Recruiting

Observational Study

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT05114876

Conditions

Delirium

Cognitive Impairment

Perioperative/Postoperative Complications

Cognitive Dysfunction

Cognitive Decline

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Multicomponent delirium-risk prevention bundle

Study Details

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.

Conditions

Delirium

Cognitive Impairment

Perioperative/Postoperative Complications

Cognitive Dysfunction

Cognitive Decline

Study ID

NCT05114876

Start date

Dec 13, 2021

Status verified date

Sep, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

260 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Standard of Care

Standard of care

active comparator: Intervention

Multicomponent delirium-risk prevention bundle

Interventions

Multicomponent delirium-risk prevention bundle

This multidisciplinary intervention will introduce new practices including:

1. Direct-to-Patient Education Program
2. Directly informing anesthesia and surgery teams about high-risk patients by flagging their chart, and providing suggestions for POD mitigation
3. Flag charts as high risk for POD so that nursing staff in both the PACU and the wards are aware, facilitating implementation of CHASM interventions (i.e. evidence-based delirium prevention protocols).
4. Reinforce CHASM best practices with regular educational sessions for nurses.

Primary outcome measure

  • Incidence of POD before and after implementation of an institutional prospective diagnostic program. [ Time Frame: twice daily on postoperative days 1-3, morning/late afternoon ]

Central Contacts and Locations

Central contacts

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada

Contacts

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Sep 12, 2025

Last verified

Sep, 2025

Keywords

  • perioperative neurocognitive disorders
  • postoperative delirium
  • delirium
  • pre-existing cognitive impairment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2025-09-12.