Recruiting

Visual Risk Display

Sponsor:

Queen's University

Code:

NCT05098535

Conditions

Risk

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Accepted

Interventions

Visual Aid

Scripted Risk Discussion

Study Details

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.

Conditions

Risk

Study ID

NCT05098535

Start date

Oct 28, 2021

Status verified date

Oct, 2021

Completion date

Jul 1, 2022

Anticipated

Primary completion date

Dec 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Visual Aid + Scripted Risk Discussion

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.

active comparator: 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.

Interventions

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.

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 ]

Central Contacts and Locations

Central contacts

Michael McMullen, MD

613-548-7827Michael.McMullen@kingstonhsc.ca

Locations

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L2V7

More Information

Sponsor

Queen's University

Last update posted

Oct 28, 2021

Last verified

Oct, 2021

Keywords

  • Preoperative Assessment
  • Myocardial Injury
  • Perioperative Medicine
  • Personalized Medicine
  • Communication

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Queen's University on 2021-10-28.