Clinical trial NCT06149208: Emergency Department Discharge for Type II Supracondylar Fractures - PROSPR Phase 5
Official title: PROSPR: PeriopeRative Opioid Stewardship Program of Research (Phase 5 - ED Discharge Study)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Supracondylar Fracture
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 200
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* requiring surgery for Type II supracondylar fracture

Exclusion Criteria:

* none

Primary outcomes:
measure: Decreasing opioid prescribing to zero 0 - year 1
timeFrame: From ED Discharge through to post-operative discharge (approximately 1 week)
measure: Decreasing opioid prescribing to zero 0 - year 2
timeFrame: From ED Discharge through to post-operative discharge (approximately 1 week)
Secondary outcomes:
measure: Reduced hospital bed occupancy - year 1
timeFrame: End of Year 1
measure: Reduced hospital bed occupancy - year 2
timeFrame: End of Year 2
measure: Improved family experience after discharge from Emergency Department (ED) - year 1
timeFrame: 2 Days post-ED discharge - year 1
measure: Improved family experience after discharge post-operatively - year 1
timeFrame: 3-5 Days post-operative discharge - year 1
measure: Improved family experience after discharge from Emergency Department (ED) - year 2
timeFrame: 2 Days post-ED discharge - year 2
measure: Improved family experience after discharge post-operatively - year 2
timeFrame: 3-5 Days post-operative discharge - year 2
measure: Reduced need for follow-up xrays - year 1
timeFrame: 3 Weeks post-operative discharge - year 1
measure: Reduced need for follow-up xrays - year 2
timeFrame: 3 Weeks post-operative discharge - year 2
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Staff Anesthesiologist
name: Conor Mc Donnell
role: PRINCIPAL_INVESTIGATOR
References: