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临床试验/NCT04213950
NCT04213950已完成不适用

Improving Adherence to Rabies Postexposure Prophylaxis Guideline Recommendations for Rabies Immune Globulin at a Multi-hospital Health System Through Education, Collaboration, and Clinical Decision Support

The Methodist Hospital Research Institute30 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年12月29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
70
试验地点
30
主要终点
Full adherence to 6 quality indicators for rabies immune globulin patient selection and delivery

研究概览

简要总结

This quasi-experimental, quality improvement study will be conducted across the Houston Methodist system, including all hospital-based and freestanding emergency departments (ED). Previous research identified opportunities to improve patient selection and delivery of rabies immune globulin (IG) as recommended by Centers for Disease Control and Prevention (CDC) guideline recommendations for rabies postexposure prophylaxis (PEP). The purpose of this study is to develop, implement, and measure the impact of a quality improvement bundle that consists of (1) rabies PEP electronic health records (EHR) enhancements, (2) education to ED staff, and (3) education to patients. Adherence to quality indicators, which are based on CDC guideline recommendations, for patient selection and delivery of rabies IG for 12 months following implementation (post-implementation group) will be compared with a historical control group.

详细描述

BACKGROUND: Rabies infection can occur in humans when key elements of the rabies PEP regimens are omitted or incorrectly administered. The CDC Advisory Committee on Immunization Practices (ACIP) recommends that patients who are exposed to rabies virus should receive prompt and thorough wound cleansing followed by administration of human rabies IG and rabies vaccine. Previous research identified three opportunities to improve adherence to CDC guideline recommendations for rabies PEP: (1) infiltration of rabies IG into and around the wounds, if anatomically feasible, (2) administration of rabies IG at an anatomical site distant from rabies vaccine administration, and (3) avoiding administration of rabies IG into the buttock.

STUDY DESIGN: This quasi-experimental, quality improvement study evaluates adherence to 6 quality indicators, which are based on CDC guideline recommendations, for patient selection and delivery of rabies IG before and after implementation of the rabies PEP quality improvement bundle. The quality improvement bundle includes EHR enhancements, ED staff education, and patient education. Patients who receive at least one dose of rabies IG or rabies vaccine at a study site during the study period will be included in this study. The historical control group includes patients treated prior to bundle implementation. The post-implementation group includes patients treated within 12 months following bundle implementation. The primary outcome is full adherence to all 6 quality indicators for rabies IG selection and delivery.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Receive at least one dose of rabies IG or rabies vaccine at a study site during the study period

排除标准

  • 未提供

结局指标

主要结局

Full adherence to 6 quality indicators for rabies immune globulin patient selection and delivery

时间窗: 1 day; during the patient's first medical encounter at a study site for rabies PEP

The proportion of patients who achieve full adherence to a composite of all 6 quality indicators for rabies IG patient selection and delivery: (1) appropriate patient selection, (2) appropriate dose, (3) appropriate timing, (4) administration into and around the wound if anatomically feasible, (5) administration distant from rabies vaccine, and (6) administration that avoids the buttock (unless the wound is near the buttock) among patients who received rabies PEP.

次要结局

  • Clear documentation of rabies immune globulin administration site(1 day; during the patient's first medical encounter at a study site where rabies IG is administered)
  • Adherence to each of the 6 quality indicators for rabies immune globulin patient selection and delivery(1 day; during the patient's first medical encounter at a study site for rabies PEP)
  • Volume of rabies immune globulin administered into or around wounds(1 day; during the patient's first medical encounter at a study site where rabies IG is administered)
  • Incidence of sciatic nerve injury(For 21 days following rabies IG administration)
  • Incidence of compartment syndrome(For 7 days following rabies IG administration)

研究者

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

Joshua Swan, PharmD, MPH, FCCM

Associate Professor of Pharmacy in Surgery and Outcomes Research

The Methodist Hospital Research Institute

研究点 (30)

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