Chronic Thromboembolic Pulmonary HypertensionCTEPH-DETECTNCT03729544
Computerized Decision Support to Increase Detection of Chronic Thromboembolic Pulmonary Hypertension in Patients With Prior Pulmonary Embolism
A study testing On-screen computerized decision support alert in people with Chronic Thromboembolic Pulmonary Hypertension, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
To address the knowledge gap that exists among providers resulting in underdiagnosis of chronic thromboembolic pulmonary hypertension (CTEPH), the investigators have devised this 400-patient single-center Quality Improvement Initiative in the form of a randomized controlled trial of an EPIC Best Practice Advisory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- On-screen computerized decision support alert
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 30 Dec 2025
- 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
- BWH outpatient
- At least 18 years of age
- Evaluated in Primary Care or Cardiovascular Medicine Clinic
- Persistent or new symptoms/signs suggestive of pulmonary hypertension [syncope, malaise and fatigue, dyspnea, exercise intolerance, hemoptysis, chest pain, dizziness/vertigo, gait abnormality, cardiomegaly, ascites, and peripheral edema] OR recent pulmonary testing (pulmonary function tests [PFTs], chest X-ray, or chest CT) suggesting unexplained respiratory symptoms at least 6 months from the diagnosis of PE
- Have not undergone echocardiography within the prior 6 months
Who cannot join
- Absence of persistent or new symptoms/signs suggestive of pulmonary hypertension OR recent pulmonary testing (pulmonary function tests [PFTs], chest X-ray, or chest CT) suggesting unexplained respiratory symptoms
- PE within the last 6 months
- Echocardiogram or invasive hemodynamic assessment with the prior 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Randomized Controlled Trial of Electronic Alert-Based Computerized Decision Support to Increase Detection of Chronic Thromboembolic Pulmonary Hypertension in Patients With Prior Pulmonary Embolism (CTEPH-DETECT)
To address the knowledge gap that exists among providers resulting in underdiagnosis of chronic thromboembolic pulmonary hypertension (CTEPH), the investigators have devised this 400-patient single-center Quality Improvement Initiative in the form of a randomized controlled trial of an EPIC Best Practice Advisory (BPA) on-screen alert versus no notification to increase echocardiographic screening for CTEPH and the diagnosis of CTEPH in patients with prior pulmonary embolism (PE) and symptoms/signs suggestive of pulmonary hypertension or recent pulmonary testing suggesting unexplained respiratory symptoms at 3 months.
Aim #1: To determine the impact of a Best Practice Advisory (BPA), using the EPIC Electronic Health Record computerized decision support (CDS) software, on echocardiographic screening for CTEPH in patient with prior PE and symptoms/signs suggestive of pulmonary hypertension or recent pulmonary testing suggesting unexplained respiratory symptoms.
Aim #2: To determine the impact of an EPIC BPA on the diagnosis of CTEPH in patient with prior PE and symptoms/signs suggestive of pulmonary hypertension or recent pulmonary testing suggesting unexplained respiratory symptoms.
Read the detailed description
Study design: 400-patient single-center Quality Improvement Initiative in the form of a randomized controlled trial. The allocation ratio will be 1:1 for an EPIC Best Practice Advisory (BPA) on-screen alert versus no notification. Investigators will be assessing the impact of the EPIC BPA on echocardiographic screening for chronic thromboembolic pulmonary hypertension (CTEPH) and the diagnosis of CTEPH in the patients enrolled in this Quality Improvement Initiative. While investigators will randomize patients by Attending Physician of Record to minimize cluster-effect, the observational unit will be the patient.
Type of control : The control group will have no electronic alert notification issued to the responsible provider.
Number of subjects: 400 subjects will be enrolled with 200 subjects to be randomized to the alert group and 200 subjects to the control group in a 1:1 allocation ratio.
Primary Efficacy Outcome: Frequency of echocardiographic screening for CTEPH in patients with prior pulmonary embolism (PE) and symptoms/signs suggestive of pulmonary hypertension or recent pulmonary testing suggesting unexplained respiratory symptoms at 3 months. Investigators will review the order entry and cardiology test results sections of the Electronic Health Record (EPIC) to make this determination.
Secondary Efficacy Outcome: Frequency of CTEPH diagnosis at 3 months. The diagnosis of CTEPH will be confirmed by clinical notation in the EHR or a mean pulmonary-artery pressure greater than 25 mmHg that persists 6 months after PE diagnosis.
