A research project aimed to understand and improve the shared decision-making process for patients at high risk of medical complications as they contemplate major surgery

Plain English summary of protocol

Background and study aims
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 medical complications leading to a long-term decline in health and quality of life. Awareness of these long-term risks is poor amongst both doctors and patients. 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 researchers 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.

Who can participate?
High-risk patients aged 60 years and over who are contemplating one or more of the following surgical procedures: colorectal bowel resection for cancer, hip replacement or elective abdominal aortic aneurysm surgery

What does the study involve?
Participating hospitals are randomly allocated to one of two groups. In the intervention group hospitals doctors will use a software-based decision support intervention combined with training to promote effective shared decision-making for high-risk surgical patients. Patients and doctors will use the intervention during all decision-making encounters with the surgeons and other healthcare staff (e.g. anaesthetists, specialist nurses). In control group hospitals, shared decision-making for high-risk patients will follow current local practices. There will be no additional training or changes to care processes for these sites.
Investigators will review a participant’s medical record and contact participants by telephone to conduct brief interviews at 30 days after surgery for those participants who have undergone surgery and at 180 days after the index decision-making episode for all patients. The researchers will request hospital episode statistics and death rate data from NHS Digital (formerly HSCIC) for participants in England or an equivalent national database.

What are the possible benefits and risks of participating?
There is a small risk that patients may find it distressing to be provided with information, which may indicate poor expected outcomes in the following months and years. It is also expected that the use of the decision aid will lengthen the consultation itself (this will be measured as part of the study). There is a potential benefit of increased patient involvement in decision making resulting in reduced decision regret after surgery, and improved satisfaction with the decision-making process. Enhanced patient participation in decision-making could also potentially improve mental quality of life outcomes, which will be assessed as part of the outcome.

Where is the study run from?
Queen Mary University of London (UK)

When is the study starting and how long is it expected to run for?
October 2023 to April 2027

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)

Who is the main contact?
Jai Vairale, admin@osiris-programme.org

Study website

Contact information

Prof Rupert Pearse
Principal Investigator

ACCU Research Offices
4th Floor
Royal London Hospital
Whitechapel
London
E1 1FR
United Kingdom

ORCID ID	0000-0002-4373-5934
Phone	+44 (0)20 3594 0351
Email	r.pearse@qmul.ac.uk

Dr Priyanthi Dias
Public

ACCU Research Offices
4th Floor
Royal London Hospital
Whitechapel
London
E1 1FR
United Kingdom

Phone	+44 (0)20 3594 0351
Email	p.dias@qmul.ac.uk

Mrs Jai Vairale
Scientific

ACCU Research Offices
4th Floor
Royal London Hospital
Whitechapel
London
E1 1FR
United Kingdom

Phone	+44 (0)20 3594 0351
Email	j.vairale@qmul.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• Scotland
• United Kingdom

Study participating centres

Sponsor information

Queen Mary University of London
University/education

Research Services, Dept. W
c/o Mile End Post Room
327 Mile End Road
London
E1 4NS
England
United Kingdom

Phone	+44 (0)20 7882 5555
Email	research.governance@qmul.ac.uk
Website	http://www.jrmo.org.uk/
"ROR"	https://ror.org/026zzn846

Funders

Funder type

Government

Results and Publications

Study outputs

Additional files

44930_PIS_V2.0_28Mar23.pdf

44930_PROTOCOL_V2.0_20Nov23.pdf

Editorial Notes

10/07/2025: The following changes were made to the study record:
1. The date of first enrolment was changed from 01/09/2023 to 15/05/2025.
2. The date of final enrolment was changed from 30/01/2025 to 01/11/2026.
3. The completion date was changed from 30/06/2025 to 30/04/2027.
29/01/2024: Study's existence confirmed by the East of England - Cambridge Central Research Ethics Committee.