Multimedia Informed Consent & PROMs in Laparoscopic Cholecystectomy (EPICS)

February 18, 2020 updated by: Nottingham University Hospitals NHS Trust

A Study to Pilot the Use of a Multimedia Application to Collect the Largest PROMs (Patient Reported Outcome Measures) Dataset in Adult Patients Undergoing Elective Laparoscopic Cholecystectomy for Symptomatic Gallstones and to Aid the Informed Consent Process

Collection of PROMs (Patient Reported Outcome Measures) data from patients before and after an operation to remove their gallbladder for the treatment of symptomatic gallstones. This PROMs data will provide information to clinicians and trusts about the health gain following this type of surgery and the impact on patient's quality of life.

This information will be collected by the implementation of the patient Website aboutmyop.org. This will not only allow patients to complete quality of life (PROMs) questionnaires online, but will also allow them to access information on their condition and necessary surgery, in addition to post-operative follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients referred with gallstone disease necessitating surgery (laparoscopic cholecystectomy) will be invited to engage with our on-line interactive website. This will allow a two-way exchange of information in a secure environment (N3 compliant) to inform the patient about the risks, benefits, alternatives to surgery (cholecystectomy), and post- operative expectations. Furthermore, it will inform clinicians about the patient's symptoms and history, and record a pre-operative Patient Reported Outcome Measure (PROM). The patient's understanding of the facts required for informed consent will be measured and a "Patient Health & Understanding Report" generated for hospital clinicians. This will form part of the electronic patient record, and will be a medico-legal document.

As with current practice patients will still attend their initial outpatient clinic appointment where they will meet a surgeon who will determine the appropriateness of surgery. Informed consent for surgery (cholecystectomy) will be obtained at this initial consultation facilitated by the information obtained from the "Patient Health & Understanding Report". The patient will then continue to interact with the on-line platform before and after their operation to ensure they are well informed and to monitor their post-operative progress.

7 days after surgery the patient will be prompted to interact with the website to answer questions about their progress and recovery. This will replace the existing telephone follow-up interaction. Any problems identified will trigger a protocol driven interaction between the hospital and the patient.

At 1, 3 and 6 months after surgery a post-operative PROMs questionnaire will be answered by the patient allowing comparison of pre- and post-operative PROMs. This study will lead to the largest PROMs assessment of the effectiveness of laparoscopic cholecystectomy, will study the feasibility of our Website as a multimedia application in assisting with the process of informed consent, and will determine whether telephone follow-up can be safely replaced by a protocol driven online system.

Study Type

Interventional

Enrollment (Actual)

349

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Nottingham, United Kingdom
        • Nottingham University Hospitals Nhs Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Male or female.

  • Adults:aged 18 to 85 years.
  • Be referred for consideration for an elective laparoscopic cholecystectomy for symptomatic gallstones based on their GPs diagnosis and referral to a general surgeon.
  • Patients initially listed for laparoscopic cholecystectomy but subsequently converted to open cholecystectomy or subsequently have a more complex 'biliary' procedure (including but not exclusive to bile duct exploration, biliary drain insertion, biliary bypass procedure).

Exclusion Criteria:

  • Patients unable to, or those choosing not to engage with the multimedia process --- including patients lacking mental capacity, patients who do not have access to a multimedia device (including but not exclusive to a computer, tablet or multimedia phone), patients who are unable to use a multimedia device unassisted.
  • Patients who are unable to read or communicate n English without the presence of a translator.
  • Patients undergoing another major non---biliary operation during the same operation as their cholecystectomy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Open Label
Administration of a disease-specific and generic PROMs survey to patients undergoing Laparoscopic Cholecystectomy
Procedure: Laparoscopic cholecystectomy
Administration of a disease-specific and generic PROMs survey to patients undergoing Laparoscopic Cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean domain PROMs scores for each study participant
Time Frame: 30-Days,3 Months and 6 Months
We will look at the change in score between: pre--op and 30-Days, Pre-op and 3 Months post-op and pre-op and 6 months post-op. For this analysis we hope to use the paired t---test, however depending on whether the data is normally distributed or not this may require non---parametric analyses with the Wilcoxon rank---sum test. We also aim to look at the overall trend, which will require analysis of variance.
30-Days,3 Months and 6 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Completion of the Multimedia Informed Consent package on aboutmyop.org
Time Frame: 30 days
30 days
Completion of the 7---Day follow---up questionnaire.
Time Frame: 7 days
7 days
Completion of a Patient Satisfaction Survey to receive feedback on the process.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nottingham University Hospitals NHS Trust

Collaborators

The Royal College of Surgeons of England
EIDO Healthcare

Investigators

  • Principal Investigator: Prita Daliya, MBChB, MRCS, PGDip(Hons), Nottingham University Hospitals Nhs Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2016

Primary Completion (Actual)

April 13, 2018

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

June 22, 2016

First Posted (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Actual)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15GS002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gallstone Disease

Clinical Trials on Laparoscopic cholecystectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe