Improved Care for Pulmonary Embolism

Overseen By Jess Burns

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Pediatric-only hospital, No physician champion, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how healthcare providers manage pulmonary embolism (PE), a condition where a blood clot blocks blood flow in the lungs. The goal is to determine if a new intervention can reduce unnecessary hospital admissions for patients with PE. Participants must work in emergency departments that handle at least 80 acute PE cases a year and be part of a specific healthcare collaboration. This trial may suit hospitals seeking to refine their PE management practices. As an unphased trial, it offers participants the chance to contribute to innovative healthcare solutions that could enhance patient care.

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 intervention is safe for pulmonary embolism patients?

Research shows that patients with low-risk pulmonary embolism (PE) treated in the emergency department (ED) generally experience similar short-term outcomes, regardless of certain test results. This suggests that the treatment is usually well-tolerated for these patients. Experts have identified a few potential side effects to monitor when treating PE at home, but these are considered in safety evaluations. Overall, studies indicate that PE care in the ED is safe for low-risk patients, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Improved Care for Pulmonary Embolism" trial because it focuses on enhancing emergency department (ED) protocols for managing pulmonary embolism (PE). Unlike the standard care options, which often involve anticoagulation therapy and sometimes invasive procedures, this trial is exploring innovative ways to streamline and optimize PE management right from the ED setting. The goal is to determine if these refined protocols can lead to quicker diagnosis and treatment, potentially improving patient outcomes and reducing complications associated with PE. This could represent a significant shift in how PE is managed, emphasizing rapid and efficient care in emergency situations.

What evidence suggests that this intervention is effective for managing pulmonary embolism?

This trial will evaluate improved care for pulmonary embolism (PE) in the emergency department (ED). Research has shown that enhancing ED management of PE can significantly impact patient outcomes. One study found that changes in the ED increased the number of PE patients sent home by 48%. Another study demonstrated that a specialized team in the ED helped diagnose and treat PE patients more quickly, ensuring immediate care. Over time, the rate of safely discharged PE patients from the ED rose from 7.8% to 32.1%. These findings suggest that better ED care can effectively manage PE and reduce unnecessary hospital stays. ^{6 7 8 9 10}

Who Is on the Research Team?

Geoff Barnes

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals who arrive at the emergency department with a pulmonary embolism (PE), which is a blockage in one of the lung's arteries. The study aims to include those who might benefit from improved care processes.

Inclusion Criteria

Participation in MEDIC collaborative

Identified site physician champion

Annual volume of acute PE ≥80 (measured in 2022)

Exclusion Criteria

No site physician champion identified

I am following a specific outpatient plan for managing my low-risk pulmonary embolism.

Annual volume of acute PE <80 (measured in 2022)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of the intervention to evaluate its effect on preventing unnecessary hospital admissions for PE patients

18 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pulmonary Embolism (PE) Care in Emergency Department (ED)

Trial Overview The intervention being tested involves new procedures for managing PE patients in the emergency department, with a focus on reducing unnecessary hospital admissions while maintaining patient safety and quality of care.

How Is the Trial Designed?

Group I: MEDIC site Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. annemergmed.com annemergmed.com/article/S0196-0644(25)00699-7/fulltext

302 Effectiveness of an Emergency Department Pulmonary ... There were 6,400 patients included in the analysis. The median age was 62 years, 51% were female and 69% were White. ED discharge rates were 48% higher post ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6599732/

The Impact of a Pulmonary Embolism Response Team on ... The efficiency of patient care in the ED following PERT implementation significantly decreased the time to diagnosis, treatment, and disposition of patients ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0735109710046528

Clinical Research Pulmonary Embolism ... This study measured the presentation features, testing, treatment strategies, and outcomes of patients diagnosed with pulmonary embolism (PE) in the emergency ...

4. ahajournals.org ahajournals.org/doi/10.1161/circ.148.suppl_1.14494

Abstract 14494: National Trends in Emergency Department ... Overall, 22.1% of patients with acute PE were discharged from the ED, which increased from 7.8% between 2006-2008 to 32.1% between 2018-2020. A ...

5. jem-journal.com jem-journal.com/article/S0736-4679(24)00327-5/fulltext

Controversies in the Management of Acute Pulmonary ... This narrative review aims to synthesize recent data and offer guidance and recommendations for the management of acute PE in the Emergency ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10233419/

Adverse Clinical Outcomes Among Patients With Acute Low ... In summary, ED patients with acute, low-risk PE had similar short-term outcomes irrespective of CTPE results. Nonetheless, specific CTPE ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10667606/

Disposition of emergency department patients with acute ... Patients with PE who arrived at the ED by EMS were less likely to be discharged home within 24 h and more likely to die within 30 days than those who arrived ...

8. nature.com nature.com/articles/s41598-023-36123-2

Pulmonary embolism in United States emergency ... A previous ED study demonstrated that the proportion of PE among US ED patients was approximately 0.08% from 2001 to 201016.

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2805451

Outcomes Among Patients With Acute Low-risk PE and ... In summary, ED patients with acute, low-risk PE had similar short-term outcomes irrespective of CTPE results. Nonetheless, specific CTPE ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S1538783625000595

Criteria for home treatment of patients with acute ... Out of 22 possible outcomes, 6 adverse events (27%) were selected by the panel of experts as critical for assessing the safety of home treatment in patients ...