Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-02-22 @ 10:33 AM
Study NCT ID:
NCT03862794
Status:
COMPLETED
Last Update Posted:
2020-03-03
First Post:
2019-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CMO Letter to Reduce Unnecessary Antibiotic Prescribing and Broad Spectrum Prescribing Winter 2018-9
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-02', 'studyFirstSubmitDate': '2019-02-27', 'studyFirstSubmitQcDate': '2019-03-01', 'lastUpdatePostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU) in November for each GP practice', 'timeFrame': '1 month', 'description': 'antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)'}, {'measure': 'total broad spectrum antibiotic prescribing weighted by STAR-PU in November for each GP practice', 'timeFrame': '1 month', 'description': 'broad spectrum antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)'}, {'measure': 'percentage broad spectrum antibiotic prescribing in November for each GP practice', 'timeFrame': '1 month', 'description': 'percentage broad spectrum antibiotic prescribing'}, {'measure': 'total non-broad spectrum antibiotic prescribing weighted by STAR-PU in November for each GP practice', 'timeFrame': '1 month', 'description': 'total overall antibiotic prescribing minus total broad spectrum antibiotic prescribing'}, {'measure': 'total antibiotic prescribing weighted by STAR-PU in December for each GP practice', 'timeFrame': '2 months', 'description': 'antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)'}, {'measure': 'total broad spectrum antibiotic prescribing weighted by STAR-PU in December for each GP practice', 'timeFrame': '2 months'}, {'measure': 'percentage broad spectrum antibiotic prescribing in December for each GP practice', 'timeFrame': '2 months'}, {'measure': 'total non-broad spectrum antibiotic prescribing weighted by STAR-PU in December for each GP practice', 'timeFrame': '2 months'}, {'measure': 'total antibiotic prescribing in January weighted by STAR-PU for each GP practice', 'timeFrame': '3 months'}, {'measure': 'total broad spectrum antibiotic prescribing weighted by STAR-PU in January for each GP practice', 'timeFrame': '3 months'}, {'measure': 'percentage broad spectrum antibiotic prescribing in January for each GP practice', 'timeFrame': '3 months'}, {'measure': 'total non-broad spectrum antibiotic prescribing weighted by STAR-PU in January for each GP practice', 'timeFrame': '3 months'}, {'measure': 'total antibiotic prescribing weighted by STAR-PU in February for each GP practice', 'timeFrame': '4 months'}, {'measure': 'total broad spectrum antibiotic prescribing weighted by STAR-PU in February for each GP practice', 'timeFrame': '4 months'}, {'measure': 'percentage broad spectrum antibiotic prescribing in February for each GP practice', 'timeFrame': '4 months'}, {'measure': 'total non-broad spectrum antibiotic prescribing weighted by STAR-PU in February for each GP practice', 'timeFrame': '4 months'}, {'measure': 'total antibiotic prescribing weighted by STAR-PU in March for each GP practice', 'timeFrame': '5 months'}, {'measure': 'total broad spectrum antibiotic prescribing weighted by STAR-PU in March for each GP practice', 'timeFrame': '5 months'}, {'measure': 'percentage broad spectrum antibiotic prescribing in March for each GP practice', 'timeFrame': '5 months'}, {'measure': 'total non-broad spectrum antibiotic prescribing weighted by STAR-PU in March for each GP practice', 'timeFrame': '5 months'}, {'measure': 'total antibiotic prescribing weighted by STAR-PU in April for each GP practice', 'timeFrame': '6 months'}, {'measure': 'total broad spectrum antibiotic prescribing weighted by STAR-PU in April for each GP practice', 'timeFrame': '6 months'}, {'measure': 'percentage broad spectrum antibiotic prescribing in April for each GP practice', 'timeFrame': '6 months'}, {'measure': 'total non-broad spectrum antibiotic prescribing weighted by STAR-PU in April for each GP practice', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prescribing, Off-Label']}, 'referencesModule': {'references': [{'pmid': '35717262', 'type': 'DERIVED', 'citation': 'Gold N, Sallis A, Saei A, Arambepola R, Watson R, Bowen S, Franklin M, Chadborn T. Using text and charts to provide social norm feedback to general practices with high overall and high broad-spectrum antibiotic prescribing: a series of national randomised controlled trials. Trials. 2022 Jun 18;23(1):511. doi: 10.1186/s13063-022-06373-y.'