PIUO Pathway for Pain and Irritability

Overseen By Anne-Mette Hermansen, MA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Age, Communication, Explained pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Hal Siden, MD

Principal Investigator

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

Eligibility Criteria

This trial is for children with severe neurological impairments who can't communicate their pain verbally. It's designed to help community pediatricians in British Columbia manage unexplained pain and irritability using the PIUO Pathway, a tool developed for systematic care.

Inclusion Criteria

General pediatricians

Practicing in a community clinic in British Columbia

My child is between 6 months and 18 years old, has special needs, and cannot explain their pain.

Exclusion Criteria

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

Healthcare professionals who are not general pediatricians (e.g., pediatrician specialists, nurse practitioners, nurses, other allied health professionals)

My child does not fall within the required age range for the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exploration

Exploration phase to assess feasibility and factors influencing the implementation of the Pain Pathway

3 months

Installation

Installation phase where community pediatricians are trained to use the Pain Pathway

3 months

Initial Implementation

Initial implementation of the Pain Pathway in community practice settings

6 months

Full Implementation

Full implementation of the Pain Pathway with ongoing evaluation and refinement

6-9 months

Follow-up

Participants are monitored for the effectiveness of the Pain Pathway and family well-being

4 weeks

Treatment Details

Interventions

• PIUO Pathway

Trial Overview The study tests the PIUO Pathway's effectiveness when used by community pediatricians outside of hospital research settings. The goal is to see if this approach can improve clinical care for children with complex medical needs experiencing unknown pain and irritability.

Participant Groups

Group I: PIUO Pathway Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+