Physician Notification for Aortic Stenosis

(DETECT AS Trial)

Overseen By Paris Jamiel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Bioprosthetic, mechanical valves, others

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

Compensation: Varies

Number of Visits: Unknown

940 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how electronic notifications to doctors about patients with severe aortic stenosis (a heart valve problem) affect the treatment process. It examines whether these notifications increase the number of patients receiving aortic valve replacement (AVR) and address racial or ethnic disparities in treatment access. The trial is ideal for individuals diagnosed with severe aortic stenosis, identified by an aortic valve area smaller than 1.0 cm², who do not have artificial heart valves. Participants' doctors will either receive a Physician Notification Letter (also known as Electronic Physician Notification or Provider Alert System) about their condition or will not, to determine if this influences the care provided. As an unphased trial, this study offers a unique opportunity to contribute to understanding and improving treatment processes for severe aortic stenosis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this electronic provider notification is safe for managing aortic stenosis?

Research has shown that electronic alert systems for doctors are being tested to improve care for patients with severe aortic stenosis, a condition where the heart's aortic valve narrows. In this study, doctors receive an electronic alert about patients with this condition.

There is no direct safety concern for patients because the "treatment" is simply a notification to doctors. The study does not test a new drug or procedure on patients. Instead, it aims to determine if these alerts help more patients receive necessary care, such as valve replacement surgery.

For those considering joining this trial, the safety concerns focus not on the treatment itself but on ensuring doctors have better information to make timely decisions. This should help reduce the risks of delayed or missed treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Physician Notification Letter trial because it aims to improve the early detection and management of aortic stenosis by directly informing doctors about potential cases. Unlike traditional treatments that rely on patient symptoms for diagnosis, this method proactively alerts physicians, potentially leading to earlier intervention. By enhancing communication between healthcare systems and providers, it could significantly improve patient outcomes without the need for new drugs or surgeries, making it an innovative approach in tackling this heart condition.

What evidence suggests that this notification method is effective for managing severe aortic stenosis?

Research has shown that electronic provider notifications (EPNs), which participants in this trial may receive as part of the Notification Letter Arm, can greatly increase the number of aortic valve replacements (AVR) for patients with severe aortic stenosis (AS). Studies have found that EPNs not only raise AVR rates but also reduce treatment disparities among different genders and age groups. EPNs alert doctors to severe AS cases and provide specific treatment advice based on guidelines. This method has been linked to better treatment outcomes and higher survival rates for patients with severe AS. Overall, EPNs appear to be a promising tool to ensure more patients receive the necessary care for their condition. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for patients with severe aortic stenosis, where the opening of their aortic valve is less than or equal to 1.0cm2. It's not for those who already have artificial (bioprosthetic or mechanical) valves in place.

Inclusion Criteria

My heart valve is severely narrowed.

Exclusion Criteria

You have a replacement valve in your aorta.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Providers in the intervention group receive electronic notifications about patients with severe aortic stenosis, highlighting management guidelines.

1 year

Follow-up

Participants are monitored for AVR utilization, mortality, heart failure hospitalization, and other secondary outcomes.

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Physician Notification Letter

Trial Overview The DETECT AS Trial tests if notifying physicians electronically about their patient's severe aortic stenosis improves management and increases the use of valve replacement surgery, especially among different ethnic and racial groups.

How Is the Trial Designed?

Group I: Notification Letter Arm Experimental Treatment 1 Intervention

Providers that will receive an electronic Physician Notification Letter.

Group II: Control Group Active Control 1 Intervention

Providers that will not be contacted.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Edwards Lifesciences

Industry Sponsor

Trials

188

Recruited

67,500+

Founded

1958

Headquarters

Irvine, California, U.S.

Known For

Structural Heart Innovations

Top Products

SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD

Published Research Related to This Trial

An automated vaccine adverse event surveillance system was implemented, which significantly improved the reporting rate of potential vaccine-related adverse events, with 686 alerts generated from 33,420 vaccinations over five months.

Clinicians found the system easy to use, leading to a reporting rate of 0.69 reports per 1,000 vaccine doses, nearly six times higher than the typical rate, suggesting that real-time prompts can enhance the detection and reporting of vaccine adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using electronic medical records to enhance detection and reporting of vaccine adverse events. Hinrichsen, VL., Kruskal, B., O'Brien, MA., et al.[2018]

The study involving 28 ED triage nurses and over 39,000 patients found that a passive EHR alert did not significantly increase the utilization of triage protocols for diagnostic testing in emergency settings.

Despite some increases in protocol implementation after the intervention, the overall benefits of using EHR alerts were minimal, suggesting that more rigorous studies are needed to optimize alert systems for improving patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic alerts for triage protocol compliance among emergency department triage nurses: a randomized controlled trial. Holmes, JF., Freilich, J., Taylor, SL., et al.[2018]

An automated email notification system was implemented to inform physicians about finalized test results pending at discharge (TPADs), improving communication and responsibility transfer between inpatient and primary care physicians.

During a 6-month pilot involving randomly selected inpatient-attending physicians, 84% reported satisfaction with the system, indicating its effectiveness in managing TPADs with an average of 1.6 notifications per discharged patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and implementation of an automated email notification system for results of tests pending at discharge. Dalal, AK., Schnipper, JL., Poon, EG., et al.[2021]

Automating the hospital discharge notification process can significantly improve communication between hospitals and primary care providers, addressing the issue of unplanned readmissions, which currently affect 20% of Medicare patients.

