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

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ClinicalTrials.gov Identifier: NCT04579445
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : May 20, 2022
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
Institut für Pharmakologie und Präventive Medizin

Brief 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)

Condition or disease Intervention/treatment
Transcatheter Aortic Valve Implantation (TAVI) Other: Education on tailored Quality Improvement measures

Detailed 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Setting a Benchmark for Resource Utilization and Quality of Care in Patients Undergoing Transcatheter Aortic Valve Implantation in Europe - The BENCHMARK Registry
Actual Study Start Date : May 3, 2021
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
TAVI patients
Consecutive, severe aortic stenosis patients undergoing transcatheter aortic valve implantation (TAVI) (there will be a retrospective part: documentation of 30 patients who underwent TAVI; and a prospective part enrolling 50 patients undergoing TAVI)
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.
Other Name: Education on Quality of Care Improvement measures




Primary Outcome Measures :
  1. Evaluation of differences in length of stay (LoS) [ Time Frame: 12 months ]
    LoS in days

  2. Complication rate (AEs), TAVI related safety outcomes [ Time Frame: 30 days ]
    According to Valve Academic Research Consortium-2 consensus (VARC-2) criteria

  3. Complication rate (AEs), TAVI related safety outcomes [ Time Frame: 12 months ]
    According to Valve Academic Research Consortium-2 consensus (VARC-2) criteria

  4. Quality of Life assessment: Toronto Aortic Stenosis Quality of Life Questionnaire [ 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.

  5. Quality of Life assessment: Toronto Aortic Stenosis Quality of Life Questionnaire [ 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.

  6. Resource utilization - Early discharge information [ Time Frame: 12 months ]
    To determine the proportion of early discharges in sAS patients undergoing TAVI

  7. Resource utilization - Working hours per patient [ Time Frame: 12 months ]
    To determine the working hours per patient

  8. Resource utilization - Number of TAVI patients in each center [ Time Frame: 12 months ]
    To determine the number of patients undergoing TAVI (per center)

  9. Physician and patient satisfaction [ Time Frame: 30 days ]
    Satisfaction score, scoring from 0 (extremely dissatisfied) to 40 (extremely satisfied)

  10. Physician and patient satisfaction [ Time Frame: 12 months ]
    Satisfaction score, scoring from 0 (extremely dissatisfied) to 40 (extremely satisfied)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 115 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Prospective phase:

50 severe Aortic stenosis patients undergoing transcatheter aortic valve implantation will be recruited within the prospective part per center.

Retrospective phase:

Retrospective documentation of 30 severe aortic stenosis pateints per center, who underwent a transcatheter aortic valve implantation will be performed.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04579445


Contacts
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Contact: Claudia Lüske, PhD +4944718503324 claudia.lueske@ippmed.de
Contact: Daniel Greinert +4944718503328 daniel.greinert@ippmed.de

Locations
Show Show 28 study locations
Sponsors and Collaborators
Institut für Pharmakologie und Präventive Medizin
Edwards Lifesciences
Investigators
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Principal Investigator: Derk Frank, Prof. UKSH Kiel
Principal Investigator: Gemma McCalmont James Cook Hospital, Middlesbrough, United Kingdom
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier: NCT04579445    
Other Study ID Numbers: BENCHMARK Registry
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no individual participant data (IPD) will be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut für Pharmakologie und Präventive Medizin:
TAVI
Severe Aortic Stenosis
Optimizing TAVI patient outcomes
Optimizing TAVI care pathways