OSIRIS Project 4.1
Research type
Research Study
Full title
Feasibility study of a decision aid for high-risk patients contemplating surgery
IRAS ID
303675
Contact name
Rupert Pearse
Contact email
Sponsor organisation
Queen Mary University of London
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
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 aim of this study is to explore the feasibility of incorporating this decision aid into existing clinical pathways. 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 study will recruit 9 doctors and 20 patients in one hospital. The consultations will be video recorded to allow direct observation and analysis of intervention use and fidelity. Following the consultation semi-structured interviews will be conducted with both patients and clinicians to explore their experience using the decision aid tool.
Lay summary of study results
We recruited three surgeons and three patients over a 10-week period at Barts NHS Trust during Q1 of 2022. During this time we identified the following key factors:
1. Usability of the decision aid: Surgeons viewed the decision-aid favourably and considered it well designed and easy to use but suggested there would be a learning curve to incorporate all the risk presented comfortably into routine practice. Patients reported that the risks presented by the decision-aid were clear and easy to understand. However, two patients reported the risks presented made the consultations overly negative when they wanted positive information from their surgeon. This fits with our Projects 1 findings that patients often come to clinic having already decided they want surgery and have a bias against risks presented during shared decision-making discussions which may threaten that decision.
2. Training: Surgeons viewed the training favourably but a common theme in feedback was to shorten the length of time for this and offer more focus on supporting implementation in clinic.
Action: Training to be provided online with more time for in-person implementation support 3. Recruitment: This was particularly challenging post-pandemic due to the disruptions in routine surgical care resulting in much lower numbers for our target procedure. We also noted that there were many screened patients with a Charlson Comorbidity Index ≥3 but very few ≥4.
Action: The eligibility criteria for the main trial have been adjusted to include patients with a Charlson Comorbidity index ≥3 rather than ≥4.
4. Data collection: All patient data was collected as planned and research nurse feedback indicated that the data burden was manageable and took no longer than our estimated time to collect.URL to summary results: The findings will be uploaded onto the OSIRIS study website (https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fosiris-programme.org%2F&data=05%7C02%7Ccambridgeeast.rec%40hra.nhs.uk%7C9059a7146ce04d7e071f08dc8bbbb01f%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638538885430598527%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=qHEBalHccp9NWm%2BSErl1%2BW%2FKf%2FVHxIIWFlwpp1m74Aw%3D&reserved=0) by 31/07/2024
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
22/EE/0021
Date of REC Opinion
9 Feb 2022
REC opinion
Further Information Favourable Opinion