To assess if a jaw surgery patient information website is effective1.6
Research type
Research Study
Full title
A single-blinded randomised controlled trial to assess the effect of a patient information website on patients understanding of orthognathic (jaw) surgery.
IRAS ID
168620
Contact name
Susan O Connell
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
1 years, 3 months, 5 days
Research summary
This is a single blinded randomised control trial, with concealed allocation, comparing patient understanding of orthognathic surgery in patients with access to a bespoke patient information website to an active control group receiving only a standard patient information leaflet.
The primary outcome is to assess patient’s understanding and satisfaction with the level of information provided utilising a self-completed, anonymised patient questionnaire completed at one of the patient’s orthodontic appointment before surgery.
The study will take place at the Birmingham Dental Hospital and Solihull Hospital Orthodontic departments. Patients 16 years of age and above, who have been seen by a consultant orthodontist and maxillofacial surgeon and are now ready for surgery and have provided consent to participate will be included in the trial. Subjects who have previously received orthognathic treatment, who are younger than 16 years of age, those with congenital craniofacial anomalies or acquired defect, non-english speaking subjects and those who do not have access to the internet either via a mobile device or a computer will be excluded.
Subjects will be randomised into two groups at an orthodontic appointment (anytime between the start of orthodontic treatment and their surgery) before surgery: the control group , who will receive a patient information leaflet and the intervention group who will receive access to a patient information website. At a consecutive orthodontic appointment (which will always be 6 - 8 weeks later), patients will be asked to complete an anonymous questionnaire regarding their satisfaction with the level of information provided to them.
Statistical analysis will be undertaken using Stata software and the data will be analysed using simple linear regression to explore the relationship between the method of information and the questionnaire score. Multivariate analysis will be used to explore the effect of co-founding factors including age, gender and ethnicity.
REC name
Wales REC 6
REC reference
15/WA/0028
Date of REC Opinion
26 Jan 2015
REC opinion
Favourable Opinion