DeliriumPROMoTENCT05114876
Redesigning the Surgical Pathway (PROMoTE)
A study testing Multicomponent delirium-risk prevention bundle in people with Delirium and Cognitive Impairment, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Delirium, Cognitive Impairment, Perioperative/Postoperative Complications
- What is being tested?
- Multicomponent delirium-risk prevention bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteCanada
- Study dates
- 13 Dec 2021to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario
Stephen Choi, MD, 416 4804864, stephen.choi@sunnybrook.ca
Beverley A Orser, MD, PHD
About this study
Official title: 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.
Read the 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.
- Conditions
- Delirium, Cognitive Impairment, Perioperative/Postoperative Complications, Cognitive Dysfunction, Cognitive Decline
- Being tested
- Multicomponent delirium-risk prevention bundle
- Keywords
- perioperative neurocognitive disorders, postoperative delirium, delirium, pre-existing cognitive impairment
- Medical subject headings
- Delirium, Cognitive Dysfunction, Postoperative Complications, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent delirium-risk prevention bundleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Standard of care |
| Intervention | Active comparator | Multicomponent delirium-risk prevention bundle Receives: Other: Multicomponent delirium-risk prevention bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: twice daily on postoperative days 1-3, morning/late afternoon
Secondary outcomes (3)
Delirium Severity
Assessed using CAM-S
Measured: twice daily on postoperative days 1-3, morning/late afternoon
Hospital length of stay
Duration of hospital admission in days
Measured: Until discharge, average of 1 week
Unit adherence rate to CHASM principles
Unit adherence rate to CHASM principles
Measured: Until discharge, average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start13 Dec 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Choi, MD, MSc, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114876
- Sponsor's protocol ID
- 5086
- Acronym
- PROMoTE
- Status last verified
- Sep 2025
- First submitted
- 29 Oct 2021
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Redesigning the Surgical Pathway: Optimizing PReOperative assessMent in Anesthesia Clinic for adulT Surgical Patients (PROMoTE)
- ClinicalTrials.gov ID
- NCT05114876
- Acronym / sponsor ID
- PROMoTE / 5086
- Conditions
- Delirium, Cognitive Impairment, Perioperative/Postoperative Complications, Cognitive Dysfunction, Cognitive Decline
- Keywords
- perioperative neurocognitive disorders, postoperative delirium, delirium, pre-existing cognitive impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Standard of care |
| Intervention | Active comparator | Other: Multicomponent delirium-risk prevention bundleMulticomponent delirium-risk prevention bundle |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 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)
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent delirium-risk prevention bundleThis 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. | Other | Intervention |
Primary outcome
Incidence of POD before and after implementation of an institutional prospective diagnostic program.
Time frame: twice daily on postoperative days 1-3, morning/late afternoon
POD evaluated by 3D-CAM and retrospectively using the CHART-DEL method
3 secondary outcomes
Delirium Severity
Time frame: twice daily on postoperative days 1-3, morning/late afternoon
Hospital length of stay
Time frame: Until discharge, average of 1 week
Unit adherence rate to CHASM principles
Time frame: Until discharge, average of 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephen Choi, MD, MSc principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent delirium-risk prevention bundle in people with Delirium and Cognitive Impairment, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen Choi, MD, MSc (416-480-4864, stephen.choi@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of POD before and after implementation of an institutional prospective diagnostic program. (time frame: twice daily on postoperative days 1-3, morning/late afternoon). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025; AzTrials last refreshed its copy on 29 Oct 2026.