[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"behavioral-sciences\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:behavioral-sciences":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":5},"100618817","reduction-of-low-value-prescribing-through-audit-and-feedback-100618817",false,"NCT07336550","Reduction of Low-value Prescribing Through Audit and Feedback","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.","AFFAP","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\u002FA\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",true,"ALL","65 Years",{"count":21,"type":22},540,"ESTIMATED","INTERVENTIONAL",[25],"NA","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 after an initial study period of 4 months in the control phase, one centre per step at 1-month intervals 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.",[28,29,30],"Inappropriate Prescribing","Implementation Science","Behavioral Sciences",[32,33,34,35,36,37,38],"low-value pharmacological prescription","De-implementation","Stepped-wedge design","Benzodiazepines","Proton pump inhibitors","Opioids","audit and feedback","NOT_YET_RECRUITING","2026-05-11",{"date":42,"type":43},"2026-05-13","ACTUAL",{"date":45,"type":22},"2026-06",{"date":47,"type":22},"2027-12",{"name":49,"class":50},"Basque Health Service","OTHER_GOV"]