A program to reduce postoperative delirium in older surgical patients
Redesigning the Surgical Pathway: Optimizing PReOperative assessMent in Anesthesia Clinic for adulT Surgical Patients (PROMoTE)
This study is testing a program to see if special education and care can help prevent confusion after surgery in older patients aged 60 and above.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05114876 on ClinicalTrials.gov |
What this trial studies
This study aims to address cognitive complications, particularly postoperative delirium (POD), which affects a significant number of older surgical patients. It involves a two-phase, prospective, observational approach where patients aged 60 and above undergoing major elective surgeries will be screened for pre-existing cognitive impairment. The first phase will assess the prevalence of POD and cognitive impairment, while the second phase will implement a comprehensive delirium-risk prevention bundle, including education for patients and healthcare providers. The goal is to evaluate the effectiveness of these strategies in reducing the incidence of POD.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 60 and older who are scheduled for major elective surgeries and have evidence of cognitive impairment.
Not a fit: Patients undergoing cardiac or intracranial neurosurgery, or those with substance use disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce the incidence of postoperative delirium, leading to better recovery outcomes and lower healthcare costs for older surgical patients.
How similar studies have performed: Previous studies have shown that non-pharmacological strategies can effectively reduce the incidence of postoperative delirium, suggesting that this approach may yield positive results.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Toronto, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Stephen Choi, MD, MSc — Sunnybrook Health Sciences Centre
- Study coordinator: Stephen Choi, MD, MSc
- Email: stephen.choi@sunnybrook.ca
- Phone: 416-480-4864
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.