Anesthesia, Pregnancy, Satisfaction, Telemedicine
Conditions
Keywords
pre anesthetic consultation, anesthesia, obstetrics, carbon footprint, e-health, electronic medical records, telehealth, telemedicine
Brief summary
Quality of teleconsultation in comparison to face-to-face consultation for pre anesthetic evaluation in pregnant persons before delivery will be evaluated. Quality is evaluated with a composite criterion comprising 7 elements required for security of anesthesia. Discordance between this composite criterion during the pre anesthesia visit the day of delivery and pre anesthesia consultation several weeks before delivery will be assessed.
Detailed description
In the third trimester of pregnancy, pre-anesthetic consultations are mandatory before childbirth, typically recommended between 32 and 36 weeks of gestation. These consultations assess risks associated with anesthesia and childbirth while providing information on anesthetic options, including neuraxial anesthesia. Since 2009, consultations can be conducted on-site or via teleconsultation. However, the quality of teleconsultations and patient satisfaction have not been evaluated in an obstetric context. This study consists of two patient groups assigned following randomization: * Teleconsultation: conducted at Bordeaux University Hospital by an obstetric anesthesia physician using the teleconsultation software provided by the hospital. * In-person consultation: conducted at Bordeaux University Hospital according to the usual procedure. Following patient enrollment, the follow-up protocol proceeds as outlined below: * Day -56 to Day -28: Patients with scheduled anesthesia appointments during designated teleconsultation periods are contacted. They are briefed about the study and provided with consent documents via email or in person if they opt to participate. * Day -56 to Day -10: Upon receipt of signed consent forms, patients undergo randomization. If necessary, their initial appointment is adjusted according to the assigned group. The rescheduled appointment is arranged for the same designated time slot, with timing aligned as closely as possible to the original appointment. For teleconsultation participants, the secretary sends anesthesia-related informational materials and instructions for connecting to the teleconsultation software. * Day 0: Pre-anesthetic consultations are conducted based on the assigned randomization modality (in-person or teleconsultation). * Day 14: Satisfaction and transportation modality questionnaires are distributed via email. * Upon childbirth, a pre-anesthetic visit is conducted.
Interventions
PROCEDURETeleconsultation
pre-anesthetic consultation conducted conducted at the Bordeaux University Hospital by an obstetric anesthesia physician using the teleconsultation software provided by the hospital.
PROCEDUREon-site consultation
In-person consultation conducted at the Bordeaux University Hospital according to the usual procedure.
Sponsors
University Hospital, Bordeaux
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pregnant patients scheduled to give birth at the Bordeaux University Hospital, ASA score 1 or 2, for their primary pregnancy, who have booked an anesthesia appointment on one of the half-days when teleconsultation is available in the department * Have access to the internet and functional computer equipment (smartphone, computer) * Have a valid email address and telephone number
Exclusion criteria
* Minor patient (under 18 years old at the time of inclusion) * Individuals not affiliated with or beneficiaries of a social security scheme * Patients who do not speak French * Persons under legal guardianship * Psychiatric conditions that impair the ability to consent to or participate in the study * Severe spinal pathology (scoliosis requiring a brace or surgery, ankylosing spondylitis), history of spinal surgery * Comorbidities with ASA score ≥3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite quality criterion | during pre-anesthetic visit, up to 2 months after inclusion (pre-anesthetic consultation) | The primary endpoint will be the discordance between the pre-anesthetic consultation and the pre-anesthetic visit based on a composite quality criterion comprising 7 elements: * Assessment of difficult intubation, defined as a mouth opening \<35 mm * Description of pre-anesthesia medication reconciliation (except therapeutic adjustments in anticoagulants and antidiabetic treatments) * Anesthetic strategy associated with a documented chronic condition if a specific strategy is needed * Adherence to pre-transfusion assessment protocols * Documentation of hematologic assessment in the 6th month, or prescription of assessment in case of absence * Therapeutic approach in case of anemia described * Criteria of difficulty in performing epidural anesthesia This primary criterion will be assessed at the conclusion of the pre-anesthetic visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 2 weeks after inclusion (pre-anesthetic consultation) | This questionnaire will include an overall assessment based on the question: "To what extent are you satisfied with your appointment with the anesthesiologist?", rated on a 5-point Likert scale (Very satisfied / Somewhat satisfied / Neither satisfied nor dissatisfied / Somewhat dissatisfied / Very dissatisfied) The remainder of the questionnaire will be developed for this study based on the validated CARE questionnaire. The CARE questionnaire is a tool developed by Stewart W. Mercer, initially for general practice, and validated in 2004. It focuses on the empathy patients perceive during consultations. It consists of 10 questions, rated on Likert scales. |
| Anesthesiologist satisfaction | at inclusion (pre anesthetic consultation) | The experience of telemedicine consultations by anesthesiologists will be evaluated at the end of each half-day of consultations. Anesthesiologists and intensivists will be asked to complete a questionnaire consisting of 6 questions: Each response will be rated on a 5-point Likert scale, ranging from "strongly disagree" to "strongly agree" |
| missed appointment | at inclusion (pre anesthetic consultation) | A missed appointment is defined as the failure to conduct a pre-anesthetic consultations on the scheduled day due to the patient's absence or tardiness at the time of the appointment. Data on missed appointments will be collected for each patient included in the study. The rate of missed or rescheduled appointments will be calculated for each group. |
| Epidural anesthesia difficult to perform | up to 2 month after inclusion | The number of epidural anesthesias that are difficult to administer will be recorded. The criteria used to define a difficult administration are: more than three attempts at puncture or the involvement of a second practitioner. |
| Carbon footprint | at inclusion (pre anesthetic consultation) | The study will assess the carbon footprint of pre-anesthesia teleconsultations compared to in-person consultations by estimating greenhouse gas emissions associated with transportation. The carbon footprint of teleconsultations will be calculated using the emissions factor per minute of viewing time for teleconsultations, which depends on the energy consumption of the internet network and the carbon footprint of the internet infrastructure. |
Countries
France
Contacts
CONTACTMarion GRITON, MD
CONTACTHela KLAY
PRINCIPAL_INVESTIGATORMarion GRITON
University Hospital, Bordeaux
STUDY_DIRECTORKarine NOUETTE-GAULAIN
University Hospital, Bordeaux
STUDY_CHAIRFlorence SAILLOUR
University Hospital, Bordeaux
Outcome results
None listed