Syngery-Evaluating the Impact of Decision Aid

September 10, 2019 updated by: Faisal Merchant MD, Emory University

Evaluating the Impact of Decision Aid Timing on Mandatory Shared Decision Making for Defibrillator Implantation

The aim of this study is to determine whether it is better to give patients an implantable cardioverter-defibrillators (ICDs) decision aid before they have their first consultation with an implanting cardiac electrophysiologist or after the consult.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There are many unanswered questions about how shared decision making should be executed and how decision aids should be employed. The aim of this study is to determine whether it is better to give patients an implantable cardioverter-defibrillators (ICDs) decision aid before they have their first consultation with an implanting cardiac electrophysiologist or after the consult.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital Midtown
      • Atlanta, Georgia, United States, 30322
        • Emory St. Joseph's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years old and older
  • evaluated for primary prevention implantable cardioverter-defibrillators (ICDs)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pre-visit decision aid
Patients receiving the decision aid pre-visit will be given a paper copy of the decision aid in the waiting room and will have a minimum of 15 minutes to review it - either in the waiting room or in the exam room while waiting for the electrophysiologist.
Behavioral: Pre-visit timing of receipt of the ICDs implantation decision aid
The intervention is the timing of receipt of the decision aid. The decision aid is designed to facilitate informing patients and helping to reach a decision.The implantable cardioverter-defibrillators (ICDs) implantation decision aid presents treatment options, risks, and benefits in lay terms.It is currently utilized in all of the Emory cardiac electrophysiology clinics as part of usual clinical care.
Experimental: Post-visit decision aid
Patients receiving the decision aid after the encounter will meet with the electrophysiologist first and receive the aid afterward.
Behavioral: Post-visit timing of receipt of the ICDs implantation decision aid
The intervention is the timing of receipt of the decision aid. The decision aid is designed to facilitate informing patients and helping to reach a decision.The implantable cardioverter-defibrillators (ICDs) implantation decision aid presents treatment options, risks, and benefits in lay terms.It is currently utilized in all of the Emory cardiac electrophysiology clinics as part of usual clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decisional ICDs knowledge score among pre-visit arm participants compare to post-visit arm participants
Time Frame: Date of ICD implantation (up to 60 days from the date of receiving the decision aid)
Patients will receive a survey including 11 questions to gauge decisional knowledge about ICDs. The survey is expected to take no more than 10-15 minutes to complete, which should allow adequate time for completion in the pre-procedure area without interrupting clinical workflow.
Date of ICD implantation (up to 60 days from the date of receiving the decision aid)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decision Conflict Scale score among pre-visit arm participants compare to post-visit arm participants
Time Frame: Date of ICD implantation (up to 60 days from the date of receiving the decision aid)
Patients will receive a survey including 12 questions to measure decisional conflict. The surveys are expected to take no more than 10-15 minutes to complete, which should allow adequate time for completion in the pre-procedure area without interrupting clinical workflow.
Date of ICD implantation (up to 60 days from the date of receiving the decision aid)
Values-choice ICDs concordance score among pre-visit arm participants compare to post-visit arm participants
Time Frame: Date of ICD implantation (up to 60 days from the date of receiving the decision aid)
Patients will receive a survey including 12 questions to measure values-choice concordance. The surveys are expected to take no more than 10-15 minutes to complete, which should allow adequate time for completion in the pre-procedure area without interrupting clinical workflow.
Date of ICD implantation (up to 60 days from the date of receiving the decision aid)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Faisal Merchant, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2019

Primary Completion (Actual)

September 6, 2019

Study Completion (Actual)

September 6, 2019

Study Registration Dates

First Submitted

February 4, 2019

First Submitted That Met QC Criteria

February 5, 2019

First Posted (Actual)

February 6, 2019

Study Record Updates

Last Update Posted (Actual)

September 12, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00107168

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data is being collected in REDCAP and is deidentified. The study team will have the tool to match subjects if needed. The team has no current plans to share data, but can if necessary (including the data dictionaries). All data can be shared after being deidentified.The study team can share the protocol, statistical plan, ICF, and survey tool. The decision tool is already available. Data will be available immediately following publication and for 3 years after. Those requesting access to data should contact the principal investigator (Dr. Faisal Merchant). Requests will be evaluated based on need and data usage agreement.

IPD Sharing Time Frame

Data will be available immediately following publication and for 3 years after.

IPD Sharing Access Criteria

Those requesting access to data should contact the principal investigator (Dr. Faisal Merchant). Requests will be evaluated based on need and data usage agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Implantable Cardioverter-defibrillators (ICDs)

Clinical Trials on Pre-visit timing of receipt of the ICDs implantation decision aid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe