RiskNCT05098535
Remembering Risk Using Visual Risk Display of MINS to Obtain Informed Consent to Undergo Elective Surgery
A study testing Visual Aid and Scripted Risk Discussion in people with Risk, run by Queen's University at 1 site in Canada.
Trial summary
Disclosure of anticipated risks to individuals considering undergoing an elective operative procedure is an important aspect of informed consent process. Recent Canadian Guidelines have highlighted the importance of perioperative risk discussion within the context of preoperative assessment but there is little prior… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Risk
- What is being tested?
- Visual Aid and Scripted Risk Discussion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteCanada
- Study dates
- 28 Oct 2021to 1 Jul 2022
- Phase
- Interventional
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 45 years of age or older
- Patient is assessed in person by an anesthesiologist at Presurgical Screening Clinic
- Patient schedule for elective non-cardiac surgery
Who cannot join
- Unable to provide consent due to communication/language barrier
- Prior enrollment in this study
- Unable to consent without a Substitute Decision Maker
- Scheduled for non-elective surgery
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L2V7
Michael McMullen, MD
About this study
Disclosure of anticipated risks to individuals considering undergoing an elective operative procedure is an important aspect of informed consent process. Recent Canadian Guidelines have highlighted the importance of perioperative risk discussion within the context of preoperative assessment but there is little prior research into potential interventions to optimize the communication of risks.
Myocaridal injury (MINS) is the most common complication and this study is focused on determining the effectiveness of current communication strategies in our presurgical consultations and to quantifying the impact of introducing a visual aid and scripted risk discussions has on patients ability to recall their individualized perioperative risk of myocardial injury.
Read the detailed description
Informed consent is an important aspect of the patient-physician relationship. Prior to agreeing to undergo treatment patients must have risks and benefits disclosed to a "reasonable patient" standard.1 The 2016 Canadian Cardiovascular Society Guidelines on Perioperative Cardiac Risk Assessment made strong recommendations emphasizing the need for clear communication of perioperative cardiac risk to patients.2 Myocardial injury is the most common post-operative complications and has significant impact on patient outcomes including survival.2. However, very few studies have examined the communication of risk to patients, particularly when communicating perioperative cardiac risk.
The aim of this study is to formally evaluate the effectiveness of perioperative risk communication and examine if the introduction of visual aids can improve communication and preoperative patient education. During this study, all patients presenting to the Presurgical Screening clinic for consultation with an anesthesiologist will receive a standardized scripted discussion of the risk of myocardial injury following noncardiac surgery (MINS) based on their revised cardiac risk index. During the study period, patients will be randomized in blocks to exposure to a visual aid representing their individualized risk of MINS during the risk discussion. Immediately following the anesthesiology consultation, all patient will be invited to participate in the study and complete a survey that will assess ability to recall individualized cardiac risk and examine current risk discussion practices, patient satisfaction with cardiac risk discussion, importance of cardiac risk disclosure, assess anxiety related to risk discussion, and seek general feedback from participants. This study is structured to assess the effectiveness of incorporating the use of structured, scripted risk discussion with and without the use of a visual aid. A subset of consenting patients will be followed-up post operatively (within 48h) to assess recall of preoperative cardiac risk discussion.
The investigators hypothesizes that the use of visual representation of perioperative risk of Myocardial Injury after Non-Cardiac Surgery during the pre-anesthetic assessment will improve the patients' satisfaction with the cardiac risk discussion and the participant's understanding and retention of the risk in the post-operative period.
- Conditions
- Risk
- Being tested
- Visual Aid, Scripted Risk Discussion
- Keywords
- Preoperative Assessment, Myocardial Injury, Perioperative Medicine, Personalized Medicine, Communication
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual AidOther
The visual aid will include a graphic display of 100 individuals with number of individuals anticipated to suffer a myocardial injury highlighted by being filled in in red. There will also be a textual description stating the anticipated risk.
For example in a patient with an rCRI score = 2 the text will state 10 out of 100 patients will have a myocardial injury (MINS) and 90 out of 100 patients will have no myocardial injury and 10 of the patients will be shaded red on the visual aid. The patients in this intervention will also received the scripted discussion of perioperative risk of MINS.
Scripted Risk DiscussionOther
The patients seen in PSS will have a standardized discussion of perioperative risk of myocardial injury read to them by the anesthesiologist in the PSS clinic.
| Study group | Role | What they receive |
|---|---|---|
| Visual Aid + Scripted Risk Discussion | Experimental | This will involve the group of patients randomized to receive their perioperative risk discussion supplemented with the use of a visual aid in addition to a scripted discussion of their personalized perioperative risk of myocardial injury (MINS) during their consultation with an anesthesiologist in the PSS clinic. Receives: Other: Visual Aid; Other: Scripted Risk Discussion |
| Scripted Risk Discussion | Active comparator | This will involve a group of patients randomized to receive a scripted discussion of their personalized perioperative risk of myocardial injury (MINS) during their consultation with an anesthesiologist in the PSS clinic. Receives: Other: Scripted Risk Discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate Recall of Perioperative Risk of Myocardial Injury (MINS)
This will be calculated as the patients who can state their risk estimate within the 95% CI for the risk estimate given their rCRI score (as outlined in the 2016 CCS Guidelines) when completing the survey This will be calculated as the patients who can state their risk estimate within the 95% CI for the risk estimate given their rCRI score (as outlined in the 2016 CCS Guidelines) when completing the survey.
