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Computerized Decision Support to Increase Detection of Chronic Thromboembolic Pulmonary Hypertension in Patients With Prior Pulmonary Embolism (CTEPH-DETECT)

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ClinicalTrials.gov Identifier: NCT03729544
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : June 24, 2021
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Samuel Z.Goldhaber, MD, Brigham and Women's Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Chronic Thromboembolic Pulmonary Hypertension Behavioral: On-screen computerized decision support alert Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 400-patient single-center Quality Improvement Initiative in the form of a randomized controlled trial
Masking: Single (Participant)
Masking Description: The allocation ratio will be 1:1 for an EPIC BPA on-screen alert versus no notification. Investigators will be assessing the impact of the EPIC BPA on echocardiographic screening for 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. The cluster-effect describes a type of confounding observed in studies of provider behavior that can result in a bias of the outcome toward the null. In such a case, a provider may carry over knowledge gained from the alert for the intervention group patient to the care of the control group patient.
Primary Purpose: Screening
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)
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : March 30, 2022


Arm Intervention/treatment
Experimental: Alert
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
On-screen electronic alert during the outpatient clinical encounter that notifies him or her that the patient should be screened for CTEPH

No Intervention: No Alert
No provider notification



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Frequency of CTEPH diagnosis at three months. [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729544


Contacts
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Contact: Gregory Piazza, MD, MS 6177326984 gpiazza@bwh.harvard.edu
Contact: Claire E Galvin, BS 6177326984 cegalvin@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Gregory Piazza, MD    857-307-1932    gpiazza@partners.org   
Principal Investigator: Gregory Piazza, MD         
Principal Investigator: Samuel Z Goldhaber, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
Bayer
Investigators
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Principal Investigator: Gregory Piazza, MD, MS BWH
Publications:
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Responsible Party: Samuel Z.Goldhaber, MD, Interim Chief of Cardiology, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03729544    
Other Study ID Numbers: 2018P001681
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: June 24, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samuel Z.Goldhaber, MD, Brigham and Women's Hospital:
echocardiography
pulmonary embolism
pulmonary hypertension
screening
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Pulmonary Embolism
Hypertension
Embolism
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Embolism and Thrombosis