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Animal-Assisted Visitation Program Chlorhexidine Trial

Primary Purpose

Methicillin-resistant Staphylococcus Aureus, Clostridium Difficile, Pseudomonas Aeruginosa

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Methicillin-resistant Staphylococcus Aureus focused on measuring therapy dog, canine, animal assisted intervention, chlorhexidine, child

Eligibility Criteria

3 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children between the ages of 3 and 17 years
  • Cleared by physician to participate in a hospital-based animal-assisted visitation program session with any enrolled dog

Exclusion Criteria:

  • Children who report sensitivity to chlorhexidine products
  • Children who report allergy to dogs or sensitivity to dog allergen

Sites / Locations

  • Johns Hopkins
  • Washington University in St. Louis
  • Children's Hospital of PhiladelphiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

CHX Intervention A

CHX Intervention B

Arm Description

Dog-handler teams will follow established hospital and therapy dog program guidelines for infection control with no changes for eight sessions. Participants enrolled in the session will derive their Arm assignment from the dog-handler team with which they interact.

Dog-handler teams will follow a modified protocol for infection control, with Treatment A first for four sessions, and cross-over to Treatment B for four sessions. Participants enrolled in the session will derive their Arm assignment from the dog-handler team with which they interact. Treatment A consists of a pre-session shampoo with a commercial veterinary chlorhexidine-based product (2-4% chlorhexidine) within 24 hours prior to the session, and wiping with a chlorhexidine-impregnated cloth (2-4% chlorhexidine) at arrival at the session and every 20 minutes during the session, or between participants if the flow of participants is structured in a way that allows this (such as visits from one room to the next to visit individual patients).

Dog-handler teams will follow a modified protocol for infection control, with Treatment B first for four sessions, and cross-over to Treatment A for four sessions. Participants enrolled in the session will derive their Arm assignment from the dog-handler team with which they interact. Treatment B will consist of the same pre-session shampoo with a commercial veterinary chlorhexidine-based product (2-4% chlorhexidine), with a single wipe with a chlorhexidine-impregnated cloth (2-4% chlorhexidine) at arrival. This treatment will depend on the residual activity of chlorhexidine throughout the visit.

Outcomes

Primary Outcome Measures

Child MRSA exposure
MRSA exposure is defined as children who do not have detectable methicillin-resistant Staphylococcus aureus (MRSA) nasal carriage before the dog session who then have MRSA detection (MRSA nasal carriage) after the dog session.

Secondary Outcome Measures

Child Pseudomonas aeruginosa exposure
Pseudomonas aeruginosa exposure is defined as children who do not have detectable P. aeruginosa nasal carriage before the dog session who then have P. aeruginosa detection after the dog session.
Child and Dog Clostridium difficile prevalence
Positivity of child and dog for C. difficile at a session

Full Information

First Posted
November 14, 2019
Last Updated
June 29, 2023
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Children's Hospital of Philadelphia, University of Pennsylvania, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04171817
Brief Title
Animal-Assisted Visitation Program Chlorhexidine Trial
Official Title
Clinical Trial of a Disinfectant Intervention in Therapy Dogs to Combat Hospital-associated Pathogens and Promote Sustainability of Animal-Assisted Visitation Programs
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Children's Hospital of Philadelphia, University of Pennsylvania, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Hospital-based Animal-Assisted visitation programs are important complementary therapies, but concerns with infection control may challenge the sustainability of these programs. Pilot data suggest that a low-cost chlorhexidine-based intervention targeted to the dogs involved in the visitation programs holds high potential to prevent pathogen transmission during sessions. In this study, the following aims will be tested: 1) To identify program-related risk factors for acquisition of hospital-associated pathogens by pediatric patients during animal-assisted intervention (AAI) sessions during an initial run-in phase of no intervention; 2) To determine the effect of chlorhexidine (CHX)-based interventions on acquisition of hospital-associated pathogens and microbial communities by patients during AAI sessions via a multicenter randomized controlled trial; and 3) To determine whether the specific benefits achieved by the visitation program, i.e. reduction in blood pressure, heart rate and self-reported pain and anxiety, are impacted by the interventions.
Detailed Description
Hospital-based Animal-Assisted visitation programs provide an important complementary treatment in holistic patient care and reduce patient stress, pain and anxiety. However, the risk of transmission of pathogens, such as methicillin-resistant Staphylococcus aureus, is a challenge to the sustainability of hospital-based Animal-Assisted visitation programs. Pilot data suggest that a low-cost chlorhexidine-based intervention targeted to the dogs involved in the visitation programs holds high potential to prevent pathogen transmission during sessions. Therefore, child participants will be enrolled who interact with 40 dogs over twelve sessions (four observational, eight where the dog is randomized to intervention or control) at two enrollment centers. The following aims will be tested: 1) To identify program-related risk factors for acquisition of hospital-associated pathogens by pediatric patients during animal-assisted intervention (AAI) sessions during an initial run-in phase of no intervention; 2) To determine the effect of chlorhexidine (CHX)-based interventions on acquisition of hospital-associated pathogens and microbial communities by patients during AAI sessions via a multicenter randomized controlled trial; and 3) To determine whether the specific benefits achieved by the visitation program, i.e. reduction in blood pressure, heart rate and self-reported pain and anxiety, are impacted by the interventions. If findings support the hypothesis that chlorhexidine interventions are effective to prevent pathogen transmission through a multicenter, parallel-arm randomized controlled trial and does not reduce Animal-Assisted visitation program benefits to the children or impact the welfare of the therapy dogs, then this will provide strong evidence on which to base recommendations for infection control guidelines for programs nationally.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methicillin-resistant Staphylococcus Aureus, Clostridium Difficile, Pseudomonas Aeruginosa
Keywords
therapy dog, canine, animal assisted intervention, chlorhexidine, child

