[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"electronic-health-records\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:electronic-health-records":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,55,100],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100585320","awarehiv-europe-supporting-healthcare-professionals-to-find-undiagnosed-hiv-in-european-hospitals-an-effectiveness-implementation-trial-100585320",false,"NCT06900829","#AWARE.HIV Europe: Supporting Healthcare Professionals to Find Undiagnosed HIV in European Hospitals: An Effectiveness-implementation Trial.","#aware hiv","Since this study involves screening individuals presenting to a specific hospital through a hospital-wide intervention, the inclusion and exclusion criteria are established at the hospital level.\n\nInclusion Criteria:\n\n1. Standard of care: HIV testing for HIV indicator conditions should be part of routine care in the country, and any prevailing guidelines on HIV testing and prevention policies can be integrated.\n2. Management approval: Hospital management must be willing to allocate resources and provide authorization for the proposed activities, including Surveillance, Audit \\&amp;amp; Feedback, Education \\&amp;amp; Training, Linkage to Prevention, and fostering an Enabling Environment, including stigma reduction.\n3. Resources: Assembling an HIV team led by a local HIV expert should be viable considering the available human resources.\n4. Data collection: There should be an IT specialist and IT infrastructure capable of flagging a pre-defined set of HIV indicator conditions and monitoring the project's implementation effects with feedback loops to healthcare professionals.\n5. Quality assurance: Continuous linkage for care and access to antiretroviral therapy must be assured.\n6. Ethics and Regulatory Compliance: Provision for ethical and regulatory compliance is necessary.\n\nExclusion Criteria:\n\nAny hospital that does not meet the inclusion criteria will be excluded from participation. We will not use data of patients who have objected against the use of their data for research.",true,"ALL","18 Years",{"count":20,"type":21},5200,"ESTIMATED","INTERVENTIONAL",[24],"NA","The #aware.hiv Europe study is a real-world, multicenter, stepped-wedge cluster randomized, effectiveness-implementation trial designed to evaluate whether the introduction of dedicated HIV teams in hospitals can improve HIV testing rates among patients presenting with HIV indicator conditions across ten European countries.\n\nStudy Design:\n\nThe study employs a stepped-wedge design, whereby clusters of hospitals transition sequentially from a control phase (routine care) to an intervention phase. All patient data are collected retrospectively from routine care, while prospective data are gathered at the healthcare professional level. The project spans four years and involves hospitals from the Netherlands, Belgium, United Kingdom, Germany, Spain, France, Italy, Romania, Poland, and Ukraine. This design allows for comparison of HIV testing rates and related outcomes before and after the implementation across different settings and time points.\n\nIntervention:\n\nThe core intervention involves the establishment of hospital-based HIV teams. Each team is led by an HIV specialist and supported by nurses and data collectors. Their responsibilities include:\n\nIdentification and Surveillance: Screening routine electronic health records for HIV indicator conditions using predefined ICD-10 codes and verifying cases that warrant HIV testing.\n\nAudit \\& Feedback: Providing targeted recommendations to treating physicians when an HIV test is indicated but has not been performed, thereby prompting action.\n\nEducation \\& Training: Delivering training sessions to healthcare professionals to improve their knowledge and attitudes towards HIV testing, prevention, and care.\n\nEnabling Environment: Implementing digital solutions and other support mechanisms to streamline testing processes, reduce stigma, and enhance overall guideline adherence.\n\nLinkage to prevention: Improving linkage to the locally available preventive services.\n\nThe intervention is intended to integrate seamlessly into routine hospital care, thereby reinforcing existing guidelines while addressing the current diagnostic testing gap.\n\nEndpoints and Outcome Measures:\n\nPrimary Endpoint:\n\nThe change in HIV testing rate among patients diagnosed with HIV indicator conditions before and after the implementation of HIV teams.\n\nKey Secondary Endpoints:\n\nThe change in the incidence of new HIV diagnoses among patients with HIV indicator conditions.\n\nVariations in HIV testing rates across different countries, medical specialties, and types of indicator conditions, as well as over time.