DISCuSs
Research type
Research Study
Full title
The development and pilot testing of a decision aid to better support patients with ulcerative colitis choose between ongoing medical treatment and surgical treatment options
IRAS ID
257044
Contact name
Alan Lobo
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS FT
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Ulcerative colitis (UC) is a chronic condition with debilitating symptoms that can impair quality of life. UC can be managed both medically and surgically. Medical management aims to induce and maintain remission by controlling inflammation and reducing symptoms. Approximately 20-30% of patients with UC will undergo surgery. A small minority of patients will require emergency surgery; however, the vast majority of patients undergoing surgery will do so electively, instead of continuing with medical therapy. This study aims to develop and pilot a new Patient Decision Aid (PtDA) to better support patients with UC considering surgery. Both continuing medical and surgical treatments are associated with risks, and evidence suggests that patients find the decision-making process complex and difficult.
National guidelines for UC emphasise the importance of providing information to support treatment decision-making, but the resources available are few and lack quality. This research aims to address this unmet need by developing a PtDA and gaining feedback on it from patients and clinicians prior to its pilot in two clinical centres. This PtDA will be developed with the study team, gastroenterologists, colorectal surgeons, nurse specialists and patients during stage 1. In stage 2, we will carry out focus groups and distribute questionnaires to patients and clinicians to refine the content and format of the information. In stage 3, we will introduce the PtDA into Sheffield and Hull and East Yorkshire Teaching Hospitals. We will measure the impact of the PtDA upon patient levels of anxiety, decision making change, decisional regret and quality of life.
It is anticipated the resource will improve the quality of life of patients living with UC by helping them to make the right treatment decisions whilst providing a freely available tool for NHS clinical teams.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
19/NE/0073
Date of REC Opinion
15 Mar 2019
REC opinion
Favourable Opinion