Clinical trial NCT05894772: Evaluating a Virtual Stepped Care Portal in Youth Awaiting Tertiary Chronic Pain Care: An Implementation-Effectiveness Hybrid Type III Study
Official title: Evaluating a Virtual Stepped Care Portal in Youth Awaiting Tertiary Chronic Pain Care: An Implementation-Effectiveness Hybrid Type III Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: University of Calgary
name: University of Saskatchewan
name: Centre for Addiction and Mental Health
name: University of British Columbia
name: Memorial University of Newfoundland
name: University of Alberta
name: St. Justine's Hospital
name: McMaster Children's Hospital
name: Dalhousie University
name: Montreal Children's Hospital of the MUHC
name: Children's Hospital of Eastern Ontario
name: Provincial Health Services Authority
name: Seattle Children's Hospital
name: University Health Network, Toronto
name: London Health Sciences Centre
name: Quebec Pain Research Network
First posted: 2023-06-08
Enrollment: 93
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Implementation-effectiveness quasi-experimental design
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Acceptability
timeFrame: 16 weeks
measure: Adoption
timeFrame: 16 weeks
measure: Appropriateness
timeFrame: 16 weeks
measure: Portal Feasibility
timeFrame: 16 weeks
measure: Fidelity
timeFrame: 16 weeks
Secondary outcomes:
measure: Pain Intensity
timeFrame: 16 weeks
measure: Pain Interference
timeFrame: 16 weeks
measure: Anxiety
timeFrame: 16 weeks
measure: Depression
timeFrame: 16 weeks
measure: Insomnia
timeFrame: 16 weeks
measure: Health Related Quality of Life
timeFrame: 16 weeks
measure: School Attendance
timeFrame: 16 weeks
measure: Healthcare Utilization
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Center
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: London
country: Canada
facility: Children's Hospital London Health Sciences
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario (CHEO)
state: Ontario
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
city: Saskatoon
country: Canada
facility: Jim Pattison
state: Saskatchewan
city: Calgary
country: Canada
facility: Alberta Children's Hospital
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
city: Montreal
country: Canada
facility: Montreal Children's Hospital
city: Vancouver
country: Canada
facility: BC Children's Hospital
Study officials:
References: