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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Alert
On-screen computerized decision support alert during the outpatient clinical encounter that notifies the provider that the patient should be screened for CTEPH
干预措施: On-screen computerized decision support alert (Behavioral)
No Alert
No provider notification
结局指标
主要结局
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.
时间窗: 3 Months
Investigators will review the Provider Order Entry and cardiology test results sections of the Electronic Health Record (EPIC) to make this determination.
次要结局
- Frequency of CTEPH diagnosis at three months.(3 Months)
研究者
Gregory Piazza, MD, MS
Associate Director, Thrombosis Research Group
Brigham and Women's Hospital