Optimizing the Consent Process for Emergent Laparoscopic Cholecystectomy

Summary

The Canadian Medical Protective Association (CMPA) defines informed consent (IC) as a voluntary process where important elements include details of the procedure, complications, and proposed alternatives. Laparoscopic cholecystectomy (LC) was the most common laparoscopic procedure cited in 423 medical-legal cases reported by CMPA in 2017, with 29% of cases citing issues in pre-operative care including inadequacy of the consent process. The investigators recently demonstrated that technology can help improve the IC process in an outpatient setting by conducting a prospective randomized controlled trial to examine the effects of adding a digital educational platform (DEP) module to a standard verbal consent (SVC) for an elective laparoscopic Roux-en-Y gastric bypass procedure. The investigators demonstrated a significant improvement in immediate post-consent knowledge of the risks, benefits and alternatives in patients who viewed the DEP module with equivalent patient satisfaction as compared to a SVC. With the proposed study the investigators plan to gather evidence to support implementing a digital education platform for emergent surgical procedures performed in an in-patient setting.

The investigators propose to conduct a randomized controlled trial to explore the benefits of adding a DEP module to a SVC for patients presenting with acute cholecystitis requiring an emergent LC as an in-patient. Participants will be randomly allocated (1:1) to either a control group (SVC) or an intervention group (SVC + DEP). Primary outcome of interest will be immediate post-consent knowledge of the risks, benefits, alternatives and expected outcomes for a LC. Secondary outcomes will include satisfaction with the consent discussion and delayed retention of knowledge of the risks, benefits, alternatives and expected outcomes for a LC .

The investigators hypothesize that completion of the DEP module in addition to SVC will result in superior immediate and delayed post-consent knowledge of risks and benefits of LC with equivalent patients satisfaction as compared to SVC alone.

The results of this study will provide evidence supporting the addition of DEP to SVC for urgent and emergent surgical procedures.

Conditions

• Consent
• Laparoscopic
• Cholecystectomy

Interventions

BEHAVIORAL

Consent process with the addition of Digital educational platform (DEP)

In-patients being consented for laparoscopic cholecystectomy will be provided with a Digital Educational Platform (DEP), in the form of modules on an iPad. These participants will still undergo the usual standard verbal consent (SVC). Multiple choice questionnaires will be given pre and post consent to determine acquisition and retention of the information provided using DEP.

BEHAVIORAL

Consent process using the standard verbal consent (SVC)

In-patients being consented for laparoscopic cholecystectomy will go through the SVC. Multiple choice questionnaires will be given pre and post consent to determine acquisition and retention of the information provided using SVC.

Sponsors & Collaborators

• Dr. Boris Zevin

  lead OTHER

Principal Investigators

• Boris Zevin · Queen's University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-09-21

Primary Completion

2023-07-31

Completion

2023-09-30

Countries

• Canada

Study Locations