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Redesigning the Surgical Pathway (PROMoTE)

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05114876
Acronym
PROMoTE
Enrollment
260
Registered
2021-11-10
Start date
2021-12-13
Completion date
2025-12-31
Last updated
2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Decline, Cognitive Dysfunction, Cognitive Impairment, Delirium, Perioperative/Postoperative Complications

Keywords

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

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.

Detailed description

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.

Interventions

OTHERMulticomponent 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

Sunnybrook Health Sciences Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Incidence of POD before and after implementation of an institutional prospective diagnostic program.twice daily on postoperative days 1-3, morning/late afternoonPOD evaluated by 3D-CAM and retrospectively using the CHART-DEL method

Secondary

MeasureTime frameDescription
Delirium Severitytwice daily on postoperative days 1-3, morning/late afternoonAssessed using CAM-S
Hospital length of stayUntil discharge, average of 1 weekDuration of hospital admission in days
Unit adherence rate to CHASM principlesUntil discharge, average of 1 weekUnit adherence rate to CHASM principles

Countries

Canada

Contacts

Primary ContactStephen Choi, MD, MSc
stephen.choi@sunnybrook.ca416-480-4864
Backup ContactLilia Kaustov, PhD
lilia.kaustov@sunnybrook.ca416-480-6100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026