PDM Alert for Postoperative Delirium

Overseen By Sanjay Mohanty

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Cognitive impairment, Alzheimer's, Drug withdrawal, others

Compensation: Varies

Number of Visits: 3

Duration: 1 week

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a "PDM Alert" (a notification system) can reduce the risk of delirium (confusion and disorientation) after surgery and prevent long-term cognitive issues like dementia. The trial compares patients with this alert on their medical records to those without it. It targets individuals aged 65 and older who are scheduled for major surgery with at least a one-day hospital stay. Participants should not have existing cognitive impairments like Alzheimer's or be experiencing withdrawal from alcohol or drugs. As an unphased trial, this study provides participants the chance to contribute to significant research that could enhance postoperative care for older adults.

Do I need to stop taking my current medications for the trial?

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 the PDM Alert is safe?

Research has shown that the PDM Alert treatment helps doctors predict and manage the risk of delirium after surgery. As a tool rather than a drug, PDM Alert has no direct data on side effects and is not expected to cause any physical side effects. This approach aids healthcare providers in identifying the risk of delirium without raising safety concerns.

Researchers are studying the tool to determine if it can reduce the chances of complications like delirium after surgery. Since it is not a medication, typical concerns about drug side effects do not apply. Instead, the focus is on enhancing patient monitoring and management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PDM Alert for postoperative delirium because it introduces a novel approach to prevention and management by utilizing a digital alert system. Unlike traditional treatments like medication adjustments and environmental interventions, the PDM Alert places a proactive notification on a patient's record to help healthcare providers identify and address delirium risk factors early. This method could streamline communication among care teams and enhance patient monitoring, potentially improving patient outcomes without relying on additional pharmaceuticals.

What evidence suggests that the PDM Alert is effective for reducing postoperative delirium?

Research shows that confusion after surgery, known as postoperative delirium, is common and affects about 19% of patients undergoing planned surgeries. This highlights the need for effective detection methods. Studies have found that severe delirium can accelerate mental decline and increase the risk of developing dementia. Reducing the severity of delirium might lower these risks. Early results suggest that alerts, such as the PDM Alert, could aid in identifying and managing delirium. In this trial, participants will either have the PDM Alert placed on their record or not, to evaluate its effectiveness. Although more information is needed, these alerts might reduce the frequency and severity of delirium after surgery. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals who are at least 65 years old and scheduled for major inpatient surgery that requires staying in the hospital for one or more days. It's not suitable for those who don't meet these criteria.

Inclusion Criteria

I am 65 or older and scheduled for major surgery that requires staying in the hospital.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo major abdominal surgery and are monitored for delirium incidence using CAM ICU and 3D-CAM assessments

1 week

Daily evaluations during post-operative inpatient hospitalization

Follow-up

Participants are monitored for long-term cognitive decline and dementia, and provider satisfaction is assessed

2-6 weeks

Survey administered to providers within 2 weeks of discharge

What Are the Treatments Tested in This Trial?

Interventions

• PDM Alert

Trial Overview

The study is testing a 'PDM Alert' system, which uses electronic medical records (EMR) data and artificial intelligence to predict the risk of postoperative delirium. Participants will receive this alert either on paper or through EMR to see if it affects delirium rates and long-term cognitive health.

How Is the Trial Designed?

Group I: PDM Alert Experimental Treatment 1 Intervention

PDM alert will be placed on subject's record

Group II: No PDM Alert Placebo Group 1 Intervention

No PDM alert will be placed on subject's record

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a study of 200 adult patients undergoing elective neurosurgery, the incidence of emergence delirium (ED) was found to be 41%, while postoperative delirium (POD) occurred in 20% of patients, indicating a higher prevalence compared to non-neurosurgical populations.

The presence of ED significantly increased the risk of developing POD by 1.8 times, and male patients were found to have a 2.5 times higher risk of experiencing POD, highlighting important risk factors for delirium after neurosurgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of and Risk Factors for Emergence Delirium and Postoperative Delirium in Neurosurgical Patients- A Prospective Cohort Study. Bharadwaj, S., Kamath, S., Chakrabarti, D., et al.[2022]

In a study of 318 cardiac surgery patients, 29.2% developed delirium in the ICU, with significant associations found between longer surgery times and higher transfusion requirements and the occurrence of delirium.

