Redesigning the Surgical Pathway (PROMoTE)

NCT05114876 | Recruiting

• 1 other identifier: 5086
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of POD before and after implementation of an institutional prospective diagnostic program.

  POD evaluated by 3D-CAM and retrospectively using the CHART-DEL method

  twice daily on postoperative days 1-3, morning/late afternoon

Secondary Outcomes (3)

• Delirium Severity

  twice daily on postoperative days 1-3, morning/late afternoon

• Hospital length of stay

  Until discharge, average of 1 week

• Unit adherence rate to CHASM principles

  Until discharge, average of 1 week

Study Arms (2)

Standard of Care

NO INTERVENTION

Standard of care

Intervention

ACTIVE COMPARATOR

Multicomponent delirium-risk prevention bundle

Other: Multicomponent delirium-risk prevention bundle

Interventions

Multicomponent delirium-risk prevention bundle OTHER

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.

Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Delirium; Cognitive Dysfunction; Postoperative Complications; Emergence Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Pathologic Processes

Study Officials

• Stephen Choi, MD, MSc

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Choi, MD, MSc

CONTACT

416-480-4864; stephen.choi@sunnybrook.ca

Lilia Kaustov, PhD

CONTACT

416-480-6100; lilia.kaustov@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 10, 2021
• Study Start: December 13, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available upon request immediately after publication of the primary results. No end date.
• Access Criteria: Direct request to PI. Anyone who wishes to access the data.

Locations

CA (1)