NCT02810860

Multimedia Informed Consent & PROMs in Laparoscopic Cholecystectomy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 349 (actual)
• Sponsor: Nottingham University Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Gallstone Disease

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic cholecystectomy	Administration of a disease-specific and generic PROMs survey to patients undergoing Laparoscopic Cholecystectomy

Timeline

• Start date: 2016-08-18
• Primary completion: 2018-04-13
• Completion: 2019-01-01
• First posted: 2016-06-23
• Last updated: 2020-02-20

Locations

1 site across 1 country: United Kingdom