Plasma levels of biomarkers such as IL-6, TNF-α, sTNFR-1, and sTNFR-2 were significantly higher in patients with delirium, with sTNFR-1 emerging as a strong potential indicator of delirium risk after adjusting for other factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma biomarkers and delirium in critically ill patients after cardiac surgery: A prospective observational cohort study. Su, LJ., Chen, MJ., Yang, R., et al.[2023]

In a study of 88 patients who underwent elective surgery, 19% developed postoperative delirium, highlighting the importance of effective screening tools in surgical wards.

The Nursing Delirium Screening Scale (Nu-DESC) was found to be the most sensitive tool for detecting postoperative delirium, outperforming the Confusion Assessment Method (CAM) and Delirium Detection Score (DDS) in identifying patients at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of three scores to screen for delirium on the surgical ward. Radtke, FM., Franck, M., Schust, S., et al.[2021]

In a study of 247 patients undergoing colonic surgery, only 2.8% developed postoperative delirium (PD), suggesting that an enhanced recovery program can significantly reduce the incidence of this complication.

Patients who developed PD were older and had longer hospital stays, indicating that age may be a risk factor, but the fast-track methodology used in the study effectively minimized the overall risk and duration of PD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delirium in fast-track colonic surgery. Kurbegovic, S., Andersen, J., Krenk, L., et al.[2022]

Elderly surgical patients often have multiple health issues, increasing their risk of developing postoperative complications like delirium, which can lead to serious outcomes such as higher mortality and cognitive decline.

Identifying patients at risk for delirium is crucial for optimizing surgical procedures and implementing preventive measures to improve patient outcomes after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Acute postoperative confusional syndrome in the elderly patient]. Martínez-Velilla, N., Alonso Bouzón, C., Ripa Zazpe, C., et al.[2012]

This pilot trial aims to evaluate whether a multicomponent decision support system can reduce the incidence of delirium in high-risk older adults (≥70 years) undergoing non-cardiac surgery, with 60 participants divided into four groups.

The primary outcome is the presence of delirium assessed by the Confusion Assessment Method, while secondary outcomes will measure neurocognitive and clinical recovery, indicating the potential for improved postoperative care through proactive support systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): Protocol for a pilot randomized controlled trial. Vlisides, PE., Ragheb, JW., Leis, A., et al.[2021]

Citations

1.

withpower.com

withpower.com/trial/phase-delirium-2-2024-47c1e?condition=&overallStatus=Recruiting&hasNoPlacebo=false&query=Online+EmReg

PDM Alert for Postoperative Delirium

In a study of 88 patients who underwent elective surgery, 19% developed postoperative delirium, highlighting the importance of effective screening tools in ...

2.

reporter.nih.gov

reporter.nih.gov/project-details/11098496

RePORT RePORTER - National Institutes of Health (NIH) |

Severe delirium accelerates the rate of global cognitive decline leading to an increased risk of ADRD. Therefore, reducing delirium severity holds great promise ...

3.

libres.uncg.edu

libres.uncg.edu/ir/uncg/f/D_Lee_Paper_2024.pdf

Prevention Initiative for Postoperative Delirium

As stated in the results, there was a slight reduction in the percentage of postoperative delirium after general anesthesia, but after data analysis, this ...

4.

researchgate.net

researchgate.net/publication/273066667_Outcomes_Associated_With_Postoperative_Delirium_After_Cardiac_Surgery

Outcomes Associated With Postoperative Delirium After ...

The occurrence of POD is associated with increased mortality, prolonged intensive care unit (ICU) and hospital stays, increased healthcare costs ...

5.

academic.oup.com

academic.oup.com/ageing/article/53/4/afae077/7650798

Assessment and report of individual symptoms in studies of ...

This systematic review investigates which individual symptoms of delirium are reported by studies of postoperative delirium in adults.

6.

trialstoday.org

trialstoday.org/list/print/NCT06216483

Using EMR Data and AI to Develop a Passive Digital ...

This study will be a pilot randomized controlled trial that will determine the effect of an indicator of delirium risk, which will be delivered ...

7.

reporter.nih.gov

reporter.nih.gov/project-details/11184607

Project Details - NIH RePORTER

Over-sedation (at 28% incidence) contributes to post-operative delirium (POD) in elderly population (≥65yrs). Notably, 11% of these elderly patients suffer from ...

8.

mdpi.com

mdpi.com/2308-3417/9/6/155

Relevance of Preoperative Cognitive Impairment for ...

The delirium rate was 5.64% (n = 11) for no or low care level (n = 195, 62.9%), 25.5% (n = 26) for moderate care level (n = 104, 33.5%) and 36.4% (n = 4) for ...