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Completed

NCT Number: NCT04213950

Improving Adherence to Rabies PEP Guideline Recommendations

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Houston Methodist Emergency Department at Baytown, Baytown, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Rabies PEP quality improvement bundle

Other

The 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.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Adherence to each of the 6 quality indicators for rabies immune globulin patient selection and delivery

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

    The proportion of patients who achieve adherence to each of the 6 quality indicators for rabies IG patient selection and delivery.

  2. Volume of rabies immune globulin administered into or around wounds

    Time frame: 1 day; during the patient's first medical encounter at a study site where rabies IG is administered

    The mean percent of the total volume of rabies IG administered into or around wounds, if anatomically feasible.

  3. Clear documentation of rabies immune globulin administration site

    Time frame: 1 day; during the patient's first medical encounter at a study site where rabies IG is administered

    The proportion of patients with clear EHR documentation of rabies IG administration sites

  4. Incidence of compartment syndrome

    Time frame: For 7 days following rabies IG administration

    The incidence of compartment syndrome at a rabies IG infiltration site that was documented in the EHR within 7 days of rabies IG administration

  5. Incidence of sciatic nerve injury

    Time frame: For 21 days following rabies IG administration

    The incidence of sciatic nerve injury that was documented in the EHR within 21 days of rabies IG administration among patients who receive rabies IG into the buttock

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Collaborators

  • Grifols Biologicals, LLC

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 30, 2019
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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