Delirium-Prevention Program for Postoperative Delirium

(PROMoTE Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Stephen Choi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Cardiac surgery, Neurosurgery, Substance use, others

No Placebo Group

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.

Trial 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 (Behavioural Intervention)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Sunnybrook Health Sciences Centre Toronto, Canada

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Patients Recruited

1,569,000+

References

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

Multi-Component Care Bundle in Geriatric Fracture Hip for Reducing Post-Operative Delirium. [2022] Delirium in elderly orthopaedic patients poses an enormous medical, social and financial burden to the healthcare system, and causes significant distress to patients and their caregivers. We examined whether a Multi-component Care Bundle (MCB) could reduce the incidence of post-operative delirium (POD) in fractured hip patients.

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

Primary Prevention to Maintain Cognition and Prevent Acute Delirium Following Orthopaedic Surgery. [2019] Cognitive impairment is a recognized predictor of acute delirium, particularly in the postoperative period. Estimates of up to 24% of patients experiencing delirium and its associated cognitive impairment during any orthopaedic procedure have been reported, with higher rates for those patients undergoing hip fracture repair. Primary prevention is the most effective strategy to maintain cognition and prevent delirium. The purpose of this article is to provide evidence-based recommendations to prevent acute delirium using bundles of care. Bundles of care are a set of 3-5 independent, evidence-based interventions that, when implemented together, result in significantly better outcomes than when implemented individually. The bundle consists of ongoing assessment of cognition, continuing orientation, and early mobilization and socialization.

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

In-facility delirium prevention programs as a patient safety strategy: a systematic review. [2018] Delirium, an acute decline in attention and cognition, occurs among hospitalized patients at rates estimated to range from 14% to 56% and increases the risk for morbidity and mortality. The purpose of this systematic review was to evaluate the effectiveness and safety of in-facility multicomponent delirium prevention programs. A search of 6 databases (including MEDLINE, EMBASE, and CINAHL) was conducted through September 2012. Randomized, controlled trials; controlled clinical trials; interrupted time series; and controlled before-after studies with a prospective postintervention portion were eligible for inclusion. The evidence from 19 studies that met the inclusion criteria suggests that most multicomponent interventions are effective in preventing onset of delirium in at-risk patients in a hospital setting. Evidence was insufficient to determine the benefit of such programs in other care settings. Future comparative effectiveness studies with standardized protocols are needed to identify which components in multicomponent interventions are most effective for delirium prevention.

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

A multicomponent intervention to prevent delirium in hospitalized older patients. [2023] Since in hospitalized older patients delirium is associated with poor outcomes, we evaluated the effectiveness of a multicomponent strategy for the prevention of delirium.

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

Commentary on "Multi-Component Care Bundle in Geriatric Fracture Hip for Reducing Postoperative Delirium". [2021] The letter to the editor suggested several questions regarding the methodology of the recent article by Lam et al who determined effect of multicomponent care bundle on the development of postoperative delirium. This article is published in Geriatric Orthopaedic Surgery & Rehabilitation .  2021; 12:21514593211004530. Our concerns included the incomplete preoperative assessment, possible influences of anaesthetic and intraoperative managements on the development of postoperative delirium, bias effect of postoperative analgesia on the primary and secondary findings, and real clinical value of multicomponent care bundle to decrease the risk of postoperative delirium. We believe that clarifying these issues would improve the transparency of this study and interpretation of findings.

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] Delirium is the most frequent complication among older people following hospitalisation. Delirium may be prevented in about one-third of patients using a multicomponent intervention. However, in the United Kingdom, the National Health Service has no routine delirium prevention care systems. We have developed the Prevention of Delirium Programme, a multicomponent delirium prevention intervention and implementation process. We have successfully carried out a pilot study to test the feasibility and acceptability of implementation of the programme. We are now undertaking preliminary testing of the programme.

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] To weight the potential of promotion, prevention, and treatment programs to help establish priorities in multipronged suicide prevention strategies.

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] The Early Psychosis Prevention and Intervention Centre (EPPIC) provides a comprehensive 'real-world' model of early intervention to young people experiencing an emerging psychotic disorder. A prospective study has already provided evidence of improved clinical outcome at 12 months after entry. The present study examined whether the service was also cost-effective.

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

Group programmes for recovery from early psychosis. [2008] We evaluate the impact of a group-based, transitional, psychosocial programme, within a comprehensive service (the Early Psychosis Prevention and Intervention Centre, EPPIC), on recovery from first-episode psychosis.

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] The stepped care program Bridging Intervention in Anesthesiology (BRIA) aims at motivating and supporting surgical patients with comorbid mental disorders to engage in psychosocial mental healthcare options. This study examined the efficacy of BRIA.

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] The Recovery After an Initial Schizophrenia Episode-Early Treatment Program compared NAVIGATE, a comprehensive program for first-episode psychosis, to clinician-choice community care over 2 years. Quality of life and psychotic and depressive symptom outcomes were found to be better with NAVIGATE. Compared with previous comprehensive first-episode psychosis interventions, NAVIGATE medication treatment included unique elements of detailed first-episode-specific psychotropic medication guidelines and a computerized decision support system to facilitate shared decision making regarding prescriptions. In the present study, the authors compared NAVIGATE and community care on the psychotropic medications prescribed, side effects experienced, metabolic outcomes, and scores on the Adherence Estimator scale, which assesses beliefs related to nonadherence.