NCT06248060

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

February 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2024

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

January 26, 2024

Last Update Submit

April 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Score of Patient endangerment (0-4)

    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 Outcomes (2)

  • Satisfaction scores reported on LIKERT scale (1-5)

    Baseline (before the procedure)

  • Pre-operative anxiety scorereported on LIKERT scale (1-5)

    Baseline (before the procedure)

Study Arms (2)

Before preanaesthetic teleconsultation implementation

ACTIVE COMPARATOR
Other: preanaesthetic classical physical consultation

After preanaesthetic teleconsultation implementation

EXPERIMENTAL
Other: preanaesthetic teleconsultation

Interventions

Pre-anaesthetic classical consultation before teleconsultation implementation

Before preanaesthetic teleconsultation implementation

Pre-anaesthetic consultation by telephone for eligible patients according to the criteria set

After preanaesthetic teleconsultation implementation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for any surgery at one day hospital and who have signed the consent form.
  • Pre-anaesthetic consultation by telephone.
  • 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

You may not qualify if:

  • Participation in another clinical study within the previous month.
  • Patient unable to complete the questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boudart Céline

Brussels, 1070, Belgium

Location

Study Officials

  • boudart céline

    HUB

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Before - After study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 26, 2024

First Posted

February 8, 2024

Study Start

February 15, 2024

Primary Completion

April 8, 2024

Study Completion

April 8, 2024

Last Updated

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations