Chronic Thromboembolic Pulmonary Hypertension Clinical Trial
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT06092424 -
High Altitude (HA) Residents With Pulmonary Vascular Diseseases (PVD), Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) vs Sea Level (LA)
|
N/A | |
| Active, not recruiting |
NCT06003244 -
High Altitude (HA) Residents With Pulmonary Vascular Diseases (PVD), 6 Minute Walk Distance (6MWD) Assessed at 2840m (HA) With and Without Supplemental Oxygen Therapy (SOT)
|
N/A | |
| Active, not recruiting |
NCT06072417 -
HA Residents With PVD, SDB Assessed at HA (2840m) vs LA (Sea Level)
|
N/A | |
| Terminated |
NCT01953965 -
Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI.
|
Phase 2 | |
| Recruiting |
NCT02061787 -
the Application of Cardiopulmonary Exercise Testing in Assessment Outcome of Patients With Pulmonary Hypertension
|
||
| Not yet recruiting |
NCT03102294 -
Inspiratory Muscle Training in Chronic Thromboembolic Pulmonary Hypertension
|
N/A | |
| Recruiting |
NCT04071327 -
Pulmonary Hypertension Association Registry
|
||
| Completed |
NCT00313222 -
Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension
|
Phase 3 | |
| Recruiting |
NCT05311072 -
Change-a Multi-center Chronic Thromboembolic Pulmonary Hypertension （CTEPH） Database in China
|
||
| Recruiting |
NCT05340023 -
Proteomic Pattern Associated With the Diagnosis of Chronic Thromboembolic Pulmonary Hypertension
|
||
| Enrolling by invitation |
NCT05568927 -
Validation of SEARCH, a Novel Hierarchical Algorithm to Define Long-term Outcomes After Pulmonary Embolism
|
||
| Completed |
NCT03786367 -
Dyspnea in Chronic Thromboembolic Pulmonary Hypertension
|
||
| Recruiting |
NCT04081012 -
N-acetyl Cysteine in Post-reperfusion Pulmonary Injury in Chronic Thromboembolic Pulmonary Hypertension.
|
N/A | |
| Not yet recruiting |
NCT06384534 -
Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy in Pulmonary Vascular Disease (PVD)
|
N/A | |
| Withdrawn |
NCT05693779 -
Exercise Therapy After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension
|
N/A | |
| Not yet recruiting |
NCT02426203 -
3D Echocardiographic Assessment of RV Function in Patients Undergoing Pulmonary Endarterectomy
|
N/A | |
| Completed |
NCT02094001 -
Pilot Study to Evaluate Right Ventricular Function With Riociguat in CTEPH
|
Phase 2 | |
| Enrolling by invitation |
NCT03388476 -
Endtidal Carbon Dioxide for Earlier Detection of Pulmonary Hypertension
|
||
| Recruiting |
NCT04206852 -
Safety and Efficacy of Balloon Pulmonary Angioplasty in China
|
||
| Completed |
NCT02111980 -
RF Surgical Sponge-Detecting System on the Function of Pacemakers and Implantable Cardioverter Defibrillators
|
N/A |