Emergency Department Discharge for Type II Supracondylar Fractures - PROSPR Phase 5

PROSPR: PeriopeRative Opioid Stewardship Program of Research (Phase 5 - ED Discharge Study)

The knowledge that patients will not suffer untreated pain at home is central to managing supracondylar fracture (SCF) patients on an outpatient basis at a time of limited healthcare resources. The investigators hypothesize that children with uncomplicated Type II supracondylar fractures (SCF) can be sent home from the Emergency Department (ED) in a temporary cast, and that fracture pain can be safely managed opioid-free at home both before and after surgical repair. The investigators further hypothesize that managing such patients on an ambulatory out-patient basis will increase hospital-bed availability without compromising surgical outcomes.

Study Overview

• Status: Not yet recruiting
• Conditions: Supracondylar Fracture
• Intervention / Treatment: Behavioral: Interview

Detailed Description

Since January 2020, some 1050 admission-days have been accountable to Type II SCF with a mean stay of 1.2 days (SD 0.52) in this institution. However, some patients spend more than 48-hours in-house awaiting surgery, often with two periods of fasting greater than 8-hours imposed, due to competing interests with higher priority cases on the OR's shared add-on board. These patients occupy a hospital bed at a time when resources are severely depleted. The COVID pandemic has enforced many stressors on healthcare across Ontario and one mitigation for same was the diversion of pediatric admissions from surrounding community hospitals to HSC to create 'extra beds' for acute adult admissions in the community. This diversion has imposed significant bed-demands on HSC and with COVID-related admission rates in the community decreasing it has proved difficult to re-route routine pediatric admissions (such as SCF) to the community. This institution's Pediatric Intensive Care Unit (PICU) has been operating above capacity for some time now leading to 'controlled slowdowns' in elective operative procedures, resulting in months of cancellation of some 40-75% of elective pediatric surgery.

This institution's PROSPR program delivered standardization of opioid prescribing at hospital discharge post pediatric SCF repair. Since 2021 the investigators decreased overprescribing of opioids to SCF patients at hospital discharge to the tune of 360%. This work has also created pathways for safe return and disposal which decreased MME amount of opioid lost to follow-up in the community by over 500%. The investigators also demonstrated that home consumption of morphine is so low that it is feasible to completely remove opioid prescribing from pediatric SCF discharge planning which opens the possibility of managing surgical scheduling on an out-patient basis whererby families will derive increased satisfaction from being able to wait at home for surgery.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Conor Mc Donnell; Phone Number: 202687 416-813-7654; Email: conor.mcdonnell@sickkids.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All children meeting eligibility criteria at our institution over the next two years (2023-2025) will be approached for consent

Description

Inclusion Criteria:

• requiring surgery for Type II supracondylar fracture

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Year 1 - Treatment Change; This group will receive the new treatment standard	Behavioral: Interview; Families will complete interviews about their experiences with the new treatment standard and managing pain at home
Year 2 - Sustainability; This group will be used to measure sustainability of the new treatment standard	Behavioral: Interview; Families will complete interviews about their experiences with the new treatment standard and managing pain at home

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decreasing opioid prescribing to zero 0 - year 1	Patient prescriptions will be reviewed to ensure no opioids were erroneously prescribed	From ED Discharge through to post-operative discharge (approximately 1 week)
Decreasing opioid prescribing to zero 0 - year 2	Patient prescriptions will be reviewed to ensure no opioids were erroneously prescribed	From ED Discharge through to post-operative discharge (approximately 1 week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduced hospital bed occupancy - year 1	Bed allocation rates will be compared to those obtained prior to the study commencing	End of Year 1
Reduced hospital bed occupancy - year 2	Bed allocation rates will be compared to those obtained prior to the study commencing and compared to year 1	End of Year 2
Improved family experience after discharge from Emergency Department (ED) - year 1	Families will complete a semi-structured interview detailing their experience with managing the child's pain at home since ED discharge	2 Days post-ED discharge - year 1
Improved family experience after discharge post-operatively - year 1	Families will complete a semi-structured interview detailing their experience with managing the child's pain at home since post-operative discharge	3-5 Days post-operative discharge - year 1
Improved family experience after discharge from Emergency Department (ED) - year 2	Families will complete a semi-structured interview detailing their experience with managing the child's pain at home since ED discharge	2 Days post-ED discharge - year 2
Improved family experience after discharge post-operatively - year 2	Families will complete a semi-structured interview detailing their experience with managing the child's pain at home since post-operative discharge	3-5 Days post-operative discharge - year 2
Reduced need for follow-up xrays - year 1	The number of follow-up xrays required at clinic check-in will be compared to the average number of x-rays required at clinic check-in prior to the commencement of the study	3 Weeks post-operative discharge - year 1
Reduced need for follow-up xrays - year 2	The number of follow-up xrays required at clinic check-in will be compared to the average number of x-rays required at clinic check-in prior to the commencement of the study and to year 1	3 Weeks post-operative discharge - year 2

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Conor Mc Donnell, Staff Anesthesiologist

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 1000080963

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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