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Delirium-Prevention Program for Postoperative Delirium (PROMoTE Trial)

N/A
Recruiting
Led By Stephen Choi, MD, MSc
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing major elective surgery (e.g., intra-abdominal, retroperitoneal, major orthopedic) with an expected postoperative stay of at least 1 night
≥ 60 years old
Must not have
Patients undergoing cardiac surgery
Patients undergoing intracranial neurosurgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up twice daily on postoperative days 1-3, morning/late afternoon
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if a delirium-reduction program can help reduce postoperative delirium (POD) in older surgical patients.

Who is the study for?
This trial is for older adults (60+) who are having major elective surgery with a hospital stay of at least one night and show signs of cognitive impairment on initial tests. It's not for those undergoing heart or brain surgery, with substance use disorders, or who may not follow the study plan.
What is being tested?
The trial is testing a program designed to prevent delirium after surgery in older patients. This includes pre-surgery cognitive tests to identify risk, care team recommendations, and educational materials for patients and families on preventing confusion post-surgery.
What are the potential side effects?
Since the intervention involves non-medical strategies like sleep aid and hydration rather than drugs, there are no direct side effects from medications. However, stress related to changes in routine or misunderstandings about the prevention measures could occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a major surgery that requires at least one night in the hospital.
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I am 60 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for heart surgery.
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I am scheduled for brain surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~twice daily on postoperative days 1-3, morning/late afternoon
This trial's timeline: 3 weeks for screening, Varies for treatment, and twice daily on postoperative days 1-3, morning/late afternoon for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of POD before and after implementation of an institutional prospective diagnostic program.
Secondary study objectives
Delirium Severity
Hospital length of stay
Unit adherence rate to CHASM principles

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Standard of CareActive Control1 Intervention
Standard of care
Group II: InterventionActive Control1 Intervention
Multicomponent delirium-risk prevention bundle

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
681 Previous Clinical Trials
1,565,498 Total Patients Enrolled
Stephen Choi, MD, MScPrincipal InvestigatorSunnybrook Health Sciences Centre

Media Library

Multicomponent delirium-risk prevention bundle Clinical Trial Eligibility Overview. Trial Name: NCT05114876 — N/A
Complications Research Study Groups: Standard of Care, Intervention
Complications Clinical Trial 2023: Multicomponent delirium-risk prevention bundle Highlights & Side Effects. Trial Name: NCT05114876 — N/A
Multicomponent delirium-risk prevention bundle 2023 Treatment Timeline for Medical Study. Trial Name: NCT05114876 — N/A
~65 spots leftby Dec 2025
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