Delirium-Prevention Program for Postoperative Delirium

(PROMoTE Trial)

Overseen By Lilia Kaustov, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Cardiac surgery, Neurosurgery, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

260 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Multicomponent Delirium-Risk Prevention Bundle can reduce confusion and memory problems, known as postoperative delirium (POD), in older adults after surgery. It targets patients likely to develop POD by assessing their memory before surgery. The program provides the care team with tips and educational materials to prevent delirium. The trial seeks participants aged 60 and older undergoing major surgery, such as abdominal or orthopedic, who have some memory issues. As an unphased study, this trial allows participants to contribute to important research that could enhance postoperative care for older adults.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this delirium-reduction program is safe for older surgical patients?

Research has shown that the multicomponent delirium-risk prevention bundle is safe for people. In past studies, this method was linked to a lower chance of delirium after surgery. For instance, one study found that using this program reduced the risk of delirium in older patients undergoing major surgeries. Another study discovered that the program not only decreased delirium but also reduced the number of falls in patients.

These studies suggest that the program is generally well-tolerated. No major reports of harmful effects from the program itself have emerged. It focuses on simple strategies like improving sleep and staying hydrated, which are known to be safe. Overall, evidence shows that this program is a safe option for reducing delirium in older surgical patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the multicomponent delirium-risk prevention bundle because it offers a comprehensive approach to preventing postoperative delirium, unlike the standard of care that often focuses on singular interventions. This bundle combines multiple strategies, such as optimizing sleep, hydration, and cognitive engagement, which together may more effectively address the various risk factors for delirium. By targeting multiple aspects of patient care, this approach has the potential to significantly reduce the incidence of postoperative delirium, improving recovery outcomes and overall patient well-being.

What evidence suggests that this delirium prevention program is effective for reducing postoperative delirium?

This trial will compare a multicomponent delirium-risk prevention bundle with standard care. Research has shown that such programs, which participants in this trial may receive, can help prevent delirium, a type of confusion, after surgery. Studies have found that these programs can reduce the frequency and duration of delirium in hospitalized patients. Specifically, another study showed fewer cases of delirium, especially after major surgeries. These programs often include simple actions like ensuring patients get enough sleep and stay hydrated. Overall, this approach has effectively reduced delirium in older surgical patients. ^{1 2 6 7 8}

Who Is on the Research Team?

Stephen Choi, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am 60 years old or older.

I am scheduled for a major surgery that requires at least one night in the hospital.

You have signs of memory or thinking problems on the initial screening tests.

Exclusion Criteria

I am scheduled for heart surgery.

Unlikely to comply with study assessment (e.g., no fixed address, without access to internet/computer/phone)

You have told your doctor that you have a problem with using drugs or alcohol.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Phase I

Establish the prevalence of POD and pre-CI in the patient population and act as a control group for Phase II

Baseline and postoperative days 1-3

Multiple visits (in-person)

Phase II

Evaluate the effects of a comprehensive delirium-risk prevention bundle, including direct-to-patient education and healthcare provider awareness strategies

Baseline and postoperative days 1-3

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Until discharge

What Are the Treatments Tested in This Trial?

Interventions

• Multicomponent delirium-risk prevention bundle

Trial Overview 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.

How Is the Trial Designed?

Group I: Standard of Care Active Control 1 Intervention

Standard of care

Group II: Intervention Active Control 1 Intervention

Multicomponent delirium-risk prevention bundle

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Published Research Related to This Trial

Cognitive impairment is a significant predictor of acute delirium, especially in postoperative patients, with up to 24% of orthopedic surgery patients experiencing delirium, particularly those undergoing hip fracture repair.

Implementing a bundle of care that includes ongoing cognitive assessment, orientation, and early mobilization can effectively prevent acute delirium and improve cognitive outcomes in at-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary Prevention to Maintain Cognition and Prevent Acute Delirium Following Orthopaedic Surgery. Holly, C.[2019]

The Multi-component Care Bundle (MCB) significantly reduced the incidence of post-operative delirium (POD) in elderly hip fracture patients, with 23.4% of patients in the MCB group experiencing POD compared to 44.2% in the control group.

Patients in the MCB group also had lower opioid consumption, less post-operative dizziness, and started walking sooner after surgery, indicating improved recovery outcomes without increasing hospital stay length.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-Component Care Bundle in Geriatric Fracture Hip for Reducing Post-Operative Delirium. Lam, DMH., Wang, C., Lee, AKH., et al.[2022]

Over two-thirds of individuals who died by suicide in New Brunswick had depressive disorders, and many also struggled with substance abuse, highlighting the need for targeted mental health and addiction services.

The study identified significant gaps in service coordination and public awareness, suggesting that integrated approaches to mental health and addiction treatment, along with professional training, are crucial for effective suicide prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic services audit of consecutive suicides in New Brunswick: the case for coordinating specialist mental health and addiction services. Lesage, A., Séguin, M., Guy, A., et al.[2022]

The NAVIGATE program for first-episode psychosis led to better quality of life and fewer side effects compared to standard community care over a 2-year period, with 223 participants in NAVIGATE experiencing less weight gain and improved adherence to medication guidelines.

