Power Over Pain Portal: A Stepped-care Virtual Solution to Deliver Early Intervention to Canadian Youth With Chronic Pain

The COVID-19 pandemic is presenting one of the greatest threats to youth mental health seen in generations. Pain is one of the most common symptoms of extreme stress in youth. In 2020, the investigators created an online "stepped-care" program called the Power over Pain Portal. Stepped care is a promising way to improve access to CP care. Stepped care tailors care based on a person's symptom severity. Like a ladder, a person must start with one type of care then "step up" or "step down" to more or less intense care depending on need. The investigators also summarized all online pain management programs for youth to find the best resources to embed into the Portal. The investigators will pilot-test the Portal with youth to ensure it can be implemented effectively and will be clinically beneficial. The investigators will recruit 100 youth with CP to use the Portal for 2 months and see how they interact with the features and if it helps to improve their pain and mental health. The investigators will include a mixture of youth who represent different ages, sexes, genders, sexual orientations, races, dwellings, and school/employment status.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Power over Pain Portal

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Chitra Lalloo, PhD; Phone Number: 302332 416-813-7654; Email: chitra.lalloo@sickkids.ca
• Study Contact Backup: Name: Jennifer N Stinson, RN, PhD; Phone Number: 304514 416-813-7654; Email: jennifer.stinson@sickkids.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Recruiting
      • The Hospital for Sick Children
      • Principal Investigator: Jennifer Stinson, RN, PhD
      • Contact: Rachel Kelly, BA; Phone Number: 302314 416-813-7654; Email: rachelr.kelly@sickkids.ca
      • Contact: Chitra Lalloo, BHSc, PhD; Phone Number: 302332 416-813-7654; Email: chitra.lalloo@sickkids.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from a community-based sample of 100 youth with chronic pain using respondent-driven sampling (RDS), a network-based (i.e. snowball-type) method wherein a diverse group of youth with chronic pain ("seeds") provide study information to members of their social networks

As per RDS recommendations, the "seeds" will be sociodemographically diverse, live in a variety of geographical areas, and be "high energy sociometric stars" who are committed to the study goals (i.e., our diverse youth advisory group). this strategy will seek to maximize variability in age, sex, gender, ethnicity, SES and rurality.

This study focuses on youth marginalized by membership in racialized groups, SES as defined by neighbourhood, rural/urban status, sex and gender, and sexual orientation. Those belonging to a racialized group, living in a low SES neighbourhood, and/or rural location will be considered marginalized.

Description

Inclusion Criteria:

• Experience chronic pain
• Speak and read English
• Access to Internet / Smartphone (or will be loaned study phone with data plan)
• Intend to use the portal for 2 months

Exclusion Criteria:

• Youth self-reports:
• Receiving tertiary care or are on waitlists for tertiary care paediatric chronic pain programs
• Have moderate to severe cognitive impairment that may impact their ability to understand and use the Power over Pain Portal or complete self-reported outcomes
• Have untreated major psychiatric illness (e.g., anorexia, psychosis) and/or active suicidality at the time of screening

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	This will be assessed using the Acceptability e-Scale administered at T2 and assessed during the post-implementation qualitative interview. The minimum value is 1 and the maximum value is 5. Higher scores on the Acceptability e-Scale indicate a better outcome.	8 weeks
Adoption (i.e.,rate of uptake of the Power over Pain Portal)	Characterized via the user-level analytics of interactions with each feature. The benchmark will be 75% of users completing 3/4 portal assessment and accessing ≥ portal intervention.	8 weeks
Appropriateness (i.e., perceived fit and compatibility of the Power over Pain Portal to the needs of users)	Assessed via the post-implementation qualitative interview.	8 weeks
Portal Feasibility as assessed by the extent to which the Power over Pain Portal can be used as planned	Assessed using frequency counts and percentages of types/severity of problems encountered via monthly audit of technical support tickets	8 weeks
Portal Feasibility as assessed by the extent to which the Power over Pain Portal can be used as planned	Assessed via characterization of the severity of encountered issues on the Power over Pain portal	8 weeks
Fidelity	Characterized by intervention use analytics.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client outcomes	Pain intensity as assessed by the 1-item PROMIS pediatric numeric rating scale v1.0 - Pain Intensity. This maximum score on the scale is 10 and the minimum score is 0, with higher scores indicating higher levels of pain experienced by the participant. This will be administered at T1 and T2	8 weeks
Client outcomes	Pain interference as assessed by the the PROMIS pediatric short form v2.0 - Pain Interference 8a. The maximum score on the scale is 5 and the lowest score is 1, with higher scores indicating higher pain interference in the participant's life. This will be administered at T1 and T2.	8 weeks
Client outcomes	Anxiety as assessed by the the PROMIS pediatric short form v2.0 - Anxiety 8a. The maximum score on the scale is 5 and the lowest score is 1, with higher scores indicating higher levels of anxiety in the participant's life. This will be administered at T1 and T2.	8 weeks
Client outcomes	Depressive symptoms as assessed by the the PROMIS pediatric short form v2.0 - Depressive Symptoms 8a. The maximum score on the scale is 5 and the lowest score is 1, with higher scores indicating higher levels of depression in the participant's life. This will be administered at T1 and T2.	8 weeks
Client outcomes	Insomnia as assessed by the the 7-item Insomnia Severity Index. The maximum score on the scale is 4 and the lowest score is 0, with higher scores indicating more severe levels of insomnia experienced by the patient. This will be administered at T1 and T2.	8 weeks

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Canadian Institutes of Health Research (CIHR)

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2022
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: REB#

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No