跳至主要内容
临床试验/NCT05085405
NCT05085405已完成不适用

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

University of Michigan2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年10月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
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

入选标准

  • 未提供

排除标准

  • 未提供

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacob E Kurlander

Assistant Professor of Internal Medicine

University of Michigan

研究点 (2)

Loading locations...

相似试验