Electronic Support for Pulmonary Embolism Emergency Disposition

NCT ID: NCT03601676

Last Updated: 2018-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1703 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2016-05-30

Brief Summary

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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

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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.

Conditions

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Pulmonary Embolism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Pragmatic clinical trial of a multidimensional technology and educational intervention undertaken over 16 months with an 8-month pre-intervention and an 8-month post-intervention period, conducted across 21 emergency departments with 10 serving as intervention and 11 as control sites.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intervention

Group Type ACTIVE_COMPARATOR

Integration of electronic clinical decision support

Intervention Type 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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Integration of electronic clinical decision support

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David R Vinson, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

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Kaiser Permanente Fremont Emergency Department

Fremont, California, United States

Site Status

Kaiser Permanente Oakland Emergency Department

Oakland, California, United States

Site Status

Kaiser Permanente Redwood City Emergency Department

Redwood City, California, United States

Site Status

Kaiser Permanente Richmond Emergency Department

Richmond, California, United States

Site Status

Kaiser Permanente Roseville Emergency Department

Roseville, California, United States

Site Status

Kaiser Permanente South Sacramento Emergency Department

Sacramento, California, United States

Site Status

Kaiser Permanente Sacramento Emergency Department

Sacramento, California, United States

Site Status

Kaiser Permanente San Francisco Emergency Department

San Francisco, California, United States

Site Status

Kaiser Permanente San Jose Emergency Department

San Jose, California, United States

Site Status

Kaiser Permanente San Leandro Emergency Department

San Leandro, California, United States

Site Status

Kaiser Permanente San Rafael Emergency Department

San Rafael, California, United States

Site Status

Kaiser Permanente Santa Clara Emergency Department

Santa Clara, California, United States

Site Status

Kaiser Permanente Santa Rosa Emergency Department

Santa Rosa, California, United States

Site Status

Kaiser Permanente South San Francisco Emergency Department

South San Francisco, California, United States

Site Status

Countries

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United States

References

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Vinson DR, Mark DG, Chettipally UK, Huang J, Rauchwerger AS, Reed ME, Lin JS, Kene MV, Wang DH, Sax DR, Pleshakov TS, McLachlan ID, Yamin CK, Elms AR, Iskin HR, Vemula R, Yealy DM, Ballard DW; eSPEED Investigators of the KP CREST Network. Increasing Safe Outpatient Management of Emergency Department Patients With Pulmonary Embolism: A Controlled Pragmatic Trial. Ann Intern Med. 2018 Dec 18;169(12):855-865. doi: 10.7326/M18-1206. Epub 2018 Nov 13.

Reference Type DERIVED
PMID: 30422263 (View on PubMed)

Other Identifiers

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CN-13-1738-H

Identifier Type: -

Identifier Source: org_study_id

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