Optimizing the Consent Process for Emergent Laparoscopic Cholecystectomy Using an Interactive Digital Education Platform: A Randomized Control Trial

Required elements for an informed consent (IC) in surgery have been well established. The Canadian Medical Protective Association (CMPA) defines IC as a voluntary process where important elements include details of the procedure, complications, and proposed alternatives. The individual should also be given ample time to ask questions to ensure best understanding of the procedure. Shortcomings in the process can lead to patient complaints, unmet expectations and have significant legal ramifications. Of all medical-legal cases involving inadequacy of informed consent reported by CMPA in 2016, 65% involved surgical procedures and 79% had unfavorable outcomes. 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 informed consent process.

The investigators conducted a retrospective chart review of 270 patients who underwent 71(26%) elective and 199(74%) emergent LC at our tertiary academic centre and demonstrated poor documentation of IC with only 5(2%) patients' charts having complete documentation of all three elements of IC. For emergent cases, discussion of possible complications of LC was documented 174(64%) of cases; details of the LC were documented in 7(2.6%) of cases; and alternatives to LC were documented in 3(1.1%) of cases. Emergent LC was associated with worse documentation of IC as compared to elective LC. It is difficult to ascertain whether poor documentation is associated with poor informed consent discussions; however, use of digital education platforms (DEP) can enhance a patient's understanding of the risks, benefits and alternatives to a proposed operative procedure and can ensure the comprehensiveness of the consent discussion.

The investigators recently conducted a prospective randomized controlled trial of 51 patients with severe obesity to examine the effects of adding a digital educational platform (DEP) to a standard verbal consent (SVC) for a laparoscopic Roux-en-Y gastric bypass procedure. In this study the investigators demonstrated that addition of DEP to SVC resulted in improved knowledge of the risks, benefits and alternatives to the procedure vs SVC alone (85.0±8.8% vs 78.7±8.7%; p=0.01; Effect Size=0.72), equivalent patient satisfaction (31.5±1.1 vs 31±2.7; p=0.10), and significantly shorter face-to-face time between patient and surgeon to obtain informed consent (358±198sec vs 751±212sec; p<0.01; Effect Size=1.92). However, the generalizability and transferability of our findings to an inpatient setting and to emergent operations is currently unknown.

The investigators will be conducting a randomized controlled trial to explore the benefits of adding a DEP module to a SVC for patients presenting with acute biliary pathology requiring an emergent LC in an in-patient setting.

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