Clinical Trial: Multimedia Informed Consent & PROMs in Laparoscopic Cholecystectomy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Sym

Brief 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 Summary:

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-operativ
Sponsor: Nottingham University Hospitals NHS Trust

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Nottingham University Hospitals NHS Trust

Dates:
Date Received: April 25, 2016
Date Started: May 2016
Date Completion: August 2018
Last Updated: December 29, 2016
Last Verified: December 2016