OSIRIS Trial
Research type
Research Study
Full title
Cluster randomised trial on Optimising Shared decision-makIng for high-RIsk major Surgery (OSIRIS Trial)
IRAS ID
282492
Contact name
Rupert Pearse
Contact email
Sponsor organisation
Queen Mary University of London
Duration of Study in the UK
2 years, 0 months, 30 days
Research summary
Each year in the NHS more than 250,000 high risk patients contemplate major surgery. These patients are older and usually have chronic disease. One in three high risk patients who choose surgery will experience will experience medical complications leading to long-term decline in health and quality of life. Awareness of these long term risks is poor amongst both doctors and patient. Consequently, many high-risk patients do not receive the information they need to make an informed decision about surgery. Shared decision-making is suggested as a means of improving the way in which patients make informed decisions about their treatment. Despite a wealth of research on shared decision making, there is little work to address the specific needs of high-risk patients contemplating major surgery, and yet this group would benefit more than any other.
By combining the work conducted within the OSIRIS programme we have developed a decision support aid. The decision aid presents population average figures about a number of important long-term outcomes to supplement those provided as part of routine care. Patients are able to select and focus on the most important outcomes for them, while the decision aid will highlight important outcomes they may not have considered. The aim of this study is to evaluate the clinical effectiveness of a decision support intervention in a cluster randomised trial to improve shared decision making for high-risk surgical patients and their doctors.
The study will recruit 600 patients in total across 40 hospitals (approx. 20 hospitals in the usual care arm and 20 hospitals in the intervention arm) providing services for high-risk patients in one or more of the following surgical procedures: colorectal bowel resection for cancer, hip-replacement or elective abdominal aortic aneurysm surgery.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
23/EE/0062
Date of REC Opinion
20 Apr 2023
REC opinion
Further Information Favourable Opinion