Pulmonary EmbolismNCT06312332
Michigan Emergency Department Improvement Collaborative (MEDIC) Alert; Pulmonary Embolism (PE)
A study testing Pulmonary Embolism (PE) Care in Emergency Department (ED) in people with Pulmonary Embolism, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Pulmonary Embolism (PE) Care in Emergency Department (ED)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation in MEDIC collaborative
- Identified site physician champion
- Annual volume of acute PE ≥80 (measured in 2022)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Emergency Department Improvement Collaborative partners
Ann Arbor, Michigan, 48109
About this study
Official title: Michigan Emergency Department Improvement Collaborative (MEDIC) AltERnaTives to Admission for Pulmonary Embolism
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.
Read the detailed description
The study team anticipates that there will be 5800 acute PE patients over multiple sites. The study team is not recruiting additional sites into the study but tracking of acute PE patients continues.
- Conditions
- Pulmonary Embolism
- Being tested
- Pulmonary Embolism (PE) Care in Emergency Department (ED)
- Keywords
- Emergency Department
- Medical subject headings
- Pulmonary Embolism, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Embolism (PE) Care in Emergency Department (ED)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MEDIC site | Experimental | Not described Receives: Behavioral: Pulmonary Embolism (PE) Care in Emergency Department (ED) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in proportion of patients discharged home from Emergency Department (ED)
Reported by participating center indicating the proportion of patients discharged home from ED
Measured: 3 months Pre-intervention, Up to 18 months Post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Mar 2024
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- cluster-randomized stepped-wedge design with two or more sites assigned at each of four steps
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Geoffrey Barnes, University of Michigan
- Investigators
- Geoff Barnes, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312332
- Sponsor's protocol ID
- HUM00220089
- Other IDs
- 1R01HL163438-01A1
- Status last verified
- Aug 2026
- First submitted
- 7 Mar 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40176133
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Michigan Emergency Department Improvement Collaborative (MEDIC) AltERnaTives to Admission for Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT06312332
- Acronym / sponsor ID
- HUM00220089
- Conditions
- Pulmonary Embolism
- Keywords
- Emergency Department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
The study team anticipates that there will be 5800 acute PE patients over multiple sites. The study team is not recruiting additional sites into the study but tracking of acute PE patients continues.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- cluster-randomized stepped-wedge design with two or more sites assigned at each of four steps
| Arm | Type | Receives |
|---|---|---|
| MEDIC site | Experimental | Behavioral: Pulmonary Embolism (PE) Care in Emergency Department (ED) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participation in MEDIC collaborative
- Identified site physician champion
- Annual volume of acute PE ≥80 (measured in 2022)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | MEDIC site |
Primary outcome
Change in proportion of patients discharged home from Emergency Department (ED)
Time frame: 3 months Pre-intervention, Up to 18 months Post-intervention
Reported by participating center indicating the proportion of patients discharged home from ED
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Derived from this study: PubMed 40176133Smith 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoff Barnes study chair
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Embolism (PE) Care in Emergency Department (ED) in people with Pulmonary Embolism, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in proportion of patients discharged home from Emergency Department (ED) (time frame: 3 months Pre-intervention, Up to 18 months Post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06312332, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.