Safety Outcomes: Because there is no reasonable expectation for adverse events or patient safety concerns with this Quality Improvement Initiative focused on increasing provider awareness about the risk of CTEPH and the indication for screening with echocardiography, investigators will not collect any safety outcomes or variables.
Plan for statistical analysis: The primary statistical analysis will be the comparison of the frequency of echocardiographic screening for CTEPH in the alert group compared with the control (no alert) group. A secondary statistical analysis will be the comparison of the frequency of CTEPH diagnosis in the alert group compared with the control (no alert) group.
- Being tested
- On-screen computerized decision support alert
- Keywords
- echocardiography, pulmonary embolism, pulmonary hypertension, screening
- Medical subject headings
- Pulmonary Embolism, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-screen computerized decision support alertBehavioural
On-screen electronic alert during the outpatient clinical encounter that notifies him or her that the patient should be screened for CTEPH
| Study group | Role | What they receive |
|---|---|---|
| Alert | Experimental | On-screen computerized decision support alert during the outpatient clinical encounter that notifies the provider that the patient should be screened for CTEPH Receives: Behavioral: On-screen computerized decision support alert |
| No Alert | No intervention | No provider notification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of echocardiographic screening for CTEPH in patients with prior PE and symptoms/signs suggestive of pulmonary hypertension or recent pulmonary testing suggesting unexplained respiratory symptoms at 3 months following randomization.
Investigators will review the Provider Order Entry and cardiology test results sections of the Electronic Health Record (EPIC) to make this determination.
Measured: 3 Months
Secondary outcomes (1)
Frequency of CTEPH diagnosis at three months.
The diagnosis of CTEPH will be confirmed by clinical notation in the EHR or a mean pulmonary artery pressure greater than 25 mmHg that persists 6 months after PE diagnosis
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start1 Mar 2019
- Primary completion30 Sep 2022
- Study completion30 Dec 2025
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 Chronic Thromboembolic Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 400-patient single-center Quality Improvement Initiative in the form of a randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Gregory Piazza, MD, MS, Brigham and Women's Hospital
- Investigators
- Gregory Piazza, MD, MS, Principal investigator, BWH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729544
- Sponsor's protocol ID
- 2018P001681
- Acronym
- CTEPH-DETECT
- Status last verified
- Feb 2026
- First submitted
- 1 Nov 2018
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piazza G, Goldhaber SZ. Chronic thromboembolic pulmonary hypertension. N Engl J Med. 2011 Jan 27;364(4):351-60. doi: 10.1056/NEJMra0910203. No abstract available.
PubMed 21268727
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Electronic Alert-Based Computerized Decision Support to Increase Detection of Chronic Thromboembolic Pulmonary Hypertension in Patients With Prior Pulmonary Embolism (CTEPH-DETECT)
- ClinicalTrials.gov ID
- NCT03729544
- Acronym / sponsor ID
- CTEPH-DETECT / 2018P001681
- Keywords
- echocardiography, pulmonary embolism, pulmonary hypertension, screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 2 Nov 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 address the knowledge gap that exists among providers resulting in underdiagnosis of chronic thromboembolic pulmonary hypertension (CTEPH), the investigators have devised this 400-patient single-center Quality Improvement Initiative in the form of a randomized controlled trial of an EPIC Best Practice Advisory (BPA) on-screen alert versus no notification to increase echocardiographic screening for CTEPH and the diagnosis of CTEPH in patients with prior pulmonary embolism (PE) and symptoms/signs suggestive of pulmonary hypertension or recent pulmonary testing suggesting unexplained respiratory symptoms at 3 months.
Aim #1: To determine the impact of a Best Practice Advisory (BPA), using the EPIC Electronic Health Record computerized decision support (CDS) software, on echocardiographic screening for CTEPH in patient with prior PE and symptoms/signs suggestive of pulmonary hypertension or recent pulmonary testing suggesting unexplained respiratory symptoms.
Aim #2: To determine the impact of an EPIC BPA on the diagnosis of CTEPH in patient with prior PE and symptoms/signs suggestive of pulmonary hypertension or recent pulmonary testing suggesting unexplained respiratory symptoms.
Detailed description
Study design: 400-patient single-center Quality Improvement Initiative in the form of a randomized controlled trial. The allocation ratio will be 1:1 for an EPIC Best Practice Advisory (BPA) on-screen alert versus no notification. Investigators will be assessing the impact of the EPIC BPA on echocardiographic screening for chronic thromboembolic pulmonary hypertension (CTEPH) and the diagnosis of CTEPH in the patients enrolled in this Quality Improvement Initiative. While investigators will randomize patients by Attending Physician of Record to minimize cluster-effect, the observational unit will be the patient.
