Improving Adherence to Rabies PEP Guideline Recommendations

August 30, 2021 updated by: Joshua Swan, PharmD, MPH, FCCM, The Methodist Hospital Research Institute

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Baytown, Texas, United States, 77521
        • Houston Methodist Emergency Department at Baytown
      • Cypress, Texas, United States, 77433
        • Houston Methodist Emergency Care Center in Cypress
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital Emergency Department
      • Houston, Texas, United States, 77057
        • Houston Methodist Emergency Care Center at Voss
      • Houston, Texas, United States, 77070
        • Houston Methodist Emergency Department at Willowbrook Hospital
      • Houston, Texas, United States, 77094
        • Houston Methodist Emergency Department at West
      • Houston, Texas, United States, 77098
        • Houston Methodist Emergency Care Center at Kirby
      • Missouri City, Texas, United States, 77459
        • Houston Methodist Emergency Care Center in Sienna Plantation
      • Nassau Bay, Texas, United States, 77058
        • Houston Methodist Emergency Department at Clear Lake
      • Pearland, Texas, United States, 77584
        • Houston Methodist Emergency Care Center in Pearland
      • Richmond, Texas, United States, 77406
        • Houston Methodist Emergency Care Center in Cinco Ranch
      • Spring, Texas, United States, 77388
        • Houston Methodist Emergency Care Center in Spring
      • Sugar Land, Texas, United States, 77479
        • Houston Methodist Emergency Department at Sugar Land
      • The Woodlands, Texas, United States, 77384
        • Houston Methodist Emergency Care Center in The Woodlands
      • The Woodlands, Texas, United States, 77385
        • Houston Methodist Emergency Department at The Woodlands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Post-implementation group
The post-implementation group will receive care that is enhanced by the rabies PEP quality improvement bundle.
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.
NO_INTERVENTION: Historical control group
The historical control group received care prior to implementation of the quality improvement bundle.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Full adherence to 6 quality indicators for rabies immune globulin patient selection and delivery
Time Frame: 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.
1 day; during the patient's first medical encounter at a study site for rabies PEP

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adherence to each of the 6 quality indicators for rabies immune globulin patient selection and delivery
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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
1 day; during the patient's first medical encounter at a study site where rabies IG is administered
Incidence of compartment syndrome
Time Frame: 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
For 7 days following rabies IG administration
Incidence of sciatic nerve injury
Time Frame: 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
For 21 days following rabies IG administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Methodist Hospital Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Grifols Biologicals, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joshua Swan, PharmD, MPH, Houston Methodist Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 29, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 23, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00022539

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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