RiskNCT04247841
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 Dr. Michael McMullen at 1 site in Canada.
Trial summary
Disclosure of anticipated risks to individuals considering undergoing an 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… Read more about this study
- Who is it for?
- Ages 45 years and older
- 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
- 456 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jan 2020to 1 Sep 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 45 years of age or older who are seen in Presurgical Screening Clinic by an anesthesiologist prior to elective hip or knee arthroplasty at Kingston Health Sciences Centre.
Who cannot join
- Unable to provide consent due to communication/language barrier
- Prior enrollment in this study
- No planned admission to hospital ( Same - Day joint arthroplasty)
Trial locations and contacts
1 site in 1 country.
About this study
Disclosure of anticipated risks to individuals considering undergoing an 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 strongly recommend the 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 a 2-stage research project to address current practice in perioperative risk communication and examine opportunity to improve communication and patient education.
Phase One is structured to assess the current practices with respect to cardiac risk discussion at our academic center. During this initial phase, a survey will be offered after the PSS consultation to patients > 45 years old, seen in consult prior to elective orthopedic surgery requiring an overnight admission to KHSC. The survey will assess current risk discussion practices, patient satisfaction with cardiac risk discussion, ability to recall cardiac risk, importance of cardiac risk disclosure, and seek general feedback from participants.
Phase Two of 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. The patients will complete the survey instrument immediately after their PSS consultation to assess patient satisfaction with cardiac risk discussion, recall of risk, importance of cardiac risk discussion from the patients' perspective, and general feedback will be sought regarding perioperative education.
A subset of consenting patients during both Phase I and II will be followed-up post operatively (within 48h) to assess recall of preoperative cardiac risk discussion.
Our study group 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 their understanding and retention of the risk in the post-operative period.
- Conditions
- Risk
- Being tested
- Visual Aid, Scripted Risk Discussion
- Keywords
- Risk, 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 discription 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 |
|---|---|---|
| Phase I: Current Practice | No intervention | This represents the first phase of the study in which a prospective cohort of patients will complete the survey to define baseline rates of recall of perioperative risk and level of patient satisfaction with risk discussion |
| Phase II Visual Aid & Scripted Risk Discussion | Experimental | This will involve a 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 |
| Phase II 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.
Measured: Within 60 minutes 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 their rCRI score (as outlined in the 2016 CCS Guidelines) when completing the survey.
Measured: Within 48 hours of undergoing their elective joint arthroplasty
Demographics and Immediate Recall of Perioperative Risk of Myocardial Injury
We 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 60 min of completing preoperative consultation
Correlation between subjective rating of individual risk and numeric risk estimate
Patients subjective responses to their level of risk (minimal, low, moderate, high, very high) will be compared with their numeric risk estimate ( rate / 100 persons)
Measured: Within 60 min completing preoperative consultation
Satisfaction with Risk Discussion
Subjects will be asked to rate their level of satisfaction with the preoperative risk discussion on a 5 point Likehert Scale and the difference between 3 arms will be examined
Measured: Within 60 min completing preoperative consultation
Recommendation of Use of Risk Discussion Tool in Future
Patients will be asked to rate their likelihood (0-10) to use a similar format of risk discussion to family or friends coming for surgery.
Measured: Within 60 min 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 posted30 Jan 2020
- Study start29 Jan 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- During Phase 1 we will be completing data collection on a prospective cohort of patients attending Presurgical Screening (PSS) Clinic in preparation for elective total joint arthroplasty of the hip or knee. During the Phase 2 we will utilize a randomized approach 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Michael McMullen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Michael McMullen, Queen's University
- Investigators
- Michael McMullen, MD, Principal investigator, Department of Anesthesiology and Perioperative Medicine, Queen's Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247841
- Sponsor's protocol ID
- TRAQ #: 6028012
- Status last verified
- Mar 2021
- First submitted
- 28 Jan 2020
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 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
- NCT04247841
- Acronym / sponsor ID
- TRAQ #: 6028012
- Conditions
- Risk
- Keywords
- Risk, Preoperative Assessment, Myocardial Injury, Perioperative Medicine, Personalized Medicine, Communication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 456 participants (estimated)
- Lead sponsor
- Dr. Michael McMullenUniversity, hospital or other
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 30 Jan 2020 (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 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 strongly recommend the 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 a 2-stage research project to address current practice in perioperative risk communication and examine opportunity to improve communication and patient education.
Phase One is structured to assess the current practices with respect to cardiac risk discussion at our academic center. During this initial phase, a survey will be offered after the PSS consultation to patients > 45 years old, seen in consult prior to elective orthopedic surgery requiring an overnight admission to KHSC. The survey will assess current risk discussion practices, patient satisfaction with cardiac risk discussion, ability to recall cardiac risk, importance of cardiac risk disclosure, and seek general feedback from participants.
Phase Two of 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. The patients will complete the survey instrument immediately after their PSS consultation to assess patient satisfaction with cardiac risk discussion, recall of risk, importance of cardiac risk discussion from the patients' perspective, and general feedback will be sought regarding perioperative education.
A subset of consenting patients during both Phase I and II will be followed-up post operatively (within 48h) to assess recall of preoperative cardiac risk discussion.
Our study group 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 their understanding and retention of the risk in the post-operative period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- During Phase 1 we will be completing data collection on a prospective cohort of patients attending Presurgical Screening (PSS) Clinic in preparation for elective total joint arthroplasty of the hip or knee. During the Phase 2 we will utilize a randomized approach 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 |
|---|---|---|
| Phase I: Current Practice | No intervention | –This represents the first phase of the study in which a prospective cohort of patients will complete the survey to define baseline rates of recall of perioperative risk and level of patient satisfaction with risk discussion |
| Phase II Visual Aid & Scripted Risk Discussion | Experimental | Other: Visual Aid, Other: Scripted Risk DiscussionThis will involve a 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. |
| Phase II 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
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 45 years of age or older who are seen in Presurgical Screening Clinic by an anesthesiologist prior to elective hip or knee arthroplasty at Kingston Health Sciences Centre.
Key exclusion criteria (3 listed)
- Unable to provide consent due to communication/language barrier
- Prior enrollment in this study
- No planned admission to hospital ( Same - Day joint arthroplasty)
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 discription 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 | Phase II 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 | Phase II Scripted Risk Discussion, Phase II Visual Aid & Scripted Risk Discussion |
Primary outcome
Immediate Recall of Perioperative Risk of Myocardial Injury (MINS)
Time frame: Within 60 minutes 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.
5 secondary outcomes
Postoperative Recall of Perioperative Risk of Myocardial Injury (MINS)
Time frame: Within 48 hours of undergoing their elective joint arthroplasty
Demographics and Immediate Recall of Perioperative Risk of Myocardial Injury
Time frame: Within 60 min of completing preoperative consultation
Correlation between subjective rating of individual risk and numeric risk estimate
Time frame: Within 60 min completing preoperative consultation
Satisfaction with Risk Discussion
Time frame: Within 60 min completing preoperative consultation
Recommendation of Use of Risk Discussion Tool in Future
Time frame: Within 60 min 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 19 Mar 2021.
- 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
Department of Anesthesiology and Perioperative Medicine, Queen's Univerisity
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 Dr. Michael McMullen 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 1 inclusion and 3 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 19 Mar 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 60 minutes 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?
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 19 Mar 2021; AzTrials last refreshed its copy on 5 Nov 2026.