Type of control : The control group will have no electronic alert notification issued to the responsible provider.
Number of subjects: 400 subjects will be enrolled with 200 subjects to be randomized to the alert group and 200 subjects to the control group in a 1:1 allocation ratio.
Primary Efficacy Outcome: Frequency of echocardiographic screening for CTEPH in patients with prior pulmonary embolism (PE) and symptoms/signs suggestive of pulmonary hypertension or recent pulmonary testing suggesting unexplained respiratory symptoms at 3 months. Investigators will review the order entry and cardiology test results sections of the Electronic Health Record (EPIC) to make this determination.
Secondary Efficacy Outcome: Frequency of CTEPH diagnosis at 3 months. The diagnosis of CTEPH will be confirmed by clinical notation in the EHR or a mean pulmonary-artery pressure greater than 25 mmHg that persists 6 months after PE diagnosis.
Safety Outcomes: Because there is no reasonable expectation for adverse events or patient safety concerns with this Quality Improvement Initiative focused on increasing provider awareness about the risk of CTEPH and the indication for screening with echocardiography, investigators will not collect any safety outcomes or variables.
Plan for statistical analysis: The primary statistical analysis will be the comparison of the frequency of echocardiographic screening for CTEPH in the alert group compared with the control (no alert) group. A secondary statistical analysis will be the comparison of the frequency of CTEPH diagnosis in the alert group compared with the control (no alert) group.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 400-patient single-center Quality Improvement Initiative in the form of a randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Alert | Experimental | Behavioral: On-screen computerized decision support alertOn-screen computerized decision support alert during the outpatient clinical encounter that notifies the provider that the patient should be screened for CTEPH |
| No Alert | No intervention | –No provider notification |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BWH outpatient
- At least 18 years of age
- Evaluated in Primary Care or Cardiovascular Medicine Clinic
- Persistent or new symptoms/signs suggestive of pulmonary hypertension [syncope, malaise and fatigue, dyspnea, exercise intolerance, hemoptysis, chest pain, dizziness/vertigo, gait abnormality, cardiomegaly, ascites, and peripheral edema] OR recent pulmonary testing (pulmonary function tests [PFTs], chest X-ray, or chest CT) suggesting unexplained respiratory symptoms at least 6 months from the diagnosis of PE
- Have not undergone echocardiography within the prior 6 months
Key exclusion criteria (3 listed)
- Absence of persistent or new symptoms/signs suggestive of pulmonary hypertension OR recent pulmonary testing (pulmonary function tests [PFTs], chest X-ray, or chest CT) suggesting unexplained respiratory symptoms
- PE within the last 6 months
- Echocardiogram or invasive hemodynamic assessment with the prior 6 months
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 |
|---|---|---|
| On-screen computerized decision support alertOn-screen electronic alert during the outpatient clinical encounter that notifies him or her that the patient should be screened for CTEPH | Behavioural | Alert |
Primary outcome
Frequency of echocardiographic screening for CTEPH in patients with prior PE and symptoms/signs suggestive of pulmonary hypertension or recent pulmonary testing suggesting unexplained respiratory symptoms at 3 months following randomization.
Time frame: 3 Months
Investigators will review the Provider Order Entry and cardiology test results sections of the Electronic Health Record (EPIC) to make this determination.
1 secondary outcome
Frequency of CTEPH diagnosis at three months.
Time frame: 3 Months
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 25 Feb 2026.
- Background: PubMed 21268727Piazza G, Goldhaber SZ. Chronic thromboembolic pulmonary hypertension. N Engl J Med. 2011 Jan 27;364(4):351-60. doi: 10.1056/NEJMra0910203. No abstract available.
- 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.
Gregory Piazza, MD, MS principal investigator
BWH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On-screen computerized decision support alert in people with Chronic Thromboembolic Pulmonary Hypertension, run by Brigham and Women's Hospital 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 5 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 25 Feb 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?
Frequency of echocardiographic screening for CTEPH in patients with prior PE and symptoms/signs suggestive of pulmonary hypertension or recent pulmonary testing suggesting unexplained respiratory symptoms at 3 months following randomization. (time frame: 3 Months). 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 NCT03729544, 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 25 Feb 2026.