Clinical trial NCT03601676: Electronic Support for Pulmonary Embolism Emergency Disposition
Official title: Increasing Safe Outpatient Care for Emergency Department Patients With Acute Pulmonary Embolism: a Pragmatic Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 1703
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Rate of home discharge from the emergency department following treatment for pulmonary embolism
timeFrame: 8 months post-implementation compared to 8 months pre-implementation
Secondary outcomes:
measure: Number of participants with major hemorrhage, recurrent venous thromboembolism, and all-cause mortality
timeFrame: 30 days
measure: Number of participants with return visits for pulmonary embolism-related signs, symptoms, or interventions
timeFrame: 5 days
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Kaiser Permanente Fremont Emergency Department
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Oakland Emergency Department
state: California
city: Redwood City
country: United States
facility: Kaiser Permanente Redwood City Emergency Department
state: California
city: Richmond
country: United States
facility: Kaiser Permanente Richmond Emergency Department
state: California
city: Roseville
country: United States
facility: Kaiser Permanente Roseville Emergency Department
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente South Sacramento Emergency Department
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Sacramento Emergency Department
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente San Francisco Emergency Department
state: California
city: San Jose
country: United States
facility: Kaiser Permanente San Jose Emergency Department
state: California
city: San Leandro
country: United States
facility: Kaiser Permanente San Leandro Emergency Department
state: California
city: San Rafael
country: United States
facility: Kaiser Permanente San Rafael Emergency Department
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Santa Clara Emergency Department
state: California
city: Santa Rosa
country: United States
facility: Kaiser Permanente Santa Rosa Emergency Department
state: California
city: South San Francisco
country: United States
facility: Kaiser Permanente South San Francisco Emergency Department
state: California
Study officials:
affiliation: Kaiser Permanente
name: David R Vinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.