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

NCT06312332 | Active Not Recruiting

• 2 other identifiers: HUM002200891R01HL163438-01A1
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Embolism

Keywords

Emergency Department

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

MEDIC site

EXPERIMENTAL

Behavioral: Pulmonary Embolism (PE) Care in Emergency Department (ED)

Interventions

Pulmonary Embolism (PE) Care in Emergency Department (ED) BEHAVIORAL

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.

MEDIC site

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participation in MEDIC collaborative
• Identified site physician champion
• Annual volume of acute PE ≥80 (measured in 2022)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Michigan Emergency Department Improvement Collaborative partners

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Smith SN, Greineder CF, Errickson J, Burns J, Seagull FJ, Kocher KE, Kline JA, Kullgren JT, Lanham MSM, Krein SL, Barnes GD. A stepped wedge cluster randomized implementation trial to increase outpatient management of low-risk pulmonary embolism from the emergency department - the MEDIC ALERT PE study. Implement Sci Commun. 2025 Apr 2;6(1):33. doi: 10.1186/s43058-025-00720-1.

  PMID: 40176133 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism; Emergencies

Interventions

Emergency Service, Hospital

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hospital Departments; Hospital Administration; Health Facility Administration; Health Facilities; Health Care Facilities Workforce and Services; Emergency Medical Services; Health Services; Organization and Administration; Health Services Administration

Study Officials

• Geoff Barnes

  University of Michigan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Model Details: cluster-randomized stepped-wedge design with two or more sites assigned at each of four steps

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 15, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)