Virtual Visits for Results Disclosure

September 1, 2018 updated by: Noreen Kelly, Brigham and Women's Hospital

Randomized Controlled Trial Evaluating Patient Satisfaction With Virtual Visits for Results Disclosure in the Brigham and Women's Hospital Cardiovascular Genetics Program

As part of this study patients who have undergone genetic testing in the Brigham and Women's Hospital Cardiovascular Genetics program will be randomized to receive the results of their genetic testing either by telephone call or virtual visit. At the completion of the telephone call or virtual visit patients will receive a survey to assess their understanding of their results and their satisfaction with their care.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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 or older
  • Undergoing genetic testing at BWH Cardiovascular Genetics clinic

Exclusion Criteria:

  • Reside outside of Massachusetts
  • Telephone or internet access unavailable

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Telephone Results Disclosure
Experimental: Virtual Visit Results Disclosure
Other: Virtual Visit
Patients will receive the results of their genetic testing via a virtual visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: within 7 days of results disclosure
Web-based survey focused on patient comprehension and satisfaction
within 7 days of results disclosure

Collaborators and Investigators

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

Sponsor

Brigham and Women's Hospital

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 (Anticipated)

September 1, 2017

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

September 1, 2018

First Submitted That Met QC Criteria

September 1, 2018

First Posted (Actual)

September 5, 2018

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

September 1, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017P000434

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plan to share data

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.

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