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Improving Adherence to Rabies PEP Guideline Recommendations

Primary Purpose

Rabies, Rabies Human, Rabies Virus Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rabies PEP quality improvement bundle
Sponsored by
The Methodist Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Rabies focused on measuring rabies immune globulin, rabies vaccine, rabies postexposure prophylaxis, rabies PEP, rabies IG

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Houston Methodist Emergency Department at Baytown
  • Houston Methodist Emergency Care Center in Cypress
  • Houston Methodist Hospital Emergency Department
  • Houston Methodist Emergency Care Center at Voss
  • Houston Methodist Emergency Department at Willowbrook Hospital
  • Houston Methodist Emergency Department at West
  • Houston Methodist Emergency Care Center at Kirby
  • Houston Methodist Emergency Care Center in Sienna Plantation
  • Houston Methodist Emergency Department at Clear Lake
  • Houston Methodist Emergency Care Center in Pearland
  • Houston Methodist Emergency Care Center in Cinco Ranch
  • Houston Methodist Emergency Care Center in Spring
  • Houston Methodist Emergency Department at Sugar Land
  • Houston Methodist Emergency Care Center in The Woodlands
  • Houston Methodist Emergency Department at The Woodlands

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Post-implementation group

Historical control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Clear documentation of rabies immune globulin administration site
The proportion of patients with clear EHR documentation of rabies IG administration sites
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
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

Full Information

First Posted
December 23, 2019
Last Updated
August 30, 2021
Sponsor
The Methodist Hospital Research Institute
Collaborators
Grifols Biologicals, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04213950
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 29, 2019 (Actual)
Primary Completion Date
December 23, 2020 (Actual)
Study Completion Date
December 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Methodist Hospital Research Institute
Collaborators
Grifols Biologicals, LLC

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rabies, Rabies Human, Rabies Virus Infection
Keywords
rabies immune globulin, rabies vaccine, rabies postexposure prophylaxis, rabies PEP, rabies IG

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post-implementation group
Arm Type
Experimental
Arm Description
The post-implementation group will receive care that is enhanced by the rabies PEP quality improvement bundle.
Arm Title
Historical control group
Arm Type
No Intervention
Arm Description
The historical control group received care prior to implementation of the quality improvement bundle.
Intervention Type
Other
Intervention Name(s)
Rabies PEP quality improvement bundle
Intervention Description
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.
Primary Outcome Measure Information:
Title
Full adherence to 6 quality indicators for rabies immune globulin patient selection and delivery
Description
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.
Time Frame
1 day; during the patient's first medical encounter at a study site for rabies PEP
Secondary Outcome Measure Information:
Title
Adherence to each of the 6 quality indicators for rabies immune globulin patient selection and delivery
Description
The proportion of patients who achieve adherence to each of the 6 quality indicators for rabies IG patient selection and delivery.
Time Frame
1 day; during the patient's first medical encounter at a study site for rabies PEP
Title
Volume of rabies immune globulin administered into or around wounds
Description
The mean percent of the total volume of rabies IG administered into or around wounds, if anatomically feasible.
Time Frame
1 day; during the patient's first medical encounter at a study site where rabies IG is administered
Title
Clear documentation of rabies immune globulin administration site
Description
The proportion of patients with clear EHR documentation of rabies IG administration sites
Time Frame
1 day; during the patient's first medical encounter at a study site where rabies IG is administered
Title
Incidence of compartment syndrome
Description
The incidence of compartment syndrome at a rabies IG infiltration site that was documented in the EHR within 7 days of rabies IG administration
Time Frame
For 7 days following rabies IG administration
Title
Incidence of sciatic nerve injury
Description
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
Time Frame
For 21 days following rabies IG administration

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Receive at least one dose of rabies IG or rabies vaccine at a study site during the study period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Swan, PharmD, MPH
Organizational Affiliation
Houston Methodist Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Houston Methodist Emergency Department at Baytown
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Houston Methodist Emergency Care Center in Cypress
City
Cypress
State/Province
Texas
ZIP/Postal Code
77433
Country
United States
Facility Name
Houston Methodist Hospital Emergency Department
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Methodist Emergency Care Center at Voss
City
Houston
State/Province
Texas
ZIP/Postal Code
77057
Country
United States
Facility Name
Houston Methodist Emergency Department at Willowbrook Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Facility Name
Houston Methodist Emergency Department at West
City
Houston
State/Province
Texas
ZIP/Postal Code
77094
Country
United States
Facility Name
Houston Methodist Emergency Care Center at Kirby
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
Houston Methodist Emergency Care Center in Sienna Plantation
City
Missouri City
State/Province
Texas
ZIP/Postal Code
77459
Country
United States
Facility Name
Houston Methodist Emergency Department at Clear Lake
City
Nassau Bay
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Houston Methodist Emergency Care Center in Pearland
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Facility Name
Houston Methodist Emergency Care Center in Cinco Ranch
City
Richmond
State/Province
Texas
ZIP/Postal Code
77406
Country
United States
Facility Name
Houston Methodist Emergency Care Center in Spring
City
Spring
State/Province
Texas
ZIP/Postal Code
77388
Country
United States
Facility Name
Houston Methodist Emergency Department at Sugar Land
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Houston Methodist Emergency Care Center in The Woodlands
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Houston Methodist Emergency Department at The Woodlands
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77385
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31210569
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.
Results Reference
background
PubMed Identifier
20300058
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.
Results Reference
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PubMed Identifier
26317441
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.
Results Reference
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PubMed Identifier
28277089
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.
Results Reference
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PubMed Identifier
8838177
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.
Results Reference
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PubMed Identifier
2815983
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.
Results Reference
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PubMed Identifier
24920643
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.
Results Reference
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PubMed Identifier
21293327
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.
Results Reference
background
Citation
HyperRab® [rabies immune globulin (human)] [package insert]. Grifols Therapeutics Inc., Research Triangle Park, NC, USA. 2018.
Results Reference
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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.
Results Reference
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Citation
HyperRab® S/D (rabies immune globulin [human]) [package insert]. Grifols Therapeutics Inc., Clayton, NC. 2012.
Results Reference
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Improving Adherence to Rabies PEP Guideline Recommendations

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