Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:49 AM
Study NCT ID:
NCT07383350
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-02-03
First Post:
2026-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Patient-centered Communication and Antibiotic Use With Information Sheets for Acute Respiratory Tract Infections: A Study Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D010612', 'term': 'Pharyngitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1144}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-26', 'studyFirstSubmitDate': '2026-01-26', 'studyFirstSubmitQcDate': '2026-01-26', 'lastUpdatePostDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Proportion of patients with one of the ARTI Info-sheets used during the consultation, as reported by healthcare professional.', 'timeFrame': 'At Initial consultation (day 0)'}, {'measure': 'Proportion of patients where the ARTI info-sheets were meaningful to use, as reported by healthcare professional.', 'timeFrame': 'At Initial consultation (day 0)'}, {'measure': 'Estimated additional meantime spent on consultation, when using ARTI Info-sheets, reported by healthcare professional.', 'timeFrame': 'At Initial consultation (day 0)'}], 'primaryOutcomes': [{'measure': 'Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections prescribed antibiotics at initial consultation.', 'timeFrame': 'At Initial consultation (day 0)'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections with redeemed antibiotic prescriptions within 14 days after the initial consultation.', 'timeFrame': 'Additional contact from day 0 until day 14.'}, {'measure': 'Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections with retrieval of prescribed antibiotics from the pharmacy within 14 days after the initial consultation.', 'timeFrame': 'Retrieval of prescribed antibiotic from day 0 until day 14'}, {'measure': 'Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections reconsultation within 14 days after the initial consultation.', 'timeFrame': 'Reconsultation from day 0 until day 14.'}, {'measure': 'Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections with "out of hours"-consultations within 14 days after the initial consultation.', 'timeFrame': 'Out of hours consultation from day 0 until day 14.'}, {'measure': 'Proportion of patients contacting the general practice clinic with symptoms of acute respiratory tract infections with hospital admissions within 14 after the initial consultation.', 'timeFrame': 'Hospital admissions from day 0 until day 14.'}, {'measure': 'Proportion of patients experiencing high level of Patient-centered communication measured by CollaboRATE.', 'timeFrame': 'Day 0.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute respiratory tract infections', 'Antibiotics', 'General practice', 'Patient-centered communication', 'Information sheets'], 'conditions': ['Acute Bronchitis', 'ACUTE SINUSITIS', 'Sore Throat']}, 'descriptionModule': {'briefSummary': 'The goal of this trial is to investigate if the use of information sheets regarding acute respiratory tract infections will lead to more rational antibiotic prescribing and increase patient-centered communication i Danish general practice.\n\nThe main questions to be answered:\n\n* Will the use of information sheets lower antibiotic prescribing.\n* Will the use of information sheets increase patient-centered communication.\n\nWe will compare use of information sheets in the consultation with patients with symptoms of acute respiratory tract infections to usual care (control) to find out if information sheets lower antibiotic prescribing.\n\nParticipants will be presented to the information sheets during the consultation regarding symptoms of acute respiratory tract infection.\n\nParticipants will fill in a short questionaire regarding patient-centered communication shortly after the consultation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible patients must contact the general practice clinic with symptoms of either acute pharyngotonsillitis, acute rhinosinusitis or acute bronchitis and should be above 18 years of age.\n\nExclusion Criteria:\n\n* Prior antibiotic treatment for the current episode of acute respiratory tract infections.\n* Urgent need of hospitalization.\n* Patients who do not understand Danish.\n* Patients not listed within the general practice clinic.'}, 'identificationModule': {'nctId': 'NCT07383350', 'briefTitle': 'Improving Patient-centered Communication and Antibiotic Use With Information Sheets for Acute Respiratory Tract Infections: A Study Protocol', 'organization': {'class': 'OTHER', 'fullName': 'Research Unit for General Practice in Aalborg'}, 'officialTitle': 'Improving Patient-centered Communication and Antibiotic Use With Information Sheets for Acute Respiratory Tract Infections: Study Protocol for a Pragmatic Cluster Randomized Trial in Danish General Practice (INFO-ARTI).', 'orgStudyIdInfo': {'id': '471-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual care arm'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ARTI Info-sheets', 'interventionNames': ['Other: ARTI Info-sheets']}], 'interventions': [{'name': 'ARTI Info-sheets', 'type': 'OTHER', 'description': 'ARTI Info-sheets are three information sheets design to be used together with patients contacting general practice with symptoms of acute respiratory tract infections. The information sheets is created as a dialog-tool to increase patient involvement in managing of acute respiratory tract infections.', 'armGroupLabels': ['ARTI Info-sheets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9260', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Research Unit for General Practice in Aalborg', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Research Unit for General Practice in Aalborg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}