\n\nAssessment of the cascade of HIV diagnosis, including the proportion of patients identified with an indicator condition, the offer and acceptance of HIV testing, and documented reasons for non-testing.\n\nEvaluation of the cascade of HIV care and prevention, including linkage to HIV care, achievement of viral suppression, and referral and uptake of preventive services.\n\nChanges in healthcare professionals' knowledge, attitudes, and levels of stigma towards HIV.\n\nImplementation outcomes such as fidelity of HIV team activities, resource utilization, cost-effectiveness, and sustainability of the intervention.\n\nAnalysis of contextual factors, barriers, and facilitators impacting the implementation process, using established frameworks like CFIR and RE-AIM.\n\nImpact:\n\nBy introducing HIV teams and systematically monitoring their effect on HIV testing practices, the study aims to enhance early HIV diagnosis and improve patient outcomes. The findings will contribute to evidence-based guidelines and may promote the adoption of similar interventions across European healthcare settings, ultimately reducing HIV-associated morbidity, mortality, and transmission rates.\n\nThis project not only addresses a critical diagnostic gap in HIV care but also provides valuable insights into the effective implementation of complex interventions in routine clinical practice.",[27,28,29,30,31,32],"HIV Infection","HIV","Stigma","Education","Prevention of Infection With HIV-1","Electronic Health Records",[34,35,36,37,38,39,40,41],"hiv","stigma","linkage to care","linkage to prevention","electronic prompts","behavioural intervention","ICD-10 code based","audit and feedback","RECRUITING","2026-03-11",{"date":45,"type":46},"2026-03-12","ACTUAL",{"date":48,"type":46},"2025-10-01",{"date":50,"type":21},"2030-02-01",{"name":52,"class":53},"Casper Rokx","OTHER",28,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":16,"sex":17,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":67,"studyType":68,"phases":4,"briefSummary":69,"conditions":70,"keywords":79,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100626909","thromboembolic-risk-associated-to-high-atrial-fibrillation-risk-100626909","NCT07441759","throMboembolic Risk Associated To High atrIal Fibrillation riSk","Economic, Clinical, and Societal Impact of Early Thromboembolic -Risk Detection in High-Risk Atrial Fibrillation: A Model -Based Evaluation of the MATHIAS Strategy.","MATHIAS","Inclusion Criteria (PREFATE study): assessed at baseline\n\n* Adults aged 65-95 years without prior AF and at High risk of AF, according to the risk score validated in the AFRICAT (Atrial Fibrilation Research in CATalonia) study. This scale considers the following variables for risk calculation: sex, age, weight, cardiac rate and CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 (doubled), diabetes mellitus, prior stroke or transient ischemic attack (doubled), vascular disease, age 65-74, female) score.\n* with active records in the HCC3\u002FCMBD systems\n* CHA2DS2-VASc score≥2.\n* Ability to use a smart phone (or at least the caregiver).\n\nExclusion Criteria: Patients with the following conditions will be excluded (exclusion criteria):\n\n* Previous diagnosis of AF.\n* Previous diagnosis of stroke.\n* Severe cognitive impairment, with a score on the Global Deterioration Scale (GDS)≥3.\n* Severe functional impairment, with a Barthel score ≤60, or modified Rankin score≥4.\n* Active anticoagulant treatment at the inclusion.\n* Vital prognosis less than 1 year.\n* Pacemaker carriers.","65 Years","95 Years",{"count":66,"type":21},1000,"2 Years","OBSERVATIONAL","Cardiovascular diseases are the leading cause of mortality from treatable conditions in the European Union and the second from preventable causes, with a standardized mortality rate of 257.8 deaths per 100,000 inhabitants. In 2022, more than 1.11 million deaths in individuals under 75 years could have been avoided. Atrial fibrillation (AF) and major adverse cardiovascular events (MACE) are highly prevalent in the elderly and generate substantial healthcare costs. AF significantly increases the risk of MACE and is projected to rise markedly in the coming decades.\n\nIn Europe, AF prevalence is expected to increase 2.5-fold over the next 50 years, with a lifetime risk of 1 in 3-5 individuals after age 55. AF-related strokes are projected to increase by 34%, and ischemic strokes in individuals over 80 are expected to triple between 2016 and 2060. Additionally, a 27% increase is anticipated among stroke survivors who subsequently develop AF or related conditions. AF substantially impacts morbidity, mortality, and disease progression, and early detection and treatment are crucial to prevent severe outcomes.