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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Multicomponent delirium-risk prevention bundle for preventing postoperative delirium?

Research shows that using a multicomponent care bundle, which includes several strategies like ongoing assessment of cognition and early mobilization, can effectively reduce the risk of delirium in hospitalized patients, especially older adults undergoing surgery. ^{1 2 3 4 5}

Is the Delirium-Prevention Program safe for humans?

The available research suggests that multicomponent delirium prevention programs are generally safe for use in hospital settings, as they focus on non-invasive strategies like ongoing assessment, orientation, and early mobilization. ^{1 2 3 5 6}

How is the Delirium-Prevention Program different from other treatments 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, rather than relying on a single method or medication. This comprehensive bundle may include elements like cognitive exercises, environmental adjustments, and medication management, making it distinct from treatments that focus solely on drugs or single interventions. ^{7 8 9 10 11}

Research Team

Stephen Choi, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Multi-Component Care Bundle in Geriatric Fracture Hip for Reducing Post-Operative Delirium. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

In-facility delirium prevention programs as a patient safety strategy: a systematic review. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

A multicomponent intervention to prevent delirium in hospitalized older patients. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Commentary on "Multi-Component Care Bundle in Geriatric Fracture Hip for Reducing Postoperative Delirium". [2021]

6. England pubmed.ncbi.nlm.nih.gov

Prevention of delirium (POD) for older people in hospital: study protocol for a randomised controlled feasibility trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Systematic services audit of consecutive suicides in New Brunswick: the case for coordinating specialist mental health and addiction services. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Is phase-specific, community-oriented treatment of early psychosis an economically viable method of improving outcome? [2019]

9. England pubmed.ncbi.nlm.nih.gov

Group programmes for recovery from early psychosis. [2008]

10. United States pubmed.ncbi.nlm.nih.gov

Effects of an Innovative Psychotherapy Program for Surgical Patients: Bridging Intervention in Anesthesiology--A Randomized Controlled Trial. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

Psychopharmacological Treatment in the RAISE-ETP Study: Outcomes of a Manual and Computer Decision Support System Based Intervention. [2022]