Clinical trial NCT05098535: Remembering Risk Using Visual Risk Display of MINS to Obtain Informed Consent to Undergo Elective Surgery
Official title: Remembering Risk Using Visual Risk Display of MINS to Obtain Informed Consent to Undergo Elective Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Risk
Keywords: Preoperative Assessment
Myocardial Injury
Perioperative Medicine
Personalized Medicine
Communication
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 108
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Immediate Recall of Perioperative Risk of Myocardial Injury (MINS)
timeFrame: Within one hour of completing consultation with anesthesiologist in PSS clinic
Secondary outcomes:
measure: Postoperative Recall of Perioperative Risk of Myocardial Injury (MINS)
timeFrame: Within 72h of undergoing their elective surgical procedure
measure: Demographics and Immediate Recall of Perioperative Risk of Myocardial Injury
timeFrame: Within one hour of completing preoperative consultation
measure: Correlation between subjective rating of individual risk and numeric risk estimate
timeFrame: Within one hour completing preoperative consultation
measure: Satisfaction with Risk Discussion
timeFrame: Within one hour completing preoperative consultation
measure: Recommendation of Use of Risk Discussion Tool in Future
timeFrame: Within one hour completing preoperative consultation
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
Study officials:
affiliation: Queens University
name: Michael McMullen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.