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OpenTrials
Completed

NCT Number: NCT03601676

Electronic Support for Pulmonary Embolism Emergency Disposition

To evaluate the impact of an integrated electronic clinical decision support system to facilitate risk stratification and site-of-care decision-making for patients with acute pulmonary embolism.

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Fremont Emergency Department, Fremont, California, United States

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About this study

Many low-risk emergency department patients with acute pulmonary embolism are routinely hospitalized despite being eligible for outpatient care. One impediment to home discharge is the difficulty of identifying which patients can safely forego hospitalization. This pragmatic clinical trial intends to evaluate the effect on emergency department disposition of a multicomponent intervention, including electronic clinical decision support system access, physician education, and physician-specific audit and feedback. The hypothesis for this study is that intervention sites, when compared with concurrent control sites, will see an increase in home discharges without an increase in 5-day pulmonary embolism-related return visits or 30-day all-cause mortality.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute objectively-confirmed pulmonary embolism, diagnosed in the emergency department

Exclusion criteria

  • Comfort-care only
  • Left the ED against medical advice
  • Current PE radiologically diagnosed >12 hrs prior to arrival
  • Recent DVT or PE diagnosed within 30 days
  • Pregnant

Treatment and study plan

Integration of electronic clinical decision support

Other

Integration of an electronic clinical decision support system into the emergency department patient care workflow to assist with site-of-care decision-making for emergency department patients with acute pulmonary embolism.

Primary outcomes

  1. Rate of home discharge from the emergency department following treatment for pulmonary embolism

    Time frame: 8 months post-implementation compared to 8 months pre-implementation

Secondary outcomes

  1. Number of participants with major hemorrhage, recurrent venous thromboembolism, and all-cause mortality

    Time frame: 30 days

  2. Number of participants with return visits for pulmonary embolism-related signs, symptoms, or interventions

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

Increasing Safe Outpatient Care for Emergency Department Patients With Acute Pulmonary Embolism: a Pragmatic Trial

Acronym: eSPEED

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 26, 2018
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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