Patient Perspectives on Advance Care Planning Discussions Prior to Cardiac Surgery

August 31, 2021 updated by: University Health Network, Toronto
The purpose of this study is to explore patient perspectives on Advance Care Planning (ACP) prior to cardiac surgery, including perceptions of benefits, drawbacks, and barriers to ACP.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

In this study, we plan to interview 40 patients who are scheduled to undergo cardiac surgery about their perspectives on preoperative ACP and discussion of their values, goals of care, and preferences for prolonged care in hospital prior to having surgery. We plan to conduct and audio record one-on-one interviews that are structured around standard questions about ACP. After recordings are completed, we plan to conduct an analysis of the interviews to find common themes and ideas that participants have about preoperative advance care planning. These results will help us understand whether patients value and wish to participate in advance care planning prior to major surgery, and will help to guide the structure and content of preoperative advance care plan programs in the future.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

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

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital - University Health Network
        • Contact:

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

Sampling Method

Non-Probability Sample

Study Population

We will enroll patients at Toronto General Hospital, a tertiary cardiac surgery centre in Toronto. We will include patients undergoing any cardiac surgery procedures that involve cardiopulmonary bypass, as well as patients undergoing off-pump coronary bypass procedures and any other high-risk cardiac surgery patients, for example, those undergoing ventricular assist device insertion or pericardectomy.

Description

Inclusion Criteria:

  • Adult patients undergoing cardiac surgical procedures that involve a sternotomy, thoracotomy, or cardiopulmonary bypass for any indication.
  • Age > 18
  • English-speaking

Exclusion Criteria:

  • Emergency surgery, regardless of indication or procedure
  • Minor/percutaneous cardiac procedure
  • Lack of decisional capacity due to dementia or other neurocognitive dysfunction
  • Previously decided upon advance care directives
  • Still considering surgery or not yet booked for an operation

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interview
Time Frame: 30-35 Minute interview
Patient perspectives and attitudes regarding advance care planning (ACP) with a focus on patient values and goals prior to cardiac surgery.
30-35 Minute interview

Collaborators and Investigators

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

Sponsor

University Health Network, Toronto

Collaborators

Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Michael Tylee, MD, University Health Network, Toronto

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)

October 1, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 12, 2021

Study Record Updates

Last Update Posted (Actual)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 19-5910

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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