Improving Adherence to Rabies PEP Guideline Recommendations

Rabies Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04213950
• Other study ID #: Pro00022539
• Status: Completed
• Phase: N/A
• Start date: December 29, 2019
• Est. completion date: December 23, 2020

Study information

• Verified date: August 2021
• Source: The Methodist Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 23, 2020
• Est. primary completion date: December 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Rabies
• Rabies Human
• Rabies Virus Infection

Intervention

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.

Locations

Country	Name	City	State
United States	Houston Methodist Emergency Department at Baytown	Baytown	Texas
United States	Houston Methodist Emergency Care Center in Cypress	Cypress	Texas
United States	Houston Methodist Emergency Care Center at Kirby	Houston	Texas
United States	Houston Methodist Emergency Care Center at Voss	Houston	Texas
United States	Houston Methodist Emergency Department at West	Houston	Texas
United States	Houston Methodist Emergency Department at Willowbrook Hospital	Houston	Texas
United States	Houston Methodist Hospital Emergency Department	Houston	Texas
United States	Houston Methodist Emergency Care Center in Sienna Plantation	Missouri City	Texas
United States	Houston Methodist Emergency Department at Clear Lake	Nassau Bay	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 Spring	Spring	Texas
United States	Houston Methodist Emergency Department at Sugar Land	Sugar Land	Texas
United States	Houston Methodist Emergency Care Center in The Woodlands	The Woodlands	Texas
United States	Houston Methodist Emergency Department at The Woodlands	The Woodlands	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The Methodist Hospital Research Institute	Grifols Biologicals, LLC

Country where clinical trial is conducted

United States, 

References & Publications (15)

Bergeson PS, Singer SA, Kaplan AM. Intramuscular injections in children. Pediatrics. 1982 Dec;70(6):944-8. Review. — View Citation

Bharti OK, Madhusudana SN, Gaunta PL, Belludi AY. Local infiltration of rabies immunoglobulins without systemic intramuscular administration: An alternative cost effective approach for passive immunization against rabies. Hum Vaccin Immunother. 2016 Mar 3;12(3):837-42. doi: 10.1080/21645515.2015.1085142. — View Citation

Bharti OK, Madhusudana SN, Wilde H. Injecting rabies immunoglobulin (RIG) into wounds only: A significant saving of lives and costly RIG. Hum Vaccin Immunother. 2017 Apr 3;13(4):762-765. doi: 10.1080/21645515.2016.1255834. Epub 2017 Feb 22. — View Citation

Centers for Disease Control and Prevention. Human Rabies. 2017; https://www.cdc.gov/rabies/location/usa/surveillance/human_rabies.html. Accessed Jan 10, 2019.

GILLES FH, FRENCH JH. Postinjection sciatic nerve palsies in infants and children. J Pediatr. 1961 Feb;58:195-204. — View Citation

Hwang GS, Rizk E, Bui LN, Iso T, Sartain EI, Tran AT, Swan JT. Adherence to guideline recommendations for human rabies immune globulin patient selection, dosing, timing, and anatomical site of administration in rabies postexposure prophylaxis. Hum Vaccin Immunother. 2020;16(1):51-60. doi: 10.1080/21645515.2019.1632680. Epub 2019 Aug 1. — View Citation

HyperRab® [rabies immune globulin (human)] [package insert]. Grifols Therapeutics Inc., Research Triangle Park, NC, USA. 2018.

HyperRab® S/D (rabies immune globulin [human]) [package insert]. Grifols Therapeutics Inc., Clayton, NC. 2012.

Jung Kim H, Hyun Park S. Sciatic nerve injection injury. J Int Med Res. 2014 Aug;42(4):887-97. doi: 10.1177/0300060514531924. Epub 2014 Jun 11. Review. — View Citation

Kline DG, Kim D, Midha R, Harsh C, Tiel R. Management and results of sciatic nerve injuries: a 24-year experience. J Neurosurg. 1998 Jul;89(1):13-23. — View Citation

Madhusudana SN, Aggarwal P, Tripathi KK. Failure of rabies postexposure treatment with purified chick embryo cell (PCEC) vaccine. Vaccine. 1989 Oct;7(5):478-9. — View Citation

National Center for Immunization and Respiratory Diseases. General recommendations on immunization --- recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2011 Jan 28;60(2):1-64. Erratum in: MMWR Recomm Rep. 2011 Jul 29;60:993. — View Citation

Rupprecht CE, Briggs D, Brown CM, Franka R, Katz SL, Kerr HD, Lett SM, Levis R, Meltzer MI, Schaffner W, Cieslak PR; Centers for Disease Control and Prevention (CDC). Use of a reduced (4-dose) vaccine schedule for postexposure prophylaxis to prevent human rabies: recommendations of the advisory committee on immunization practices. MMWR Recomm Rep. 2010 Mar 19;59(RR-2):1-9. Erratum in: MMWR Recomm Rep. 2010 Apr 30;59(16):493. — View Citation

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.

Wilde H, Sirikawin S, Sabcharoen A, Kingnate D, Tantawichien T, Harischandra PA, Chaiyabutr N, de Silva DG, Fernando L, Liyanage JB, Sitprija V. Failure of postexposure treatment of rabies in children. Clin Infect Dis. 1996 Feb;22(2):228-32. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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