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

14 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a quality improvement project to evaluate health care management of pulmonary embolism (PE) patients. The researchers are testing an intervention to determine if it prevents unnecessary hospital admissions.

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 the treatment Pulmonary Embolism (PE) Care in Emergency Department (ED)?

The research suggests that actively searching for pulmonary embolism (PE) in patients with other conditions, like chronic obstructive pulmonary disease (COPD), can improve outcomes, indicating that focused care in the emergency department (ED) may be beneficial for PE patients. ^{1 2 3 4 5}

Is the treatment for pulmonary embolism safe for humans?

The research highlights the importance of patient safety in emergency departments, focusing on minimizing adverse events and improving medication safety, which suggests a general emphasis on safety practices in such settings. ^{6 7 8 9 10}

How does this treatment for pulmonary embolism differ from other treatments?

The treatment for pulmonary embolism (PE) in this trial may involve novel approaches to outpatient management, which traditionally requires hospital admission for monitoring and anticoagulation (blood-thinning) treatment. This could mean a shift towards managing PE with less invasive methods or in different settings, potentially improving patient comfort and reducing healthcare costs. ^{1 5 11 12 13}

Research Team

Geoff Barnes

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

Best Clinical Practice: Controversies in Outpatient Management of Acute Pulmonary Embolism. [2018]

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

An emergency department guideline for the diagnosis of pulmonary embolism: an outcome study. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Delayed Diagnosis in Pulmonary Embolism: Frequency, Patient Characteristics, and Outcome. [2021]

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

Comparing predictive performance of pulmonary embolism risk stratification tools for acute clinical deterioration. [2023]

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

Effect of a Pulmonary Embolism Diagnostic Strategy on Clinical Outcomes in Patients Hospitalized for COPD Exacerbation: A Randomized Clinical Trial. [2022]

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

Hospital ward transfer to intensive care unit as a quality marker in emergency medicine. [2017]

7. Spain pubmed.ncbi.nlm.nih.gov

[Patient safety in emergency care]. [2010]

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

Analysis of Risk Factors for Patient Safety Events Occurring in the Emergency Department. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Assessment of adverse drug event recognition by emergency physicians in a French teaching hospital. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Use of an electronic information system to identify adverse events resulting in an emergency department visit. [2018]

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

Pulmonary embolism. [2022]

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

Development of massive pulmonary embolism during echocardiographic imaging: A case report. [2022]

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

Rapid Systematic Review: Age-Adjusted D-Dimer for Ruling Out Pulmonary Embolism. [2019]