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NCT Number: NCT05114876

Redesigning the Surgical Pathway (PROMoTE)

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location status: Recruiting

Location contact

Barbara Liu, MD

SUB_INVESTIGATOR

Beverley A Orser, MD, PHD

SUB_INVESTIGATOR

Jane Huang, MD

SUB_INVESTIGATOR

Stephen Choi, MD

CONTACT

[email protected]

416 4804864

About this study

Postoperative delirium (POD), an acute, reversible disturbance in brain function characterized by fluctuating levels of consciousness, attention and cognition is a common postoperative complication in older surgical patients. POD is associated with increased morbidity, mortality, and risk of dementia; in addition to longer hospital stays and increased healthcare costs. Despite this, POD frequently goes unrecognized by healthcare providers and is often poorly proactively managed. There are currently no effective pharmacological treatments for POD, although non-pharmacological prevention strategies (e.g. promoting sleep hygiene, hydration, and early mobilization) have proven effective.

This will be a two-phase, prospective, observational comparative study in patients (age ≥60) presenting for major, elective surgical procedures with an expected postoperative stay ≥1 day(s). In both phases, baseline cognitive screening will be used to identify individuals with evidence of pre-existing cognitive impairment (pre-CI), a key risk factor for POD, and only individuals with pre-CI will be eligible to continue in the study.

Phase I will establish the prevalence of POD and pre-CI in our patient population at Sunnybrook Health Sciences Centre, a tertiary care academic health sciences centre, and act as a control group for Phase II. Phase II will evaluate the effects of a comprehensive delirium-risk prevention bundle, which includes direct-to-patient education and healthcare provider awareness strategies. Participants in both Phase I and Phase II will provide written/verbal informed consent.

In each phase the study team will complete delirium assessments for 130 patients at baseline and on postoperative days 1-3. Demographic and clinical data will be abstracted from participants medical records. PHQ-9 (depression) and AD-8 (dementia screening interview) questionnaires will be completed at baseline.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Multicomponent delirium-risk prevention bundle

Other

This multidisciplinary intervention will introduce new practices including:

  • Direct-to-Patient Education Program
  • Directly informing anesthesia and surgery teams about high-risk patients by flagging their chart, and providing suggestions for POD mitigation
  • 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).
  • Reinforce CHASM best practices with regular educational sessions for nurses.

Primary outcomes

  1. 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

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

Secondary outcomes

  1. Delirium Severity

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

    Assessed using CAM-S

  2. Hospital length of stay

    Time frame: Until discharge, average of 1 week

    Duration of hospital admission in days

  3. Unit adherence rate to CHASM principles

    Time frame: Until discharge, average of 1 week

    Unit adherence rate to CHASM principles

Study contacts

Contact information is provided by the study sponsor or research team.

Lilia Kaustov, PhD

CONTACT

[email protected]

416-480-6100 ext. 89607

Stephen Choi, MD, MSc

CONTACT

[email protected]

416-480-4864

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

Redesigning the Surgical Pathway: Optimizing PReOperative assessMent in Anesthesia Clinic for adulT Surgical Patients (PROMoTE)

Acronym: PROMoTE

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 10, 2021
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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