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Redesigning the Surgical Pathway (PROMoTE) (PROMoTE)

Primary Purpose

Delirium, Cognitive Impairment, Perioperative/Postoperative Complications

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Multicomponent delirium-risk prevention bundle
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium focused on measuring perioperative neurocognitive disorders, postoperative delirium, delirium, pre-existing cognitive impairment

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Sunnybrook Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard of Care

Intervention

Arm Description

Standard of care

Multicomponent delirium-risk prevention bundle

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Delirium Severity
Assessed using CAM-S
Hospital length of stay
Duration of hospital admission in days
Unit adherence rate to CHASM principles
Unit adherence rate to CHASM principles

Full Information

First Posted
October 29, 2021
Last Updated
March 14, 2022
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05114876
Brief Title
Redesigning the Surgical Pathway (PROMoTE)
Acronym
PROMoTE
Official Title
Redesigning the Surgical Pathway: Optimizing PReOperative assessMent in Anesthesia Clinic for adulT Surgical Patients (PROMoTE)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Cognitive Impairment, Perioperative/Postoperative Complications, Cognitive Dysfunction, Cognitive Decline
Keywords
perioperative neurocognitive disorders, postoperative delirium, delirium, pre-existing cognitive impairment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard of care
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Multicomponent delirium-risk prevention bundle
Intervention Type
Other
Intervention Name(s)
Multicomponent delirium-risk prevention bundle
Intervention Description
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 Outcome Measure Information:
Title
Incidence of POD before and after implementation of an institutional prospective diagnostic program.
Description
POD evaluated by 3D-CAM and retrospectively using the CHART-DEL method
Time Frame
twice daily on postoperative days 1-3, morning/late afternoon
Secondary Outcome Measure Information:
Title
Delirium Severity
Description
Assessed using CAM-S
Time Frame
twice daily on postoperative days 1-3, morning/late afternoon
Title
Hospital length of stay
Description
Duration of hospital admission in days
Time Frame
Until discharge, average of 1 week
Title
Unit adherence rate to CHASM principles
Description
Unit adherence rate to CHASM principles
Time Frame
Until discharge, average of 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Choi, MD, MSc
Phone
416-480-4864
Email
stephen.choi@sunnybrook.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Lilia Kaustov, PhD
Phone
416-480-6100
Ext
89607
Email
lilia.kaustov@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Choi, MD, MSc
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Choi, MD
Phone
416 4804864
Email
stephen.choi@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Beverley A Orser, MD, PHD
First Name & Middle Initial & Last Name & Degree
Jane Huang, MD
First Name & Middle Initial & Last Name & Degree
Barbara Liu, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Redesigning the Surgical Pathway (PROMoTE)

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