Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2025-12-31 @ 10:44 AM
Study NCT ID:
NCT04013061
Status:
COMPLETED
Last Update Posted:
2025-12-11
First Post:
2019-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of a Pharmacist-anesthesiologist Collaboration During Anesthesia Consultation on Prevention of Perioperative Medication Errors of Patients in Programmed Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 378}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2019-07-05', 'studyFirstSubmitQcDate': '2019-07-05', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients with at least one medication error for chronic treatment', 'timeFrame': '48 hours post-admission', 'description': '%'}], 'secondaryOutcomes': [{'measure': 'Nature of medication error', 'timeFrame': '48 hours post-admission', 'description': 'According to REMED (Revue des Erreurs liées aux Médicaments Et Dispositifs médicaux) classification'}, {'measure': 'Rate of medication errors corrected', 'timeFrame': '48 hours post-admission', 'description': '%'}, {'measure': "Rate of prescriptions respecting the Société Française d'Anesthésie et de Réanimation recommendations", 'timeFrame': '48 hours post-admission', 'description': '%'}, {'measure': 'Rate of corrected medication errors or major, critical or catastrophic severity according to HAS 2018', 'timeFrame': '48 hours post-admission', 'description': '%'}, {'measure': 'Rate of patients whose usually prescribed medication at admission is not available for them in the evening following surgery', 'timeFrame': '48 hours post-admission', 'description': '%'}, {'measure': "Rate of medications not available on the establishment's therapeutic book and not brought by the patient", 'timeFrame': '48 hours post-admission', 'description': '%'}, {'measure': 'Duration in hospital', 'timeFrame': 'End of hospitalization (max 30 days)', 'description': 'Days'}, {'measure': 'Rate of delay or cancellation of surgery linked to preoperational medication error', 'timeFrame': 'End of study (13 months)', 'description': '%'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Procedures, Operative']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must have given their free and informed consent\n* The patient must be a member or beneficiary of a health insurance plan\n* The patient has at least one chronic medication prescription (associated with a chronic illness)\n* 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\n\nExclusion Criteria:\n\n* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study\n* The subject refuses to sign the consent\n* It is impossible to give the subject informed information\n* The patient is under safeguard of justice or state guardianship\n* The patient is having ambulatory programmed surgery\n* The patient has an anesthetic consultation in a different health establishment'}, 'identificationModule': {'nctId': 'NCT04013061', 'acronym': 'PREVEMCA', 'briefTitle': 'Impact of a Pharmacist-anesthesiologist Collaboration During Anesthesia Consultation on Prevention of Perioperative Medication Errors of Patients in Programmed Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Impact of a Pharmacist-anesthesiologist Collaboration During Anesthesia Consultation on Prevention of Perioperative Medication Errors of Patients in Programmed Surgery', 'orgStudyIdInfo': {'id': 'PHRCI/2018/GL-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard consultation'}, {'type': 'EXPERIMENTAL', 'label': 'Pharmacist-anesthesiologist consultation', 'interventionNames': ['Other: Pluridisciplinary consultation']}], 'interventions': [{'name': 'Pluridisciplinary consultation', 'type': 'OTHER', 'description': 'Pharmacist-anesthesiologist team will be present during the anesthetic consultation', 'armGroupLabels': ['Pharmacist-anesthesiologist consultation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34090', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Géraldine Leguelinel-Blache', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHU Nimes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}