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Clinical Trials/NCT03601676
NCT03601676CompletedNot Applicable

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

Kaiser Permanente14 sites in 1 country1,703 target enrollmentStarted: January 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,703
Locations
14
Primary Endpoint
Rate of home discharge from the emergency department following treatment for pulmonary embolism

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Intervention

Active Comparator

Intervention: Integration of electronic clinical decision support (Other)

Control

No Intervention

Outcomes

Primary Outcomes

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

  • Number of participants with major hemorrhage, recurrent venous thromboembolism, and all-cause mortality(30 days)
  • Number of participants with return visits for pulmonary embolism-related signs, symptoms, or interventions(5 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (14)

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