Clinical trial NCT04213950: Improving Adherence to Rabies PEP Guideline Recommendations
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rabies
Rabies Human
Rabies Virus Infection
Keywords: rabies immune globulin
rabies vaccine
rabies postexposure prophylaxis
rabies PEP
rabies IG
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Grifols Biologicals, LLC
First posted: 2019-12-30
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Full adherence to 6 quality indicators for rabies immune globulin patient selection and delivery
timeFrame: 1 day; during the patient's first medical encounter at a study site for rabies PEP
Secondary outcomes:
measure: Adherence to each of the 6 quality indicators for rabies immune globulin patient selection and delivery
timeFrame: 1 day; during the patient's first medical encounter at a study site for rabies PEP
measure: Volume of rabies immune globulin administered into or around wounds
timeFrame: 1 day; during the patient's first medical encounter at a study site where rabies IG is administered
measure: Clear documentation of rabies immune globulin administration site
timeFrame: 1 day; during the patient's first medical encounter at a study site where rabies IG is administered
measure: Incidence of compartment syndrome
timeFrame: For 7 days following rabies IG administration
measure: Incidence of sciatic nerve injury
timeFrame: For 21 days following rabies IG administration
Other outcomes:
Locations:
city: Baytown
country: United States
facility: Houston Methodist Emergency Department at Baytown
state: Texas
city: Cypress
country: United States
facility: Houston Methodist Emergency Care Center in Cypress
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital Emergency Department
state: Texas
city: Houston
country: United States
facility: Houston Methodist Emergency Care Center at Voss
state: Texas
city: Houston
country: United States
facility: Houston Methodist Emergency Department at Willowbrook Hospital
state: Texas
city: Houston
country: United States
facility: Houston Methodist Emergency Department at West
state: Texas
city: Houston
country: United States
facility: Houston Methodist Emergency Care Center at Kirby
state: Texas
city: Missouri City
country: United States
facility: Houston Methodist Emergency Care Center in Sienna Plantation
state: Texas
city: Nassau Bay
country: United States
facility: Houston Methodist Emergency Department at Clear Lake
state: Texas
city: Pearland
country: United States
facility: Houston Methodist Emergency Care Center in Pearland
state: Texas
city: Richmond
country: United States
facility: Houston Methodist Emergency Care Center in Cinco Ranch
state: Texas
city: Spring
country: United States
facility: Houston Methodist Emergency Care Center in Spring
state: Texas
city: Sugar Land
country: United States
facility: Houston Methodist Emergency Department at Sugar Land
state: Texas
city: The Woodlands
country: United States
facility: Houston Methodist Emergency Care Center in The Woodlands
state: Texas
city: The Woodlands
country: United States
facility: Houston Methodist Emergency Department at The Woodlands
state: Texas
Study officials:
affiliation: Houston Methodist Health System
name: Joshua Swan, PharmD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: 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. doi: 10.1093/clinids/22.2.228.
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. doi: 10.1016/0264-410x(89)90185-0. No abstract available.
citation: 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.
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.
citation: HyperRab® [rabies immune globulin (human)] [package insert]. Grifols Therapeutics Inc., Research Triangle Park, NC, USA. 2018.
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.
citation: HyperRab® S/D (rabies immune globulin [human]) [package insert]. Grifols Therapeutics Inc., Clayton, NC. 2012.
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. doi: 10.3171/jns.1998.89.1.0013.
citation: GILLES FH, FRENCH JH. Postinjection sciatic nerve palsies in infants and children. J Pediatr. 1961 Feb;58:195-204. doi: 10.1016/s0022-3476(61)80158-3. No abstract available.
citation: Bergeson PS, Singer SA, Kaplan AM. Intramuscular injections in children. Pediatrics. 1982 Dec;70(6):944-8.
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.