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

NCT ID: NCT06312332

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Pulmonary Embolism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

cluster-randomized stepped-wedge design with two or more sites assigned at each of four steps
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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MEDIC site

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Geoffrey Barnes

Associate Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Geoff Barnes

Role: STUDY_CHAIR

University of Michigan

Locations

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Michigan Emergency Department Improvement Collaborative partners

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40176133 (View on PubMed)

Other Identifiers

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1R01HL163438-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00220089

Identifier Type: -

Identifier Source: org_study_id

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