Pulmonary EmbolismeSPEEDNCT03601676
Electronic Support for Pulmonary Embolism Emergency Disposition
A study testing Integration of electronic clinical decision support in people with Pulmonary Embolism, run by Kaiser Permanente at 14 sites in United States.
Trial summary
To evaluate the impact of an integrated electronic clinical decision support system to facilitate risk stratification and site-of-care decision-making for patients with acute pulmonary embolism. 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?
- Integration of electronic clinical decision support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,703 participants
- Where
- 14 sitesUnited States
- Study dates
- 1 Jan 2015to 30 May 2016
- 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
- Acute objectively-confirmed pulmonary embolism, diagnosed in the emergency department
Who cannot join
- Comfort-care only
- Left the ED against medical advice
- Current PE radiologically diagnosed >12 hrs prior to arrival
- Recent DVT or PE diagnosed within 30 days
- Pregnant
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Kaiser Permanente Fremont Emergency Department
Fremont, California, 94538
Kaiser Permanente Oakland Emergency Department
Oakland, California, 94611
Kaiser Permanente Redwood City Emergency Department
Redwood City, California, 94063
Kaiser Permanente Richmond Emergency Department
Richmond, California, 94801
Kaiser Permanente Roseville Emergency Department
Roseville, California, 95661
Kaiser Permanente South Sacramento Emergency Department
Sacramento, California, 95823
Kaiser Permanente Sacramento Emergency Department
Sacramento, California, 95825
Kaiser Permanente San Francisco Emergency Department
San Francisco, California, 94115
Kaiser Permanente San Jose Emergency Department
San Jose, California, 95119
Kaiser Permanente San Leandro Emergency Department
San Leandro, California, 94577
Kaiser Permanente San Rafael Emergency Department
San Rafael, California, 94903
Kaiser Permanente Santa Clara Emergency Department
Santa Clara, California, 95051
Kaiser Permanente Santa Rosa Emergency Department
Santa Rosa, California, 95403
Kaiser Permanente South San Francisco Emergency Department
South San Francisco, California, 94080
About this study
Official title: Increasing Safe Outpatient Care for Emergency Department Patients With Acute Pulmonary Embolism: a Pragmatic Trial
To evaluate the impact of an integrated electronic clinical decision support system to facilitate risk stratification and site-of-care decision-making for patients with acute pulmonary embolism.
Read the detailed description
Many low-risk emergency department patients with acute pulmonary embolism are routinely hospitalized despite being eligible for outpatient care. One impediment to home discharge is the difficulty of identifying which patients can safely forego hospitalization. This pragmatic clinical trial intends to evaluate the effect on emergency department disposition of a multicomponent intervention, including electronic clinical decision support system access, physician education, and physician-specific audit and feedback. The hypothesis for this study is that intervention sites, when compared with concurrent control sites, will see an increase in home discharges without an increase in 5-day pulmonary embolism-related return visits or 30-day all-cause mortality.
- Conditions
- Pulmonary Embolism
- Being tested
- Integration of electronic clinical decision support
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integration of electronic clinical decision supportOther
Integration of an electronic clinical decision support system into the emergency department patient care workflow to assist with site-of-care decision-making for emergency department patients with acute pulmonary embolism.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Not described Receives: Other: Integration of electronic clinical decision support |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of home discharge from the emergency department following treatment for pulmonary embolism
Measured: 8 months post-implementation compared to 8 months pre-implementation
Secondary outcomes (2)
Number of participants with major hemorrhage, recurrent venous thromboembolism, and all-cause mortality
Measured: 30 days
Number of participants with return visits for pulmonary embolism-related signs, symptoms, or interventions
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Jan 2015
- Primary completion30 Apr 2016
- Study completion30 May 2016
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.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic clinical trial of a multidimensional technology and educational intervention undertaken over 16 months with an 8-month pre-intervention and an 8-month post-intervention period, conducted across 21 emergency departments with 10 serving as intervention and 11 as control sites.