}]}, 'descriptionModule': {'briefSummary': 'This trial aims to reduce unnecessary prescription of antibiotics and broad spectrum antibiotics by general practitioners (GPs) in England. Unnecessary prescriptions are defined as those that do not improve patient health outcomes. The intervention is to send GPs a letter from the Chief Medical Officer (CMO) that gives feedback on their practice\'s prescribing levels. Specifically the sample was GPs whose practices whose prescribed more than 1.161 items per STAR-PU or whose practices prescribed more that .965 items per STAR-PU and greater than 10% broad spectrum items. The intervention groups received a letter telling them they are among the highest prescribers of either their total or broad spectrum antibiotics, with a graph showing their prescribing compared to average prescribing ("their peers"). The letter also contained a leaflet to help GPs discuss self-care advice with patients and some advice to use delayed prescriptions. The investigators hypothesize that the antibiotic prescribing rate in will be lower for the treatment group compared to the control group, following the receipt of the letter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* GP practices that prescribed more than 1.161 Antibacterial Items/STAR-PU for the twelve months (June 2017 - May 2018)\n* GP practices that prescribed more than 0.965 Antibacterial Items/STAR-PU and also more than 10% broad spectrum items for the twelve months (June 2017 - May 2018).\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT03862794', 'acronym': 'CMO2018-9', 'briefTitle': 'CMO Letter to Reduce Unnecessary Antibiotic Prescribing and Broad Spectrum Prescribing Winter 2018-9', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Public Health England'}, 'officialTitle': 'A Randomized Controlled Trial of Behaviourally Informed Feedback Letters Sent by the Chief Medical Officer on the Amount of Antibiotics and the Percentage of Broad Spectrum Antibiotics Prescribed in Primary Care', 'orgStudyIdInfo': {'id': 'R&D 193'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high total and high broad spectrum prescribing letter', 'description': 'social norm feedback letter with bar chart GPs who prescribe more than 1.161 Antibacterial Items/ STAR-PU and more than 10% broad spectrum receive a letter that has specific information about the percentile they are on for broad spectrum prescribing and a bar chart representing their broad spectrum prescribing compared to the average', 'interventionNames': ['Behavioral: new social norm feedback letter with bar chart']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'high total and high broad spectrum prescribing control', 'description': 'standard social norm feedback letter GPs who prescribe more than 1.161 Antibacterial Items/ STAR-PU and more than 10% broad spectrum receive the standard practice overall prescribing letter as a control', 'interventionNames': ['Behavioral: standard social norm feedback letter']}, {'type': 'EXPERIMENTAL', 'label': 'high total prescribing only intervention letter', 'description': 'social norm feedback letter with bar chart GPs who prescribe more than 1.161 Antibacterial Items/ STAR-PU and less than 10% broad spectrum receive a letter that has specific information about the percentile they are on for overall prescribing and a bar chart representing their overall prescribing compared to the average', 'interventionNames': ['Behavioral: new social norm feedback letter with bar chart']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'high total prescribing control letter', 'description': 'standard social norm feedback letter GPs who prescribe more than 1.161 Antibacterial Items/ STAR-PU and less than 10% broad spectrum receive the standard practice overall prescribing letter as a control', 'interventionNames': ['Behavioral: standard social norm feedback letter']}, {'type': 'EXPERIMENTAL', 'label': 'moderate total prescribing and high broad spectrum letter', 'description': 'social norm feedback letter with bar chart GPs who prescribe more than 0.965 but less than 1.161 Antibacterial Items/ STAR-PU and more than 10% broad spectrum will receive a letter that has specific information about the percentile they are on for broad spectrum prescribing and a bar chart representing their broad spectrum prescribing compared to the average', 'interventionNames': ['Behavioral: new social norm feedback letter with bar chart']}, {'type': 'NO_INTERVENTION', 'label': 'moderate total prescribing and high broad spectrum control', 'description': 'GPs who prescribe more than 0.965 but less than 1.161 Antibacterial Items/ STAR-PU and more than 10% broad spectrum receive no letter, which is standard practice, as a control.'}], 'interventions': [{'name': 'new social norm feedback letter with bar chart', 'type': 'BEHAVIORAL', 'description': 'letter with the percentile prescribing the practice is on and a bar chart, comparing prescribing to the national average', 'armGroupLabels': ['high total and high broad spectrum prescribing letter', 'high total prescribing only intervention letter', 'moderate total prescribing and high broad spectrum letter']}, {'name': 'standard social norm feedback letter', 'type': 'BEHAVIORAL', 'description': 'social norm feedback letter used as standard practice, without specific information about the prescribing percentile', 'armGroupLabels': ['high total and high broad spectrum prescribing control', 'high total prescribing control letter']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Public Health England', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Public Health England', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}