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

NCT05098535 | Unknown

• 1 other identifier: ANAE35219
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Postoperative Recall of Perioperative Risk of Myocardial Injury (MINS)

  Within 72h of undergoing their elective surgical procedure

• Demographics and Immediate Recall of Perioperative Risk of Myocardial Injury

  Within one hour of completing preoperative consultation

• Correlation between subjective rating of individual risk and numeric risk estimate

  Within one hour completing preoperative consultation

• Satisfaction with Risk Discussion

  Within one hour completing preoperative consultation

• Recommendation of Use of Risk Discussion Tool in Future

  Within one hour completing preoperative consultation

Study Arms (2)

Visual Aid + Scripted Risk Discussion

EXPERIMENTAL

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.

Other: Visual Aid; Other: Scripted Risk Discussion

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.

Other: Scripted Risk Discussion

Interventions

Visual Aid OTHER

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.

Visual Aid + Scripted Risk Discussion

Scripted Risk Discussion OTHER

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.

Scripted Risk Discussion; Visual Aid + Scripted Risk Discussion

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Kingston Health Sciences Centre

Kingston, Ontario, K7L2V7, Canada

RECRUITING

Related 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.

  PMID: 27865641 BACKGROUND

MeSH Terms

Conditions

Communication

Interventions

Audiovisual Aids

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Educational Technology; Technology; Technology, Industry, and Agriculture

Study Officials

• Michael McMullen, MD

  Queens University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael McMullen, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be masked to the primary purpose of the study during their preoperative consultation. Upon receiving and completing the survey responses participants will be asked to recall their individualized risk of myocardial injury and provide feedback on the risk discussion they had with the anesthesiologist.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Anesthesiology and Perioperative Medicine

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: October 28, 2021
• Study Start: October 28, 2021
• Primary Completion: December 1, 2021
• Study Completion: July 1, 2022
• Last Updated: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)