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

NCT04247841 | Unknown

• 1 other identifier: TRAQ #: 6028012
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Risk

Keywords

Risk; 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.

  Within 60 minutes of completing consultation with anesthesiologist in PSS clinic

Secondary Outcomes (5)

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

  Within 48 hours of undergoing their elective joint arthroplasty

• Demographics and Immediate Recall of Perioperative Risk of Myocardial Injury

  Within 60 min of completing preoperative consultation

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

  Within 60 min completing preoperative consultation

• Satisfaction with Risk Discussion

  Within 60 min completing preoperative consultation

• Recommendation of Use of Risk Discussion Tool in Future

  Within 60 min completing preoperative consultation

Study Arms (3)

Phase I: Current Practice

NO INTERVENTION

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

Phase II Visual Aid & Scripted Risk Discussion

EXPERIMENTAL

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: Visual Aid; Other: Scripted Risk Discussion

Phase II 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 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.

Phase II 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.

Phase II Scripted Risk Discussion; Phase II Visual Aid & Scripted Risk Discussion

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Michael McMullen: lead

Study Sites (1)

Kingston Health Sciences Centre

Kingston, Ontario, K7L2V7, Canada

Location

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

  Department of Anesthesiology and Perioperative Medicine, Queen's Univerisity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, 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 they 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: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: During Phase 1 we will be completing data collection on a prospective cohort of patients attending Presurgical Screening (PSS) Clinic in preparation for elective total joint arthroplasty of the hip or knee. During the Phase 2 we will utilize a randomized approach 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: January 28, 2020
• First Posted: January 30, 2020
• Study Start: January 29, 2020
• Primary Completion: June 30, 2021
• Study Completion: September 1, 2021
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)