Multimedia Informed Consent & PROMs in Laparoscopic Cholecystectomy
Condition: Gallstone Disease
MeSH terms: Gallstones; Cholelithiasis; Cholecystolithiasis
Study type: Interventional

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.
    

Intervention name(s): Laparoscopic cholecystectomy
Intervention type(s): Procedure
Intervention description(s): Administration of a disease-specific and generic PROMs survey to patients undergoing Laparoscopic Cholecystectomy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: laparoscopic cholecystectomy