Improving Adherence to Rabies PEP Guideline Recommendations
- Conditions
- Rabies Virus InfectionRabiesRabies Human
- Interventions
- Other: Rabies PEP quality improvement bundle
- Registration Number
- NCT04213950
- Lead Sponsor
- The Methodist Hospital Research Institute
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
• Receive at least one dose of rabies IG or rabies vaccine at a study site during the study period
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Post-implementation group Rabies PEP quality improvement bundle The post-implementation group will receive care that is enhanced by the rabies PEP quality improvement bundle.
- Primary Outcome Measures
Name Time Method Full adherence to 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 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 Outcome Measures
Name Time Method 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 The proportion of patients with clear EHR documentation of rabies IG administration sites
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 The proportion of patients who achieve adherence to each of the 6 quality indicators for rabies IG patient selection and delivery.
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 The mean percent of the total volume of rabies IG administered into or around wounds, if anatomically feasible.
Incidence of sciatic nerve injury 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
Incidence of compartment syndrome 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
Trial Locations
- Locations (15)
Houston Methodist Hospital Emergency Department
🇺🇸Houston, Texas, United States
Houston Methodist Emergency Care Center in Cypress
🇺🇸Cypress, Texas, United States
Houston Methodist Emergency Care Center in Pearland
🇺🇸Pearland, Texas, United States
Houston Methodist Emergency Care Center in Cinco Ranch
🇺🇸Richmond, Texas, United States
Houston Methodist Emergency Care Center in The Woodlands
🇺🇸The Woodlands, Texas, United States
Houston Methodist Emergency Department at Sugar Land
🇺🇸Sugar Land, Texas, United States
Houston Methodist Emergency Department at The Woodlands
🇺🇸The Woodlands, Texas, United States
Houston Methodist Emergency Care Center in Sienna Plantation
🇺🇸Missouri City, Texas, United States
Houston Methodist Emergency Department at West
🇺🇸Houston, Texas, United States
Houston Methodist Emergency Care Center at Kirby
🇺🇸Houston, Texas, United States
Houston Methodist Emergency Department at Clear Lake
🇺🇸Nassau Bay, Texas, United States
Houston Methodist Emergency Department at Baytown
🇺🇸Baytown, Texas, United States
Houston Methodist Emergency Care Center at Voss
🇺🇸Houston, Texas, United States
Houston Methodist Emergency Department at Willowbrook Hospital
🇺🇸Houston, Texas, United States
Houston Methodist Emergency Care Center in Spring
🇺🇸Spring, Texas, United States