Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT07269002
Status:
COMPLETED
Last Update Posted:
2025-12-08
First Post:
2025-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Pharmacist Impact Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-11-21', 'studyFirstSubmitQcDate': '2025-12-04', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication-Safety Composite Indicator', 'timeFrame': 'From hospital admission through study completion (an average of 5 days)'}, {'measure': 'Medication-Safety Composite Indicator', 'timeFrame': 'From hospital admission through study completion (an average of 5 days)', 'description': 'A composite measure assessing medication-safety performance in inpatient settings, including identification of medication discrepancies, potential medication risks, and pharmacist-detected issues during routine clinical care. The measure reflects overall improvement in medication-safety processes following the implementation of the pharmacist-led program.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clinical pharmacist', 'Medication review', 'Smartphone clinical apps'], 'conditions': ['Medication Safety', 'Preventable Medication Harm', 'Pharmacotherapy Optimization']}, 'descriptionModule': {'briefSummary': 'This study evaluated a pharmacist-led medication-safety program in hospitalized patients. The program included routine inpatient medication review and the use of smartphone-based clinical decision-support applications to identify potential medication issues and support therapeutic decision-making. The study was conducted in both adult and pediatric inpatients as part of routine clinical care. No investigational drugs or devices were used.', 'detailedDescription': 'This study was conducted to assess the impact of a structured pharmacist-led medication-safety program implemented across inpatient units in a multispecialty hospital. The program incorporated routine clinical pharmacist review of inpatient medication therapy and the use of smartphone-based clinical decision-support applications to assist with identifying potential medication issues and supporting therapeutic optimization.\n\nThe intervention was applied prospectively in both adult and pediatric inpatients receiving pharmacologic treatment. All activities were performed as part of routine clinical service enhancement, without the use of investigational drugs or devices. The study focused on evaluating medication-safety indicators, clinical process measures, and patient-related outcomes before and after implementation of the pharmacist-led program.\n\nThe aim of the project was to enhance medication accuracy, reduce preventable medication-related problems, and support evidence-based decision-making in a real-world hospital environment. This description summarizes the overall service-improvement approach without disclosing study-specific operational details.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized patients receiving medication therapy\n\nAdult and pediatric inpatients\n\nPatients receiving at least one scheduled medication dose during admission\n\nExclusion Criteria:\n\n* Patients not receiving any pharmacologic treatment\n\nPatients admitted for procedures with no medication administration\n\nPatients discharged before assessment could be performed'}, 'identificationModule': {'nctId': 'NCT07269002', 'briefTitle': 'Clinical Pharmacist Impact Study', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': '"Role of Clinical Pharmacy and Mobile Medical Applications in Detection and Minimization of Different Medication Errors in Hospitalized Patients From Adults and Children".', 'orgStudyIdInfo': {'id': 'F PH-BSU-HREC-0001025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Usual inpatient medication practices before implementation of the pharmacist-led safety program.'}, {'type': 'OTHER', 'label': 'Intervention', 'description': 'Structured pharmacist-led medication review and safety support using smartphone clinical decision-support applications.', 'interventionNames': ['Other: Pharmacist-Led Medication Safety Program']}], 'interventions': [{'name': 'Pharmacist-Led Medication Safety Program', 'type': 'OTHER', 'description': 'A structured clinical pharmacist program that includes inpatient medication review, identification of potential medication-related problems, and use of smartphone-based clinical decision-support applications to support therapeutic decision-making and enhance medication safety practices.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Banī Suwayf', 'country': 'Egypt', 'facility': 'Clinical Research Coordination Unit', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Pharmacist and Principal Investigator', 'investigatorFullName': 'Sara Mohammed Abd Elhamid Mohammed Tony', 'investigatorAffiliation': 'Beni-Suef University'}}}}