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Improving Adherence to Rabies PEP Guideline Recommendations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04213950
Recruitment Status : Completed
First Posted : December 30, 2019
Last Update Posted : December 28, 2020
Sponsor:
Collaborator:
Grifols Biologicals, LLC
Information provided by (Responsible Party):
Joshua Swan, PharmD, MPH, FCCM, The Methodist Hospital System

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.

Condition or disease Intervention/treatment Phase
Rabies Rabies Human Rabies Virus Infection Other: Rabies PEP quality improvement bundle Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention 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)
Primary Purpose: Health Services Research
Official 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
Actual Study Start Date : December 29, 2019
Actual Primary Completion Date : December 23, 2020
Actual Study Completion Date : December 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

Arm Intervention/treatment
Experimental: Post-implementation group
The post-implementation group will receive care that is enhanced by the rabies PEP quality improvement bundle.
Other: Rabies PEP quality improvement bundle
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.

No Intervention: Historical control group
The historical control group received care prior to implementation of the quality improvement bundle.



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04213950


Locations
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United States, Texas
Houston Methodist Emergency Department at Baytown
Baytown, Texas, United States, 77521
Houston Methodist Emergency Care Center in Cypress
Cypress, Texas, United States, 77433
Houston Methodist Hospital Emergency Department
Houston, Texas, United States, 77030
Houston Methodist Emergency Care Center at Voss
Houston, Texas, United States, 77057
Houston Methodist Emergency Department at Willowbrook Hospital
Houston, Texas, United States, 77070
Houston Methodist Emergency Department at West
Houston, Texas, United States, 77094
Houston Methodist Emergency Care Center at Kirby
Houston, Texas, United States, 77098
Houston Methodist Emergency Care Center in Sienna Plantation
Missouri City, Texas, United States, 77459
Houston Methodist Emergency Department at Clear Lake
Nassau Bay, Texas, United States, 77058
Houston Methodist Emergency Care Center in Pearland
Pearland, Texas, United States, 77584
Houston Methodist Emergency Care Center in Cinco Ranch
Richmond, Texas, United States, 77406
Houston Methodist Emergency Care Center in Spring
Spring, Texas, United States, 77388
Houston Methodist Emergency Department at Sugar Land
Sugar Land, Texas, United States, 77479
Houston Methodist Emergency Care Center in The Woodlands
The Woodlands, Texas, United States, 77384
Houston Methodist Emergency Department at The Woodlands
The Woodlands, Texas, United States, 77385
Sponsors and Collaborators
Joshua Swan, PharmD, MPH, FCCM
Grifols Biologicals, LLC
Investigators
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Principal Investigator: Joshua Swan, PharmD, MPH Houston Methodist Health System
Publications:
HyperRab® [rabies immune globulin (human)] [package insert]. Grifols Therapeutics Inc., Research Triangle Park, NC, USA. 2018.
Salva EP, Dimaano EM, Villarama JB, Suquilla JT. An evaluation of the safety and potency of equine rabies immunoglobulin through measurements of suppression on vaccine induced antibody production among healthy volunteers. Philippine Journal of Internal Medicine. 2014;52(2):1-7.
HyperRab® S/D (rabies immune globulin [human]) [package insert]. Grifols Therapeutics Inc., Clayton, NC. 2012.
Centers for Disease Control and Prevention. Human Rabies. 2017; https://www.cdc.gov/rabies/location/usa/surveillance/human_rabies.html. Accessed Jan 10, 2019.

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Responsible Party: Joshua Swan, PharmD, MPH, FCCM, Associate Professor of Pharmacy in Surgery and Outcomes Research, The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT04213950    
Other Study ID Numbers: Pro00022539
First Posted: December 30, 2019    Key Record Dates
Last Update Posted: December 28, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Joshua Swan, PharmD, MPH, FCCM, The Methodist Hospital System:
rabies immune globulin
rabies vaccine
rabies postexposure prophylaxis
rabies PEP
rabies IG
Additional relevant MeSH terms:
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Rabies
Virus Diseases
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections