Computerized Decision Support to Increase Detection of Chronic Thromboembolic Pulmonary Hypertension in Patients With Prior Pulmonary Embolism

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Chronic Thromboembolic Pulmonary Hypertension

Intervention / Treatment
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* Behavioral: On-screen computerized decision support alert


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 400-patient single-center Quality Improvement Initiative in the form of a randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alert<br>On-screen computerized decision support alert during the outpatient clinical encounter that notifies the provider that the patient should be screened for CTEPH | Behavioral: On-screen computerized decision support alert<br>* On-screen electronic alert during the outpatient clinical encounter that notifies him or her that the patient should be screened for CTEPH<br>|
| No Intervention: No Alert<br>No provider notification | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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echocardiography, pulmonary embolism, pulmonary hypertension, screening