Tele-Collaborative Outreach to Rural Patients With Chronic Pain

NCT ID: NCT06091202

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

608 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-11

Study Completion Date

2027-06-01

Brief Summary

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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

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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

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CORPs Intervention

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.

Group Type ACTIVE_COMPARATOR

CORPs Intervention

Intervention Type BEHAVIORAL

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.

Minimally Enhanced Usual Care (MEUC)

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.

Group Type PLACEBO_COMPARATOR

Minimally Enhanced Usual Care (MEUC)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Nurse-led collaborative care One-time Education Session

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Portland VA Medical Center

FED

Sponsor Role collaborator

Minneapolis Veterans Affairs Medical Center

FED

Sponsor Role collaborator

North Texas Veterans Healthcare System

FED

Sponsor Role collaborator

VA Tennessee Valley Health Care System

FED

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Travis Lovejoy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Travis Lovejoy, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Oregon Health & Science University, VA Portland Health Care System

Benjamin Morasco, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health & Science University, VA Portland Health Care System

Locations

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VA Minneapolis Health Care System

Minneapolis, Minnesota, United States

Site Status RECRUITING

VA Portland Health Care System

Portland, Oregon, United States

Site Status RECRUITING

VA Tennessee Valley Health Care System

Nashville, Tennessee, United States

Site Status RECRUITING

VA North Texas Health Care System

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Natassja Pal, BS

Role: CONTACT

503-220-8262 ext. 55536

Facility Contacts

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Gloria Wang, BA

Role: primary

612-467-2693

Hannah Flegal, BA

Role: primary

503-220-8262 ext. 58320

Thomas Rangsikul, BA

Role: primary

615-873-8648

Jazmyn Criss, BS

Role: primary

214-857-3040

Kanika Allison-Coleman

Role: backup

214-857-4546

Other Identifiers

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1UG3AT012257-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

4UH3AT012257-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

25384

Identifier Type: -

Identifier Source: org_study_id

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