- Masking
- None (open label)
- Enrolment
- 1,703 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David R Vinson, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601676
- Sponsor's protocol ID
- CN-13-1738-H
- Acronym
- eSPEED
- Status last verified
- Jul 2018
- First submitted
- 17 Jul 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vinson DR, Mark DG, Chettipally UK, Huang J, Rauchwerger AS, Reed ME, Lin JS, Kene MV, Wang DH, Sax DR, Pleshakov TS, McLachlan ID, Yamin CK, Elms AR, Iskin HR, Vemula R, Yealy DM, Ballard DW; eSPEED Investigators of the KP CREST Network. Increasing Safe Outpatient Management of Emergency Department Patients With Pulmonary Embolism: A Controlled Pragmatic Trial. Ann Intern Med. 2018 Dec 18;169(12):855-865. doi: 10.7326/M18-1206. Epub 2018 Nov 13.
PubMed 30422263
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Safe Outpatient Care for Emergency Department Patients With Acute Pulmonary Embolism: a Pragmatic Trial
- ClinicalTrials.gov ID
- NCT03601676
- Acronym / sponsor ID
- eSPEED / CN-13-1738-H
- Conditions
- Pulmonary Embolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,703 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 30 May 2016 (actual)
- First posted
- 26 Jul 2018 (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.
To evaluate the impact of an integrated electronic clinical decision support system to facilitate risk stratification and site-of-care decision-making for patients with acute pulmonary embolism.
Detailed description
Many low-risk emergency department patients with acute pulmonary embolism are routinely hospitalized despite being eligible for outpatient care. One impediment to home discharge is the difficulty of identifying which patients can safely forego hospitalization. This pragmatic clinical trial intends to evaluate the effect on emergency department disposition of a multicomponent intervention, including electronic clinical decision support system access, physician education, and physician-specific audit and feedback. The hypothesis for this study is that intervention sites, when compared with concurrent control sites, will see an increase in home discharges without an increase in 5-day pulmonary embolism-related return visits or 30-day all-cause mortality.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic clinical trial of a multidimensional technology and educational intervention undertaken over 16 months with an 8-month pre-intervention and an 8-month post-intervention period, conducted across 21 emergency departments with 10 serving as intervention and 11 as control sites.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Integration of electronic clinical decision support |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acute objectively-confirmed pulmonary embolism, diagnosed in the emergency department
Key exclusion criteria (5 listed)
- Comfort-care only
- Left the ED against medical advice
- Current PE radiologically diagnosed >12 hrs prior to arrival
- Recent DVT or PE diagnosed within 30 days
- Pregnant
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 |
|---|---|---|
| Integration of electronic clinical decision supportIntegration of an electronic clinical decision support system into the emergency department patient care workflow to assist with site-of-care decision-making for emergency department patients with acute pulmonary embolism. | Other | Intervention |
Primary outcome
Rate of home discharge from the emergency department following treatment for pulmonary embolism
Time frame: 8 months post-implementation compared to 8 months pre-implementation
2 secondary outcomes
Number of participants with major hemorrhage, recurrent venous thromboembolism, and all-cause mortality
Time frame: 30 days
Number of participants with return visits for pulmonary embolism-related signs, symptoms, or interventions
Time frame: 5 days
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 26 Jul 2018.
- Derived from this study: PubMed 30422263Vinson DR, Mark DG, Chettipally UK, Huang J, Rauchwerger AS, Reed ME, Lin JS, Kene MV, Wang DH, Sax DR, Pleshakov TS, McLachlan ID, Yamin CK, Elms AR, Iskin HR, Vemula R, Yealy DM, Ballard DW; eSPEED Investigators of the KP CREST Network. Increasing Safe Outpatient Management of Emergency Department Patients With Pulmonary Embolism: A Controlled Pragmatic Trial. Ann Intern Med. 2018 Dec 18;169(12):855-865. doi: 10.7326/M18-1206. Epub 2018 Nov 13.
- 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.
David R Vinson, MD principal investigator
Kaiser Permanente
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integration of electronic clinical decision support in people with Pulmonary Embolism, run by Kaiser Permanente at 14 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 1 inclusion and 5 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 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
Rate of home discharge from the emergency department following treatment for pulmonary embolism (time frame: 8 months post-implementation compared to 8 months pre-implementation). 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 NCT03601676, 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 26 Jul 2018.