Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-03-11 @ 10:28 PM
Study NCT ID:
NCT03388567
Status:
COMPLETED
Last Update Posted:
2020-04-10
First Post:
2017-11-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effectiveness of a Continuing Education Program in Community Pharmacies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006266', 'term': 'Health Education'}], 'ancestors': [{'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'study protocol for a multicenter, cluster-randomized controlled trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-08', 'studyFirstSubmitDate': '2017-11-28', 'studyFirstSubmitQcDate': '2017-12-24', 'lastUpdatePostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacy staff competences (Pharmacy staff knowledge, skills and attitudes. )', 'timeFrame': '12 months', 'description': 'Pharmacy staff knowledge, skills and attitudes.\n\nAn adapted and self-designed questionnaire is used from different bibliographical references, among them, the General Level Framework (GLF), as well as the guidelines of the Colombian legislation for pharmacy staff competences. The main areas of competency (competency clusters): which are:\n\n* Delivery of patient care\n* Personal\n* Problem Solving\n* Management and Organisation\n\nThe assessment rating is on a 4-point scale ranging from rarely, sometimes, usually to consistently:\n\n* Rarely: Very rarely meets the standard expected. No logical thought process appears to apply (0-20 %)\n* Sometimes: Much more haphazard than "usually" (21-50 %)\n* Usually: Implies standard practice with occasional lapses (51-84 %)\n* Consistently: Demonstrates the expected standard of practice with very rare lapses (85-100 %)'}], 'secondaryOutcomes': [{'measure': 'Characterize the processes associated with the use of medications in the Pharmaceutical Establishments', 'timeFrame': '2 months', 'description': 'Recognize basic information of the Pharmaceutical Establishments (PE), to characterize some processes related to the use of controlled drugs (CD), including compliance with the regulations, and determine the level of risk perception and the continuing education needs of the pharmacy staff. An adapted and self-designed questionnaire is used from different bibliographical references.\n\nThe assessment rating is on a 4-point scale ranging from rarely, sometimes, usually to consistently:\n\n* Rarely: Very rarely meets the standard expected. No logical thought process appears to apply (0-20 %)\n* Sometimes: Much more haphazard than "usually" (21-50 %)\n* Usually: Implies standard practice with occasional lapses (51-84 %)\n* Consistently: Demonstrates the expected standard of practice with very rare lapses (85-100 %)'}, {'measure': 'Implementation of pharmaceutical professional services', 'timeFrame': '12 months', 'description': 'Measure the degree of implementation of pharmaceutical professional services: Dispensation, Health Education and Pharmacovigilance services. An adapted and self-designed questionnaire is used from different bibliographical references, among them, the guidelines of the Colombian legislation for the development of pharmaceutical services.\n\nThe assessment rating is on a 4-point scale ranging from rarely, sometimes, usually to consistently:\n\n* Rarely: Very rarely meets the standard expected. No logical thought process appears to apply (0-20 %)\n* Sometimes: Much more haphazard than "usually" (21-50 %)\n* Usually: Implies standard practice with occasional lapses (51-84 %)\n* Consistently: Demonstrates the expected standard of practice with very rare lapses (85-100 %)'}, {'measure': 'Satisfaction level pharmacy staff', 'timeFrame': '12 months', 'description': 'Pharmacy staff satisfaction about the continuing education program. An adapted and self-designed questionnaire is used from different bibliographical references, among them, the General Level Framework (GLF), as well as the guidelines of the Colombian legislation for the development of labor competences from the pharmaceutical services.\n\nA five points scale (5=Excellent, 4=Good, 3=Satisfactory, 2=Needs Improvement, and 1=Unacceptable) will used in the questionnaire.'}, {'measure': 'Satisfaction level patients', 'timeFrame': '12 months', 'description': 'Patients satisfaction of pharmacy professional services. An adapted and self-designed questionnaire is used from different bibliographical references.\n\nA five points scale (5=Excellent, 4=Good, 3=Satisfactory, 2=Needs Improvement, and 1=Unacceptable) will used in the questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dispensation', 'Health Education', 'Pharmacovigilance', 'Pharmacists'], 'conditions': ['Controlled Drug Dependence']}, 'referencesModule': {'references': [{'pmid': '32560735', 'type': 'DERIVED', 'citation': 'Ceballos M, Salazar-Ospina A, Sabater-Hernandez D, Amariles P. Evaluation of the effects of a drug with fiscalized substance dispensation, health education, and pharmacovigilance continuing education program in Colombia drugstores and drugstores/pharmacies: study protocol of a multicenter, cluster-randomized controlled trial. Trials. 2020 Jun 19;21(1):545. doi: 10.1186/s13063-020-04481-1.'}]}, 'descriptionModule': {'briefSummary': 'Preventable failures in the drug chain are related to Drugs Problems Related Use and are associated with medication errors (prescription, dispensing, administration or use by the patient or caregiver), including failures In the Medication Supply System (availability and quality).\n\nThe controlled drugs are those that contain substances regulated by international conventions on drug control. They are important in various fields of medicine, such as pain management, obstetric emergencies, mental disorders such as the treatment of substance dependence, psychiatry and neurology. It has been defined as abuse of drugs the improper use of these for non-medical purposes, and associated with the use without medical prescription, which can produce addiction or psychic or physical dependence.', 'detailedDescription': 'Experimental study with random assignment of the staff pharmacist of Pharmacies. The staff pharmacists admitted will be followed for 12 months (1 year). The study will make it possible to determine the effect of the continuing education program accompanied by Information and Communication Technologies (ICT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pharmacy staff working in Pharmacy or Drugstore, located geographically in the city of Medellín and in the Metropolitan Area\n2. That the owner works in the establishment\n\nInclusion Exclusion:\n\n1\\. Pharmacy staff who do not agree to participate in the study'}, 'identificationModule': {'nctId': 'NCT03388567', 'briefTitle': 'Evaluation of the Effectiveness of a Continuing Education Program in Community Pharmacies', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Antioquia'}, 'officialTitle': 'Evaluation of the Effects of a Drug With Fiscalized Substances Dispensation, Health Education and Pharmacovigilance Continuing Education Program in Community Pharmacies: Study Protocol for a Multicenter, Cluster-randomized Controlled Trial', 'orgStudyIdInfo': {'id': '0017102017MC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Staff pharmacy whith intervention', 'description': 'Staff pharmacy who will receive continuous education through technology and communication tools, as well as accompaniment and advice from a pharmaceutical chemist', 'interventionNames': ['Other: Staff pharmacy whith intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Staff pharmacy without intervention', 'description': 'Staff pharmacy who will receive only pharmacy information'}], 'interventions': [{'name': 'Staff pharmacy whith intervention', 'type': 'OTHER', 'description': 'Pharmacists who will receive continuous education through technology and communication tools, as well as accompaniment and advice from a pharmaceutical chemist', 'armGroupLabels': ['Staff pharmacy whith intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1226', 'city': 'Medellín', 'state': 'Antioquia', 'country': 'Colombia', 'facility': 'Universidad de Antioquia', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}], 'overallOfficials': [{'name': 'Pedro Amariles, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Antioquia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Antioquia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigador principal', 'investigatorFullName': 'Pedro Amariles', 'investigatorAffiliation': 'Universidad de Antioquia'}}}}