Satisfaction, PatientSNAPNCT04787133
Supervised Nurse Assisted Preoperative Assessment (SNAP)
An observational study of Satisfaction, Patient and Surgery, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Compare the experience of patients receiving an "optimized" preoperative anesthesia consultation (PAC) performed by a Nurse Anesthetist (supervised by an anesthetist) to those receiving a "standard" CSA ( CSA by an anesthetist alone). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Satisfaction, Patient, Surgery
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2022to Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: patients who will have an anesthesia consultation on one of the randomized shifts
Who may be able to join
- Patient over 18 years old
- Must benefit from an anesthesia consultation for general or regional anesthesia for scheduled surgery, whatever it is.
- Express consent to participate in the study
- Affiliate or beneficiary of a social security scheme
Who cannot join
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
- Patient unable to understand and read French, as well as to complete a self-administered questionnaire
- Patient with mental retardation with impaired judgment
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Fondation Adolphe de Rothschild
Paris, Île-de-France Region, 75019
About this study
Official title: Assessment of the Perioperative Experience of Patients According to Different Preoperative Anesthesia Consultation (PAC) Modalities
Compare the experience of patients receiving an "optimized" preoperative anesthesia consultation (PAC) performed by a Nurse Anesthetist (supervised by an anesthetist) to those receiving a "standard" CSA ( CSA by an anesthetist alone).
Read the detailed description
Preoperative anesthesia consultations (PACs) are a key moment in the perioperative care journey. During the PAC, the doctor assesses the patient's state of health (allowing an assessment of the perioperative risk), establishes the anesthesia protocol and writes the preoperative prescriptions. PAC also helps inform and educate patients to reduce their anxiety.
Indeed, if the perioperative care pathway and the risks associated with anesthesia are poorly understood, there is an increased risk of preoperative anxiety, poor compliance with preoperative prescriptions, and therefore potential cancellation of the surgical intervention.
In many countries, preoperative PACs are performed by nurses trained and supervised by anesthetists. These PACs take longer than a consultation carried out by a doctor alone, but would on the one hand have a positive effect on patient education and, on the other hand, ultimately reduce the time and costs associated with the PAC . On the other hand, the impact of PACs performed by nurses supervised by physicians on the perioperative experience of patients and on the rate of cancellations of scheduled interventions has not yet been demonstrated.
Since 2013, so-called "optimized" consultations (PAC carried out by a state-certified nurse - IDE - supervised by an anesthesiologist) have been carried out at the Adolphe de Rothschild Foundation (Paris), for patients having a scheduled surgery intervention. cataract under locoregional or general anesthesia. First, the IDE collects the patient's history and treatments and informs him of the perioperative care pathway. In a second step, the doctor performs the pre-anesthetic medical examination, completes the medical examination and writes the appropriate pre and postoperative prescriptions. This method of consultation made it possible to optimize medical time while providing complete, even better, information to the patient.
That is why optimized PACs may improve the patient's perioperative experience and reduce preoperative cancellations regardless of the type of surgery. programmed.
- Conditions
- Satisfaction, Patient, Surgery
- Keywords
- Anesthesia consultation, Patient satisfaction
- Medical subject headings
- Patient Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of patient satisfaction with a perioperative anesthetic evaluation
Patient satisfaction will be assess within 48h after surgery using the "Evaluation du Vécu de l'Anesthésie" or "EVAN" (EVAN-G for EVAN-General anesthesia or EVAN-LR for EVAN-locoregional anesthesia).
The EVAN-G includes 26 items; six specific scores (Attention, Information, Discomfort, Privacy, Waiting and Pain) and one global index score. The EVAN-LR comprises 19 items; five specific scores (Attention, Information, Discomfort, Waiting, and Pain) and one global index score.
