Improving Adherence to Rabies PEP Guideline Recommendations

NCT04213950 | Completed

• 1 other identifier: Pro00022539
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 15

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.

Conditions

Rabies; Rabies Human; Rabies Virus Infection

Keywords

rabies immune globulin; rabies vaccine; rabies postexposure prophylaxis; rabies PEP; rabies IG

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

• 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

• Incidence of compartment syndrome

  For 7 days following rabies IG administration

• Incidence of sciatic nerve injury

  For 21 days following rabies IG administration

Study Arms (2)

Post-implementation group

EXPERIMENTAL

The post-implementation group will receive care that is enhanced by the rabies PEP quality improvement bundle.

Other: Rabies PEP quality improvement bundle

Historical control group

NO INTERVENTION

The historical control group received care prior to implementation of the quality improvement bundle.

Interventions

Rabies PEP quality improvement bundle OTHER

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.

Post-implementation group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• Grifols Biologicals, LLC: collaborator

Study Sites (15)

Houston Methodist Emergency Department at Baytown

Baytown, Texas, 77521, United States

Location

Houston Methodist Emergency Care Center in Cypress

Cypress, Texas, 77433, United States

Location

Houston Methodist Hospital Emergency Department

Houston, Texas, 77030, United States

Location

Houston Methodist Emergency Care Center at Voss

Houston, Texas, 77057, United States

Location

Houston Methodist Emergency Department at Willowbrook Hospital

Houston, Texas, 77070, United States

Location

Houston Methodist Emergency Department at West

Houston, Texas, 77094, United States

Location

Houston Methodist Emergency Care Center at Kirby

Houston, Texas, 77098, United States

Location

Houston Methodist Emergency Care Center in Sienna Plantation

Missouri City, Texas, 77459, United States

Location

Houston Methodist Emergency Department at Clear Lake

Nassau Bay, Texas, 77058, United States

Location

Houston Methodist Emergency Care Center in Pearland

Pearland, Texas, 77584, United States

Location

Houston Methodist Emergency Care Center in Cinco Ranch

Richmond, Texas, 77406, United States

Location

Houston Methodist Emergency Care Center in Spring

Spring, Texas, 77388, United States

Location

Houston Methodist Emergency Department at Sugar Land

Sugar Land, Texas, 77479, United States

Location

Houston Methodist Emergency Care Center in The Woodlands

The Woodlands, Texas, 77384, United States

Location

Houston Methodist Emergency Department at The Woodlands

The Woodlands, Texas, 77385, United States

Location

Related Publications (15)

• 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.

  PMID: 31210569 BACKGROUND

• 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.

  PMID: 20300058 BACKGROUND

• 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.

  PMID: 26317441 BACKGROUND

• 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.

  PMID: 28277089 BACKGROUND

• 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.

  PMID: 8838177 BACKGROUND

• 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.

  PMID: 2815983 BACKGROUND

• 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.

  PMID: 24920643 BACKGROUND

• 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.

  PMID: 21293327 BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 9647167 BACKGROUND

• 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.

  PMID: 13705320 BACKGROUND

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

  PMID: 6755373 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Joshua Swan, PharmD, MPH

  Houston Methodist Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pharmacy in Surgery and Outcomes Research

Model Details: 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.

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: December 30, 2019
• Study Start: December 29, 2019
• Primary Completion: December 23, 2020
• Study Completion: December 23, 2020
• Last Updated: September 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)