Participants in the NAVIGATE program were more likely to receive appropriate antipsychotic prescriptions and had improved scores on the Adherence Estimator scale, indicating better management of their treatment compared to the 181 participants receiving community care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychopharmacological Treatment in the RAISE-ETP Study: Outcomes of a Manual and Computer Decision Support System Based Intervention. Robinson, DG., Schooler, NR., Correll, CU., et al.[2022]

The letter raises concerns about the methodology used in the study by Lam et al., particularly regarding the completeness of preoperative assessments and the potential impact of anesthesia and intraoperative management on postoperative delirium.

It emphasizes the need for clarification on how postoperative analgesia may bias the study's findings and questions the real clinical value of the multicomponent care bundle in reducing the risk of postoperative delirium.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commentary on "Multi-Component Care Bundle in Geriatric Fracture Hip for Reducing Postoperative Delirium". Shao, LJ., Xue, FS., Su, K.[2021]

Multicomponent delirium prevention programs in hospitals have been shown to be effective in reducing the onset of delirium among at-risk patients, based on a systematic review of 19 studies.

There is currently insufficient evidence to assess the effectiveness of these programs in settings outside of hospitals, highlighting the need for further research to identify the most effective components of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-facility delirium prevention programs as a patient safety strategy: a systematic review. Reston, JT., Schoelles, KM.[2018]

The Prevention of Delirium Programme is being tested in a multicentre feasibility study across 16 wards in 8 NHS hospitals, aiming to evaluate its effectiveness in reducing new-onset delirium in patients aged 65 and over.

This study will provide important data on the incidence of delirium, compliance with the intervention, and potential cost-effectiveness, which will help shape a future larger randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of delirium (POD) for older people in hospital: study protocol for a randomised controlled feasibility trial. Young, J., Cheater, F., Collinson, M., et al.[2022]

The Early Psychosis Prevention and Intervention Centre (EPPIC) demonstrated improved clinical outcomes for young people with emerging psychotic disorders, showing effectiveness in a real-world setting over a 12-month period.

EPPIC was found to be more cost-effective than its predecessor service, saving an average of $AUD 7110 per patient due to reduced inpatient costs, despite higher community care expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is phase-specific, community-oriented treatment of early psychosis an economically viable method of improving outcome? Mihalopoulos, C., McGorry, PD., Carter, RC.[2019]

A group-based psychosocial program for individuals experiencing first-episode psychosis showed potential benefits, as participants had lower levels of premorbid adjustment and higher negative symptoms before starting, but no significant differences in outcomes were observed at the 6-month follow-up compared to those who did not attend the program.

The program may have provided crucial support during a critical period, helping to stabilize participants and potentially preventing further deterioration and disability, especially for those with poorer initial functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group programmes for recovery from early psychosis. Albiston, DJ., Francey, SM., Harrigan, SM.[2008]

The BRIA program significantly increased engagement in psychosocial mental healthcare among surgical patients with comorbid mental disorders, with 30% of participants in BRIA seeking further therapy compared to only 11.8% in the control group.

Patients in the BRIA group also experienced a significant reduction in psychological distress over six months, indicating that integrating such psychotherapy programs into surgical care can be beneficial for mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an Innovative Psychotherapy Program for Surgical Patients: Bridging Intervention in Anesthesiology--A Randomized Controlled Trial. Kerper, LF., Spies, CD., Salz, AL., et al.[2015]

A multicomponent intervention strategy significantly reduced the incidence of delirium in hospitalized patients aged 70 and older, with only 9.9% developing delirium compared to 15.0% in the usual-care group, indicating its effectiveness in preventing this condition.

The intervention also led to fewer total days and episodes of delirium, while improving cognitive impairment and reducing the use of sleep medications, suggesting that addressing multiple risk factors can enhance patient outcomes in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicomponent intervention to prevent delirium in hospitalized older patients. Inouye, SK., Bogardus, ST., Charpentier, PA., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10593633/

Effectiveness of a Multi-component Delirium Prevention ... Our evaluation showed that the implementation of a multicomponent delirium program led to a reduction in delirium prevalence and fall incidences ...

2. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2787212

Outcomes of a Delirium Prevention Program in Older ... The intervention reduced delirium incidence after various major procedures, most significantly in patients undergoing noncardiac surgery.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0952818024001958

Effectiveness of a delirium risk assessment and ... Our findings suggest that the PRE-DELIRIC-guided SMART/SmART care intervention is effective in preventing and managing delirium among surgical ICU patients.

4. bmcnurs.biomedcentral.com bmcnurs.biomedcentral.com/articles/10.1186/s12912-024-02547-y

The effectiveness of postoperative delirium prevention ... This quasi-experimental study aimed to assess the effectiveness of a postoperative delirium prevention, diagnosis, and intervention protocol in patients ...

5. nejm.org nejm.org/doi/full/10.1056/NEJM199903043400901

A Multicomponent Intervention to Prevent Delirium in ... The risk-factor intervention strategy that we studied resulted in significant reductions in the number and duration of episodes of delirium in hospitalized ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0952818024001351

A first assessment of the safe brain initiative care bundle for ... A significant reduction in postoperative delirium risk was observed for 19 months after initiating the care bundle.

7. withpower.com withpower.com/trial/phase-postoperative-complications-11-2022-ff68c

Delirium-Prevention Program for Postoperative Delirium The Delirium-Prevention Program is unique because it uses a multicomponent approach, combining several strategies to reduce the risk of delirium after surgery, ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8674802/

Outcomes of a Delirium Prevention Program in Older ... The intervention reduced delirium incidence after various major procedures, most significantly in patients undergoing noncardiac surgery.