Testing the usability of the eRAPID system in surgery

• Research type

  Research Study

• Full title

  Developing a system for cancer patients to report symptoms online (eRAPID): Testing the usability of the eRAPID system with surgical patients and staff

• IRAS ID

  187505

• Contact name

  Birgit Whitman

• Contact email

  researchgovernance@contacts.bham.ac.uk

• Sponsor organisation

  University of Bristol

• Duration of Study in the UK

  1 years, 1 months, 31 days

• Research summary

  Background:
  An adverse event (AE) is any unfavourable sign, symptom or disease, temporarily associated with the use of a treatment, but that may or may not be considered related to the treatment. The current system for reporting AEs, the Common Terminology Criteria for Adverse Event (CTCAE) relies on the clinician’s interpreting patient symptoms. The value of patient self-reports of AEs and other Patient Reported Outcome Measures (PROMs) has been recognised by clinicians, regulatory authorities and health-care commissioners. Once eRAPID is developed, it will allow patients to: electronically report AEs through an online questionnaire; get advice on how to manage mild symptoms and when to seek medical advice; and an alert will be sent straightaway to a patients doctor or specialist nurse when patients report serious adverse events (SAE). The proposed work described in this form relates to the sub-study in Bristol to undertake the usability testing of the eRAPID system following surgery for UGI cancer.

  Objectives:
  The aim of this project is to test the usability of the eRAPID system with patients and surgical oncology staff after patients are discharged from hospital following their surgery.

  Study Sample:
  The participant sample will comprise two groups: patients who are undergoing surgery for UGI cancer (N=30-40) and health professional staff involved in their care (N=5).

  Study measures:
  Partients will be asked to complete symptom questionnaire 2-3 days after discharge, 5-7 after discharge and then weekly up until 8 weeks has passed since they were discharged. Patient-reported outcome questionnaires (EQ-5D) will also be posted to patients at 4 and 8 weeks post discharge. Health professional staff involved in the care of patients will be asked to monitor electronic reports generated by patient completion of the questionnaire via the eRAPID system and be asked to provide feedback on the study

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  15/LO/2017

• Date of REC Opinion

  19 Nov 2015

• REC opinion

  Favourable Opinion