Computerized Decision Support to Increase Detection of Chronic Thromboembolic Pulmonary Hypertension in Patients With Prior Pulmonary Embolism
| Status: | Not yet recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), High Blood Pressure (Hypertension), Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/14/2018 |
| Start Date: | February 1, 2019 |
| End Date: | March 30, 2021 |
| Contact: | Gregory Piazza, MD, MS |
| Email: | gpiazza@bwh.harvard.edu |
| Phone: | 6177326984 |
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.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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