Redesigning the Surgical Pathway (PROMoTE) (PROMoTE)

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

Study Overview

• Status: Recruiting
• Conditions: Delirium; Cognitive Impairment; Cognitive Dysfunction; Cognitive Decline; Perioperative/Postoperative Complications
• Intervention / Treatment: Other: Multicomponent delirium-risk prevention bundle

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.

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephen Choi, MD, MSc; Phone Number: 416-480-4864; Email: stephen.choi@sunnybrook.ca
• Study Contact Backup: Name: Lilia Kaustov, PhD; Phone Number: 89607 416-480-6100; Email: lilia.kaustov@sunnybrook.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Recruiting
      • Sunnybrook Health Sciences Centre
      • Contact: Stephen Choi, MD; Phone Number: 416 4804864; Email: stephen.choi@sunnybrook.ca
      • Sub-Investigator: Beverley A Orser, MD, PHD
      • Sub-Investigator: Jane Huang, MD
      • Sub-Investigator: Barbara Liu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; Standard of care
Active Comparator: Intervention; Multicomponent delirium-risk prevention bundle	Other: Multicomponent delirium-risk prevention bundle; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium Severity	Assessed using CAM-S	twice daily on postoperative days 1-3, morning/late afternoon
Hospital length of stay	Duration of hospital admission in days	Until discharge, average of 1 week
Unit adherence rate to CHASM principles	Unit adherence rate to CHASM principles	Until discharge, average of 1 week

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Stephen Choi, MD, MSc, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: delirium; postoperative delirium; perioperative neurocognitive disorders; pre-existing cognitive impairment
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Delirium; Cognitive Dysfunction; Postoperative Complications
• Other Study ID Numbers: 5086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All de-identified participants data collected during this trial that underlie the results reported in the publication(s) will be available upon request after publication of the primary results.
• IPD Sharing Time Frame: Data will be available upon request immediately after publication of the primary results. No end date.
• IPD Sharing Access Criteria: Direct request to PI. Anyone who wishes to access the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No