NCT05114876 Redesigning the Surgical Pathway (PROMoTE)
| NCT ID | NCT05114876 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Delirium |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2021-12-13 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 260 participants in total. It began in 2021-12-13 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cognitive complications, that is problems with thinking and memory, are incredibly common after surgery, occurring in 10-50% of all older surgical patients. These complications can take different forms, but one of the most common is postoperative delirium (POD), a short-term state of confusion. In addition to being stressful for patients and their families, POD is linked to longer hospital stays, increased costs, higher mortality rates and other problems after surgery. Despite this, POD is often not recognized by doctors and there are currently no effective medications to treat POD. However, simple strategies such as helping patients to sleep properly and remain hydrated, have been shown to help. This study is testing if a delirium-reduction program will reduce postoperative delirium (POD) in older surgical patients. The investigators will first test memory and thought processes before surgery to find people who are most likely to develop POD. Once these people have been identified, they will be enrolled in a program which includes recommendations for their care team (e.g. surgeon, anesthesiologist, nurses) as well as educational materials for them and their family related to things that can be done to prevent delirium. By identifying at-risk patients and making sure that their doctors and caregivers are aware of how to prevent delirium, the investigators expect that this study will make surgery safer for older surgical patients.
Eligibility Criteria
Inclusion Criteria: * ≥ 60 years old * Undergoing major elective surgery (e.g., intra-abdominal, retroperitoneal, major orthopedic) with an expected postoperative stay of at least 1 night * Evidence of cognitive impairment on baseline screening tests (i.e. any score \< 90 on CBB or \>10 on S-OMCT) Exclusion Criteria: * Patients undergoing cardiac surgery * Patients undergoing intracranial neurosurgery * Patients with known substance use disorder (verbally declared by patients) * Unlikely to comply with study assessment (e.g., no fixed address, without access to internet/computer/phone).
Contact & Investigator
Stephen Choi, MD, MSc
PRINCIPAL INVESTIGATOR
Sunnybrook Health Sciences Centre
Frequently Asked Questions
Who can join the NCT05114876 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05114876 currently recruiting?
Yes, NCT05114876 is actively recruiting participants. Contact the research team at stephen.choi@sunnybrook.ca for enrollment information.
Where is the NCT05114876 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05114876 clinical trial?
NCT05114876 is sponsored by Sunnybrook Health Sciences Centre. The principal investigator is Stephen Choi, MD, MSc at Sunnybrook Health Sciences Centre. The trial plans to enroll 260 participants.