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

NCT06149208 | Not Yet Recruiting

• 1 other identifier: 1000080963
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Supracondylar Fracture

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Reduced hospital bed occupancy - year 1

  End of Year 1

• Reduced hospital bed occupancy - year 2

  End of Year 2

• Improved family experience after discharge from Emergency Department (ED) - year 1

  2 Days post-ED discharge - year 1

• Improved family experience after discharge post-operatively - year 1

  3-5 Days post-operative discharge - year 1

• Improved family experience after discharge from Emergency Department (ED) - year 2

  2 Days post-ED discharge - year 2

Study Arms (2)

Year 1 - Treatment Change

This group will receive the new treatment standard

Behavioral: Interview

Year 2 - Sustainability

This group will be used to measure sustainability of the new treatment standard

Behavioral: Interview

Interventions

Interview BEHAVIORAL

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

Year 1 - Treatment Change; Year 2 - Sustainability

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• requiring surgery for Type II supracondylar fracture

You may not qualify if:

• none

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Conor Mc Donnell

  Staff Anesthesiologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Conor Mc Donnell

CONTACT

416-813-7654; conor.mcdonnell@sickkids.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Associate Professor

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 28, 2023
• Study Start: June 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 28, 2026
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)