Specific and global index scores were linearly transformed to a 0-100 scale, with 100 indicating the best possible level of satisfaction and 0 indicating the worst.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study startFeb 2022 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionSep 2022 (estimated)
Why it stopped: budgetary reason
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Satisfaction, PatientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787133
- Sponsor's protocol ID
- JDS_2020_29
- Acronym
- SNAP
- Status last verified
- Aug 2022
- First submitted
- 26 Jan 2021
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Perioperative Experience of Patients According to Different Preoperative Anesthesia Consultation (PAC) Modalities
- ClinicalTrials.gov ID
- NCT04787133
- Acronym / sponsor ID
- SNAP / JDS_2020_29
- Conditions
- Satisfaction, Patient, Surgery
- Keywords
- Anesthesia consultation, Patient satisfaction
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: budgetary reason
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Feb 2022 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare the experience of patients receiving an "optimized" preoperative anesthesia consultation (PAC) performed by a Nurse Anesthetist (supervised by an anesthetist) to those receiving a "standard" CSA ( CSA by an anesthetist alone).
Detailed description
Preoperative anesthesia consultations (PACs) are a key moment in the perioperative care journey. During the PAC, the doctor assesses the patient's state of health (allowing an assessment of the perioperative risk), establishes the anesthesia protocol and writes the preoperative prescriptions. PAC also helps inform and educate patients to reduce their anxiety.
Indeed, if the perioperative care pathway and the risks associated with anesthesia are poorly understood, there is an increased risk of preoperative anxiety, poor compliance with preoperative prescriptions, and therefore potential cancellation of the surgical intervention.
In many countries, preoperative PACs are performed by nurses trained and supervised by anesthetists. These PACs take longer than a consultation carried out by a doctor alone, but would on the one hand have a positive effect on patient education and, on the other hand, ultimately reduce the time and costs associated with the PAC . On the other hand, the impact of PACs performed by nurses supervised by physicians on the perioperative experience of patients and on the rate of cancellations of scheduled interventions has not yet been demonstrated.
Since 2013, so-called "optimized" consultations (PAC carried out by a state-certified nurse - IDE - supervised by an anesthesiologist) have been carried out at the Adolphe de Rothschild Foundation (Paris), for patients having a scheduled surgery intervention. cataract under locoregional or general anesthesia. First, the IDE collects the patient's history and treatments and informs him of the perioperative care pathway. In a second step, the doctor performs the pre-anesthetic medical examination, completes the medical examination and writes the appropriate pre and postoperative prescriptions. This method of consultation made it possible to optimize medical time while providing complete, even better, information to the patient.
That is why optimized PACs may improve the patient's perioperative experience and reduce preoperative cancellations regardless of the type of surgery. programmed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients who will have an anesthesia consultation on one of the randomized shifts
Key inclusion criteria (4 listed)
- Patient over 18 years old
- Must benefit from an anesthesia consultation for general or regional anesthesia for scheduled surgery, whatever it is.
- Express consent to participate in the study
- Affiliate or beneficiary of a social security scheme
Key exclusion criteria (4 listed)
- Patient benefiting from a legal protection measure
- Pregnant or breastfeeding woman
- Patient unable to understand and read French, as well as to complete a self-administered questionnaire
- Patient with mental retardation with impaired judgment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of patient satisfaction with a perioperative anesthetic evaluation
Time frame: 48 hours
Patient satisfaction will be assess within 48h after surgery using the "Evaluation du Vécu de l'Anesthésie" or "EVAN" (EVAN-G for EVAN-General anesthesia or EVAN-LR for EVAN-locoregional anesthesia). The EVAN-G includes 26 items; six specific scores (Attention, Information, Discomfort, Privacy, Waiting and Pain) and one global index score. The EVAN-LR comprises 19 items; five specific scores (Attention, Information, Discomfort, Waiting, and Pain) and one global index score. Specific and global index scores were linearly transformed to a 0-100 scale, with 100 indicating the best possible level of satisfaction and 0 indicating the worst.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Satisfaction, Patient and Surgery, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of patient satisfaction with a perioperative anesthetic evaluation (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.