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

Cluster randomized trial on Optimising Shared decision-making for high-RIsk major Surgery

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN27859150

Enrollment

600

Registered

2024-01-30

Start date

2025-05-15

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who contemplate elective surgery for colorectal bowel resection for cancer, hip replacement and abdominal aortic aneurysm Surgery

Interventions

This is a complex intervention, combining training to promote effective shared decision-making for high-risk surgical patients (see above) together with a software-based decision-support intervention.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients contemplating elective colorectal bowel resection for cancer, hip replacement or abdominal aortic aneurysm surgery 2. Age 60 years and over 3. Age-adjusted Charlson co-morbidity index =3

Exclusion criteria

Exclusion criteria: 1. Inability or refusal to provide informed consent 2. Patients expected to die within 12 months of treatment

Design outcomes

Primary

Measure	Time frame
1. Patients’ decision regret measured using the Decision Regret Scale (DRS) at 180 days after the index decision-making episode 2. Patients’ mental-health-related quality of life measured using the Mental Component Summary (MCS) score of the Short Form-12 (SF-12) at 180 days after the index decision-making episode	—

Secondary

Measure	Time frame
1. Patients’ physical-health-related quality of life measured using the Physical Component Summary (PCS) score of the Short Form-12 (SF-12) at 180 days after the index decision-making episode 2. Patient satisfaction with decision-making measured using the Shared Decision-Making Questionnaire within 48 hours of decision-making 3. Generic health-related quality of life utility, derived from participants’ EQ-5D-5L questionnaire responses at 180 days after the index decision-making episode	—

Measure

Time frame

1. Patients’ physical-health-related quality of life measured using the Physical Component Summary (PCS) score of the Short Form-12 (SF-12) at 180 days after the index decision-making episode 2. Patient satisfaction with decision-making measured using the Shared Decision-Making Questionnaire within 48 hours of decision-making 3. Generic health-related quality of life utility, derived from participants’ EQ-5D-5L questionnaire responses at 180 days after the index decision-making episode

—

Countries

England, Scotland, United Kingdom

Contacts

Public ContactPriyanthi Dias

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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026