Virtual Stepped Care Program for Chronic Pain

Recruiting at 10 trial locations

Overseen By Chitra Lalloo, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Disqualifiers: Cognitive impairments, Untreated psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

93 Participants Needed

Trial Summary

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 seems focused on using an online program to help manage chronic pain, so you may not need to change your medication routine.

What data supports the effectiveness of the treatment Power over Pain Portal for chronic pain?

The Empower Veterans Program (EVP) shows positive outcomes for veterans with chronic pain by teaching self-care skills through a whole health approach, which aligns with the goals of the Power over Pain Portal. Additionally, the Patient Education Empowerment Programme (PEEP) adapted to a telehealth format (ePEEP) was found to be feasible and acceptable, suggesting that virtual programs can effectively support individuals with chronic pain. ^{1 2 3 4 5}

Is the Virtual Stepped Care Program for Chronic Pain safe for humans?

The available research does not provide specific safety data for the Virtual Stepped Care Program for Chronic Pain or its related programs like the Power over Pain Portal. However, these programs focus on non-drug approaches, which generally have fewer safety concerns compared to traditional medication-based treatments. ^{1 2 6 7 8}

How is the Power over Pain Portal treatment different from other treatments for chronic pain?

The Power over Pain Portal is unique because it offers a virtual stepped care program that combines self-management education and remote pain management through video-conferencing, making it accessible and adaptable for patients who may not have easy access to traditional face-to-face pain services. ^{5 8 9 10 11}

What is the purpose of this trial?

Pain is one of the most common symptoms of extreme stress in youth. Without treatment, short-term pain can last for months to years (called 'chronic pain'; CP), a problem already affecting 1 in 5 Canadian youth. The COVID-19 pandemic is one of the greatest threats to youth mental health seen in generations. CP in childhood can trigger a wave of mental health issues that last well into adulthood. In 2019, we learned that "access to pain care" is poor and a priority for youth with CP and their families. Unfortunately, COVID-19 has only made access more difficult. In 2020, we created an online "stepped care" program called the Power over Pain Portal for youth with CP. Stepped care is a promising way to improve access to CP care by tailoring care based on the symptoms each youth is experiencing. Like a ladder, youth start with one type of care and then "step up" or "step down" to more or less intense care depending on what they need. Over the past year, funded by CIHR, we worked with hundreds of youth and healthcare professionals across Canada to understand how the pandemic has affected pain and mental health. We also summarized all online pain self-management programs including peer support for youth to find the best resources to include in the Portal and will translate the portal content into French. Together with a diverse group of youth with CP, we have now co-designed the online Portal. The next step (focus of this grant) is to test the Portal with youth to ensure it can be implemented and is helpful. We will recruit 93 youth with CP waiting for specialist care at 11 CP clinics across Canada to use the Portal for 4 months. We will see how they use the Portal and if it helps to improve their pain and mental health. This study is important because it will allow us to understand how the Portal works in the real world before wide public release (English and French) to support all youth in Canada with CP with accessible, evidence-based pain care.

Eligibility Criteria

This trial is for Canadian youth experiencing chronic pain who are waiting for specialist care. Participants must be willing to use the Power over Pain Portal for 4 months, speak English or French, have internet access or accept a loaned phone with data, and be able to consent. Those with severe cognitive impairments or untreated major psychiatric illnesses are excluded.

Inclusion Criteria

I am able to understand and agree to the study's procedures and risks.

I experience chronic pain.

Intend to use the PoP Portal for at least 4 months

Exclusion Criteria

I have difficulty understanding or using digital tools due to cognitive issues.

I don't have untreated major mental health issues or current suicidal thoughts.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Power over Pain Portal for 4 months to manage chronic pain and mental health

16 weeks

Monthly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after using the Portal

4 weeks

Treatment Details

Interventions

• Power over Pain Portal

Trial Overview The study tests an online 'stepped care' program called the Power over Pain Portal designed for youths with chronic pain. It aims to tailor care based on individual needs and allows users to adjust the intensity of their treatment through the portal as required.

Participant Groups

Group I: Intervention arm Experimental Treatment 1 Intervention

Power over Pain Portal

Power over Pain Portal is already approved in Canada for the following indications:

Approved in Canada as Power Over Pain Portal for:

• Chronic pain management in youth

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Children's Hospital of Eastern Ontario

Collaborator

Trials

134

Recruited

61,000+

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

University of Calgary

Collaborator

Trials

827

Recruited

902,000+

Montreal Children's Hospital of the MUHC

Collaborator

Trials

32

Recruited

117,000+

Seattle Children's Hospital

Collaborator

Trials

319

Recruited

5,232,000+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Provincial Health Services Authority

Collaborator

Trials

40

Recruited

31,900+

University of Saskatchewan

Collaborator

Trials

261

Recruited

156,000+

Centre for Addiction and Mental Health

Collaborator

Trials

388

Recruited

84,200+

Findings from Research

The Empower Veterans Program (EVP) successfully helped 639 veterans with chronic pain by teaching them self-care skills over a 10-week period, with a graduation rate of 69.5% and high participant satisfaction (median rating of 8.41).

Participants reported significant improvements in pain intensity, interference, and catastrophizing, as well as enhancements in physical and psychological well-being, indicating that non-pharmacological approaches can effectively manage chronic pain in veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empower Veterans Program (EVP): a chronic pain management program demonstrates positive outcomes among veterans. Haun, JN., Fowler, CA., Venkatachalam, HH., et al.[2023]

The ePEEP program, a telehealth adaptation of the Patient Education Empowerment Programme for chronic pain, was found to be acceptable and feasible for participants, indicating its potential as a valuable resource for pain management during the COVID-19 pandemic.

Participants reported significant benefits from ePEEP, including personal development, relationship building, and enhanced learning about pain, suggesting that telehealth can effectively support chronic pain management and empower individuals in their health journeys.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"So, you must understand that that group changed everything": perspectives on a telehealth group intervention for individuals with chronic pain. Ernstzen, D., Keet, J., Louw, KA., et al.[2023]

Chronic pain is increasingly recognized as a significant public health issue, necessitating improved management strategies that address its complex nature and impact on patients and communities.

The P.A.I.N. Initiative has been established to enhance pain management quality through workshops for professionals, a software program for documenting patient data, an online discussion forum, and an education program for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pain Associates' International Network Initiative: a novel practical approach to the challenge of chronic pain management in Europe. Morlion, B., Walch, H., Yihune, G., et al.[2011]

The electronic Persistent Pain Outcomes Collaboration (ePPOC) has expanded to support over 100 adult and pediatric services in Australia and New Zealand since its inception in 2013, enhancing care for individuals with persistent pain.

Improvements in benchmarking, quality indicators, and research collaborations have strengthened the integration of quality improvement initiatives within pain services, contributing to a more comprehensive outcomes registry for persistent pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A decade of outcomes: The evolution of an australasian outcomes collaboration for chronic pain services. Holloway, D., Allingham, S., Bryce, M., et al.[2023]

A remotely delivered pain management program (vPMP) was successfully developed and implemented for patients with chronic musculoskeletal pain during the COVID-19 pandemic, involving 14 participants across three cycles.

Patient involvement was crucial in designing the vPMP and addressing challenges such as technical issues and communication, highlighting the importance of stakeholder engagement in remote healthcare solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid design and implementation of a virtual pain management programme due to COVID-19: a quality improvement initiative. Williams, D., Booth, G., Cohen, H., et al.[2022]

The implementation of the Stepped Care Model for Pain Management (SCM-PM) at a large Federally Qualified Health Center led to an 11% increase in primary care providers' knowledge about pain management and improved their confidence in treating pain.

The intervention resulted in significant improvements in pain assessment and management practices, including a 27.3% increase in the use of opioid treatment agreements and a 5.96% increase in referrals to behavioral health providers, indicating a more comprehensive approach to chronic pain care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving pain care through implementation of the Stepped Care Model at a multisite community health center. Anderson, DR., Zlateva, I., Coman, EN., et al.[2020]

Over a four-year study period, the proportion of Veterans receiving high-dose opioids for chronic pain management decreased from 27.7% to 24.7%, indicating a positive shift towards safer opioid prescribing practices.