Measured: Within one hour of completing consultation with anesthesiologist in PSS clinic
Secondary outcomes (5)
Postoperative Recall of Perioperative Risk of Myocardial Injury (MINS)
This will be calculated as the patients who can state their risk estimate within the 95% CI for the risk estimate given the participant's rCRI score (as outlined in the 2016 CCS Guidelines) when completing the survey
Measured: Within 72h of undergoing their elective surgical procedure
Demographics and Immediate Recall of Perioperative Risk of Myocardial Injury
Investigators will compare the impact sex, age and level of education have on the percentage of patients able to recall their risk estimate within the 95% CI outlined in CCS guidelines
Measured: Within one hour of completing preoperative consultation
Correlation between subjective rating of individual risk and numeric risk estimate
Patients subjective responses to the level of risk (minimal, low, moderate, high, very high) will be compared with their numeric risk estimate ( rate / 100 persons)
Measured: Within one hour completing preoperative consultation
Satisfaction with Risk Discussion
Subjects will be asked to rate the level of satisfaction with the preoperative risk discussion on a 5 point likehert scale and the difference between two groups will be examined
Measured: Within one hour completing preoperative consultation
Recommendation of Use of Risk Discussion Tool in Future
Patients will be asked to rate the likelihood the participant would recommend (0-10) the use of a similar format of risk discussion to family or friends coming for surgery
Measured: Within one hour completing preoperative consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start28 Oct 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RiskStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A block randomized approach will be used to generate 2 groups of patients who will have their preoperative risk discussion guided by the use of a structured script or have the risk discussion guided by the use of a structured script and the display of a visual aid outlining the risk of myocardial injury.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Michael McMullen, Queen's University
- Investigators
- Michael McMullen, MD, Principal investigator, Queens University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098535
- Sponsor's protocol ID
- ANAE35219
- Status last verified
- Oct 2021
- First submitted
- 29 Jul 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duceppe E, Parlow J, MacDonald P, Lyons K, McMullen M, Srinathan S, Graham M, Tandon V, Styles K, Bessissow A, Sessler DI, Bryson G, Devereaux PJ. Canadian Cardiovascular Society Guidelines on Perioperative Cardiac Risk Assessment and Management for Patients Who Undergo Noncardiac Surgery. Can J Cardiol. 2017 Jan;33(1):17-32. doi: 10.1016/j.cjca.2016.09.008. Epub 2016 Oct 4.
PubMed 27865641
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remembering Risk Using Visual Risk Display of MINS to Obtain Informed Consent to Undergo Elective Surgery
- ClinicalTrials.gov ID
- NCT05098535
- Acronym / sponsor ID
- ANAE35219
- Conditions
- Risk
- Keywords
- Preoperative Assessment, Myocardial Injury, Perioperative Medicine, Personalized Medicine, Communication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- 28 Oct 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 28 Oct 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.
Disclosure of anticipated risks to individuals considering undergoing an elective operative procedure is an important aspect of informed consent process. Recent Canadian Guidelines have highlighted the importance of perioperative risk discussion within the context of preoperative assessment but there is little prior research into potential interventions to optimize the communication of risks.
Myocaridal injury (MINS) is the most common complication and this study is focused on determining the effectiveness of current communication strategies in our presurgical consultations and to quantifying the impact of introducing a visual aid and scripted risk discussions has on patients ability to recall their individualized perioperative risk of myocardial injury.
Detailed description
Informed consent is an important aspect of the patient-physician relationship. Prior to agreeing to undergo treatment patients must have risks and benefits disclosed to a "reasonable patient" standard.1 The 2016 Canadian Cardiovascular Society Guidelines on Perioperative Cardiac Risk Assessment made strong recommendations emphasizing the need for clear communication of perioperative cardiac risk to patients.2 Myocardial injury is the most common post-operative complications and has significant impact on patient outcomes including survival.2. However, very few studies have examined the communication of risk to patients, particularly when communicating perioperative cardiac risk.
The aim of this study is to formally evaluate the effectiveness of perioperative risk communication and examine if the introduction of visual aids can improve communication and preoperative patient education. During this study, all patients presenting to the Presurgical Screening clinic for consultation with an anesthesiologist will receive a standardized scripted discussion of the risk of myocardial injury following noncardiac surgery (MINS) based on their revised cardiac risk index. During the study period, patients will be randomized in blocks to exposure to a visual aid representing their individualized risk of MINS during the risk discussion. Immediately following the anesthesiology consultation, all patient will be invited to participate in the study and complete a survey that will assess ability to recall individualized cardiac risk and examine current risk discussion practices, patient satisfaction with cardiac risk discussion, importance of cardiac risk disclosure, assess anxiety related to risk discussion, and seek general feedback from participants. This study is structured to assess the effectiveness of incorporating the use of structured, scripted risk discussion with and without the use of a visual aid. A subset of consenting patients will be followed-up post operatively (within 48h) to assess recall of preoperative cardiac risk discussion.
