Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04126837 |
| Other study ID # |
38RC19.200 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 5, 2020 |
| Est. completion date |
April 5, 2024 |
Study information
| Verified date |
April 2023 |
| Source |
University Hospital, Grenoble |
| Contact |
Damien VIGLINO, MD,PhD |
| Phone |
0033476766784 |
| Email |
DViglino[@]chu-grenoble.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The ankle and/or foot injuries incidence is high. Lateral ankle sprains are most common
diagnosis, while fractures represent less than 15% of final diagnosis. Ankle and/or foot
injuries are associated with significant morbidity in terms of pain and chronic instability.
The societal cost of these injuries is significant mainly related to hospital care and
sick-leave. In summary ankle and/or foot injuries are very frequent reason for emergency
admission.
The study hypothesis is that an accelerated nursing care system for traumatized ankle and/or
foot patients is feasible and allows patients to be cared for in accordance to current
medical recommendations. Such a branch should be followed by a return to work and sports
within a time frame consistent with the literature. The duration of patient management in
emergency department should be short, less than that observed in a historical cohort. Finally
patient satisfaction should be high. In the medium term, the implementation of an accelerated
nursing branch for the diagnosis and treatment of ankle and/or foot injuries should
contribute to effective care and reduction of over activity in emergency departments.
Description:
The incidence of ankle and/or foot injuries is high. Lateral ankle sprains are the most
common diagnosis, while fractures represent less than 15% of the final diagnosis. Ankle
and/or foot injuries are associated with significant morbidity in terms of pain and chronic
instability. The societal cost of these injuries is significant mainly related to hospital
care and sick-leave. Ankle and/or foot injuries are very frequent reason for emergency
admission.
The aim of this study is to assess the accelerated nursing branch for the diagnosis and
treatment of ankle and/or foot injuries in emergency department.
Target Follow-Up duration: 1 month (30 days).
The study will be conducted in 3 phases:
1. Training volunteer emergency department nurses. The training course of 10-hours session
(2 hours e-learning and 8 hours attendance) will cover all aspects of management of
ankle and/or foot injuries (from diagnosis to treatment). The nurses will have at least
one year of clinical experience in emergency department. This training will be conducted
by medical experts (emergency doctor, radiologist and orthopedist ). At the end of the
training a formative assessment both theoretical and practical will be carried out with
participants.
The following intervention will be performed by emergency nurses:
- Pain intensity assessment
- Record of the trauma mechanism and history of the patient
- Ottawa rules and clinical examination
- Radiographic prescription and interpretation
- Prescription and interpretation of additional examination
- Foot and Ankle Survey (FAO)
- Evaluation of ankle joint function
- Treatment: medicine prescription, immobilization, physiotherapy…. Following the
management of ankle and/or foot injuries patients by a nurse, every working day a
systemic review of the emergency file including X-rays performed will be carried
out by a medical staff composed of an emergency doctor, an orthopedist and a
radiologist. This review will be done every morning in the emergency department.
2. Enroll patients admitted to the emergency department for ankle and/or foot injuries. The
ability of trained nurses to treat these traumas will be assessed.
3. Phone follow-up of patient after one month to collect data: the date of return to work
or sports, patient satisfaction and possible consultation (by a physician, an
orthopedist and/or care consummation).
Two groups of data will be collected: clinical and paraclinical parameters. Clinical
parameters: respiratory rate, saturation, blood pressure, heart rate, Glasgow score , weight,
size, Numerical Scale ranges of pain , Ottawa rule, treatment, radiography..
Paraclinical parameters: radiography examination, X-ray interpretation, Foot and Ankle
Survey(FAS), Evaluation of ankle joint function, patient satisfaction survey, follow-up at
one month (30 days).
Outcome measure
The overall adequacy of care will be assessed at the end of the study by a committee of
experts whose judgment will be based on the latest medical recommendations. This expert
committee will consist of an orthopedic physician, a radiologist, an emergency physician and
a quality health executive (nurse) and will make decisions by consensus. These members will
be independent of the investigators of the study. The delivered care will be considered
globally adequate if it respects the recognized indications of:
- Realization and interpretation of radiography (Ottawa criteria and early radiography
service protocol)
- analgesic treatments according to the recommendations of the scientific societies
(acetaminophen for EN> 0 +/- WHO step 2 treatment for pain of moderate intensity and WHO
step 3 for pain of severe intensity)
- Immobilization: according to the recommendations of the scientific societies: protocol
RICE (Rest, Ice,Compression and elevation) immobilization plastered in case of fracture
etc.
- Specialist advice: orthopedic opinion if a fracture or other severe pathology is
detected
Study design
• Estimation enrollment: 66 participants A sample of 60 patients can be used to estimate an
adequate percentage of care tending towards 100% (optimal management defined by the experts),
with an accuracy of 5% corresponding to the lower limit of the one-sided confidence interval.
95% (PASS vs 15.0.5., NCSS, LLC, Kaysville, Utah, USA). This is equivalent to establishing
95% non-inferiority using an exact one-sided test with a power of 80% (Normal approximation).
A rate of patients lost to follow-up estimated at 10% implies that 66 patients will have to
be included.
Analysis:
The main objective of this pilot study is to assess the feasibility of managing ankle or foot
trauma by an emergency nurse protocol, describing the percentage of patients who are
adequately cared for by this protocol. Statistical methods will therefore be essentially
descriptive.
The descriptive analysis will cover all the variables collected. The quantitative parameters
for which normality has been accepted will be described by mean and standard deviation. They
will be expressed as median, 25th and 75th percentiles when normality has been rejected. The
qualitative parameters will be expressed in numbers and percentages framed by their 95%
confidence interval.
Serious Adverse events The individual risk is related to a possible misdiagnosis of the nurse
who took care of the patient, requiring a further consultation with a general practitioner or
emergency. A systematic re-reading of x-rays by the daily medical staff is planned in working
days. Patients will be contacted directly by an emergency doctor to advise them to consult
their treating or specialist doctor, in case of anomaly detected during the re-reading of the
radiography and / or a marked adequacy on the immobilization techniques.
In addition, the following adverse events are likely to occur, related to the management of
on-trial trauma care:
- Complications related to limb immobilization (venous thrombosis, eschar, nerve and/or
vascular compression)
- Complications related to analgesics Given the purpose of the research and the low risk
associated with the investigation procedures, no monitoring committee and no interim
analysis are planned. In the event of a security alert, the expert committee will inform
the promoter.
In the event of an adverse event considered to be severe by the investigator and possibly
involving the health of the subjects, the investigator may stop the study in agreement with
the promoter.
