Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-02-24 @ 5:08 AM
Study NCT ID:
NCT05416892
Status:
COMPLETED
Last Update Posted:
2022-06-14
First Post:
2022-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
What is the Impact of Implementing Pharmaceutical Algorithms in the PharmaClass® Software, on the Handling the Patient's Medication Load, by the Clinical Pharmacist?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-09', 'studyFirstSubmitDate': '2022-06-09', 'studyFirstSubmitQcDate': '2022-06-09', 'lastUpdatePostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time', 'timeFrame': '5 months', 'description': 'Time required to perform an intervention (pharmacist versus software)'}, {'measure': 'Dosage compliance', 'timeFrame': '5 months', 'description': 'Dosage compliance with existing recommendations and laboratory results/clinical parameters (pharmacist versus software)'}, {'measure': 'Medication error severity', 'timeFrame': '5 months', 'description': 'Severity of the medication error that could be avoided (pharmacist versus software)'}, {'measure': 'Geriatrician approval', 'timeFrame': '5 months', 'description': 'Number of interventions validated/refused by the geriatrician (pharmacist versus software)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pharmacist-Patient Relations']}, 'descriptionModule': {'briefSummary': "The clinical pharmacists present in the hospitalisation units aim to ensure the daily review of the drug prescriptions of hospitalized patients.\n\nIn order to optimize their work, the objective of this study would be to provide them with a clinical decision support tool via artificial intelligence in order to improve the patient's medication management. This study will test the Pharmaclass® software."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized patient entering the SU06 or SU13 geriatrics unit of the Paul Brien site of the CHU Brugmann Hospital between November 16 2021 and April 15, 2022', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Hospitalized patient entering the SU06 or SU13 geriatrics unit of the Paul Brien site of the CHU Brugmann Hospital between November 16 2021 and April 15, 2022\n* Speaking French and/or Dutch\n* With chronic renal failure or taking at least one medicine for diabetes, heart, COPD, asthma, high blood pressure, epilepsy, atrial fibrillation, osteoporosis, high cholesterol, pain, parkinsonism, blood clotting, constipation, thyroid, depression, benign prostatic hypertrophy, gastric ulcer, Alzheimer's disease, cirrhosis as well as for electrolyte disorders (hypo or hypernatremia / potassium / calcium/magnesemia/phosphatemia).\n\nExclusion Criteria:\n\n* Patient who died or was transferred to another care unit during his/her hospitalization"}, 'identificationModule': {'nctId': 'NCT05416892', 'briefTitle': "What is the Impact of Implementing Pharmaceutical Algorithms in the PharmaClass® Software, on the Handling the Patient's Medication Load, by the Clinical Pharmacist?", 'organization': {'class': 'OTHER', 'fullName': 'Brugmann University Hospital'}, 'officialTitle': "What is the Impact of Implementing Pharmaceutical Algorithms in the PharmaClass® Software, on the Handling the Patient's Medication Load, by the Clinical Pharmacist? Analysis of These Impacts Within 2 Geriatric Units of the CHU Brugmann Hospital", 'orgStudyIdInfo': {'id': 'CHUB-PharmaClass'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients of Geriatric Wards SU06 and SU13 of the CHU Brugmann Hospital', 'interventionNames': ['Other: Pharmaclass® software']}], 'interventions': [{'name': 'Pharmaclass® software', 'type': 'OTHER', 'description': "Clinical decision support tool via artificial intelligence in order to improve the patient's medication management.", 'armGroupLabels': ['Patients of Geriatric Wards SU06 and SU13 of the CHU Brugmann Hospital']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Brugmann university hospital', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Charline DANNEEL', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Brugmann'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Murielle Surquin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Geriatry Department', 'investigatorFullName': 'Murielle Surquin', 'investigatorAffiliation': 'Brugmann University Hospital'}}}}