Optimizing Stroke Prophylaxis of Acute Atrial Fibrillation with an Electronic Clinical Decision Support Tool: a Stepped-Wedge Cluster Randomized Trial Design
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Number of patients appropriately prescribed OACs after CDS tool implementation.
研究概览
简要总结
Atrial fibrillation (AF) is the most common arrhythmia in the world, with significant morbidity and mortality. With appropriate oral anticoagulation, the risk of stroke due to atrial fibrillation decreases by 64%. Although atrial fibrillation is commonly diagnosed and treated in the Emergency Department (ED), oral anticoagulation is significantly underprescribed. Underprescribing has been attributed to a lack of empowerment and deferral of prescribing to longitudinal care clinicians.
Using a convergent parallel quantitative-qualitative design (mixed-methods), we propose a stepped-wedge cluster randomized trial design with the implementation of a clinical decision support (CDS) tool in adults with new-onset AF that are OAC-naïve and at significant risk for stroke. In parallel, we will use qualitative approaches to evaluate clinician facilitators and barriers to tool utilization as well as patient satisfaction and engagement with the tool.
详细描述
OBJECTIVES:
AIM 1: Compare the magnitude of change of appropriate OAC prescribing over time at each ED with EHR-Based CDS tool implementation.
H1a. A CDS tool will increase the prescribing of OACs at ED discharge in patients with new AF.
H1b. The highly-integrated EHR-based CDS tool with a trigger will have a greater impact on the volume of prescribing compared to a less integrated web-based portal.
AIM 2: Evaluate clinician experiences with factors that influence the CDS tool implementation through a qualitative approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •(Patients):
- •A diagnosis of atrial fibrillation or paroxysmal atrial fibrillation (ICD-10 I48.0, I48.1, I48.9) during an ED visit with start dates between 1/11/2022 and 12/31/2025 within the patient's age >18 years.
排除标准
- •(Patients):
- •Valvular disease, pregnancy, large esophageal varices, thrombocytopenia, severe or uncontrolled bleeding, severe liver or kidney disease, major surgery within 72 hours; OR
- •Recent brain, eye or spinal cord injury or surgery; OR
- •ED stroke, death or hospitalization at index visit; OR
- •Patient transferred from another hospital (to ensure availability of index ED visit data); OR
- •Left against medical advice; OR
- •Evidence of non-OAC naïve patient:
- •OAC prescribed in the prior 3mo to index ED visit; OR
- •Being managed by an anticoagulation clinic (ACC);
- •Inclusion/Exclusion Criteria (Clinicians): All ED clinicians (board certified or eligible) interfacing with patients.
研究组 & 干预措施
Link-Out
Clinicians will be trained on the web-based portal of the CDS tool and shown where the Link to the tool will be available in the EHR.
干预措施: Clinical Decision Support (CDS) tool (Other)
BPA + Link-out
Clinicians will be trained on how a BPA is triggered when a patient is diagnosed with AF. The alert will pop up within the EHR with the Link-out to the web portal.
干预措施: Clinical Decision Support (CDS) tool (Other)
BPA + FHIR
Instead of a link to the web-based portal, the BPA will contain a link to the FHIR-integrated CDS tool portal. FHIR will automatically pull EHR data about the patient into the CDS tool portal. Data include demographic information, comorbidities in the active problem list, past medical and surgical history, and social history. Clinicians will also receive training before the implementation of this step.
干预措施: Clinical Decision Support (CDS) tool (Other)
结局指标
主要结局
Number of patients appropriately prescribed OACs after CDS tool implementation.
时间窗: through study completion, up to 4 years
The primary outcome is the number of patients appropriately prescribed OACs after CDS tool implementation.
次要结局
- Clinician and patient feedback on acceptability and identification of barriers and facilitators to use of the tool.(through study completion, up to 4 years)
研究者
Bory Kea
Principal Investigator
Oregon Health and Science University