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

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03729544

Collaborator

Bayer (Industry)

400

Enrollment

Location

Arms

Anticipated Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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 trial400-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 :

Mar 1, 2019

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Mar 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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. [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

Frequency of CTEPH diagnosis at three months. [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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