- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06248060
Comparison and Opinion on the Safety of Teleconsultation Versus Traditional Anaesthetic Consultation in a Day Hospital
Comparison and Opinion on the Safety of Teleconsultation
A pre-anaesthetic consultation is compulsory. It must be carried out at least 8 days before a scheduled medical and/or surgical operation. Its main objectives are to take the patient's history, carry out a clinical examination, select the complementary examinations that should be carried out, and inform the patient of the procedure and the type of anaesthetic proposed. In a world moving towards virtualisation, a number of medical specialities have opted for remote consultations, either by telephone or video-conferencing. Teleconsultation seems to offer greater satisfaction, not only for patients, but also for surgeons and anaesthetists. It is also associated with a reduction in the distance travelled by patients, costs and financial expenditure, with no increase in the rate of cancellation of surgery. For the first time at the Brussels University Hospital (Erasme), the anaesthesia and intensive care team will gradually introduce the system of pre-anaesthetic teleconsultation by telephone from October 2023.
The aim of our study is to evaluate the effectiveness of preanaesthetic teleconsultation at the Erasme HUB. In fact, it would be better to have results based on local expertise in order to give an answer on the effectiveness, safety and security of this innovative method, which will be officially implemented in October 2023.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bruxelles, Belgium, 1070
- Boudart Céline
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria for prospective group (AFTER):
- Patients scheduled for any surgery at one day hospital and who have signed the consent form.
- Pre-anaesthetic consultation by telephone.
Inclusion Criteria for retrospective group (BEFORE):
- patients having undergone any surgery at one day hospital during the period between 01/01/2023 and 31/06/2023.
- Pre-anaesthetic consultation carried out face-to-face.
- Patients eligible for teleconsultation
Exclusion Criteria:
- Participation in another clinical study within the previous month.
- Patient unable to complete the questionnaire.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Before preanaesthetic teleconsultation implementation
|
Pre-anaesthetic classical consultation before teleconsultation implementation
|
|
Experimental: After preanaesthetic teleconsultation implementation
|
Pre-anaesthetic consultation by telephone for eligible patients according to the criteria set
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Score of Patient endangerment (0-4)
Time Frame: at the 1 day of surgery
|
Patient endangerment : 0 = Nothing to report; 1 = Lack of information but no danger to the patient; 2 =Lack of information and reduced safety but intervention maintained; 3 = Too great a risk to the patient.
|
at the 1 day of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction scores reported on LIKERT scale (1-5)
Time Frame: Baseline (before the procedure)
|
How do you feel about the anaesthetic teleconsultation? 1 = Very satisfied; 2 = Satisfied; 3 = Neither satisfied nor dissatisfied; 4 = Not very satisfied; 5 = Not at all satisfied.
|
Baseline (before the procedure)
|
|
Pre-operative anxiety scorereported on LIKERT scale (1-5)
Time Frame: Baseline (before the procedure)
|
How would you rate your level of anxiety? 1 = Not at all anxious; 2 = Slightly anxious; 3 = Moderately anxious; 4 = Somewhat anxious; 5 = Very anxious
|
Baseline (before the procedure)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: boudart céline, HUB
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
Other Study ID Numbers
- SRB2023303
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.
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