Improving Adherence to Rabies PEP Guideline Recommendations

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Rabies, Rabies Human, Rabies Virus Infection

Intervention / Treatment
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* Other: Rabies PEP quality improvement bundle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Receive at least one dose of rabies IG or rabies vaccine at a study site during the study period
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: The study consists of 2 groups: (1) the historical control group and (2) the post-implementation group. The historical control group includes patients who received rabies PEP from January 2015 to June 2018. The quality improvement bundle will be implemented across the Houston Methodist health system in December 2019. The post-implementation group includes patients who receive rabies PEP within 12 months following bundle implementation. An estimated sample size of 70 patients in the post-implementation group and 254 patients in the historical control group will provide 80% power to detect an absolute increase of 20% in the primary endpoint using a two-sided alpha of 0.05.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Post-implementation group<br>The post-implementation group will receive care that is enhanced by the rabies PEP quality improvement bundle. | Other: Rabies PEP quality improvement bundle<br>* 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.<br>|
| No Intervention: Historical control group<br>The historical control group received care prior to implementation of the quality improvement bundle. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Full adherence to 6 quality indicators for rabies immune globulin patient selection and delivery | 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. | 1 day; during the patient's first medical encounter at a study site for rabies PEP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to each of the 6 quality indicators for rabies immune globulin patient selection and delivery | The proportion of patients who achieve adherence to each of the 6 quality indicators for rabies IG 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 | The mean percent of the total volume of rabies IG administered into or around wounds, if anatomically feasible. | 1 day; during the patient's first medical encounter at a study site where rabies IG is administered | 
| Clear documentation of rabies immune globulin administration site | The proportion of patients with clear EHR documentation of rabies IG administration sites | 1 day; during the patient's first medical encounter at a study site where rabies IG is administered | 
| Incidence of compartment syndrome | The incidence of compartment syndrome at a rabies IG infiltration site that was documented in the EHR within 7 days of rabies IG administration | For 7 days following rabies IG administration | 
| Incidence of sciatic nerve injury | 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 | For 21 days following rabies IG administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rabies immune globulin, rabies vaccine, rabies postexposure prophylaxis, rabies PEP, rabies IG