Digital Consent using a Patient portal

• Research type

  Research Study

• Full title

  Digitally supported vs. conventional consent for wisdom tooth surgery using PKB ((Patient Know Best) software application: A randomised controlled feasibility study on patient comprehension and satisfaction.

• IRAS ID

  332838

• Contact name

  JOTHI VASAN O'LEARY

• Contact email

  jothi.vasan-oleary@nhs.net

• Sponsor organisation

  University Hospital of Derby and Burton NHS Trust

• Duration of Study in the UK

  0 years, 7 months, 1 days

• Research summary

  This study would be a two- arm parallel randomised controlled feasibility clinical trial involving 6O patients over a period of 6-8 months.Patients from the hospital who are referred from General medical or General Dental practitioners for wisdom tooth removal would be included in the study.
  The study population will be the group of patients who meet the indications specified in the NICE (National Institute of Clinical Excellence) guidelines and RCS (Royal College of surgeons)guidance for removal of wisdom tooth
  The patients will be selected based on the following criteria prior to randomisation in to two groups.
  • Patients referred for wisdom tooth surgery which involves a surgical approach (flap surgery).
  • Able and willing to give informed consent, over 16 years of age.
  • Access to a suitable personal electronic device
  Currently there are no reliable data about the ability of patients to recall the risks and specific complications of the extraction procedure following the consent process (with or without audio visual (AV aids), with a wide range of estimates reported in the existing literature. There is also no reliable data exploring the association between the ability of patients to recall risks of the procedure with their comprehension of those risks. Finally, there are no reliable data regarding patient acceptance of AV aids as an adjunct to the consent process, or with giving consent digitally. Therefore, the purpose of this study is to address some of these knowledge gaps by collecting data, and to explore the feasibility of a definitive trial assessing the impact of providing a digital consent package using the patient portal PKB(Patient knows Best ) which is used in our trust.

• REC name

  London - South East Research Ethics Committee

• REC reference

  25/PR/1509

• Date of REC Opinion

  23 Dec 2025

• REC opinion

  Further Information Favourable Opinion