Tele-Collaborative Care for Chronic Pain

(CORPs Trial)

Recruiting at 3 trial locations

Overseen By Natassja Pal, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Cognitive impairment, Terminal illness, others

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 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.

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 Tele-Collaborative Care for Chronic Pain safe for humans?

The TelePain intervention, which is a form of tele-collaborative care, has been used in the military health system to manage chronic pain and involves consultations with pain specialists. While the study focused on effectiveness and implementation challenges, it did not report any specific safety concerns, suggesting it is generally safe for use in humans. ^{1 2 3 4 5}

What makes the CORPs Intervention treatment for chronic pain unique?

The CORPs Intervention is unique because it uses tele-collaborative care, which involves remote consultations and discussions with a team of pain specialists through videoconferencing. This approach improves access to expert pain management advice, especially for those in areas with limited specialist availability, and is cost-effective and convenient for patients. ^{1 6 7 8 9}

What data supports the effectiveness of the CORPs Intervention treatment for chronic pain?

Research shows that telehealth interventions, like the TelePain program, can improve access to pain specialists and enhance pain management, leading to better outcomes in pain intensity, sleep, and anxiety. Additionally, videoconferencing for pain management has been found to be satisfactory and cost-effective for patients and staff, suggesting that similar tele-collaborative approaches could be beneficial for chronic pain care. ^{1 3 7 10 11}

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.

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

Inability, or unwillingness, to complete informed consent via DocuSign

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

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Development and implementation of a telehealth-enhanced intervention for pain and symptom management. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

TelePain: Primary Care Chronic Pain Management through Weekly Didactic and Case-based Telementoring. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Videoconferencing for a veteran's pain management follow-up clinic. [2019]

4. Ireland pubmed.ncbi.nlm.nih.gov

Experience-based design: Empowering individuals while they wait for interprofessional chronic pain care. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Stepped Care to Optimize Pain care Effectiveness (SCOPE) trial study design and sample characteristics. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Health benefits of an adverse events reporting system for chronic pain patients using long-term opioids. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

"I Was a Little Surprised": Qualitative Insights From Patients Enrolled in a 12-Month Trial Comparing Opioids With Nonopioid Medications for Chronic Musculoskeletal Pain. [2020]

8. United States 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. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

ECHO Pain Curriculum: Balancing Mandated Continuing Education With the Needs of Rural Health Care Practitioners. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Best practices for virtual care to support youth with chronic pain and their families: a rapid systematic review to inform health care and policy during COVID-19 and beyond. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

A comprehensive review of telehealth for pain management: where we are and the way ahead. [2018]