Patient Reported Outcomes (PROMs) in Transcatheter Aortic Valve Implantation (TAVI) Patients

Assessing Discrepancies in Patient/Physician Evaluation of Transcatheter Aortic Valve Implantation and Developing a Patients Reported Outcomes Based Model to Predict Procedure Benefits Using a Novel Patient-oriented Questionnaire

The transcatheter Aortic Valve Implantation (TAVI) population with severe aortic stenosis (AS) is characterized by advanced age (most patients are octogenarians) and multiple comorbidities. For elderly patients, improvements in heart failure symptoms, functional status, and quality of life (QOL) maybe as important as longevity or even more. Over the last decade, we observe a change in trend, estimating medical interventions by clinical parameters along with other non-clinical parameters indicating a day-to-day improvement in factors which are more valuable to the patient and their families. This change is based on the understanding that treating a patient's physical symptoms successfully does not necessarily mean improving their QOL. The patient reported outcome measures (PROMs) initiative is focused upon what matters to patients during and following medical interventions. Data on PROMs in TAVI patients is increasing over the years but is still lacking, despite its potential to improve patient's care. In this study, we intend to create a novel self-developed patient-oriented PROM questionnaire specifically for TAVI patients and use it to assess the differences between physician's and patient's perception of a successful TAVI procedure. These discrepancies will form the basis for building a forecast model for a successful TAVI from the patient's perspective.

Study Overview

• Status: Recruiting
• Conditions: PROM; Transcatheter Aortic Valve Implantation; Patient Reported Outcomes
• Intervention / Treatment: Other: Questionnaire

Detailed Description

The transcatheter Aortic Valve Implantation (TAVI) population with severe aortic stenosis (AS) is characterized by advanced age (most patients are octogenarians) and multiple comorbidities. For elderly patients, improvements in heart failure symptoms, functional status, and quality of life (QOL) maybe as important as longevity or even more. Over the last decade, we observe a change in trend, estimating medical interventions by clinical parameters along with other non-clinical parameters indicating a day-to-day improvement in factors which are more valuable to the patient and their families. This change is based on the understanding that treating a patient's physical symptoms successfully does not necessarily mean improving their QOL. The patient reported outcome measures (PROMs) initiative is focused upon what matters to patients during and following medical interventions. A Patient Reported Outcome (PRO) is "any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient response by a clinician or anyone else". Data on PROMs in TAVI patients is increasing over the years but is still lacking, despite its potential to improve patient's care. Until recently, studies have used pre-validated questionnaires (such as KCCQ, ED-5D, PROMIS-10 or SF-36) for other patient's populations and validated them for the TAVI patient's population. Recently, the MacNew questionnaire was validated for TAVI patients. However, as far as we know, no questionnaire has been developed in collaboration with TAVI patients. As we believe that patient's involvement in a PROM's development is essential to truly capture patient's perspective, we decided to develop a new questionnaire collaborating with TAVI patients instead of using a pre-validated questionnaire.

In this research proposal our main objective is to define what is a successful TAVI in the patient's perspective. To do so, we wish to create and validate a new TAVI PROM questionnaire RT-20 (Rabin TAVI 20 questions questionnaire) and use it to assess the differences between physician's and patient's perception of a successful TAVI procedure. In the first phase, to form the questionnaire, 30 patients up to 6 months after TAVI procedure, will be recruited to choose the questions from a questions' repository. To validate the questionnaire, 30 physicians (cardiology consultants, internal medicine, and geriatrics consultants) will be recruited to assure content validity and 30 new patients after TAVI will be recruited to examine the face validity of the questionnaire. In the second phase, after obtaining the validated RT-20 questionnaire, 150 new patients will be recruited for the two discrepancies assessments: the first, between patient's perception and his/her physician's perception and the second, between physician himself before and after exposure to the RT-20 validated questionnaire regarding the successfulness of the TAVI procedure. All patients and physicians will be recruited from Rabin Medical Center - Beilinson campus.

These discrepancies will form the basis for building a forecast model for a successful TAVI from the patient's perspective. We will look for independent predictors of disagreement between patients and physicians as to the success of the procedure; as well as predictors of the physician's assessment before and after seeing the PROM questionnaire RT-20. These possible determinants such as living alone, need for assistance in activities of daily living and multiple comorbidities will be entered into a logistic regression model. We will also build a model to predict the patient satisfaction with the procedure. This model will help to aid in the triage of patients suffering from severe AS in an attempt to avoid futile procedures and thus optimize procedural success and/or resources utilization.

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Ruthie Vizel, M.Sc; Phone Number: +972-3-6969216; Email: ruthievi@clalit.org.il

Study Locations

• Israel
  • Petach Tikva, Israel
    • Recruiting
    • Rabin Medical Center
    • Contact: Ruthie Vizel, M.Sc; Phone Number: +972-546456666; Email: nruthie@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Transcatheter Aortic Valve Implantation (TAVI) Patients before and after the procedure

Description

Inclusion Criteria:

1. Patients (men and women) who underwent a successful TAVI procedure (defined according to VARC 2) REF
2. Patients who agreed to participate in the study and gave their written inform consent.
3. Patients who are capable to fulfill the PROMs questionnaires.

Exclusion Criteria:

1. Patients that are not able to give their consent.
2. Patients that from any reason are not able to fulfill the PROM's questionnaire.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dependent variable (model) - Successful TAVI from the patient perspective.	In this research our main objective is to define what is a successful TAVI in the patient's perspective. To do so, we will create and validate a new TAVI PROM questionnaire RT-20 (Rabin TAVI 20 questions questionnaire) and use it to assess the differences between physician's and patient's perception of a successful TAVI procedure. These differences will be used to build a model to predict the patient satisfaction with the TAVI procedure. This model will help to aid in the triage of patients suffering from severe AS in an attempt to avoid futile procedures and thus optimize procedural success and/or resources utilization.	Before the TAVI procedure until 3 months after it.
The disagreement between the patient and his/her doctor's perception	For the discrepancy assessment part, the following outcomes will be measured: Primary - The disagreement between the patient and his/her doctor's perception of the patient's health, measured at 3 months FU visit by the Likert scale.	Before the TAVI procedure until 3 months after it.
correlation assessment between patient's survival and patient's RT-20 score	For the correlation assessment between patient's survival and patient's RT-20 score part: Primary outcome - Correlation extent between patient's survival 12 months post TAVI and patient's RT-20 score.	Before the TAVI procedure until 12months after it.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The disagreement between the doctor's perception before and after observing the RT-20 questionnaire.	For the discrepancy assessment part, the following outcomes will be measured: Secondary outcome - The disagreement between the doctor's perception (regarding the successfulness of the TAVI) before and after the exposure to the RT-20 questionnaire (representing the patient's perception of his health status and the successfulness of the TAVI procedure).	Before the TAVI procedure until 3 months after it.

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Study Chair: Prof. Ran Kornowski, MD FESC FACC, Chairmain of Cardiology devision

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2018
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: July 8, 2018
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): April 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Patient reported outcomes; PROM; Transcatheter Aortic Valve Implantation
• Other Study ID Numbers: 453-18-RMC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No