- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04013061
Impact of a Pharmacist-anesthesiologist Collaboration During Anesthesia Consultation on Prevention of Perioperative Medication Errors of Patients in Programmed Surgery (PREVEMCA)
March 17, 2022 updated by: Centre Hospitalier Universitaire de Nīmes
The investigators will evaluate the efficiency of a pharmacist-anesthesiologist collaboration in the anesthetic consultation in the prevention of medical errors perioperatively in patients undergoing scheduled surgery
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
378
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Montpellier, France, 34090
- CHU de Montpellier
-
Nîmes, France, 30029
- CHU de Nimes
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Toulouse, France
- CHU de Toulouse
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients hospitalized for a programmed surgery in the service of urology or digestive surgery at the CHU Nimes or orthopedic surgery in the CHU Montpellier or Toulouse
Description
Inclusion Criteria:
- The patient must have given their free and informed consent
- The patient must be a member or beneficiary of a health insurance plan
- The patient has at least one chronic medication prescription (associated with a chronic illness)
- The patient is hospitalized for a programmed surgery in the service of urology or digestive surgery at the CHU Nimes or orthopedic surgery in the CHU Montpellier or Toulouse
Exclusion Criteria:
- The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- The patient is having ambulatory programmed surgery
- The patient has an anesthetic consultation in a different health establishment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Standard consultation
|
|
Pharmacist-anesthesiologist consultation
|
Pharmacist-anesthesiologist team will be present during the anesthetic consultation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of patients with at least one medication error for chronic treatment
Time Frame: 48 hours post-admission
|
48 hours post-admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nature of medication error
Time Frame: 48 hours post-admission
|
According to REMED (Revue des Erreurs liées aux Médicaments Et Dispositifs médicaux) classification
|
48 hours post-admission
|
Rate of medication errors corrected
Time Frame: 48 hours post-admission
|
48 hours post-admission
|
|
Rate of prescriptions respecting the Société Française d'Anesthésie et de Réanimation recommendations
Time Frame: 48 hours post-admission
|
48 hours post-admission
|
|
Rate of corrected medication errors or major, critical or catastrophic severity according to HAS 2018
Time Frame: 48 hours post-admission
|
48 hours post-admission
|
|
Rate of patients whose usually prescribed medication at admission is not available for them in the evening following surgery
Time Frame: 48 hours post-admission
|
48 hours post-admission
|
|
Rate of medications not available on the establishment's therapeutic book and not brought by the patient
Time Frame: 48 hours post-admission
|
48 hours post-admission
|
|
Duration in hospital
Time Frame: End of hospitalization (max 30 days)
|
Days
|
End of hospitalization (max 30 days)
|
Rate of delay or cancellation of surgery linked to preoperational medication error
Time Frame: End of study (13 months)
|
End of study (13 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Géraldine Leguelinel-Blache, Chu Nimes
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 25, 2020
Primary Completion (ACTUAL)
August 20, 2021
Study Completion (ACTUAL)
September 30, 2021
Study Registration Dates
First Submitted
July 5, 2019
First Submitted That Met QC Criteria
July 5, 2019
First Posted (ACTUAL)
July 9, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 18, 2022
Last Update Submitted That Met QC Criteria
March 17, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- PHRCI/2018/GL-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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