Optimizing the Consent Process for Emergent Laparoscopic Cholecystectomy
Condition: Consent; Laparoscopic; Cholecystectomy
Study type: Interventional

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.
    

Detailed description: 
      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.

      Significance:

      Although addition of the DEP to SVC has been shown to result in improved patient
      understanding of risks, benefits and alternatives of a proposed operation in an elective
      setting, there is a paucity of data in an emergent acute care setting where the environment
      can be chaotic with shortened time for comprehensive informed consent discussions. The
      investigators hope that the results of this study will not only provide the evidence to
      support adding DEP to SVC for emergent surgical procedures, but will also improve informed
      consent discussions and patients' comprehension of the risks and benefits of proposed
      procedures in an acute care setting.

      Hypotheses:

        1. Participants in the intervention (DEP + SVC) group will demonstrate greater immediate
           and delayed (4-6 weeks) post-consent knowledge of the risks, benefits, alternatives and
           expected outcomes for the LC operation as compared to participants in the control (SVC)
           group.

        2. Participants in the intervention (DEP + SVC) group will demonstrate equivalent
           satisfaction with the consent process as compared to participants in the control (SVC)
           group.

      Methods:

      Study Design and Setting:

      This study will be a prospective non-blinded randomized control trial conducted at Kingston
      Health Sciences Centre (tertiary academic hospital in Kingston, Ontario, Canada). The
      investigators will recruit patients who are admitted to hospital with biliary pathology to
      undergo an emergent laparoscopic cholecystectomy (LC). Study participants will be randomly
      allocated in a 1:1 ratio to a control group (SVC) or an intervention group (DEP+SVC).

      Recruitment and Randomization:

      Patients (potential study participants) will be invited to participate in the current study
      once a clinical decision to recommend laparoscopic cholecystectomy has been made.
      Randomization will occur 1:1 to either an intervention (DEP+SVC) or a control group (SVC)
      using a sealed envelope technique.

      Baseline Data:

      The investigators will use the online Qualtrics platform to collect all of the demographic
      and outcomes data for this study. For baseline data, the investigators will collect
      participant data including age, sex, level of education ("did not complete high school",
      "high school", "college", "university"), background in a medical field (yes/no), previous
      consultation with a surgeon regarding laparoscopic cholecystectomy (yes/no). The
      investigators will also document the setting in which the consent discussion took place
      (emergency room or surgery ward), as well as admission diagnosis (biliary colic, acute
      cholecystitis, gallstone pancreatitis, choledocholithiasis, cholangitis) (Appendix 1) The
      investigators will ask study participants to complete a baseline basic English literacy
      reading test (Appendix 2), a self-reported rating of their understanding of the LC operation
      (scale of 1 to 10), and a multiple-choice knowledge test (MCQ, 20 questions, maximum score
      20) assessing baseline knowledge of LC, indications for surgery, alternatives, risk,
      complications, and anticipated recovery. The knowledge test will be piloted with relevant
      stakeholders including general surgeons and patients who have undergone a LC prior to its use
      in the study. Participants will not be made aware of the correct answers to the questions on
      the test.

      Standard Verbal Consent (control group):

      Study participants who are randomized to the control (SVC) group will discuss the LC
      procedure, indications for surgery, alternatives, risks, 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, a standard
      informed consent form for LC will be signed.

      Digital Education Platform (intervention group):

      Study participants who are randomized to the intervention (DEP+SVC) group will be presented
      with an iPad an interactive DEP module discussing the indications for LC, alternatives,
      risks, complications, expectations and anticipated recovery. Participants 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. They will have the opportunity to move back and forth
      within the module until they are satisfied. 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, risks,
      complications, expectations and anticipated recovery. Once all of participant's questions are
      answered, a standard informed consent form for LC will be signed.

      Primary Outcome:

      Knowledge of LC procedure, indications for surgery, alternatives, risks, complications,
      expectations and anticipated recovery will be measured using the same knowledge test (20
      questions, maximum score 20) as for baseline knowledge assessment. The knowledge test will be
      completed right after the informed consent form is signed for LC.

      Secondary Outcomes:

      Self-reported understanding of the LC operation after signing of the informed consent will be
      assessed by asking study participants to rate their understanding on a scale of 1 to 10.
      Retention of knowledge about the LC procedure, indications for surgery, alternatives, risks,
      complications, expectations and anticipated recovery will be assessed in 4-6 weeks using the
      same knowledge test (20 MCQ questions, maximum score 20) as for baseline assessment. This
      delayed knowledge test will be administered on the day of patient's follow-up appointment
      with the surgeon, which is usually 4-6 weeks after their discharge from hospital.

      Participant's satisfaction with the clinical encounter will be assessed using a modified
      Client Satisfaction Questionnaire (CSQ-8, maximum score 32) - a validated assessment tool of
      patient satisfaction[6] - at the end of the consent discussion after signing the informed
      consent form for LC (Appendix 3).

      Sample Size:

      Based on the results from the investigator's previous study, assuming a standard deviation of
      9.0 and medium Cohen's d effect size of 0.66 for the MCQ knowledge test, the investigators
      will plan to recruit 36 patients per group to detect a 1.2 point difference in MCQ score (6%)
      change between two groups, with 80% power for the two sample t test (α = 0.05).

      Statistical Analysis:

      Demographic data will be compared between groups using the Student's t test (continuous
      variables) and Chi squared test (categorical variables). Participant satisfaction scores and
      knowledge test scores will be compared between groups using a Student's t test. Within group
      changes (eg. baseline vs immediate post test) in knowledge test scores with be compared using
      a paired t-test. Effect sizes will be calculated using Cohen's d. Statistical significance
      will be set to α = 0.05.

      Timeline:

      March 2021-May 2021:

      Pilot testing of knowledge MCQ with key stakeholders (surgeons and patients) Creation of the
      DEP module for laparoscopic cholecystectomy Creation of online data collection forms
      (baseline testing and post-intervention testing) using Qualtrics

      June 2021 - February 2023 Participant recruitment, randomization and data collection

      January 2023 - February 2023 Data analysis Manuscript and abstract preparation
    

Intervention name(s): Consent process with the addition of Digital educational platform (DEP); Consent process using the standard verbal consent (SVC)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other