Supracondylar FractureNCT06149208
Emergency Department Discharge for Type II Supracondylar Fractures - PROSPR Phase 5
An observational study of Supracondylar Fracture, run by The Hospital for Sick Children at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Supracondylar Fracture
- What is being tested?
- Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2024to 28 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Child, Adult
Study population: All children meeting eligibility criteria at our institution over the next two years (2023-2025) will be approached for consent
Who may be able to join
- requiring surgery for Type II supracondylar fracture
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Supracondylar Fracture
- Being tested
- Interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewBehavioural
Families will complete interviews about their experiences with the new treatment standard and managing pain at home
| Study group | Role | What they receive |
|---|---|---|
| Year 1 - Treatment Change | This group will receive the new treatment standard Receives: Behavioral: Interview | |
| Year 2 - Sustainability | This group will be used to measure sustainability of the new treatment standard Receives: Behavioral: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreasing opioid prescribing to zero 0 - year 1
Patient prescriptions will be reviewed to ensure no opioids were erroneously prescribed
Measured: 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
Measured: From ED Discharge through to post-operative discharge (approximately 1 week)
Secondary outcomes (8)
Reduced hospital bed occupancy - year 1
Bed allocation rates will be compared to those obtained prior to the study commencing
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 Weeks post-operative discharge - year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start1 Jun 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion28 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supracondylar FractureStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Conor McDonnell, The Hospital for Sick Children
- Investigators
- Conor Mc Donnell, Principal investigator, Staff Anesthesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149208
- Sponsor's protocol ID
- 1000080963
- Status last verified
- May 2024
- First submitted
- 20 Nov 2023
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPR: PeriopeRative Opioid Stewardship Program of Research (Phase 5 - ED Discharge Study)
- ClinicalTrials.gov ID
- NCT06149208
- Acronym / sponsor ID
- 1000080963
- Conditions
- Supracondylar Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 28 Jun 2026 (estimated)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Year 1 - Treatment Change | – | Behavioral: InterviewThis group will receive the new treatment standard |
| Year 2 - Sustainability | – | Behavioral: InterviewThis group will be used to measure sustainability of the new treatment standard |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- All children meeting eligibility criteria at our institution over the next two years (2023-2025) will be approached for consent
Key inclusion criteria (1 listed)
- requiring surgery for Type II supracondylar fracture
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewFamilies will complete interviews about their experiences with the new treatment standard and managing pain at home | Behavioural | Year 1 - Treatment Change, Year 2 - Sustainability |
Primary outcome
Decreasing opioid prescribing to zero 0 - year 1
Time frame: From ED Discharge through to post-operative discharge (approximately 1 week)
Patient prescriptions will be reviewed to ensure no opioids were erroneously prescribed
Decreasing opioid prescribing to zero 0 - year 2
Time frame: From ED Discharge through to post-operative discharge (approximately 1 week)
Patient prescriptions will be reviewed to ensure no opioids were erroneously prescribed
8 secondary outcomes
Reduced hospital bed occupancy - year 1
Time frame: End of Year 1
Reduced hospital bed occupancy - year 2
Time frame: End of Year 2
Improved family experience after discharge from Emergency Department (ED) - year 1
Time frame: 2 Days post-ED discharge - year 1
Improved family experience after discharge post-operatively - year 1
Time frame: 3-5 Days post-operative discharge - year 1
Improved family experience after discharge from Emergency Department (ED) - year 2
Time frame: 2 Days post-ED discharge - year 2
Improved family experience after discharge post-operatively - year 2
Time frame: 3-5 Days post-operative discharge - year 2
Reduced need for follow-up xrays - year 1
Time frame: 3 Weeks post-operative discharge - year 1
Reduced need for follow-up xrays - year 2
Time frame: 3 Weeks post-operative discharge - year 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Conor Mc Donnell principal investigator
Staff Anesthesiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Supracondylar Fracture, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Conor Mc Donnell (416-813-7654 ext. 202687, conor.mcdonnell@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreasing opioid prescribing to zero 0 - year 1 (time frame: From ED Discharge through to post-operative discharge (approximately 1 week)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.