Implementation of the Pain and Irritability of Unknown Origin (PIUO) Pathway in Community Pediatric Practices

NCT06869928 | Recruiting

• 1 other identifier: H24-00078
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The Pain and Irritability of Unknown Origin (PIUO) Pathway is a clinical pathway that was developed to evaluate and manage unexplained pain and irritability for children with severe neurological impairments (SNI) who cannot verbally communicate 'where it hurts'. The investigators studied the usefulness of the Pathway with families and expert clinicians in 4 centres across Canada. The aim of this Phase 2 study is to determine whether this tool can transfer from hospital research centres into the community. The Pathway will be used by community pediatricians across British Columbia (BC) when they see patients with PIUO. The investigators want to know how well these pediatricians can follow the Pathway. The goal is to create a systematic, cohesive approach to enhance the clinical care for all children with complex medical needs experiencing PIUO.

Conditions

Pain; Irritability; Neuropathic Pain

Keywords

Pain; Irritability; Pediatrics; Community; Neuropathic Pain; Severe Neurological Disabilities; Implementation Science; Patient Engagement

Outcome Measures

Primary Outcomes (4)

• Implementation Adoption

  Adoption of the Pain Pathway will be measured by completion rates, self-reported by community pediatricians.

  End of the Pain Pathway, an average of 1 year to 18 months

• Implementation Reach

  Reach of the Pain Pathway will be measured by recruitment and retention rates of community pediatricians, self-reported by community pediatricians.

  Baseline and end of the Pain Pathway, an average of 1 year to 18 months

• Implementation Acceptability

  Acceptability of the Pain Pathway will be measured by level of satisfaction (e.g., 1 = very unsatisfied; 7 = very satisfied) based on a Likert scale and self-reported by community pediatricians. Scores will be averaged and higher scores reflect higher levels of satisfaction/acceptability.

  End of the Pain Pathway, an average of 1 year to 18 months

• PIUO Pain Pathway Effectiveness

  Effectiveness of the PIUO Pain Pathway will be measured by proportion of children with SNI and families who received appropriate steps of investigation and treatment options based on following the steps of the PIUO Pain Pathway.

  End of the Pain Pathway, an average of 1 year to 18 months

Secondary Outcomes (3)

• Pain and Irritability (PIUO)

  Baseline and end of the Pain Pathway, an average of 1 year to 18 months

• Family Well-being

  Baseline and end of the Pain Pathway, an average of 1 year to 18 months

• Factors Influencing Implementation

  Baseline and end of the Pain Pathway, an average of 1 year to 18 months

Study Arms (1)

PIUO Pathway

OTHER

The PIUO Pathway targets PIUO in an intentional, focused, timely, sequential order of standardized steps to support best outcomes for children with SNI and families. The PIUO Pathway is comprised of 2 steps. Step 1 is for the pediatrician to conduct a thorough history that includes a pain history to identify known and unknown sources of past and current pain, and a physical examination. Step 2 is to carry out a series of screening tests to further explore any potential underlying disease or injury if not apparent based on the Step 1 history and physical examination. The standard screening tests may include urinalysis, ultrasound, gastric pH, and bloodwork. Each child proceeds through the Pain Pathway as long as their pain persists but may not go through all steps if their pain source is identified or pain resolves at any stage. The Steps of the Pain Pathway may be refined by the team based on the results of Phase 1 study analysis, which is underway.

Other: PIUO Pathway

Interventions

PIUO Pathway OTHER

see arm description.

PIUO Pathway

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children aged 6 months to 18 years with SNI (from any cause) with unexplained pain and irritability and whose cognitive or communication impairments prevent determination of pain location, cause, and type will be eligible to participate.
• Eligible children will have cognitive impairment or be non-verbal. Parents should have sufficient English skills, or have access to assistance, to participate in the clinic visits and complete survey tools.

You may not qualify if:

• Children not within the specified age range
• Children with communication capabilities and cognitive development to localize their pain
• Children that have an explained and treatable cause of pain and irritability. Parents that do not have sufficient English skills, or have access to assistance, to participate in the clinic visits and complete survey tools.
• General pediatricians
• Practicing in a community clinic in British Columbia
• \- Healthcare professionals who are not general pediatricians (e.g., pediatrician specialists, nurse practitioners, nurses, other allied health professionals)

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

RECRUITING

MeSH Terms

Conditions

Pain; Neuralgia; Patient Participation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Hal Siden, MD

  University of British Columbia and BC Children's Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Hou, PhD

CONTACT

604-875-2345; sharon.hou@bcchr.ca

Anne-Mette Hermansen, MA

CONTACT

604-875-2000; ahermansen@bcchr.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: The investigators will conduct a hybrid implementation-effectiveness study using a pre-post, quasi-experimental design. This study adheres to a patient-oriented research framework, integrates principles of equity, diversity, inclusion, and decolonization in the research process, and includes an integrated knowledge mobilization plan.

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: March 11, 2025
• Study Start: June 28, 2024
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)