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

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Queen's University, Kingston, Canada
Cholecystectomy+2 More
Consent process with the addition of Digital educational platform (DEP) - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Optimizing the Consent Process for Emergent Laparoscopic Cholecystectomy

See full description

Eligible Conditions

  • Cholecystectomy
  • Consent
  • Laparoscopic

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Consent process with the addition of Digital educational platform (DEP) will improve 1 primary outcome and 3 secondary outcomes in patients with Cholecystectomy. Measurement will happen over the course of 1 day.

1 day
Knowledge of the Laparoscopic Cholecystectomy Procedure
Participant satisfaction with the clinical encounter
Self-reported rating of understanding of the laparoscopic cholecystectomy procedure.
4-6 weeks
Retention of Knowledge

Trial Safety

Trial Design

2 Treatment Groups

Standard Verbal Consent
1 of 2
Digital Educational Platform
1 of 2
Active Control
Experimental Treatment

This trial requires 72 total participants across 2 different treatment groups

This trial involves 2 different treatments. Consent Process With The Addition Of Digital Educational Platform (DEP) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Digital Educational Platform
Behavioral
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.
Standard Verbal Consent
Behavioral
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4-6 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4-6 weeks for reporting.

Who is running the study

Principal Investigator
D. B. Z.
Prof. Dr. Boris Zevin, MD
Queen's University

Closest Location

Queen's University - Kingston, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You must be able to read, write and speak English in order to be hired for this position. show original
Must be able to provide consent is a condition for this study. show original
to purchase You must be at least 18 years old to purchase this product. show original
will be discharged when they are considered clinically stable and meet the discharge criteria show original

Patient Q&A Section

Can cholecystectomy be cured?

"In most cases, patients with gallstones and gallbladder cancers can expect curative treatment of gallbladder cancers after cholecystectomy. In the case of gallbladder cancer, the prognosis of the remaining gallbladder appears to be good in most cases." - Anonymous Online Contributor

Unverified Answer

What is cholecystectomy?

"At cholecystectomy, one third of the patients were discharged from hospital within 2 days, and only one tenth required a post-operative stay of over 12 days. Inadequate patient education, and lack of patient and family understanding and consent, contribute to prolonged stays in the hospital post-operatively. The impact of inefficient and incomplete patient education can significantly reduce the benefit of cholecystectomy." - Anonymous Online Contributor

Unverified Answer

What are the signs of cholecystectomy?

"The most common signs of cholecystitis are flu like symptoms which usually last less than 24 hours but are more likely to be present in the elderly. The most common complication of cholecystectomy is post-operative bile leak." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cholecystectomy?

"The surgical treatment of gallbladders is expanding rapidly. It takes about 45 minutes to perform cholecystectomy to remove a single stone and about 15 minutes to remove a single gallbladder. In the United States, there are about 586,000 elective laparoscopic cholecystectomies per year. There are 20 to 30 elective open cholecystectomies a day. Although there is little doubt that [elective surgery has reduced the rate of death and hospitalization after cholecystectomy compared with [transitional or urgent surgery is not clear. However, these conclusions apply mostly to cholecystectomy." - Anonymous Online Contributor

Unverified Answer

What causes cholecystectomy?

"When symptomatic cholecystectomy is performed, it is often because the gallbladder is too small or atrophic for medical management. Causes of gallbladder atrophy are not fully understood, but cholelithiasis and increased workload are both probable." - Anonymous Online Contributor

Unverified Answer

How many people get cholecystectomy a year in the United States?

"A small but non-negligible number of patients undergo cholecystectomy every year in the US (1-2%). Because of the low rate of cholecystectomy in the United States, it is important for a national health policy that patients with acute biliary pancreatitis be aggressively managed and that more extensive efforts be made to increase cholecystectomy rates." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating cholecystectomy?

"Laparoscopic procedure has been proven to provide a wider range of indications for cholecystectomy, reduces intraoperative surgical complications and is more accurate in diagnosing cystic lesions." - Anonymous Online Contributor

Unverified Answer

Does cholecystectomy run in families?

"Among patients with gallstone disease and a family history, 30% had relatives with gallstone disease. Gallbladder function, the presence or history of cholelithiasis, and genetic factors probably have an influence on patients with gallstone disease and their family members." - Anonymous Online Contributor

Unverified Answer

What is consent process with the addition of digital educational platform (dep)?

"The addition of a digital educational platform with patients has the potential to increase knowledge for patients before surgery and lead to a decreased need for repeat visits. There is a significant increase in patients with their consent form and a significant decrease in the time interval between consent and surgery." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets cholecystectomy?

"In 2013, 11.0% and 11.4% of the U.S. population had uncomplicated cholecystolithiasis and biliary diseases; 5.4% and 9.3% of males and females had gallbladder and bile duct disease. The prevalence in males and females was 11.0% and 11.4% respectively, however, the difference was not significant. The prevalence was higher amongst younger age cohort, 11.2% for ages <40 years (p=0.04) compared to 10.6% in adults aged 65 years or older (p=0.42). Males in the age of 20-40 years had 13.7% prevalence as compared to 6." - Anonymous Online Contributor

Unverified Answer

How serious can cholecystectomy be?

"Nearly a third of patients undergoing cholecystectomy are admitted to a hospital for at least 1 night postoperatively. Only half receive the allotted postoperative care, including only 40% receiving the allotted number of postoperative care after the second postoperative day. The high rate of admission for 24 hours could be improved upon by using the hospital's own surgical services rather than use a second hospital postoperatively." - Anonymous Online Contributor

Unverified Answer

Has consent process with the addition of digital educational platform (dep) proven to be more effective than a placebo?

"Digital educare is a promising new method of improving the education process for patients undergoing laparoscopic cholecystectomy. Adding dep resulted in significantly improved comprehension of the content of the learning modules. Dep is not effective in improving comprehension for patients receiving standard patient education. Future studies with larger sample sizes are mandatory." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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