Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:48 AM
Study NCT ID:
NCT07336550
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-13
First Post:
2025-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction of Low-value Prescribing Through Audit and Feedback
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'A closed-cohort stepped-wedge cluster-randomised trial will be conducted. All health centre clusters will start under the control condition, and at each step, three centres will be randomly assigned to crossover to the intervention.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 540}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-30', 'studyFirstSubmitDate': '2025-12-17', 'studyFirstSubmitQcDate': '2025-12-30', 'lastUpdatePostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary effectiveness: Proportion of patients with deprescribing or tapering of any of the PIP', 'timeFrame': 'From baseline to 16 months', 'description': 'proportion of patients for whom appropriateness is achieved, either through deprescribing or tapering (for example, dose reduction) of any of the drugs potentially inappropriately prescribed in the patients included in the clusters.'}], 'secondaryOutcomes': [{'measure': 'Secondary effectiveness: Proportion of patients with deprescribing or tapering for each PIP', 'timeFrame': 'From baseline to 16 months', 'description': 'proportion of patients in whom appropriateness is achieved for each of the potentially inappropriately prescribed drugs assessed separately'}, {'measure': 'Secondary Effectiveness: Rate of new PIP', 'timeFrame': 'From baseline to 16 months', 'description': 'Rate of new PIP among patients over 65 years old seeking medical care during the study period'}, {'measure': 'Adoption: Percentage of General Practitioners who agree to receive the active components of the strategies', 'timeFrame': 'From baseline to 16 months', 'description': 'Percentage of doctors, out of the total number invited to participate at the start of the intervention, who agree to receive the active components of the strategies, as well as the characteristics of those who do and do not agree to participate.'}, {'measure': 'Degree of implementation fidelity', 'timeFrame': 'From baseline to 16 months', 'description': 'The degree of fidelity with which each strategy has been implemented compared to what was originally planned will be evaluated. For this, the implementation process and any adaptations made to the strategies or their active components will be recorded and subsequently described. Furthermore, we will evaluate the degree of exposure of GPs to the strategies.'}, {'measure': 'General Practitioners´ perception of the feasibility and acceptability', 'timeFrame': 'From baseline to 22 months', 'description': 'GPs perception of the feasibility and acceptability of the deprescribing strategy based on the AF to adapt/reduce their practice of unnecessary pharmacological prescribing.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['low-value pharmacological prescription', 'De-implementation', 'Stepped-wedge design', 'Benzodiazepines', 'Proton pump inhibitors', 'Opioids', 'audit and feedback'], 'conditions': ['Inappropriate Prescribing', 'Implementation Science', 'Behavioral Sciences']}, 'descriptionModule': {'briefSummary': "The objective is to estimate the effect attributable to a primary care pharmacist-led audit and feedback (AF) strategy compared to the currently used AF strategy as a management tool to evaluate healthcare performance focusing on processes and outcomes, for reducing the rate of patients over 65 years of age with potentially inappropriate prescribing (PIP) of benzodiazepines, proton pump inhibitors and opioids.\n\nA closed-cohort stepped-wedge cluster-randomised trial will be conducted in nine PC centres from Barakaldo-Sestao Integrated Health Organization, Basque Health Service (Osakidetza). All health centre clusters will start under the control condition, and at each step, some three centres will be randomly assigned to crossover to the intervention, under which they will be exposed to an additional component of AF, namely, primary care pharmacist-led facilitation.\n\nMixed-methods analysis will be performed, gathering quantitative data to assess the results of the implementations at health centre and clinician levels, and qualitative data to assess the feasibility and perceived impact of the de-implementation strategies from the clinicians' perspective, and explore the experience and satisfaction of patients regarding the healthcare received.\n\nThis study will provide useful knowledge on the effect attributable to a more intensive AF strategy (facilitated AF) compared to standard procedures of AF reports, and of the characteristics of AF that are most effective."