The investigators hypothesizes that the use of visual representation of perioperative risk of Myocardial Injury after Non-Cardiac Surgery during the pre-anesthetic assessment will improve the patients' satisfaction with the cardiac risk discussion and the participant's understanding and retention of the risk in the post-operative period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A block randomized approach will be used to generate 2 groups of patients who will have their preoperative risk discussion guided by the use of a structured script or have the risk discussion guided by the use of a structured script and the display of a visual aid outlining the risk of myocardial injury.
| Arm | Type | Receives |
|---|---|---|
| Visual Aid + Scripted Risk Discussion | Experimental | Other: Visual Aid, Other: Scripted Risk DiscussionThis will involve the group of patients randomized to receive their perioperative risk discussion supplemented with the use of a visual aid in addition to a scripted discussion of their personalized perioperative risk of myocardial injury (MINS) during their consultation with an anesthesiologist in the PSS clinic. |
| Scripted Risk Discussion | Active comparator | Other: Scripted Risk DiscussionThis will involve a group of patients randomized to receive a scripted discussion of their personalized perioperative risk of myocardial injury (MINS) during their consultation with an anesthesiologist in the PSS clinic. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 45 years of age or older
- Patient is assessed in person by an anesthesiologist at Presurgical Screening Clinic
- Patient schedule for elective non-cardiac surgery
Key exclusion criteria (4 listed)
- Unable to provide consent due to communication/language barrier
- Prior enrollment in this study
- Unable to consent without a Substitute Decision Maker
- Scheduled for non-elective surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual AidThe visual aid will include a graphic display of 100 individuals with number of individuals anticipated to suffer a myocardial injury highlighted by being filled in in red. There will also be a textual description stating the anticipated risk. For example in a patient with an rCRI score = 2 the text will state 10 out of 100 patients will have a myocardial injury (MINS) and 90 out of 100 patients will have no myocardial injury and 10 of the patients will be shaded red on the visual aid. The patients in this intervention will also received the scripted discussion of perioperative risk of MINS. | Other | Visual Aid + Scripted Risk Discussion |
| Scripted Risk DiscussionThe patients seen in PSS will have a standardized discussion of perioperative risk of myocardial injury read to them by the anesthesiologist in the PSS clinic. | Other | Scripted Risk Discussion, Visual Aid + Scripted Risk Discussion |
Primary outcome
Immediate Recall of Perioperative Risk of Myocardial Injury (MINS)
Time frame: Within one hour of completing consultation with anesthesiologist in PSS clinic
This will be calculated as the patients who can state their risk estimate within the 95% CI for the risk estimate given their rCRI score (as outlined in the 2016 CCS Guidelines) when completing the survey This will be calculated as the patients who can state their risk estimate within the 95% CI for the risk estimate given their rCRI score (as outlined in the 2016 CCS Guidelines) when completing the survey.
5 secondary outcomes
Postoperative Recall of Perioperative Risk of Myocardial Injury (MINS)
Time frame: Within 72h of undergoing their elective surgical procedure
Demographics and Immediate Recall of Perioperative Risk of Myocardial Injury
Time frame: Within one hour of completing preoperative consultation
Correlation between subjective rating of individual risk and numeric risk estimate
Time frame: Within one hour completing preoperative consultation
Satisfaction with Risk Discussion
Time frame: Within one hour completing preoperative consultation
Recommendation of Use of Risk Discussion Tool in Future
Time frame: Within one hour completing preoperative consultation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Background: PubMed 27865641Duceppe E, Parlow J, MacDonald P, Lyons K, McMullen M, Srinathan S, Graham M, Tandon V, Styles K, Bessissow A, Sessler DI, Bryson G, Devereaux PJ. Canadian Cardiovascular Society Guidelines on Perioperative Cardiac Risk Assessment and Management for Patients Who Undergo Noncardiac Surgery. Can J Cardiol. 2017 Jan;33(1):17-32. doi: 10.1016/j.cjca.2016.09.008. Epub 2016 Oct 4.
- Individual participant dataSharing planned: No
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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 McMullen, MD principal investigator
Queens University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Aid and Scripted Risk Discussion in people with Risk, run by Queen's University 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 4 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 28 Oct 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 McMullen, MD (613-548-7827, Michael.McMullen@kingstonhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate Recall of Perioperative Risk of Myocardial Injury (MINS) (time frame: Within one hour of completing consultation with anesthesiologist in PSS clinic). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05098535, which also lists 1 linked publication.
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 28 Oct 2021; AzTrials last refreshed its copy on 1 Nov 2026.