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Redesigning the Surgical Pathway (PROMoTE)

NCT05114876 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2025-09-12

No results posted yet for this study

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

Interventions

OTHER

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.

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Stephen Choi, MD, MSc · Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-13
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05114876 on ClinicalTrials.gov