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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03729544
Other study ID # 2018P001681
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date December 30, 2024

Study information

Verified date March 2024
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 (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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 400
Est. completion date December 30, 2024
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
On-screen computerized decision support alert
On-screen electronic alert during the outpatient clinical encounter that notifies him or her that the patient should be screened for CTEPH

Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Brigham and Women's Hospital Bayer

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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