Trials / Recruiting
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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | CORPs Intervention | 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. |
| BEHAVIORAL | Minimally 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.