Setting a Benchmark for Resource Utilization and Quality of Care in Patients Undergoing TAVI in Europe

Transcatheter Aortic Valve Implantation (TAVI) Clinical Trial

— BENCHMARK  

Official title:

Setting a Benchmark for Resource Utilization and Quality of Care in Patients Undergoing Transcatheter Aortic Valve Implantation in Europe - The BENCHMARK Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04579445
• Other study ID #: BENCHMARK Registry
• Status: Active, not recruiting
• Start date: May 3, 2021
• Est. completion date: July 2024

Study information

• Verified date: April 2024
• Source: Institut für Pharmakologie und Präventive Medizin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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)

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2408
• Est. completion date: July 2024
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 115 Years

Eligibility

Inclusion Criteria:

Retrospective phase:

• Consecutive, severe symptomatic aortic stenosis patients who underwent transcatheter aortic valve implantation with a balloon-expandable transcatheter aortic valve prior to the center education on BENCHMARK QoC (Quality of Care) improvement measure (prior to the first education call)).

• Patient is or was scheduled to undergo a 30 Day and 12 Months follow-up (30 Day and 12 Months follow-up: hospital visit or phone call)

• All patients irrespective of valve type or access route will be documented in an electronic Case Report Form (eCRF) based patient logbook.

Prospective phase:

• Consecutive patients with a diagnosis of severe symptomatic aortic stenosis admitted for TAVI with a balloon-expandable transcatheter heart valve after center education on BENCHMARK Quality of Care measures and after the center has passed the implementation phase.

• All patients irrespective of valve type or access route will be documented in an eCRF based patient logbook.

Exclusion Criteria:

Retrospective phase:

• Patients with largely incomplete data with respect to the aims of the project.

• Patients without signed informed consent / data protection statement (according to requirements of local ethical committee).

• Pregnant women at the time of the TAVI.

Prospective phase:

• Patients without signed informed consent prior to the TAVI procedure (data protection statement included; ideally covered by hospital routine to enable consecutiveness).

• Pregnant women at the time of the TAVI.

Related Conditions & MeSH terms

• Transcatheter Aortic Valve Implantation (TAVI)

Intervention

Other:
• Education on tailored Quality Improvement measures
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.

Locations

Country	Name	City	State
Austria	St. Pölten University Hospital	St. Pölten
Austria	KH Nord, Klinik Floridsdorf	Vienna
Czechia	IKEM Prague	Prague
France	Centre Hospitalier Universitaire de Besancon	Besançon
France	Polyclinique Du Bois	Lille
France	Infirmerie Protestante de Lyon	Lyon
France	Hopital Saint Joseph	Marseille
France	Centre Hospitalier Universitaire de Montpellier	Montpellier
France	IMM (Institut Mutualiste Montsouris) Paris	Paris
France	Pitie Salpetriere Hospital Paris	Paris
France	CHU Rennes	Rennes
France	CHRU Tours	Tours
Germany	Herzzentrum Köln	Cologne
Germany	University Medical Center Göttingen	Göttingen
Germany	University Hospital Heidelberg	Heidelberg
Germany	Saarland University Medical Center	Homburg
Germany	CKMS Munich, Artemed Clinics	Munich
Germany	Brüderkrankenhaus Trier	Trier
Italy	L'Ospedale S.Giuseppe Moscati di Avellino	Avellino
Italy	Careggi Hospital	Florence
Italy	Centro Cardiologico, Monzino Hospital	Milan
Italy	Azienda Ospedaliera Ordine Mauriziano di Torino	Torino
Romania	Institutul de Urgenta pentru Boli Cardiolvasculaire	Bucharest
Spain	Hospital Bellvitge	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Regional Universitario de Málaga	Málaga
Spain	Hospital Universitari Son Espases	Palma De Mallorca

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Pharmakologie und Präventive Medizin	Edwards Lifesciences

Countries where clinical trial is conducted

Austria,  Czechia,  France,  Germany,  Italy,  Romania,  Spain, 

References & Publications (2)

Frank D, Durand E, Lauck S, Muir DF, Spence M, Vasa-Nicotera M, Wood D, Saia F, Urbano-Carrillo CA, Bouchayer D, Iliescu VA, Etienne CS, Leclercq F, Auffret V, Asmarats L, Di Mario C, Veugeois A, Maly J, Schober A, Nombela-Franco L, Werner N, Gomez-Hospit — View Citation

McCalmont G, Durand E, Lauck S, Muir DF, Spence MS, Vasa-Nicotera M, Wood D, Saia F, Chatel N, Luske CM, Kurucova J, Bramlage P, Frank D. Setting a benchmark for resource utilization and quality of care in patients undergoing transcatheter aortic valve implantation in Europe-Rationale and design of the international BENCHMARK registry. Clin Cardiol. 2021 Oct;44(10):1344-1353. doi: 10.1002/clc.23711. Epub 2021 Sep 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of differences in length of stay (LoS)	LoS in days	12 months
Primary	Complication rate (AEs), TAVI related safety outcomes	According to Valve Academic Research Consortium-2 consensus (VARC-2) criteria	30 days
Primary	Complication rate (AEs), TAVI related safety outcomes	According to Valve Academic Research Consortium-2 consensus (VARC-2) criteria	12 months
Primary	Quality of Life assessment: Toronto Aortic Stenosis Quality of Life Questionnaire	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.	30 days
Primary	Quality of Life assessment: Toronto Aortic Stenosis Quality of Life Questionnaire	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.	12 months
Primary	Resource utilization - Early discharge information	To determine the proportion of early discharges in sAS patients undergoing TAVI	12 months
Primary	Resource utilization - Working hours per patient	To determine the working hours per patient	12 months
Primary	Resource utilization - Number of TAVI patients in each center	To determine the number of patients undergoing TAVI (per center)	12 months
Primary	Physician and patient satisfaction	Satisfaction score, scoring from 0 (extremely dissatisfied) to 40 (extremely satisfied)	30 days
Primary	Physician and patient satisfaction	Satisfaction score, scoring from 0 (extremely dissatisfied) to 40 (extremely satisfied)	12 months

External Links

•   Registry webpage