Fast Track for Wrist and Scaphoid Fractures
Primary Purpose
Wrist Fracture, Scaphoid Fracture
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
fast track
normal pathway
Sponsored by
About this trial
This is an interventional diagnostic trial for Wrist Fracture
Eligibility Criteria
Inclusion Criteria:
- adults patients presenting at the emergency dept with suspected scaphoid or wrist fracture
- monotrauma
- written informed consent
Exclusion Criteria:
- patients younger than 18 yr
- pregnant women
- either vascular or neural impairment
- signs of open fracture
- multiple trauma patient
Sites / Locations
- Ospedale Regionale di Lugano - ORLRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
fast track
normal pathway
Arm Description
patients arriving at Emergency Department with suspected wrist or scaphoid fracture, randomly allocated to the fast track pathway (xray requested at triage by nurse)
patients arriving at Emergency Department with suspected wrist or scaphoid fracture, randomly allocated to waiting room and than medical examination before asking for xrays
Outcomes
Primary Outcome Measures
number of x rays requested
the number of xray requested
Secondary Outcome Measures
waiting time before examination
waiting time before xray
total length of stay in the emergency department
patient's satisfaction
Patients' satisfaction will be tested with the help of the brief emergency department patient satisfaction scale (BEPSS). The questionnaire consists of 20 questions and for each item, a response scale form 1 (completely disagree) to 4 (completely agree) is used.
Full Information
NCT ID
NCT05183477
First Posted
December 7, 2021
Last Updated
March 29, 2023
Sponsor
Ente Ospedaliero Cantonale, Bellinzona
1. Study Identification
Unique Protocol Identification Number
NCT05183477
Brief Title
Fast Track for Wrist and Scaphoid Fractures
Official Title
Fast Track in the Emergency Department for Wrist and Scaphoid Fractures: a Randomised Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 17, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ente Ospedaliero Cantonale, Bellinzona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a mono centric, prospective, randomised trial on the implementation and assessment of a shortened pathway for mono-trauma of the wrist and suspected fracture of distal radius and/or ulna and/or scaphoid bone.
Detailed Description
Patients will be randomised into two groups: fast track and normal pathway. At the arrival in the Emergency Department a triage will be performed. In case of met inclusion criteria the patient will sign the informed consent and will be randomised in one of the two study groups.
The fast track group will be straightforwardly evaluated for absence of exclusion criteria (in case of exclusion criteria present the investigators will follow the normal pathway and the patient will not be included in the study). Then, patients will be assessed with an ad hoc checklist and then sent for x-ray performance, if necessary. After the x-ray the patients will be examined by an emergency physician that will have the opportunity to request new x-ray views if necessary.
The normal pathway group will go straight to medical examination as soon as possible, depending on waiting times in the Emergency Department.
Investigators will collect anagraphical data, waiting times, time to x-ray, overall length of stay in the Emergency Department, patients' and staff's satisfaction for the two groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wrist Fracture, Scaphoid Fracture
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
712 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
fast track
Arm Type
Experimental
Arm Description
patients arriving at Emergency Department with suspected wrist or scaphoid fracture, randomly allocated to the fast track pathway (xray requested at triage by nurse)
Arm Title
normal pathway
Arm Type
Active Comparator
Arm Description
patients arriving at Emergency Department with suspected wrist or scaphoid fracture, randomly allocated to waiting room and than medical examination before asking for xrays
Intervention Type
Other
Intervention Name(s)
fast track
Intervention Description
short cut for the request of xrays directly at triage
Intervention Type
Other
Intervention Name(s)
normal pathway
Intervention Description
x-ray would be required according to doctor's clinical evaluation.
Primary Outcome Measure Information:
Title
number of x rays requested
Description
the number of xray requested
Time Frame
From admission to discharge, up to 2.5 hours
Secondary Outcome Measure Information:
Title
waiting time before examination
Time Frame
From admission to discharge, up to 2.5 hours
Title
waiting time before xray
Time Frame
From admission to discharge, up to 2.5 hours
Title
total length of stay in the emergency department
Time Frame
From admission to discharge, up to 2.5 hours
Title
patient's satisfaction
Description
Patients' satisfaction will be tested with the help of the brief emergency department patient satisfaction scale (BEPSS). The questionnaire consists of 20 questions and for each item, a response scale form 1 (completely disagree) to 4 (completely agree) is used.
Time Frame
From admission to discharge, up to 2.5 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adults patients presenting at the emergency dept with suspected scaphoid or wrist fracture
monotrauma
written informed consent
Exclusion Criteria:
patients younger than 18 yr
pregnant women
either vascular or neural impairment
signs of open fracture
multiple trauma patient
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Uccella, MD
Phone
0041918116657
Email
laura.uccella@eoc.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Uccella, MD
Organizational Affiliation
Ente Ospedaliero Cantonale, Bellinzona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Regionale di Lugano - ORL
City
Lugano
State/Province
Ticino
ZIP/Postal Code
6900
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
laura uccella
Phone
+41918116657
Email
zebru73@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
no plan at the moment
Citations:
PubMed Identifier
32125528
Citation
Mallee WH, Walenkamp MMJ, Mulders MAM, Goslings JC, Schep NWL. Detecting scaphoid fractures in wrist injury: a clinical decision rule. Arch Orthop Trauma Surg. 2020 Apr;140(4):575-581. doi: 10.1007/s00402-020-03383-w. Epub 2020 Mar 3.
Results Reference
background
PubMed Identifier
26682537
Citation
Walenkamp MM, Bentohami A, Slaar A, Beerekamp MS, Maas M, Jager LC, Sosef NL, van Velde R, Ultee JM, Steyerberg EW, Goslings JC, Schep NW. The Amsterdam wrist rules: the multicenter prospective derivation and external validation of a clinical decision rule for the use of radiography in acute wrist trauma. BMC Musculoskelet Disord. 2015 Dec 18;16:389. doi: 10.1186/s12891-015-0829-2.
Results Reference
background
PubMed Identifier
15000019
Citation
Chudleigh J. Nurse requested X-rays in A&E department. Emerg Nurse. 2004 Feb;11(9):32-6. doi: 10.7748/en2004.02.11.9.32.c1146. No abstract available.
Results Reference
background
PubMed Identifier
24487265
Citation
Streppa J, Schneidman V, Biron AD. Requesting wrist radiographs in emergency department triage: developing a training program and diagnostic algorithm. Adv Emerg Nurs J. 2014 Jan-Mar;36(1):62-77. doi: 10.1097/TME.0000000000000005.
Results Reference
background
PubMed Identifier
23915492
Citation
van den Brand CL, van Leerdam RH, van Ufford JH, Rhemrev SJ. Is there a need for a clinical decision rule in blunt wrist trauma? Injury. 2013 Nov;44(11):1615-9. doi: 10.1016/j.injury.2013.07.006. Epub 2013 Jul 31.
Results Reference
background
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Fast Track for Wrist and Scaphoid Fractures
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