Alert-Based Care for Cardiac Device Management

(RAPTOR-CIED Trial)

Overseen By Linda Valsdottir, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Cardiac monitor, Transplantation, Other study

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

Compensation: Varies

Number of Visits: 90

120 Participants Needed

Trial Summary

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 is best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Alert-based care for Cardiac Device Management?

Research shows that advanced alert systems in clinical decision support can improve adherence to guidelines by providing more specific and relevant alerts, which helps clinicians make better decisions. This suggests that alert-based care for cardiac device management could be effective by reducing unnecessary alerts and focusing on critical information. ^{1 2 3 4 5}

Is alert-based care for cardiac device management safe for humans?

There is limited information on the safety of alert-based care systems, and some reports suggest that these systems may not always be designed or implemented effectively, which could impact their safety. ^{2 6 7 8 9}

How does the Alert-Based Care treatment for cardiac device management differ from other treatments?

Alert-Based Care for cardiac device management is unique because it uses a system to classify and prioritize alerts from cardiac devices, like pacemakers, by integrating patient data. This approach aims to reduce the burden of alerts on healthcare providers, making it more efficient than traditional methods that may not prioritize alerts based on their importance. ^{2 10 11 12 13}

What is the purpose of this trial?

The Remote Alert Pathway to Optimize Care of Cardiac Implantable Electrical Devices (RAPTOR-CIED) Study is a pragmatic, multi-center, randomized trial with 1:1 patient-level randomization comparing the safety and effectiveness of alert-driven care versus guideline-based care for patients with wireless cardiac implantable electrical devices (CIEDs). The study will be conducted in 2 phases: a Feasibility Phase and a Main Phase. This registration outlines the goals and design features of the Feasibility Phase of the study.

Eligibility Criteria

The RAPTOR-CIED study is for individuals with wireless dual chamber pacemakers or ICDs. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions and agree to follow the study procedures.

Inclusion Criteria

Has a newly implanted or existing wireless CIED: single, dual-chamber, biventricular, subcutaneous/extravascular, and leadless systems are all eligible, including pacemakers or implantable cardioverter-defibrillators (ICDs)

I am older than 18 years.

Clinically stable by investigator assessment

Exclusion Criteria

Presence of insertable cardiac monitor, either in isolation or in combination with any other CIED

Listed for cardiac transplantation prior to enrollment (N.B. if a patient becomes listed for transplantation during the study, they may continue study participation)

Participation in another study related to novel CIED technology or remote monitoring.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Feasibility Phase

Initial phase to assess the feasibility of alert-driven care versus guideline-based care for patients with CIEDs

6 months

Remote monitoring with scheduled transmissions every 90 days

Main Phase

Main phase to evaluate the safety and effectiveness of alert-driven care versus guideline-based care

6 months

Remote monitoring with patient-initiated and alert transmissions

Follow-up

Participants are monitored for safety and effectiveness after the main phase

4 weeks

Treatment Details

Interventions

• Alert-based care
• Guideline-based care

Trial Overview This trial compares two types of care for patients with cardiac devices: alert-driven care where doctors respond to alerts from the device, and guideline-based care that follows standard medical guidelines. It's a randomized trial meaning people are put into groups by chance.

Participant Groups

Group I: Guideline-based Care Active Control 1 Intervention

Remote monitoring programming scheduled for alert transmissions, patient-initiated transmissions, and routine transmissions (scheduled to occur every 90 days from the date of enrollment in the study); in-office interrogations on at least an annual basis

Group II: Alert-based Care Active Control 1 Intervention

Remote monitoring programming scheduled for alert transmissions and patient-initiated transmissions only

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Findings from Research

In a study analyzing 1012 medication regimens in a nephrology clinic, more specific alerting strategies significantly reduced the number of alerts generated, with the most advanced strategy (D) resulting in alerts for only 7.81% of regimens compared to 87.5% with the least specific strategy (A).

The findings suggest that using patient and drug-specific information in alert systems can effectively minimize alert fatigue among physicians, potentially improving the safety of prescribing medications to patients with renal impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailoring of alerts substantially reduces the alert burden in computerized clinical decision support for drugs that should be avoided in patients with renal disease. Czock, D., Konias, M., Seidling, HM., et al.[2017]

Opioid alerts in clinical decision support systems were overridden 96.3% of the time, indicating a high override rate compared to non-opioid alerts, which raises concerns about alert fatigue among healthcare providers.

Despite the high override rates, only 0.31% of patients experienced adverse drug events related to opioids, and none of these events were preventable by the alerts, suggesting that while alerts can avert some adverse events, the system generates many unnecessary alerts that could hinder patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinically Inconsequential Alerts: The Characteristics of Opioid Drug Alerts and Their Utility in Preventing Adverse Drug Events in the Emergency Department. Genco, EK., Forster, JE., Flaten, H., et al.[2018]

References

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

Tailoring of alerts substantially reduces the alert burden in computerized clinical decision support for drugs that should be avoided in patients with renal disease. [2017]

2. Ireland pubmed.ncbi.nlm.nih.gov

Best practices for preventing malfunctions in rule-based clinical decision support alerts and reminders: Results of a Delphi study. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of alert specifications on clinicians' adherence. [2011]

4. Ireland pubmed.ncbi.nlm.nih.gov

Radiology report alerts - are emailed 'Fail-Safe' alerts acknowledged and acted upon? [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of medication related clinical decision support at the time of physician order entry. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Risk management, or just a different risk? [2018]

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

A framework for evaluating the appropriateness of clinical decision support alerts and responses. [2021]

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

An automated clinical alert system for newly-diagnosed atrial fibrillation. [2022]

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

Clinically Inconsequential Alerts: The Characteristics of Opioid Drug Alerts and Their Utility in Preventing Adverse Drug Events in the Emergency Department. [2018]

10. Germany pubmed.ncbi.nlm.nih.gov

[SmartCare: automatizing clinical guidelines]. [2010]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Remote Monitoring of Cardiac Implantable Devices: Ontology Driven Classification of the Alerts. [2019]

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

Acute coronary syndrome emergency treatment strategies: a rationale and road map for critical pathway implementation. [2008]

13. England pubmed.ncbi.nlm.nih.gov

Quality improvement in acute coronary syndromes: translating evidence into practice. [2015]