Cardiac SurgeryNCT04796233
Patient Perspectives on Advance Care Planning Discussions Prior to Cardiac Surgery
An observational study of Cardiac Surgery, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2021to Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patients undergoing cardiac surgical procedures that involve a sternotomy, thoracotomy, or cardiopulmonary bypass for any indication.
- Age > 18
- English-speaking
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto General Hospital - University Health Network
Toronto, Ontario, M5G 2C4
Michael Tylee, MD, (416) 340-5164, michael.tylee@uhn.ca
About this study
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.
Read the 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.
- Conditions
- Cardiac Surgery
- Keywords
- Advance Care Planning
What is being measured
The primary outcome is the main question the study is designed to answer.
Interview
Patient perspectives and attitudes regarding advance care planning (ACP) with a focus on patient values and goals prior to cardiac surgery.
Measured: 30-35 Minute interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study startOct 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Responsible party
- Sponsor
- Investigators
- Michael Tylee, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796233
- Sponsor's protocol ID
- 19-5910
- Status last verified
- Feb 2021
- First submitted
- 10 Mar 2021
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Perspectives on Advance Care Planning Discussions Prior to Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04796233
- Acronym / sponsor ID
- 19-5910
- Conditions
- Cardiac Surgery
- Keywords
- Advance Care Planning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Study start
- Oct 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Adult patients undergoing cardiac surgical procedures that involve a sternotomy, thoracotomy, or cardiopulmonary bypass for any indication.
- Age > 18
- English-speaking
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Tylee, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Tylee, MD ((416) 340-5164, michael.tylee@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interview (time frame: 30-35 Minute interview). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.