NCT04796233

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

September 1, 2021

Status Verified

February 1, 2021

Enrollment Period

5 months

First QC Date

March 10, 2021

Last Update Submit

August 31, 2021

Conditions

Keywords

Advance Care Planning

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital - University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Study Officials

  • Michael Tylee, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 12, 2021

Study Start

October 1, 2021

Primary Completion

March 1, 2022

Study Completion

March 1, 2023

Last Updated

September 1, 2021

Record last verified: 2021-02

Locations