Implementing automated notification systems has been shown to enhance care coordination by triggering timely follow-up assessments and plans, ultimately supporting better patient outcomes in posthospital care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Where are my patients? It is time to automate notification of hospital use to primary care practices. Moran, WP., Davis, KS., Moran, TJ., et al.[2011]

Integrating adverse event (AE) reporting into a mobile application used by physicians significantly increased AE reporting, with a more than 37-fold rise in reports (from 21 to 806).

The proportion of AE reports submitted by physicians also increased dramatically, from 0.1% to 12% of all reports, highlighting the effectiveness of this integration in enhancing patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Adverse Event Reporting Into a Free-Text Mobile Application Used in Daily Workflow Increases Adverse Event Reporting by Physicians. Delio, J., Catalanotti, JS., Marko, K., et al.[2021]

Nearly half (47.1%) of time-sensitive alerts regarding medication concerns for older patients were opened by primary care providers within 24 hours, indicating a significant delay in alert review that could affect patient safety.

The likelihood of opening alerts decreased with a higher number of total InBasket notifications at the time of delivery and was particularly low for alerts sent on Saturdays, suggesting that alert management strategies need improvement to enhance timely responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary Care Providers' Opening of Time-Sensitive Alerts Sent to Commercial Electronic Health Record InBaskets. Cutrona, SL., Fouayzi, H., Burns, L., et al.[2019]

The implementation of a computerized alert system in primary care significantly improved the initiation of osteoporosis treatment among high-risk patients, with 30% starting treatment within 2 years of the alert activation.

The time to treatment initiation decreased notably after the alert system was introduced, with initiation rates within 6 months rising from 52% to 59.8% for T-score cases, indicating the system's effectiveness in addressing previously missed cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and efficacy of a computerized decision support system for osteoporosis management in the community. Goldshtein, I., Shamai-Lubovitz, O., Guindy, M., et al.[2020]

Primary care practitioners (PCPs) received an average of 56.4 asynchronous electronic health record (EHR) alerts per day, which significantly contributes to their workload.

On average, PCPs spent about 49 minutes each day processing these alerts, highlighting the need for further investigation into the effectiveness and management of such alert systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Notifications received by primary care practitioners in electronic health records: a taxonomy and time analysis. Murphy, DR., Reis, B., Sittig, DF., et al.[2022]

The implementation of event notification service (ENS) alerts significantly improved timely follow-up care for older veterans, with a fourfold increase in phone contact within 7 days and a twofold increase in in-person visits within 30 days compared to usual care.

Despite the improved follow-up, there was no significant reduction in hospital or emergency department readmissions within 30 days, indicating that while ENS alerts enhance care coordination, they may not directly impact readmission rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of event notification services on timely follow-up and rehospitalization among primary care patients at two Veterans Affairs Medical Centers. Dixon, BE., Judon, KM., Schwartzkopf, AL., et al.[2022]

Public health agencies can enhance the effectiveness of health alerts by integrating them into electronic health record (EHR) systems, ensuring timely and accessible information for healthcare providers at critical moments.

A review of public health alerts over a 3-year period identified key data attributes that can improve the relevance and actionability of alerts in EHR systems, aiding in clinical care and reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of public health alerts and their suitability for alerting in electronic health record systems. Garrett, NY., Mishra, N., Nichols, B., et al.[2019]

A new alert system for inpatients successfully notified physicians about serious clinical conditions, with a high response rate of 70.2% to 1730 alerts over a 6-month period.

Physicians acted quickly, responding to 82.5% of alerts within 15 minutes, and indicated they would take action in 71.5% of cases, suggesting the system is effective in facilitating timely medical responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detecting alerts, notifying the physician, and offering action items: a comprehensive alerting system. Kuperman, GJ., Teich, JM., Bates, DW., et al.[2018]

The study by Reber et al. is significant as it investigates how 'Dear Doctor' letters, which inform physicians about potential drug safety issues, impact their prescribing behaviors.

Despite the frequent issuance of these safety alerts, there is limited understanding of their effectiveness in actually improving patient outcomes, highlighting a gap in knowledge regarding their real-world impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

If you don't know where you are going, you can't tell if you have arrived: defining goals for drug safety announcements. Wood, AJ.[2018]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.125.074470

Electronic Provider Notification to Facilitate the Recognition ... In this first study of EPNs for valvular heart disease, EPNs increased rates of AVR for severe AS, lessened sex and age disparities in AVR use, and improved ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38950668/

Electronic physician notification to facilitate the recognition ... The DETECT AS trial will provide insight into whether electronic notification of providers on the presence of severe aortic stenosis and associated clinical ...

3. jwatch.org jwatch.org/na58700/2025/05/08/can-electronic-provider-notification-improve-outcomes

Can Electronic Provider Notification Improve Outcomes in ... The EPN informed clinicians of the diagnosis, provided information about prognosis with medical therapy, and made patient-specific management recommendations.

4. massgeneralbrigham.org massgeneralbrigham.org/en/about/newsroom/press-releases/notifications-improve-treatment-for-valvular-heart-disease

Clinical Trial Shows Electronic Provider Notifications Can ... A new method of alerting clinical care providers holds promise for increasing treatment and improving survival for patients with severe aortic stenosis (AS).

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002870324001637

Trial Designs Electronic physician notification to facilitate ... The primary endpoint is the proportion of patients with severe aortic stenosis receiving an aortic valve replacement within one year of the index echocardiogram ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05230225

Study Details | NCT05230225 | Electronic Physician ... Determining whether an electronic physician notification letter improves recognition and management of severe AS through its impact on the utilization of aortic ...

7. tctmd.com tctmd.com/news/detect-alert-system-increases-av-replacement-eligible-patients

Alert System Increases AV Replacement in Eligible Patients The study showed the alert increased the rate of aortic valve replacement (AVR) and reduced treatment disparities, including in elderly patients and women, ...