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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05894772
• Other study ID #: 4025
• Status: Recruiting
• Phase: N/A
• Start date: August 5, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: The Hospital for Sick Children
• Contact: Jennifer N Stinson, RN, PhD
• Phone: 416-813-7654
• Email: jennifer.stinson[@]sickkids.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 93
• Est. completion date: December 31, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Power over Pain Portal
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.

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary
Canada	Stollery Children's Hospital	Edmonton
Canada	IWK Health Center	Halifax	Nova Scotia
Canada	McMaster Children's Hospital	Hamilton	Ontario
Canada	Children's Hospital London Health Sciences	London	Ontario
Canada	CHU Sainte-Justine	Montreal	Quebec
Canada	Montreal Children's Hospital	Montreal
Canada	Children's Hospital of Eastern Ontario (CHEO)	Ottawa	Ontario
Canada	Jim Pattison	Saskatoon	Saskatchewan
Canada	Hospital for Sick Children	Toronto	Ontario
Canada	BC Children's Hospital	Vancouver

Sponsors (17)

Lead Sponsor

Collaborator

The Hospital for Sick Children

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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Adoption	Characterized via participant-level analytics of interactions with each feature. The benchmark will be >60% of participants completing = 1 portal intervention.	16 weeks
Primary	Appropriateness	Perceived fit and compatibility of portal participants' needs. Assessed via the qualitative interview at T2.	16 weeks
Primary	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
Primary	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	Pain Intensity	Will be measured using the PROMIS Pain Intensity Scale which assesses pain the past 7 days using an 11-point numerical rating scale (NRS) with verbal anchors "no pain" at 0 and "worst pain you can think of" at 10. This tool demonstrates relevance, feasibility, and understandability for youth with chronic pain.	16 weeks
Secondary	Pain Interference	Will be assessed using the PROMIS Pain Interference Short-form Scale and 8-item tool that uses a 5-point Likert scale, ranging from never to almost always, with higher scores representing greater interference with function.	16 weeks
Secondary	Anxiety	Will be assessed using a PROMIS Paediatric Anxiety Short-form Scale, an 8-item tool that uses a 5-point Likert scale, ranging from never to almost always, with higher scores representing more anxiety symptoms.	16 weeks
Secondary	Depression	Will be assessed using PROMIS Paediatric Depression Short-form Scale, an 8-item tool that used a 5-point Likert scale, ranging from never to almost always, with higher scores representing more depressive symptoms.	16 weeks
Secondary	Insomnia	Will be assessed using a 7-item Insomnia Severity Index, higher score representing more severe insomnia.	16 weeks
Secondary	Health Related Quality of Life	Will be assessed using a 7-item PROMIS Paediatric Global Health Short-form Scales with higher scores representing overall better health.	16 weeks
Secondary	School Attendance	Will be assessed using a single item modified by investigators to capture school absenteeism as a continuous variable ranging from 0 to 240 days. Self-report of school attendance among a CP population is comparable to school administrative data.	16 weeks
Secondary	Healthcare Utilization	Will capture family physician and emergency visits, psychological or physical therapies and changes in medication, using a CP modified version of Ambulatory and Home Care Record at T1 and T2.	16 weeks