The implementation of the Stepped Care Model of Pain Management led to increased use of opioid risk mitigation strategies and referrals to non-opioid treatments like physical therapy and topical analgesics, aligning with evidence-based guidelines for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A partnered approach to opioid management, guideline concordant care and the stepped care model of pain management. Dorflinger, L., Moore, B., Goulet, J., et al.[2022]

A scoping review identified 185 virtual care solutions for pediatric chronic pain, with a focus on self-guided apps and websites, indicating a strong availability of resources at lower levels of care.

Significant evidence gaps were found at higher levels of care, particularly in areas requiring more professional involvement, highlighting the need for improved integration with health records and support for various aspects of chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid Evidence and Gap Map of virtual care solutions across a stepped care continuum for youth with chronic pain and their families in response to the COVID-19 pandemic. Birnie, KA., Pavlova, M., Neville, A., et al.[2023]

A new approach using Virtual Patients (VPs) for educating patients with chronic pain, specifically those with rheumatic disorders, received an excellent usability score of 88/100, indicating high satisfaction and effectiveness.

The positive feedback from participants suggests that this VP educational method can successfully empower patients with self-management skills and coping strategies for their chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and evaluation of mobile scenario based learning in the self-management of chronic pain. Koulas, I., Billis, A., Kousouri, N., et al.[2021]

In a study involving 246 participants with chronic pain, the Manage My Pain (MMP) app was associated with lower anxiety levels and reduced pain catastrophizing, indicating its potential effectiveness in managing chronic pain alongside standard care.

Approximately 73.6% of participants agreed to use the app, and those who engaged with it reported significant improvements in mental health outcomes, suggesting that digital tools can enhance patient self-management in chronic pain treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User Engagement and Clinical Impact of the Manage My Pain App in Patients With Chronic Pain: A Real-World, Multi-site Trial. Bhatia, A., Kara, J., Janmohamed, T., et al.[2021]

The Reboot Online chronic pain program saw a 287% increase in registrations during the COVID-19 pandemic, indicating a significant rise in demand for online pain management services.

Despite the increase in participants during the pandemic, the program maintained similar adherence and effectiveness levels as before, with moderate improvements in pain-related outcomes, demonstrating its scalability and efficacy in addressing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Uptake and Effectiveness of a Multidisciplinary Online Program for Managing Chronic Pain before and During the COVID-19 Pandemic. Shiner, CT., Gardner, T., Haskelberg, H., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Empower Veterans Program (EVP): a chronic pain management program demonstrates positive outcomes among veterans. [2023]

2. England pubmed.ncbi.nlm.nih.gov

"So, you must understand that that group changed everything": perspectives on a telehealth group intervention for individuals with chronic pain. [2023]

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

The Pain Associates' International Network Initiative: a novel practical approach to the challenge of chronic pain management in Europe. [2011]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A decade of outcomes: The evolution of an australasian outcomes collaboration for chronic pain services. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Rapid design and implementation of a virtual pain management programme due to COVID-19: a quality improvement initiative. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Improving pain care through implementation of the Stepped Care Model at a multisite community health center. [2020]

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

A partnered approach to opioid management, guideline concordant care and the stepped care model of pain management. [2022]

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

Rapid Evidence and Gap Map of virtual care solutions across a stepped care continuum for youth with chronic pain and their families in response to the COVID-19 pandemic. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Design and evaluation of mobile scenario based learning in the self-management of chronic pain. [2021]

10. Canada pubmed.ncbi.nlm.nih.gov

User Engagement and Clinical Impact of the Manage My Pain App in Patients With Chronic Pain: A Real-World, Multi-site Trial. [2021]

11. England pubmed.ncbi.nlm.nih.gov

The Uptake and Effectiveness of a Multidisciplinary Online Program for Managing Chronic Pain before and During the COVID-19 Pandemic. [2022]