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'PRIMARY CARE CENTERS IN THE BARAKALDO-SESTAO INTEGRATED HEALTHCARE ORGANISATION OF OSAKIDETZA-BASQUE HEALTH SERVICE:\n\nInclusion Criteria:\n\n* collaboration is achieved from at least 51% of the General Practitioners (GP) or at least 4 GPs\n* At least 60 patients aged 65 years or older on at least one of the drugs of interest that may be potentially inappropriately prescribed\n\nExclusion Criteria:\n\n* N/A\n\nPATIENTS ASSIGNED TO THE PARTICIPATING PC CENTERS:\n\nInclusion Criteria:\n\n* Patients over 65 years of age with any of the following unsuitability criteria:\n* PIP of benzodiazepines: patients on benzodiazepines for more than 3 months\n* PIP of proton pump inhibitors: patients on proton pump inhibitors for more than 8 weeks without a diagnosed gastrointestinal disease and with no long-term prescription of gastrotoxic drugs.\n* PIP of opioids: patients on opioids for non-cancer pain for more than 3 months.\n\nExclusion Criteria:\n\n* Patients who, in the opinion of the general practitioner, are not suitable candidates for tapering or discontinuation of the potentially inappropriately prescribed drug\n* Patients residing in care homes\n* Patients receiving palliative care'}, 'identificationModule': {'nctId': 'NCT07336550', 'acronym': 'AFFAP', 'briefTitle': 'Reduction of Low-value Prescribing Through Audit and Feedback', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Basque Health Service'}, 'officialTitle': 'AFFAP Trial: The Comparative Evaluation of Audit and Feedback-based De-implementation Strategies to Reduce Low-value Prescribing in Primary Care in Patients Over 65 Years of Age.', 'orgStudyIdInfo': {'id': '2024111054'}, 'secondaryIdInfos': [{'id': '2018111085', 'type': 'OTHER_GRANT', 'domain': 'Health Department of the Basque Government'}, {'id': '2021111024', 'type': 'OTHER_GRANT', 'domain': 'Health Department of the Basque Government'}, {'id': 'PI21/00025', 'type': 'OTHER_GRANT', 'domain': 'Instituto de Salud Carlos III (ISCIII) and European Union (European Regional Development Fund "A way to make Europe")'}, {'id': 'RD24/0005/0017', 'type': 'OTHER_GRANT', 'domain': 'Instituto de Salud Carlos III (ISCIII) and European Union'}, {'id': 'RD21/0016/0003', 'type': 'OTHER_GRANT', 'domain': 'Instituto de Salud Carlos III (ISCIII) and European Union (NextGenerationEU funds, MRR)'}, {'id': 'RD16/0007/0002', 'type': 'OTHER_GRANT', 'domain': 'Instituto de Salud Carlos III (ISCIII) and European Union (European Regional Development Fund "A way to make Europe")'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'All health centre clusters will start under the control condition', 'interventionNames': ['Behavioral: Usual AF']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'At each step, three centres will be randomly assigned to crossover to the intervention', 'interventionNames': ['Behavioral: Usual AF', 'Behavioral: Facilitated AF']}], 'interventions': [{'name': 'Usual AF', 'type': 'BEHAVIORAL', 'description': "The strategy currently used as a management tool to evaluate healthcare performance focusing on processes and outcomes, as part of Osakidetza's operating contract: provision of AF, sent to PC centres every 4 months with data on overall rates of PIP, lists of patients over 65 years old who have a potentially inappropriate prescription of at least one of the drugs of interest, and provision of support materials related to appropriate prescribing and recommendations on deprescribing.", 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Facilitated AF', 'type': 'BEHAVIORAL', 'description': "Based on a facilitation component delivered by PC pharmacy staff. Specifically, the PC pharmacists will conduct a facilitation session with the centre's clinicians in which they will review the magnitude of PIP in the centre (PIP rates), appropriateness/inappropriateness criteria, and guidelines to encourage deprescribing, and draw up an action plan at clinician and centre levels.", 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48903', 'city': 'Barakaldo', 'state': 'Bizkaia', 'country': 'Spain', 'facility': 'Primary Care Research Unit of Bizkaia', 'geoPoint': {'lat': 43.29639, 'lon': -2.98813}}], 'centralContacts': [{'name': 'Alvaro Sanchez Perez', 'role': 'CONTACT', 'email': 'ALVARO.SANCHEZPEREZ@osakidetza.eus', 'phone': '(+34)946006673'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Starting 6 months after the publication of results', 'ipdSharing': 'YES', 'description': 'Individual participant data that support future results will be shared, after deidentification', 'accessCriteria': 'Since data supporting the present study will mostly concern routine data retrieved from the electronic health record of the Basque Health Service-Osakidetza, it will only be made available on reasonable request to the study guarantors (proposals should be directed to the Responsible Party). It will only be shared with researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Basque Health Service', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Biobizkaia', 'class': 'UNKNOWN'}, {'name': 'Health Department of the Basque Government', 'class': 'UNKNOWN'}, {'name': 'European Union', 'class': 'OTHER'}, {'name': 'Carlos III Health Institute (ISCIII), Spain', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mikel Baza Bueno', 'investigatorAffiliation': 'Basque Health Service'}}}}