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Clinical Trials/NCT05894772
NCT05894772
Recruiting
Not Applicable

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

The Hospital for Sick Children11 sites in 1 country93 target enrollmentAugust 5, 2023
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
The Hospital for Sick Children
Enrollment
93
Locations
11
Primary Endpoint
Acceptability
Status
Recruiting
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 5, 2023
End Date
September 1, 2025
Last Updated
10 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer Stinson

Senior Scientist

The Hospital for Sick Children

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
  • Have untreated major psychiatric illness (e.g., anorexia, psychosis) and/or active suicidality as assessed by the PoP Portal screening. Youth who have co-occurring clinically significant anxiety or depression that is currently being treated will be eligible if they meet other inclusion criteria.

Outcomes

Primary Outcomes

Acceptability

Time Frame: 16 weeks

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.

Fidelity

Time Frame: 16 weeks

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

Adoption

Time Frame: 16 weeks

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

Portal Feasibility

Time Frame: 16 weeks

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.

Appropriateness

Time Frame: 16 weeks

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

Secondary Outcomes

  • Pain Intensity(16 weeks)
  • Pain Interference(16 weeks)
  • Anxiety(16 weeks)
  • Depression(16 weeks)
  • Insomnia(16 weeks)
  • Healthcare Utilization(16 weeks)
  • Health Related Quality of Life(16 weeks)
  • School Attendance(16 weeks)

Study Sites (11)

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