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

Supracondylar Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06149208
• Other study ID #: 1000080963
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: June 28, 2026

Study information

• Verified date: May 2024
• Source: The Hospital for Sick Children
• Contact: Conor Mc Donnell
• Phone: 416-813-7654
• Email: conor.mcdonnell[@]sickkids.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 28, 2026
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• requiring surgery for Type II supracondylar fracture

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Fractures, Bone
• Supracondylar Fracture

Intervention

Behavioral:
• Interview
Families will complete interviews about their experiences with the new treatment standard and managing pain at home

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Reduced hospital bed occupancy - year 1	Bed allocation rates will be compared to those obtained prior to the study commencing	End of Year 1
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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