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

Trial Summary

What data supports the effectiveness of the treatment PDM Alert for postoperative delirium?

The RADAR pilot trial suggests that a system sending alerts and recommendations to care programs and family members may help improve recovery after surgery by reducing delirium, a serious complication in older adults. This approach is based on providing social and behavioral support, which has been shown to potentially reduce delirium. ¹

How is the PDM Alert treatment different from other treatments for postoperative delirium?

The PDM Alert treatment is unique because it focuses on early detection and prevention of postoperative delirium, rather than just managing symptoms after they occur. This proactive approach may help reduce the incidence and severity of delirium by addressing risk factors before they lead to complications. ^{2 3 4 5 6}

What is the purpose of this trial?

This study will be a pilot randomized controlled trial that will determine the effect of an indicator of delirium risk, which will be delivered either via a paper form or via the electronic medical record, on (1)postoperative delirium incidence; and (2)the development of long term cognitive decline and dementia.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): Protocol for a pilot randomized controlled trial. [2021]

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

A comparison of three scores to screen for delirium on the surgical ward. [2021]

3. India pubmed.ncbi.nlm.nih.gov

Incidence of and Risk Factors for Emergence Delirium and Postoperative Delirium in Neurosurgical Patients- A Prospective Cohort Study. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Delirium in fast-track colonic surgery. [2022]

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

Plasma biomarkers and delirium in critically ill patients after cardiac surgery: A prospective observational cohort study. [2023]

6. Spain pubmed.ncbi.nlm.nih.gov

[Acute postoperative confusional syndrome in the elderly patient]. [2012]