Data Collection Without Identifiers

We are conducting a survey of adult and pediatric cardiologists, electrophysiologists, ACHD specialists, and others engaged in the cardiac care of patients with repaired tetralogy of Fallot (rTOF). Our goal is to analyze practice patterns for risk stratification and primary prevention of sudden cardiac death. We are reaching out to PACES members at this time and would be grateful for your participation! Our goal is to have at least one survey completed by your program, although multiple entries are welcomed, especially when there is not a consensus on management of these patients. This survey should take about 15 minutes to complete.

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CONSENT TO PARTICIPATE IN A RESEARCH STUDY

TITLE OF STUDY: Survey of Practice Patterns for Ordering and Interpreting Diagnostic Electrophysiology Studies and Sudden Cardiac Death Screening in Adolescent and Adult Patients with Repaired Tetralogy of Fallot

PRINCIPAL INVESTIGATOR: Jeremy Nicolarsen, MD, FACC

CO-INVESTIGATOR: Charles Christian Anderson, MD, FAAP, CEPS-PC

INTRODUCTION

You are being asked to volunteer to take part in this research study because you are a member of the Pediatric & Congenital Electrophysiology Society (PACES).

Before deciding whether you want to participate in this research study or not, it is important that you read and understand the following explanation of the study procedures. This consent describes the purpose, procedures, benefits, and risks of the study. No promises can be made about how you will be affected if you consent to be in the study.

Please review this informed consent carefully before agreeing to participate. If you have questions about this consent form, you may contact Dr. Nicolarsen at (509) 474-6707 or Dr. Anderson at (509) 474-6707.

WHY IS THIS STUDY BEING DONE?

The purpose of this study is to gain an understanding of how electrophysiologists approach patients with repaired tetralogy of Fallot (rTOF).

Sudden cardiac death (SCD) remains a concern in patients with repaired tetralogy of Fallot. Assessment of SCD risk should be performed at regular intervals, but certainly before transcatheter or surgical pulmonary valve replacement (PVR), as there may be an opportunity to modify risk before/during PVR with selective electrophysiologic study (EPS) and ventricular tachycardia (VT) ablation.

Despite increasingly better understanding of the risk factors for SCD in rTOF, there remains considerable variability in the management of these patients. Perhaps the results of this survey can aid the development of a consensus-driven risk assessment tool and algorithm for management, specifically addressing which patients to study with EPS, who should get VT ablation, who to consider for Implantable Cardioverter (ICD) implantation, etc.

HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?

A total of about 670 participants will take part in this study.

WHAT IS INVOLVED IN THE STUDY?

This study involves a one-time REDCap survey. The survey questions cover information about rTOF and EP case volume at individual centers, assessment of risk of rTOF patients, and details of electrophysiologic practices at each center. Your name and email address will also be collected for possible future collaboration.

HOW LONG WILL YOU BE IN THE STUDY?

This is a one-time survey that will take about 15 minutes to complete.

WHAT ARE THE RISKS OF THE STUDY?

There is a possibility of loss of confidentiality.

WHAT ARE THE BENEFITS TO TAKING PART IN THE STUDY?

There may be no direct benefit to you.
The data could eventually lead to improved and standardized practices for patients with rTOF.

WHAT OTHER POSSIBLE OPTIONS ARE THERE?

You may choose not to participate in this survey.

WHAT ARE THE COSTS?

There are no costs to you for participating in this study.

WHAT ABOUT CONFIDENTIALITY?

By completing this survey, you are agreeing to share information about your center. The data may also be published in journals or presented publicly. If you do not want information about your center shared, you do not have to complete the survey.

WHAT ARE YOUR RIGHTS AS A PARTICIPANT?

Participation in this study is voluntary. There will be no penalty or loss of benefits to which you are otherwise entitled if you decide not to participate.

The study PI and this facility will not receive payment for conducting this study. If you have any questions regarding this, any aspect of your rights you may contact Dr. Nicolarsen at (509) 474-6707 or Dr. Anderson at (509) 474-6707 at any time.

Should you have further questions regarding your rights as a research participant or complaints regarding this research study you may contact the Providence St. Joseph Health Institutional Review Board at irbsharedservices@providence.org.

CAN I STOP PARTICIPATING IN THIS STUDY?

You may end the survey without submitting it without prejudice or loss of benefits to which you are entitled.

PARTICIPANT CONSENT

I have read the information describing the study, and it is written in a language that I understand. All my questions have been answered to my satisfaction. By continuing on to complete the survey, my consent is implied.

You have selected an option that triggers this survey to end right now.

To save your responses and end the survey, click the 'End Survey' button below. If you have selected the wrong option by accident and/or wish to return to the survey, click the 'Return and Edit Response' button.