\n\nEuropean action plans (2018-2030) and the 2024 ESC\u002FESO guidelines emphasize early detection and management of AF in primary care. Although several AF prediction models exist, their integration into clinical practice remains challenging. AF represents a clinical continuum, with thrombotic risk present even before arrhythmia onset. High-risk patients for AF also show a high incidence of MACE, defined as a composite of myocardial infarction, stroke, systemic embolic events, and cardiovascular death.\n\nThe proposed strategy involves developing and clinically validating an Artificial Intelligence (AI) model to improve early thrombotic risk prediction in patients at high risk of AF, using MACE as the primary outcome. This model aims to outperform the traditional CHA₂DS₂-VASc score by incorporating both classical and emerging clinical factors. The estimated timeline from clinical validation to commercialization is approximately 48 months.\n\nAI-based prediction is expected to enable personalized treatment, reduce the incidence of MACE, hospitalizations, and disability, and improve cost-effectiveness, ultimately decreasing the social and economic burden of AF and stroke in Europe.",[71,72,73,32,74,75,76,77,78],"MACE","Atrial Fibrillation (AF)","Quality-adjusted Life-years","Thromboembolic Risk","Cost-effectiveness Analysis","Artificial Intelligence (AI)","Cardio Vascular Disease","Cardio-cerebrovascular Disease",[80,81,82,83,84,85,86,87,88],"Atrial fibrillation","Thromboembolic risk","Artificial intelligence","Stroke","Major Adverse Cardiovascular Events","Sex differences","Primary care","Cost-effectiveness analysis","Quality-adjusted life-years","NOT_YET_RECRUITING","2026-02-27",{"date":92,"type":46},"2026-03-02",{"date":94,"type":21},"2026-07-06",{"date":96,"type":21},"2028-12-31",{"name":98,"class":53},"Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina",1,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":111,"conditions":112,"keywords":118,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":99},"100580273","automatic-feedback-indicator-to-enhance-the-hospital-discharge-communication-between-acute-care-and-primary-care-100580273","NCT06835153","Automatic Feedback Indicator to Enhance the Hospital Discharge Communication Between Acute Care and Primary Care.","Automatic Feedback Indicator to Enhance the Hospital Discharge Communication Between Acute Care and Primary Care: a Randomized Controlled Cluster Trial","FIAQLS","Inclusion Criteria:\n\n* Patients hospitalized for at least 24 hours in participating services.\n* Patients discharged alive directly from participating services.\n\nExclusion Criteria:\n\n* Patients hospitalized for less than 24 hours.\n* Patients who died during hospitalization.\n* Stays in services not meeting inclusion criteria (e.g., psychiatry, long-term care, emergency services with rare direct discharges, or critical care units).",{"count":109,"type":21},132000,[24],"This study, titled \"Automated Indicator Feedback for Improving the Quality of Discharge Letters: A Cluster-Randomized Controlled Trial\" (FIAQ-LS), aims to evaluate whether continuous real-time feedback to hospital teams can improve the quality of discharge letters. Discharge letters are critical for ensuring continuity of care and reducing adverse events by providing detailed information about a patient's hospital stay to both the patient and their primary care physician.\n\nThe study will be conducted at Grenoble Alpes University Hospital and involve 40 hospital services across three campuses. The trial design includes two parallel arms: an intervention group receiving monthly performance feedback through automated dashboards and a control group with no additional intervention. Services are randomized into these groups using a stratified cluster approach.\n\nThe primary objective is to assess whether this intervention increases the proportion of discharge letters validated on the day of discharge compared to usual care. Secondary objectives include evaluating patient satisfaction, rates of unplanned 30-day readmissions, and completeness of discharge letter content.\n\nThe study will include data from approximately 132,000 patient stays over two phases: a pre-implementation observational period (12 months) and an intervention phase (12 months). All data will be collected and analyzed anonymously, with findings expected to inform the broader implementation of quality improvement strategies in French hospitals.",[113,114,115,116,117,32],"Continuity of Care","Patient Safety","Hospital Discharge Communication Processes","Communication","Quality Indicators, Health Care",[119,120,121,122,123,124,125,126,127],"Discharge Summary","Patient Handover","Quality Improvement","Cluster Randomized Trial","Healthcare Outcomes","Patient Satisfaction","Quality Indicators","Real-Time Feedback","Electronic Health Records (EHR)","2025-02-13",{"date":130,"type":46},"2025-02-19",{"date":132,"type":21},"2025-03-01",{"date":134,"type":21},"2026-02-01",{"name":136,"class":53},"University Hospital, Grenoble"]