Clinical Trials Directory

Trials / Completed

CompletedNCT04213950

Improving Adherence to Rabies PEP Guideline Recommendations

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
70 (actual)
Sponsor
The Methodist Hospital Research Institute · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERRabies PEP quality improvement bundleThe rabies PEP quality improvement bundle consists of (1) electronic health record enhancements to support rabies PEP treatment selection, administration, and discharge process; (2) education to ED staff on rabies PEP; and (3) education to patients on rabies PEP and follow-up care.

Timeline

Start date
2019-12-29
Primary completion
2020-12-23
Completion
2020-12-23
First posted
2019-12-30
Last updated
2021-09-05

Locations

15 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT04213950. Inclusion in this directory is not an endorsement.