Pulmonary EmbolismNCT02532387
Outpatient Treatment of PE and DVT in the Emergency Department
An observational study of Pulmonary Embolism and Deep Vein Thrombosis, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
Standardize the approach to outpatient Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT) treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Deep Vein Thrombosis
- What is being tested?
- Telephone follow-up
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2015to Feb 2017
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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
Study population: This is a multi-center prospective, observational study of MGH or BWH patients with PE or DVTwith historical and contemporary controls.
Who may be able to join
- Subject is 18 years of age or older at time of enrollment.
- Subject is diagnosed with acute VTE (DVT or PE) in the MGH or BWH ED or transferred to the MGH or BWH ED (e.g from a clinic or outside hospital) with a diagnosis of acute VTE.
- Subject is treated as an outpatient (i.e. discharged) directly from the ED or admitted to the ED Observation Unit/ED Short Stay Unit on the outpatient treatment protocol.
Who cannot join
- Subjects admitted from the ED to an inpatient service will not be enrolled as study subjects, but will be used as contemporary controls.
- Subjects who are unable to understand or provide informed consent.
- Subjects unable or unlikely to follow up (e.g. prisoners).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Outpatient Treatment of Pulmonary Embolism and Deep Vein Thrombosis: Impact of a New Protocol on Emergency Department Efficiency and Patient Safety
Standardize the approach to outpatient Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT) treatment.
Read the detailed description
In the current protocol, we will study the outcomes most likely to influence emergency physician behavior, such as improved Emergency Department (ED) throughput, and decreased ED and Emergency Department Observation Unit (EDOU) length of stay. Metrics such as decreased admissions are also very important to hospital administrators so our results will have impact outside the ED as well. At the end of this study we will demonstrate that a carefully planned and data-driven approach to the outpatient treatment of Pulmonary Embolism (PE) is safe, improves operational metrics, and reduces cost.
- Conditions
- Pulmonary Embolism, Deep Vein Thrombosis
- Being tested
- Telephone follow-up
- Medical subject headings
- Pulmonary Embolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone follow-upOther
Prospectively enrolled subjects will have a 7- and 30-day phone call.
| Study group | Role | What they receive |
|---|---|---|
| MGH ED/EDOU patients | Subjects who present to the Massachusetts General Hospital (MGH) ED or EDOU who meet all inclusion and no exclusion criteria.
Intervention: Telephone follow-up at 7 and 30 days. Receives: Other: Telephone follow-up | |
| BWH ED/EDOU patients | Subjects who present to the Brigham and Women's Hospital (BWH) ED or EDOU who meet all inclusion and no exclusion criteria.
Intervention: Telephone follow-up at 7 and 30 days. Receives: Other: Telephone follow-up | |
| Control subjects | 1. Contemporary controls: subjects diagnosed with Venous Thromboembolism (VTE) in the ED and who are not eligible for outpatient treatment 2. Historical controls: 1. Subjects enrolled in the prospective and retrospective SPEED-D study (PI: Kabrhel) and diagnosed with PE between 2006-2012. 2. Subjects diagnosed with VTE in the MGH and BWH ED in the 18 months prior to the use of the clinical outpatient treatment of PE protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency & cost of clinical protocol
To compare patients diagnosed with VTE after protocol implementation to those diagnosed with VTE prior to protocol implementation in terms of four measures of efficiency:
- ED length of stay - defined as time from ED registration to departure from the ED (to either the inpatient floor or to the EDOU).
- ED disposition time - defined as time from ED registration to bed request.
- Hospital length of stay - defined as time from ED registration to departure from the hospital.
- Cost - defined as the estimated cost of care including diagnostic testing, imaging, hospital inpatient/observation unit stay, medication/pharmacy costs.
