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

Study 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.

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

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Behavioral: Power over Pain Portal


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Implementation-effectiveness quasi-experimental design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Power over Pain Portal | Behavioral: Power over Pain Portal<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Insomnia | Will be assessed using a 7-item Insomnia Severity Index, higher score representing more severe insomnia. | 16 weeks | 
| 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 | 
| 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 | 
| 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 |