Remembering Risk Using Visual Risk Display of MINS to Obtain Informed Consent to Undergo Elective Surgery

Risk Clinical Trial

Official title:

Remembering Risk Using Visual Risk Display of MINS to Obtain Informed Consent to Undergo Elective Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05098535
• Other study ID #: ANAE35219
• Status: Recruiting
• Phase: N/A
• Start date: October 28, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: October 2021
• Source: Queen's University
• Contact: Michael McMullen, MD
• Phone: 613-548-7827
• Email: Michael.McMullen[@]kingstonhsc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: July 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Risk

Intervention

Other:
• Visual Aid
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 Discussion
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.

Locations

Country	Name	City	State
Canada	Kingston Health Sciences Centre	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. Review. Erratum in: Can J Cardiol. 2017 Dec;33(12 ):1735. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within one hour of completing consultation with anesthesiologist in PSS clinic
Secondary	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	Within 72h of undergoing their elective surgical procedure
Secondary	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	Within one hour of completing preoperative consultation
Secondary	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)	Within one hour completing preoperative consultation
Secondary	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	Within one hour completing preoperative consultation
Secondary	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	Within one hour completing preoperative consultation