Measured: Up to 30 days
Safety of clinical protocol
To assess the safety of outpatient VTE treatment, specifically with regards to:
- recurrent venous thromboembolism;
- bleeding (major or minor);
- unscheduled return to hospital for any reason;
- death from any cause: occurring up to 30 days after their discharge.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Kabrhel, Massachusetts General Hospital
- Investigators
- Christopher Kabrhel, MD MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532387
- Sponsor's protocol ID
- 2015P000877
- Status last verified
- Mar 2019
- First submitted
- 20 Aug 2015
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Treatment of Pulmonary Embolism and Deep Vein Thrombosis: Impact of a New Protocol on Emergency Department Efficiency and Patient Safety
- ClinicalTrials.gov ID
- NCT02532387
- Acronym / sponsor ID
- 2015P000877
- Conditions
- Pulmonary Embolism, Deep Vein Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 25 Aug 2015 (estimated)
- 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.
Standardize the approach to outpatient Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT) treatment.
Detailed description
In the current protocol, we will study the outcomes most likely to influence emergency physician behavior, such as improved Emergency Department (ED) throughput, and decreased ED and Emergency Department Observation Unit (EDOU) length of stay. Metrics such as decreased admissions are also very important to hospital administrators so our results will have impact outside the ED as well. At the end of this study we will demonstrate that a carefully planned and data-driven approach to the outpatient treatment of Pulmonary Embolism (PE) is safe, improves operational metrics, and reduces cost.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MGH ED/EDOU patients | – | Other: Telephone follow-upSubjects who present to the Massachusetts General Hospital (MGH) ED or EDOU who meet all inclusion and no exclusion criteria. Intervention: Telephone follow-up at 7 and 30 days. |
| BWH ED/EDOU patients | – | Other: Telephone follow-upSubjects who present to the Brigham and Women's Hospital (BWH) ED or EDOU who meet all inclusion and no exclusion criteria. Intervention: Telephone follow-up at 7 and 30 days. |
| Control subjects | – | –1. Contemporary controls: subjects diagnosed with Venous Thromboembolism (VTE) in the ED and who are not eligible for outpatient treatment 2. Historical controls: 1. Subjects enrolled in the prospective and retrospective SPEED-D study (PI: Kabrhel) and diagnosed with PE between 2006-2012. 2. Subjects diagnosed with VTE in the MGH and BWH ED in the 18 months prior to the use of the clinical outpatient treatment of PE protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a multi-center prospective, observational study of MGH or BWH patients with PE or DVTwith historical and contemporary controls.
Key inclusion criteria (3 listed)
- Subject is 18 years of age or older at time of enrollment.
- Subject is diagnosed with acute VTE (DVT or PE) in the MGH or BWH ED or transferred to the MGH or BWH ED (e.g from a clinic or outside hospital) with a diagnosis of acute VTE.
- Subject is treated as an outpatient (i.e. discharged) directly from the ED or admitted to the ED Observation Unit/ED Short Stay Unit on the outpatient treatment protocol.
Key exclusion criteria (3 listed)
- Subjects admitted from the ED to an inpatient service will not be enrolled as study subjects, but will be used as contemporary controls.
- Subjects who are unable to understand or provide informed consent.
- Subjects unable or unlikely to follow up (e.g. prisoners).
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 |
|---|---|---|
| Telephone follow-upProspectively enrolled subjects will have a 7- and 30-day phone call. | Other | BWH ED/EDOU patients, MGH ED/EDOU patients |
Primary outcome
Efficiency & cost of clinical protocol
Time frame: Up to 30 days
To compare patients diagnosed with VTE after protocol implementation to those diagnosed with VTE prior to protocol implementation in terms of four measures of efficiency: A) ED length of stay - defined as time from ED registration to departure from the ED (to either the inpatient floor or to the EDOU). B) ED disposition time - defined as time from ED registration to bed request. C) Hospital length of stay - defined as time from ED registration to departure from the hospital. D) Cost - defined as the estimated cost of care including diagnostic testing, imaging, hospital inpatient/observation unit stay, medication/pharmacy costs.
Safety of clinical protocol
Time frame: Up to 30 days
To assess the safety of outpatient VTE treatment, specifically with regards to: A) recurrent venous thromboembolism; B) bleeding (major or minor); C) unscheduled return to hospital for any reason; D) death from any cause: occurring up to 30 days after their discharge.
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 6 Mar 2019.
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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.
Christopher Kabrhel, MD MPH principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism and Deep Vein Thrombosis, run by Massachusetts General Hospital at 2 sites 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 3 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 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Efficiency & cost of clinical protocol (time frame: Up to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2019.