NCT Number: NCT04579445
Non-interventional, multi-center, international registry in patients with severe aortic stenosis (sAS) undergoing transcatheter aortic valve implantation (TAVI). The BENCHMARK Registry aims to implement standardized, reproducible and scalable quality improvement measures, which will help to reduce resource requirements, intensive care unit bed occupancy and overall length of hospitalization with uncompromised patient safety.
The registry will consist of the following phases:
* Retrospective phase (purpose: capture the status quo of each site prior to any Quality of Care improvement measures): The TAVI of patients being eligible for retrospective documentation must have been performed prior to the site's enrollment into the BENCHMARK prospective phase (follow-up: 30 days, 12 months). * Education phase: Each center will undergo an online BENCHMARK education. The contents of the education will be: Reflection on treatment pathways with the TAVI team, education on 8 defined Quality of Care improvement measures, followed by a center self-assessment (to self-assess the current alignment of hospital performance with the BENCHMARK Quality od Care measures). * Implementation phase: After having self-assessed the current alignment of hospital performance with the following BENCHMARK Quality of care measures, each center will start to introduce the tailored Quality of Care improvement measures to their hospital routine within a time frame of 2 months. * Prospective phase (purpose: to document the effects of defined quality of care improvement measure and to make sure patient safety is as least as good as in the retrospective phase. (8 months of recruitment, Follow-up: 30 days, 12 months)
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Notify Me18 year–115 year
All sexes
Observational
St. Pölten University Hospital, Sankt Pölten, Austria
Transcatheter aortic valve implantation (TAVI) has become standard of care in patients suffering from severe, symptomatic aortic stenosis, irrespective of risk. However, despite the advances in valve technology and implantation techniques, there is still no consensus on how to effectively screen, manage and discharge patients undergoing such an intervention.
In an effort not to lose grounds because of an increasing inner-hospital competition for resources including intensive care unit (ICU) and general hospital beds, there is a need for a streamlined Quality of Care (QoC) pathway that delivers the procedure more efficient, but with at least the same patient safety. In this context, the recent FAST-TAVI (Feasibility And Safety of early discharge after Transfemoral TAVI) and North American Multidisciplinary, Multimodality, But Minimalist (3M) studies have shown that optimized risk assessment and patient management results in a more effective, as least as safe treatment pathway and a reduced length of stay (LoS).
The results gain importance especially in a situation where patients suffering from the coronavirus disease compete for hospital resources throughout Europe. Using a clear set of Quality of Care criteria, the BENCHMARK registry aims to document the progress that can be made if tailored Quality of Care improvement measures are initiated.
The hypothesis is that the implementation of standardized, reproducible and scalable Quality of Care improvement measures will help reducing resource requirements, intensive care unit bed occupancy and overall length of hospitalization with uncompromised patient safety.
There will be up to 30 centers participating across Europe (Germany, Austria, Italy, France, Spain, Czech Republic, Romania). Each center will enroll 80 patients (retrospective documentation of 30 patients, prospective enrollment of 50 patients), resulting in 2400 patients in total.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Retrospective phase:
Prospective phase:
Exclusion criteria
Retrospective phase:
Prospective phase:
Centers will undergo an education on defined Quality of Care measures, with the aim to implement a standardized pathway which is reproducible, scalable and which will allow increased access. The implementation of these measures will help to reduce resource requirements, intensive care bed occupancy and overall length of hospital stay with uncompromised patient safety.
Other names: Education on Quality of Care Improvement measures
Time frame: 12 months
LoS in days
Time frame: 30 days
According to Valve Academic Research Consortium-2 consensus (VARC-2) criteria
Time frame: 12 months
According to Valve Academic Research Consortium-2 consensus (VARC-2) criteria
Time frame: 30 days
Assess the Quality of Life by using the Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ). Each question has a maximum score of 7 (response options from "not very much" to "very much"), giving the complete questionnaire a maximum total score of 112 with a higher score indicating improved Quality of Life.
Time frame: 12 months
Assess the Quality of Life by using the Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ). Each question has a maximum score of 7 (response options from "not very much" to "very much"), giving the complete questionnaire a maximum total score of 112 with a higher score indicating improved Quality of Life.
Time frame: 12 months
To determine the proportion of early discharges in sAS patients undergoing TAVI
Time frame: 12 months
To determine the working hours per patient
Time frame: 12 months
To determine the number of patients undergoing TAVI (per center)
Time frame: 30 days
Satisfaction score, scoring from 0 (extremely dissatisfied) to 40 (extremely satisfied)
Time frame: 12 months
Satisfaction score, scoring from 0 (extremely dissatisfied) to 40 (extremely satisfied)
Institut für Pharmakologie und Präventive Medizin
Network
Setting a Benchmark for Resource Utilization and Quality of Care in Patients Undergoing Transcatheter Aortic Valve Implantation in Europe - The BENCHMARK Registry
Acronym: BENCHMARK
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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