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

NCT03729544 | Completed

• 1 other identifier: 2018P001681
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Keywords

echocardiography; pulmonary embolism; pulmonary hypertension; screening

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (1)

• Frequency of CTEPH diagnosis at three months.

  3 Months

Study Arms (2)

Alert

EXPERIMENTAL

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

No Alert

NO INTERVENTION

No provider notification

Interventions

On-screen computerized decision support alert BEHAVIORAL

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

Alert

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Bayer: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related 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.

  PMID: 21268727 BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Hypertension

Study Officials

• Gregory Piazza, MD, MS

  BWH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, Thrombosis Research Group

Model Details: 400-patient single-center Quality Improvement Initiative in the form of a randomized controlled trial

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 2, 2018
• Study Start: March 1, 2019
• Primary Completion: September 30, 2022
• Study Completion: December 30, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)