Tele-Collaborative Care for Chronic Pain

(CORPs Trial)

Recruiting at 3 trial locations

Overseen By Natassja Pal, BS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Oregon Health and Science University

Disqualifiers: Cognitive impairment, Terminal illness, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 16 weeks

608 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a nurse-led, remote care program (CORPs Intervention) manages chronic pain more effectively than standard care. Participants will either join a group receiving regular check-ins and resources or one attending a single educational session. The trial seeks U.S. veterans living in rural areas who experience chronic pain that disrupts daily activities. Participants must have a phone and be able to speak English. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for chronic pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team for clarification.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that treatments like the CORPs Intervention are generally well-tolerated by people with chronic pain. In studies, many participants experienced noticeable relief with similar pain management strategies. For instance, about 8 out of 10 people reported moderate pain relief with these types of interventions.

The CORPs Intervention is a program led by nurses that includes regular check-ins and educational sessions. It focuses on non-medication options, reducing the risk of side effects often linked to pain medications. While all treatments carry some risks, this approach emphasizes safe and supportive care to manage pain effectively.

This trial is in a later phase, indicating that earlier stages have already tested the treatment for safety. This suggests it is generally safe, although individual experiences can vary. Overall, current evidence supports the intervention as safe and effective for managing chronic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional chronic pain treatments that often rely heavily on medications, the CORPs Intervention stands out for its comprehensive, non-medication approach. It involves a nurse-led program that emphasizes personalized care coordination and patient education, providing continuous support through regular check-ins and optional virtual classes on pain management. Researchers are excited about this method because it empowers patients to manage pain using integrative techniques, potentially reducing reliance on medications and improving overall quality of life.

What evidence suggests that this trial's treatments could be effective for chronic pain?

Research has shown that the CORPs Intervention, a treatment in this trial, can greatly aid in managing chronic pain. Studies have found that this tele-collaborative care model, particularly for veterans in rural areas, effectively reduces pain's impact on daily life. Specifically, previous participants reported significant improvements in daily pain management. In this trial, participants in the CORPs Intervention arm will collaborate with a nurse care manager to set goals and organize care, a proven strategy for better chronic pain management. This method emphasizes non-medication options, providing a comprehensive and supportive plan for pain relief. ^{6 7 8 9 10}

Who Is on the Research Team?

Travis Lovejoy, PhD, MPH

Principal Investigator

Oregon Health & Science University, VA Portland Health Care System

Benjamin Morasco, PhD

Principal Investigator

Oregon Health & Science University, VA Portland Health Care System

Are You a Good Fit for This Trial?

This trial is for U.S. veterans living in rural areas with chronic pain that significantly affects their daily life. Participants must speak English, have access to a phone and the internet, and be able to consent electronically. Those with recent surgery, cognitive impairments, plans to move soon, or currently in other pain studies cannot join.

Inclusion Criteria

U.S. Veteran

Access to landline or cell phone

Internet Access

Exclusion Criteria

I have not had surgery in the last 3 months.

Inability, or unwillingness, to complete informed consent via DocuSign

I do not have any cognitive issues that would affect my participation in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a nurse-led tele-collaborative pain care intervention or a one-time education session

16 weeks

5 check-in appointments (phone/video) at 2-, 4-, 8-, 12-, and 16-weeks

Follow-up

Participants are monitored for pain interference, depressive symptoms, suicidal behavior, anxiety symptoms, quality of sleep, engagement in non-pharmacological services, pain intensity, physical functioning, and quality of life

12 months

Research assessments at 3-, 6-, 9-, and 12-months by phone

Optional Education

Optional 6-week virtual group education class covering topics like complementary and integrative approaches to pain, sleep and pain, and the neurobiology of pain

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CORPs Intervention
• Minimally Enhanced Usual Care (MEUC)

Trial Overview

The study is testing two approaches: Minimally Enhanced Usual Care (MEUC) versus CORPs Intervention for managing chronic pain in rural veterans. It aims to refine methods for a larger trial by assessing recruitment strategies and intervention effectiveness at four VA sites.

How Is the Trial Designed?

Group I: CORPs Intervention Active Control 1 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 II: Minimally Enhanced Usual Care (MEUC) Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

North Texas Veterans Healthcare System

Collaborator

Trials

39

Recruited

4,005,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Minneapolis Veterans Affairs Medical Center

Collaborator

Trials

77

Recruited

355,000+

Portland VA Medical Center

Collaborator

Trials

44

Recruited

7,800+

VA Tennessee Valley Health Care System

Collaborator

Trials

1

Recruited

610+

VA Tennessee Valley Health Care System

Collaborator

Trials

5

Recruited

1,400+

Published Research Related to This Trial

The OPTI study involved 100 veterans with chronic pain and high-risk opioid use, testing a 12-week Collaborative Care intervention aimed at improving opioid safety and promoting non-drug pain management strategies.

Preliminary results suggest that the intervention, which included personalized Pain Care Plans and Motivational Interviewing sessions, may enhance the management of chronic pain and reduce reliance on prescription opioids among veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing pain treatment interventions (OPTI): A pilot randomized controlled trial of collaborative care to improve chronic pain management and opioid safety-Rationale, methods, and lessons learned. Seal, KH., Borsari, B., Tighe, J., et al.[2020]

A study involving 753 patients over 24 months found that those with suspected adverse drug reactions (ADRs) experienced significantly higher pain intensity and more adverse events compared to controls, indicating a need for careful monitoring in chronic non-cancer pain management.

The pharmacovigilance data recording system improved the management of pain therapy, leading to better patient health outcomes and potentially reducing healthcare costs, as it identified previously unknown ADRs and highlighted the risks associated with polypharmacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health benefits of an adverse events reporting system for chronic pain patients using long-term opioids. Planelles, B., Margarit, C., Ajo, R., et al.[2020]

An online self-management program for chronic pain was developed with the active involvement of people with lived experience (PWLE), ensuring the content is relevant and sensitive to their needs.

Usability testing showed that the program, which includes eight interactive modules and motivational interviewing coaching, was highly accessible and easy to use, setting the stage for future studies on its effectiveness in helping individuals manage chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience-based design: Empowering individuals while they wait for interprofessional chronic pain care. Bosma, R., Bisson, EJ., Cooper, LK., et al.[2023]

Citations

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pmc.ncbi.nlm.nih.gov

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Across outcome domains, pain intensity and emotional functioning were the most frequently assessed in XR trials across the life span and in ...