Anticoagulation With Enhanced Gastrointestinal Safety (AEGIS): A Pilot Trial to Evaluate Clinician- and Patient-facing Strategies to Reduce Upper Gastrointestinal Bleeding Risk in Patients on Combination Antithrombotic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The Proportion of Randomized Patients That Complete a Brief Medication Review Phone Call at Week 5
研究概览
简要总结
This is a pragmatic, single center, feasibility pilot cluster randomized trial with embedded individual randomization to evaluate implementation strategies to increase the use of evidence-based practices to reduce upper gastrointestinal bleeding risk in patients using combination antithrombotic therapy (including warfarin) and that are managed by the Michigan Medicine anticoagulation monitoring service.
详细描述
In February 2022, the IRB approved adding a small additional substudy for the collection of exploratory qualitative outcomes only, involving up to 8 primary care physicians. As no data for the primary and secondary outcome measures was collected for this substudy, and all data collection for this group was related to exploratory outcome measures and collected through qualitative interviews with clinicians, no inclusion exclusion criteria specific to the participants in this substudy are listed, nor does the data collection from them show in the study completion date or results data. However, these physicians (n=8) and their patients (n=9) are counted in the actual enrollment total since they were randomized to intervention arms and received study interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 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
- •for Patients:
- •Enrollment with the Michigan Medicine anticoagulation monitoring service
- •Currently prescribed warfarin with anticipated use for greater or equal to 90 days on day 1 of trial enrollment, according to electronic medical record documentation
- •Currently prescribed an antiplatelet drug (aspirin, clopidogrel, ticagrelor, or prasugrel) according to the electronic medical record medication list
排除标准
- •for Patients:
- •Prescribed a Proton Pump Inhibitor (PPI)
- •Documented intolerance or allergy to PPI use
- •Left ventricular assist device
- •Heart transplant
- •Inclusion Criteria for Clinicians:
- •Practicing cardiologists at Michigan Medicine who in the prior year had a face-to-face or virtual visit with a patient who meets eligibility criteria for this study
- •Practicing clinicians in any specialty who are designated as the clinician of record with the anticoagulation clinic for a patient who meets eligibility criteria
- •Exclusion Criteria for Clinicians:
- •Cardiologists specializing in electrophysiology unless they are the clinician of record for a patient followed by the anticoagulation service.
研究组 & 干预措施
Clinician Notification with Nurse Facilitation / Patient Activation
干预措施: Clinician Notification with Nurse Facilitation / Patient Activation (Behavioral)
Clinician Notification only
干预措施: Clinician notification (Behavioral)
Clinician Notification with Nurse Facilitation only
干预措施: Clinician Notification with Nurse Facilitation (Behavioral)
Clinician Notification / Patient Activation
干预措施: Clinician Notification / Patient Activation (Behavioral)
结局指标
主要结局
The Proportion of Randomized Patients That Complete a Brief Medication Review Phone Call at Week 5
时间窗: Week 5
The proportion of randomized patients that complete a brief medication review phone call at week 5 after up to 3 attempts.
次要结局
- Feasibility of Delivering Intervention Components as Intended(week 1)
研究者
Jacob E Kurlander
Assistant Professor of Internal Medicine
University of Michigan