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

Trial Summary

What is the purpose of this trial?

This trial tests if sending doctors alerts about patients with severe heart valve problems can improve treatment and reduce care differences among different groups.

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 data supports the effectiveness of this treatment for aortic stenosis?

Research shows that electronic alerts and notifications can improve communication and coordination among healthcare providers. For example, automated systems have been effective in ensuring timely follow-up care and improving awareness of patient conditions, which suggests that similar notification systems could help manage aortic stenosis by keeping physicians informed and facilitating better care coordination. ^{1 2 3 4 5}

Is the Physician Notification for Aortic Stenosis generally safe for humans?

The research articles do not provide specific safety data for the Physician Notification for Aortic Stenosis or similar systems. They focus on improving adverse event reporting and alert systems, but do not address the safety of these notification systems themselves. ^{2 6 7 8 9}

How does the Physician Notification for Aortic Stenosis treatment differ from other treatments for this condition?

The Physician Notification for Aortic Stenosis treatment is unique because it involves using electronic health record (EHR) alerts to notify physicians about patient conditions, which can improve timely follow-up and management compared to traditional methods that may not provide real-time updates. ^{2 3 10 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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

Electronic alerts for triage protocol compliance among emergency department triage nurses: a randomized controlled trial. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Development and efficacy of a computerized decision support system for osteoporosis management in the community. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Design and implementation of an automated email notification system for results of tests pending at discharge. [2021]

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

Where are my patients? It is time to automate notification of hospital use to primary care practices. [2011]

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

Detecting alerts, notifying the physician, and offering action items: a comprehensive alerting system. [2018]

6. United States 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. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Using electronic medical records to enhance detection and reporting of vaccine adverse events. [2018]

8. Netherlands 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. [2021]

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

Primary Care Providers' Opening of Time-Sensitive Alerts Sent to Commercial Electronic Health Record InBaskets. [2019]

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

Notifications received by primary care practitioners in electronic health records: a taxonomy and time analysis. [2022]

11. England 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. [2022]

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

Characterization of public health alerts and their suitability for alerting in electronic health record systems. [2019]