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Improving Adherence to Rabies PEP Guideline Recommendations

NCT04213950 — Not applicable, Completed, 70 participants, The Methodist Hospital Research Institute

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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

RegistryNCT04213950
StatusCompleted
PhaseNot applicable
Study typeInterventional; non randomized, sequential, masking: none, health services research
Enrollment70 (Actual)
SponsorThe Methodist Hospital Research Institute (Other); collaborators: Grifols Biologicals, LLC
ConditionsRabies, Rabies Human, Rabies Virus Infection
InterventionsRabies PEP quality improvement bundle (Other)
Datesstart 2019-12-29, primary completion 2020-12-23, completion 2020-12-23, first posted 2019-12-30, last updated 2021-09-05
Locations15 sites in United States

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Post-implementation groupExperimentalOther: Rabies PEP quality improvement bundleThe post-implementation group will receive care that is enhanced by the rabies PEP quality improvement bundle.
Historical control groupNo interventionThe historical control group received care prior to implementation of the quality improvement bundle.
  • 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.

+Outcome measures

Primary outcomes

  • Full adherence to 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]: 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 outcomes

  • 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]: The proportion of patients who achieve adherence to each of the 6 quality indicators for rabies IG patient selection and delivery.
  • 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]: The mean percent of the total volume of rabies IG administered into or around wounds, if anatomically feasible.
  • 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]: The proportion of patients with clear EHR documentation of rabies IG administration sites
  • Incidence of compartment syndrome [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
  • Incidence of sciatic nerve injury [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

+Eligibility

Sex: All

Inclusion Criteria:

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

+Locations (15)

FacilityCityCountryStatus
Houston Methodist Emergency Department at BaytownBaytown, TexasUnited States
Houston Methodist Emergency Care Center in CypressCypress, TexasUnited States
Houston Methodist Hospital Emergency DepartmentHouston, TexasUnited States
Houston Methodist Emergency Care Center at VossHouston, TexasUnited States
Houston Methodist Emergency Department at Willowbrook HospitalHouston, TexasUnited States
Houston Methodist Emergency Department at WestHouston, TexasUnited States
Houston Methodist Emergency Care Center at KirbyHouston, TexasUnited States
Houston Methodist Emergency Care Center in Sienna PlantationMissouri City, TexasUnited States
Houston Methodist Emergency Department at Clear LakeNassau Bay, TexasUnited States
Houston Methodist Emergency Care Center in PearlandPearland, TexasUnited States
Houston Methodist Emergency Care Center in Cinco RanchRichmond, TexasUnited States
Houston Methodist Emergency Care Center in SpringSpring, TexasUnited States
Houston Methodist Emergency Department at Sugar LandSugar Land, TexasUnited States
Houston Methodist Emergency Care Center in The WoodlandsThe Woodlands, TexasUnited States
Houston Methodist Emergency Department at The WoodlandsThe Woodlands, TexasUnited States

+Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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
  • 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
  • Bergeson PS, Singer SA, Kaplan AM. Intramuscular injections in children. Pediatrics. 1982 Dec;70(6):944-8. PMID 6755373
  • Centers for Disease Control and Prevention. Human Rabies. 2017; https://www.cdc.gov/rabies/location/usa/surveillance/human_rabies.html. Accessed Jan 10, 2019.

+Investigators

My Notes