Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT06605820
Status:
RECRUITING
Last Update Posted:
2025-06-04
First Post:
2024-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Shared Decision-making and Antimicrobial Stewardship in Secondary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-29', 'studyFirstSubmitDate': '2024-09-18', 'studyFirstSubmitQcDate': '2024-09-18', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient and prescriber views and experiences with shared decision making (SDM) around antibiotic prescribing in secondary care and to identify further opportunities for SDM.', 'timeFrame': '1 year', 'description': 'Data will be analysed using thematic analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Antibiotic Prescribing is the Study Focus (no Condition)']}, 'descriptionModule': {'briefSummary': 'To identify opportunities for antibiotic prescribing shared decision making between patients and prescribers in secondary care.', 'detailedDescription': 'This is a qualitative study with patients and clinicians in secondary care.\n\nWe will use semi-structured interviews with patients and clinicians to address the research question. Patients that have received antibiotics during a recent inpatient stay will be identified using the hospital electronic prescribing system and a letter inviting study participation will be included in their discharge medication pack. Senior prescribing decision makers will be recruited from participating hospitals. In total, we hope to carry out up to 50 interviews with patients and clinicians.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We will use semi-structured interviews with patients and clinicians to address the research question. Patients that have received antibiotics during a recent inpatient stay will be identified using the hospital electronic prescribing system and a letter inviting study participation will be included in their discharge medication pack. Senior prescribing decision makers will be recruited from participating hospitals.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor clinicians:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Senior registrar or consultant medical or surgical doctor working at participating hospitals and caring for inpatients.\n* Fluent in English.\n\nFor patients:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Male or Female, aged 16 years or above (no upper age limit).\n* Good standard of speaking English and able to read and understand study materials.\n* Received antibiotic for treatment of suspected or confirmed bacterial infection during inpatient stay.\n\nExclusion Criteria:\n\n* For clinicians:\n\n * Prescribers not currently caring for inpatients\n\nFor patients:\n\n• Patient who received prophylaxis antibiotics only'}, 'identificationModule': {'nctId': 'NCT06605820', 'acronym': 'SHARE', 'briefTitle': 'Shared Decision-making and Antimicrobial Stewardship in Secondary Care', 'organization': {'class': 'OTHER', 'fullName': 'Royal Cornwall Hospitals Trust'}, 'officialTitle': 'Shared Decision-making and Antimicrobial Stewardship in Secondary Care: Exploring Opportunities Along the Start Smart Then Focus Patient Pathway', 'orgStudyIdInfo': {'id': '2023.RCHT.05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'interventionNames': ['Other: None - Interview Only']}, {'label': 'Healthcare workers', 'interventionNames': ['Other: None - Interview Only']}], 'interventions': [{'name': 'None - Interview Only', 'type': 'OTHER', 'description': 'None - Interview Only', 'armGroupLabels': ['Healthcare workers', 'Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'TR1 3LJ', 'city': 'Truro', 'state': 'Cornwall', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Verity Teague', 'role': 'CONTACT', 'email': 'rcht.sponsor@nhs.net', 'phone': '01872256429'}, {'name': 'Neil Powell, Pharmacist', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Cornwall Hospital', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}, {'zip': 'TR1 3LJ', 'city': 'Truro', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Verity Teague', 'role': 'CONTACT', 'email': 'rcht.sponsor@nhs.net', 'phone': '01872256429'}, {'name': 'Stephen Hughes, Pharmacist', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chelsea and Westminster Hospital', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}], 'centralContacts': [{'name': 'Verity Teague', 'role': 'CONTACT', 'email': 'rcht.sponsor@nhs.net', 'phone': '44 01872256429'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Cornwall Hospitals Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oxford', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}