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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Risk
• Intervention / Treatment: Other: Scripted Risk Discussion; Other: Visual Aid

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 Type: Interventional
• Enrollment (Anticipated): 456
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L2V7
      • Kingston Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Unable to provide consent due to communication/language barrier
• Prior enrollment in this study
• No planned admission to hospital ( Same - Day joint arthroplasty)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Phase I: Current Practice; 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
Experimental: Phase II Visual Aid & Scripted Risk Discussion; 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.	Other: 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.; 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 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.
Active Comparator: Phase II Scripted Risk Discussion; 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 60 minutes of completing consultation with anesthesiologist in PSS clinic

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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)	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	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.	Within 60 min completing preoperative consultation

Collaborators and Investigators

• Sponsor: Dr. Michael McMullen
• Investigators: Principal Investigator: Michael McMullen, MD, Department of Anesthesiology and Perioperative Medicine, Queen's Univerisity

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2020
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Personalized Medicine; Risk; Perioperative Medicine; Communication; Myocardial Injury; Preoperative Assessment
• Other Study ID Numbers: TRAQ #: 6028012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No