Implementation of the Pain and Irritability of Unknown Origin (PIUO) Pathway in Community Pediatric Practices
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorUniversity of British Columbia
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
PIUO Pathway
Other interventionsee arm description.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: PIUO PathwayOther 1 intervention
Trial outcomes
Primary outcomes
1
Implementation Adoption
Adoption of the Pain Pathway will be measured by completion rates, self-reported by community pediatricians.
Time frame
End of the Pain Pathway, an average of 1 year to 18 months2
Implementation Reach
Reach of the Pain Pathway will be measured by recruitment and retention rates of community pediatricians, self-reported by community pediatricians.
Time frame
Baseline and end of the Pain Pathway, an average of 1 year to 18 months3
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.
Time frame
End of the Pain Pathway, an average of 1 year to 18 months4
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.
Time frame
End of the Pain Pathway, an average of 1 year to 18 monthsSecondary outcomes
1
Pain and Irritability (PIUO)
Number of participants whose pain and irritability (PIUO) scores are lower over time, measured by the parent-reported Pain Survey.
Time frame
Baseline and end of the Pain Pathway, an average of 1 year to 18 months2
Family Well-being
Family well-being, measured by standardized measures of well-being (e.g., PROMIS-57; 1 = unable to do; 5 = without any difficulty) based on parent/caregiver-report of their child and family unit (scoring min. = 8 and max. = 40). Scores are converted to T-scores (mean T-score = 50; standard deviation = 10).
Time frame
Baseline and end of the Pain Pathway, an average of 1 year to 18 months3
Factors Influencing Implementation
Factors influencing implementation, including barriers and facilitators and health equity-related, will be measured by identification of these factors through survey and interviews with community pediatricians.
Time frame
Baseline and end of the Pain Pathway, an average of 1 year to 18 monthsSponsors and contacts
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Source ClinicalTrials.gov