NCT03601676

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,703

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

1.3 years

First QC Date

July 17, 2018

Last Update Submit

July 24, 2018

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

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

    8 months post-implementation compared to 8 months pre-implementation

Secondary Outcomes (2)

  • 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

Study Arms (2)

Intervention

ACTIVE COMPARATOR
Other: Integration of electronic clinical decision support

Control

NO INTERVENTION

Interventions

Integration of electronic clinical decision supportOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Kaiser Permanente Fremont Emergency Department

Fremont, California, 94538, United States

Location

Kaiser Permanente Oakland Emergency Department

Oakland, California, 94611, United States

Location

Kaiser Permanente Redwood City Emergency Department

Redwood City, California, 94063, United States

Location

Kaiser Permanente Richmond Emergency Department

Richmond, California, 94801, United States

Location

Kaiser Permanente Roseville Emergency Department

Roseville, California, 95661, United States

Location

Kaiser Permanente South Sacramento Emergency Department

Sacramento, California, 95823, United States

Location

Kaiser Permanente Sacramento Emergency Department

Sacramento, California, 95825, United States

Location

Kaiser Permanente San Francisco Emergency Department

San Francisco, California, 94115, United States

Location

Kaiser Permanente San Jose Emergency Department

San Jose, California, 95119, United States

Location

Kaiser Permanente San Leandro Emergency Department

San Leandro, California, 94577, United States

Location

Kaiser Permanente San Rafael Emergency Department

San Rafael, California, 94903, United States

Location

Kaiser Permanente Santa Clara Emergency Department

Santa Clara, California, 95051, United States

Location

Kaiser Permanente Santa Rosa Emergency Department

Santa Rosa, California, 95403, United States

Location

Kaiser Permanente South San Francisco Emergency Department

South San Francisco, California, 94080, United States

Location

Related Publications (1)

  • 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.

    PMID: 30422263DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • David R Vinson, MD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2018

First Posted

July 26, 2018

Study Start

January 1, 2015

Primary Completion

April 30, 2016

Study Completion

May 30, 2016

Last Updated

July 26, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

US(14)