Tele-Collaborative Outreach to Rural Patients With Chronic Pain (CORPs)

Oregon Health & Science University (OHSU)

Status and phase: Enrolling; Phase 3

Conditions: Chronic Pain

Treatments: Behavioral: CORPs Intervention; Behavioral: Minimally Enhanced Usual Care (MEUC)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT06091202

1UG3AT012257-01 (U.S. NIH Grant/Contract)

4UH3AT012257-02 (U.S. NIH Grant/Contract)

25384

Details and patient eligibility

About

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.

Full 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.

Enrollment: 608 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• U.S. Veteran
• Rural Residence based on Rural Urban Commuting Area codes
• High Impact Chronic pain, determined through a phone screening
• Access to landline or cell phone
• English Speaking

Exclusion criteria

• Cognitive impairment that would impact participation in the study
• Plans to move in the next 3 months
• Surgery in the past 3 months
• In long-term inpatient or hospice care
• Terminal illness (defined as life expectancy of less than 12 months)
• Active participation in another pain intervention study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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608 participants in 2 patient groups, including a placebo group

CORPs Intervention

Active Comparator group

Description:

The CORPs Intervention is a nurse-led intervention. A) An intake assessment with a Nurse Care Manager at the start of the study by phone or video to discuss the patient's pain experience, care options, and goals. Resources are provided and focus on non-medication options at the VA, and as appropriate, in the community. B) 5 Check-in phone/video appointments with a Nurse Care Manager, scheduled to take place near 2-, 4-, 8-, 12-, and 16-weeks. These visits will provide further assistance with goal planning and care coordination for pain management. C) Optional 6-week virtual group education class covering topics like complementary and integrative approaches to pain, sleep and pain, and the neurobiology of pain. D) Patients in this arm can contact their nurse with questions for the full 12 months of participation.

Treatment:

Behavioral: CORPs Intervention

Minimally Enhanced Usual Care (MEUC)

Placebo Comparator group

Description:

The minimally enhanced usual care arm is a one-time education session. A) One-time education session with a Nurse Care Manager by phone/video to review pain resources. These resources focus on non-medication options at the VA, and as appropriate, in the community.

Treatment:

Behavioral: Minimally Enhanced Usual Care (MEUC)