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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up twice daily on postoperative days 1-3, morning/late afternoon
Awards & highlights

PROMoTE Trial 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.Check my eligibility
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.See study design
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.

PROMoTE Trial 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.

PROMoTE Trial 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

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

PROMoTE 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
656 Previous Clinical Trials
1,550,417 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation currently recruiting participants?

"Clinicaltrials.gov posts state that this clinical trial is presently accepting participants. The initial posting of the study was on December 13th 2021, with the most recent edit taking place on March 14th 2022."

Answered by AI

How many study participants are receiving treatment from this clinical investigation?

"Affirmative. The clinical trial record hosted on clinicaltrials.gov confirms that the medical study, which was initially posted in December 2021, is actively recruiting participants. This research necessitates an enrolment of 260 individuals across a single site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Redesigning the Surgical Pathway (PROMoTE)
2021. "Redesigning the Surgical Pathway (PROMoTE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05114876.
All > Mci
~52 spots leftby Dec 2024
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