Optimizing the Consent Process for Emergent Laparoscopic Cholecystectomy

NCT04852016 | Completed

• 1 other identifier: SURG-534-20
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Knowledge of the Laparoscopic Cholecystectomy Procedure

  Understanding indications for surgery, alternatives, risks, complications, expectations and anticipated recovery will be one of the primary outcomes for this study. A 20 question multiple choice questionnaire will be used to measure this outcome.

  1 day

Secondary Outcomes (3)

• Self-reported rating of understanding of the laparoscopic cholecystectomy procedure.

  1 day

• Retention of Knowledge

  4-6 weeks

• Participant satisfaction with the clinical encounter

  1 day

Study Arms (2)

Digital Educational Platform

EXPERIMENTAL

Study participants randomized to the DEP+SVC group (intervention) will be presented with an iPad with a link to an interactive DEP module discussing the indications for LC, alternatives, risks, complications, expectations and anticipated recovery. They will be asked to review the DEP module at their own pace and will be required to confirm understanding of all of the material presented on the DEP. Upon completion of the module, a member of the surgery team will ask the patient if they have any additional questions or require further clarification regarding the LC procedure, indications for surgery, alternatives, risk, complications, expectations and anticipated recovery. Once all of participant's questions are answered, an informed paper-based consent form for LC will be signed.

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

Standard Verbal Consent

ACTIVE COMPARATOR

Study participants randomized to the SVC group (control) will discuss the LC procedure, indications for surgery, alternatives, risk, complications, expectations and anticipated recovery with a member of the surgery team. The study participant will be given the opportunity to ask questions and once all of the questions have been answered, an informed paper-based consent form for LC will be signed.

Behavioral: Consent process using the standard verbal consent (SVC)

Interventions

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

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.

Digital Educational Platform

Consent process using the standard verbal consent (SVC) BEHAVIORAL

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.

Standard Verbal Consent

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be 18 years of age or older
• Individuals admitted to Kingston Health Sciences Centre with acute cholecystitis
• Must be able to read, write and speak English
• Must be able to provide consent

You may not qualify if:

• Individuals who are not able to provide informed consent for laparoscopic cholecystectomy.
• Individuals who are not able to access and view the interactive digital education platform
• Individuals who can not read, write or speak English

Sponsors & Collaborators

• Dr. Boris Zevin: lead

Study Sites (1)

Queen's University

Kingston, Ontario, K7L4V1, Canada

Location

Related Publications (1)

• Zevin B, Almakky M, Mancini U, Robertson DI. Digital approach to informed consent in bariatric surgery: a randomized controlled trial. Surg Endosc. 2022 Jan;36(1):809-816. doi: 10.1007/s00464-020-08277-x. Epub 2021 Jan 27.

  PMID: 33502615 BACKGROUND

Study Officials

• Boris Zevin

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: April 21, 2021
• Study Start: September 21, 2021
• Primary Completion: July 31, 2023
• Study Completion: September 30, 2023
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)