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NCT06312332 Clinical Trial

Michigan Emergency Department Improvement Collaborative (MEDIC) Alert; Pulmonary Embolism (PE)

Pulmonary Embolism Clinical Trial

Official title:
Michigan Emergency Department Improvement Collaborative (MEDIC) AltERnaTives to Admission for Pulmonary Embolism

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06312332
Other study ID # HUM00220089
Secondary ID 1R01HL163438-01A
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date August 2026

Study information
Verified date April 2024
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a quality improvement project to evaluate health care management of pulmonary embolism (PE) patients. The researchers are testing an intervention to determine if it prevents unnecessary hospital admissions.

Description:

The study team anticipates that there will be 5800 acute PE patients over multiple sites.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 14
Est. completion date August 2026
Est. primary completion date August 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participation in MEDIC collaborative - Identified site physician champion - Annual volume of acute PE =80 (measured in 2022) Exclusion Criteria: - Pediatric-only hospital/ED - No site physician champion identified - Annual volume of acute PE <80 (measured in 2022) - Existing formal clinical pathway for outpatient management of low-risk PE

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Pulmonary Embolism (PE) Care in Emergency Department (ED)
Utilize implementation mapping to facilitate intervention development and evaluation that can be disseminated broadly in diverse settings. Intervention to include a structured education program for clinicians on home management of patients with low-risk PE led by regional/national leaders, the development of Clinician pre-commitment, point-of-care nudge including a clinical guideline integrated into an electronic health record clinical decision support, facilitated medication access, and dedicated outpatient rapid-follow up.

Locations
Country Name City State
United States Michigan Emergency Department Improvement Collaborative partners Ann Arbor Michigan

Sponsors (2)
Lead Sponsor Collaborator
University of Michigan National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in proportion of patients discharged home from Emergency Department (ED) Reported by participating center indicating the proportion of patients discharged home from ED 3 months Pre-intervention, Up to 18 months Post-intervention
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