- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05765045
A Nursing Triage Protocol for Minor Orthopedic Traumata: the Effect on Flow Time, Quality of Care and Patient Satisfaction in an Emergency Department (TRINU-RX)
In 2019, nearly half of all hospital contacts in Belgium took place through the emergency department, and more than a third of patients arrived after an accident or trauma. In instances of overcrowding, patients with minor orthopedic injuries face prolonged waiting times. Previous studies have shown that implementing triage protocols for medical imaging conducted by a triage nurse can reduce the Total Length of Stay (TLOS) for this patient group.
This is a single-center, unblinded, randomized, controlled trial that aims to evaluate the impact of a nurse triage protocol on turnaround time (primary outcome), quality of care, and patient satisfaction. The study population consists of adults who present with minor orthopedic injuries below the elbow or knee and have an Emergency Severity Index (ESI) of 4 or 5. Participants are randomly assigned to either the 'nurse triage protocol' group (n=110) or the 'usual care' group (n=110).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tom Van Zundert, PhD
- Phone Number: 003214712000
- Email: tom.vanzundert@azmol.be
Study Contact Backup
- Name: Filip Haegdorens, PhD
- Email: filip.haegdorens@uantwerpen.be
Study Locations
-
-
Antwerp
-
Wilrijk, Antwerp, Belgium, 2610
- University of Antwerp
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults (18 years old)
- ESI 4 or ESI 5 Recent trauma (< 10 days after trauma)
- Accidental trauma mechanism
- Trauma below the elbow (forearm, wrist, hand, finger)
- Trauma below the knee (lower leg, ankle, foot, toe)
Exclusion Criteria:
- ESI 1 or ESI 2 or ESI 3
- Return visit after previous emergency department contact for the same injury (e.g. increased pain, tight cast, ...)
- Trauma resulting from underlying somatic pathology (e.g. syncope, epileptic attack, vertigo, vasovagal collapse, ...)
- Atraumatic (pain) complaints (e.g. pain in the calf, toe, foot, wrist, ... without a clear trauma mechanism)
- Additional, non-orthopedic injuries (e.g. laceration, signs of cerebral commotion, ...)
- Pregnancy or a suspicion of pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nursing triage group
Using a triage protocol for medical imaging conducted by a triage nurse in the emergency department
|
Medically approved and supervised standing order that allows trained ER nurses to start medical imaging (RX) for adult patients with minor traumata to the limbs.
|
No Intervention: Regular care group
Regular triage in the emergency department
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TLOS
Time Frame: 6-8 weeks
|
Total length of stay
|
6-8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient satisfaction
Time Frame: 6-8 weeks
|
Patient satisfaction measured by a 10-point Likert scale at discharge using a questionnaire
|
6-8 weeks
|
Treatment efficiency
Time Frame: 6-8 weeks
|
Measurement if the patient diagnosis and/or treatment was correctly initiated at the Emergency Department.
Yes = no additional diagnosis or treatments were necessary; No = within 14 days after discharge a change in treatment or new diagnosis was done.
Data will be collected using the hospital's patient records or by calling patients if no information is found in the record.
|
6-8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Filip Haegdorens, PhD, University of Antwerp, Belgium
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRINU-RX
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Trauma Injury
-
Second Affiliated Hospital, School of Medicine,...Not yet recruiting
-
Chi-Ming HuangUMKC School of MedicineNot yet recruitingConcussion | Head Injury Trauma
-
Advocate Health CareRosalind Franklin University of Medicine and ScienceCompletedTrauma | Blunt Trauma | Blunt Injury | Accident | Multiorgan InjuryUnited States
-
Assiut UniversityNot yet recruitingChest Injury Trauma
-
Wake Forest University Health SciencesMind and Life Institute, Hadley, MassachusettsCompleted
-
Australian and New Zealand Intensive Care Research...Monash University; University College Dublin; Health Research Board, Ireland; Health... and other collaboratorsRecruitingWounds and Injuries | Trauma | Traumatic Brain Injury | Multiple Trauma | Major Trauma | Traumatic Injury | Penetrating Injury | Blunt InjuryAustralia, Ireland, Finland, New Zealand, Slovenia, Germany, Saudi Arabia, Switzerland
-
Assiut UniversityUnknown
-
University of PittsburghCompletedHead Injury, MinorUnited States
-
University Hospital, CaenUnknown
Clinical Trials on Nursing triage protocol
-
Hager AbdelNasser HusseinNot yet recruiting
-
University of ZurichCompleted
-
Assiut UniversityCompletedThoracoscopy | PrehabilitationEgypt
-
National Institute of Nursing Research (NINR)CompletedSudden Cardiac ArrestUnited States
-
University of California, San FranciscoTerminatedStroke | Catheter Associated Urinary Tract InfectionUnited States
-
Hospital San Carlos, MadridNot yet recruitingKidney Transplant; ComplicationsSpain
-
Alexandria UniversityCompletedNurse-Patient Relations | Patient Satisfaction | CaringEgypt
-
Instituto de Cardiologia do Rio Grande do SulCompleted
-
Valleywise HealthAgency for Healthcare Research and Quality (AHRQ)Completed
-
Stanford UniversitySociety of Thoracic RadiologyWithdrawn