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Electronic Support for Pulmonary Embolism Emergency Disposition (eSPEED)

Primary Purpose

Pulmonary Embolism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integration of electronic clinical decision support
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Embolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Permanente Fremont Emergency Department
  • Kaiser Permanente Oakland Emergency Department
  • Kaiser Permanente Redwood City Emergency Department
  • Kaiser Permanente Richmond Emergency Department
  • Kaiser Permanente Roseville Emergency Department
  • Kaiser Permanente South Sacramento Emergency Department
  • Kaiser Permanente Sacramento Emergency Department
  • Kaiser Permanente San Francisco Emergency Department
  • Kaiser Permanente San Jose Emergency Department
  • Kaiser Permanente San Leandro Emergency Department
  • Kaiser Permanente San Rafael Emergency Department
  • Kaiser Permanente Santa Clara Emergency Department
  • Kaiser Permanente Santa Rosa Emergency Department
  • Kaiser Permanente South San Francisco Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention

Control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 17, 2018
Last Updated
July 24, 2018
Sponsor
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT03601676
Brief Title
Electronic Support for Pulmonary Embolism Emergency Disposition
Acronym
eSPEED
Official Title
Increasing Safe Outpatient Care for Emergency Department Patients With Acute Pulmonary Embolism: a Pragmatic Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
April 30, 2016 (Actual)
Study Completion Date
May 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1703 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Integration of electronic clinical decision support
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Number of participants with major hemorrhage, recurrent venous thromboembolism, and all-cause mortality
Time Frame
30 days
Title
Number of participants with return visits for pulmonary embolism-related signs, symptoms, or interventions
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Vinson, MD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Fremont Emergency Department
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Kaiser Permanente Oakland Emergency Department
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Kaiser Permanente Redwood City Emergency Department
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Kaiser Permanente Richmond Emergency Department
City
Richmond
State/Province
California
ZIP/Postal Code
94801
Country
United States
Facility Name
Kaiser Permanente Roseville Emergency Department
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Kaiser Permanente South Sacramento Emergency Department
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
Kaiser Permanente Sacramento Emergency Department
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Kaiser Permanente San Francisco Emergency Department
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Kaiser Permanente San Jose Emergency Department
City
San Jose
State/Province
California
ZIP/Postal Code
95119
Country
United States
Facility Name
Kaiser Permanente San Leandro Emergency Department
City
San Leandro
State/Province
California
ZIP/Postal Code
94577
Country
United States
Facility Name
Kaiser Permanente San Rafael Emergency Department
City
San Rafael
State/Province
California
ZIP/Postal Code
94903
Country
United States
Facility Name
Kaiser Permanente Santa Clara Emergency Department
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
Kaiser Permanente Santa Rosa Emergency Department
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Kaiser Permanente South San Francisco Emergency Department
City
South San Francisco
State/Province
California
ZIP/Postal Code
94080
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30422263
Citation
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.
Results Reference
derived

Learn more about this trial

Electronic Support for Pulmonary Embolism Emergency Disposition

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