Evaluating a Virtual Stepped Care Portal in Youth Awaiting Tertiary Chronic Pain Care: An Implementation-Effectiveness Hybrid Type III Study

NCT05894772 | Recruiting

• 1 other identifier: 4025
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (5)

• Acceptability

  Will be assessed using the Acceptability e-Scale administered at T2 and during the qualitative interview. Participants rate features of the portal on a scale from 1-5 with higher scores indicating higher acceptability.

  16 weeks

• Adoption

  Characterized via participant-level analytics of interactions with each feature. The benchmark will be \>60% of participants completing ≥ 1 portal intervention.

  16 weeks

• Appropriateness

  Perceived fit and compatibility of portal participants' needs. Assessed via the qualitative interview at T2.

  16 weeks

• Portal Feasibility

  Degree to which to PoP Portal could be used as intended. Will be assessed via monthly audit of support tickets and characterization of the severity of encountered issues.

  16 weeks

• Fidelity

  Degree to which the PoP Portal and each intervention independently (WEBMap, iCanCope, iPeer2Peer) was used as intended. Will be characterized by intervention use analytics.

  16 weeks

Secondary Outcomes (8)

• Pain Intensity

  16 weeks

• Pain Interference

  16 weeks

• Anxiety

  16 weeks

• Depression

  16 weeks

• Insomnia

  16 weeks

Study Arms (1)

Intervention arm

EXPERIMENTAL

Power over Pain Portal

Behavioral: Power over Pain Portal

Interventions

Power over Pain Portal BEHAVIORAL

Youth from different ages, sexes, gender, sexual orientations, races, dwelling and school/employment status will receive access to the Power over Pain Portal for 4 months. The portal consists of self-assessment tools (bi-weekly check-ins to provide users with feedback on their mood, anxiety, pain, and sleep and guide decision making on choice of interventions), evidence-based virtual educational (pain neuroscience) and cognitive behavioural therapy (CBT) pain interventions that are delivered in a stepped care manner based on participant needs/preference. The overall objective is to determine the implementation (guided by Proctor's implementation conceptual framework) and clinical effectiveness of the PoP Portal in a sample of youth (12-18 years of age) who are on the waitlist for tertiary care consultation at any pediatric CP clinic in Canada.

Intervention arm

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Experience chronic pain
• Speak and read English or French
• Have access to internet / smartphone (or are willing to be loaned a study phone with a data plan)
• Are on the waitlist of a tertiary care CP clinic in Canada
• Intend to use the PoP Portal for at least 4 months
• Have the capacity to consent

You may not qualify if:

• Have moderate to severe cognitive impairments that may impact their ability to understand and use the PoP Portal or complete self-reported clinical outcome measures

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• University of Calgary: collaborator
• University of Saskatchewan: collaborator
• Centre for Addiction and Mental Health: collaborator
• University of British Columbia: collaborator
• Memorial University of Newfoundland: collaborator
• University of Alberta: collaborator
• St. Justine's Hospital: collaborator
• McMaster Children's Hospital: collaborator
• Dalhousie University: collaborator
• Montreal Children's Hospital of the MUHC: collaborator
• Children's Hospital of Eastern Ontario: collaborator
• Provincial Health Services Authority British Columbia: collaborator
• Seattle Children's Hospital: collaborator
• University Health Network, Toronto: collaborator
• London Health Sciences Centre: collaborator
• Quebec Pain Research Network: collaborator

Study Sites (11)

IWK Health Center

Halifax, Nova Scotia, Canada

NOT YET RECRUITING

McMaster Children's Hospital

Hamilton, Ontario, L8S 4K1, Canada

RECRUITING

Children's Hospital London Health Sciences

London, Ontario, N6A 5W9, Canada

NOT YET RECRUITING

Children's Hospital of Eastern Ontario (CHEO)

Ottawa, Ontario, Canada

NOT YET RECRUITING

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

NOT YET RECRUITING

Jim Pattison

Saskatoon, Saskatchewan, Canada

NOT YET RECRUITING

Alberta Children's Hospital

Calgary, Canada

NOT YET RECRUITING

Stollery Children's Hospital

Edmonton, Canada

NOT YET RECRUITING

Montreal Children's Hospital

Montreal, Canada

NOT YET RECRUITING

BC Children's Hospital

Vancouver, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jennifer N Stinson, RN, PhD

CONTACT

416-813-7654; jennifer.stinson@sickkids.ca

Chitra Lalloo, PhD

CONTACT

416-813-7654; chitra.lalloo@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Model Details: Implementation-effectiveness quasi-experimental design

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 8, 2023
• Study Start: August 5, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

CA (11)