timeline

Start date
2024-07-11
Primary completion
2027-05-01
Completion
2027-06-01
First posted
2023-10-19
Last updated
2025-07-20

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT06091202. Inclusion in this directory is not an endorsement.