Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04213950
Study type Interventional
Source The Methodist Hospital Research Institute
Contact
Status Completed
Phase N/A
Start date December 29, 2019
Completion date December 23, 2020

See also
  Status Clinical Trial Phase
Completed NCT03961555 - Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies Phase 2
Completed NCT04644484 - A Phase III Clinical Study to Evaluate SYN023's Efficacy and Safety Phase 3
Active, not recruiting NCT05667974 - A Study to Evaluate a PIKA Rabies Vaccine(Vero Cell)for Human Use,Freeze-dried Phase 3
Completed NCT01641315 - Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins N/A
Completed NCT02238756 - Safety and Tolerability of CV8102 Alone and in Combination With a Rabies Virus Vaccine in Healthy Adults Phase 1
Completed NCT01930357 - Purified Vero Rabies Vaccine-Serum Free Compared to Human Diploid Cell Vaccine in a Pre-exposure Prophylaxis Regimen Phase 2
Completed NCT01680016 - A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults Phase 3
Completed NCT04019444 - Dosage-Escalation Study of the Safety and Immunogenicity of a Novel Rabies Vaccine ChAd155-RG vs. the Comparator RABAVERT Vaccine in Healthy Adult Subjects Phase 1
Completed NCT02729168 - Safety Study of Rabies Vaccine INDIRAB® Five Doses (0.5ml) Post Exposure Administered Intramuscularly N/A
Completed NCT02241135 - RNActive® Rabies Vaccine (CV7201) in Healthy Adults Phase 1
Completed NCT01388985 - Simplifying the Rabies Pre-exposure Vaccination Phase 3
Completed NCT04829630 - Immunity Persistence After Abridged Intradermal Rabies PEP N/A
Completed NCT03713086 - A Study to Assess the Safety, Reactogenicity and Immune Response of CureVac's Candidate Rabies mRNA Vaccine in Healthy Adults Phase 1
Completed NCT05350735 - Phone Text Message Reminders on Compliance With Human Rabies Post Exposure Prophylaxis Project N/A
Active, not recruiting NCT06132789 - A Clinical Trial of Rabies Vaccine(Human Diploid Cell)for Human Use,Freeze-dried in a Population Aged 10-60 Years Phase 1
Completed NCT02281396 - The Safety Research of Freeze-dried Rabies Vaccine(MRC-5 Cell) in Chinese Humans Phase 1
Completed NCT01466387 - A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults Phase 3
Completed NCT00825305 - Safety and Immunogenicity (Non-inferiority) of a Purified Chick Embryo Cell Vaccine Vaccine Administered in Two Different Schedules (Conventional Versus Abbreviated Schedule) Phase 3
Completed NCT05547815 - Observation on the Immune Persistence of People Aged 10-60 Years Old Immunized With Five Doses of Rabies Vaccine Phase 4
Completed NCT02564471 - Effect of Antimalarial Drugs to Rabies Vaccine for Post-exposure Prophylaxis. Phase 4