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This is a multicenter, parallel-arm randomized controlled trial, with 1:1 allocation for intervention versus control. Among those randomized to intervention, dog-handler teams will be additionally randomized to Intervention A first, with crossover to Intervention B, or to Intervention B first, with crossover to Intervention A.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
412 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Dog-handler teams will follow established hospital and therapy dog program guidelines for infection control with no changes for eight sessions. Participants enrolled in the session will derive their Arm assignment from the dog-handler team with which they interact.
Arm Title
CHX Intervention A
Arm Type
Experimental
Arm Description
Dog-handler teams will follow a modified protocol for infection control, with Treatment A first for four sessions, and cross-over to Treatment B for four sessions. Participants enrolled in the session will derive their Arm assignment from the dog-handler team with which they interact. Treatment A consists of a pre-session shampoo with a commercial veterinary chlorhexidine-based product (2-4% chlorhexidine) within 24 hours prior to the session, and wiping with a chlorhexidine-impregnated cloth (2-4% chlorhexidine) at arrival at the session and every 20 minutes during the session, or between participants if the flow of participants is structured in a way that allows this (such as visits from one room to the next to visit individual patients).
Arm Title
CHX Intervention B
Arm Type
Experimental
Arm Description
Dog-handler teams will follow a modified protocol for infection control, with Treatment B first for four sessions, and cross-over to Treatment A for four sessions. Participants enrolled in the session will derive their Arm assignment from the dog-handler team with which they interact. Treatment B will consist of the same pre-session shampoo with a commercial veterinary chlorhexidine-based product (2-4% chlorhexidine), with a single wipe with a chlorhexidine-impregnated cloth (2-4% chlorhexidine) at arrival. This treatment will depend on the residual activity of chlorhexidine throughout the visit.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine
Other Intervention Name(s)
CHX
Intervention Description
The goal of this work is to assess the effect of chlorhexidine (CHX)-based interventions--specifically use of pre-session chlorhexidine shampoo for the dog and use of chlorhexidine wipes on the dog's fur--on patient exposure to hospital-associated pathogens during the sessions with the dogs
Primary Outcome Measure Information:
Title
Child MRSA exposure
Description
MRSA exposure is defined as children who do not have detectable methicillin-resistant Staphylococcus aureus (MRSA) nasal carriage before the dog session who then have MRSA detection (MRSA nasal carriage) after the dog session.
Time Frame
Baseline through intervention completion, an average of 60 minutes
Secondary Outcome Measure Information:
Title
Child Pseudomonas aeruginosa exposure
Description
Pseudomonas aeruginosa exposure is defined as children who do not have detectable P. aeruginosa nasal carriage before the dog session who then have P. aeruginosa detection after the dog session.
Time Frame
Baseline through intervention completion, an average of 60 minutes
Title
Child and Dog Clostridium difficile prevalence
Description
Positivity of child and dog for C. difficile at a session
Time Frame
Baseline to intervention completion, an average of 60 minutes
Other Pre-specified Outcome Measures:
Title
Dog MRSA fur contamination difference
Description
Measure of dog dorsal fur ("petting zone") contamination with methicillin-resistant Staphylococcus aureus post session compared to pre session, reported as colony-forming units per dog per visit
Time Frame
Baseline through intervention completion, an average of 60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children between the ages of 3 and 17 years Cleared by physician to participate in a hospital-based animal-assisted visitation program session with any enrolled dog Exclusion Criteria: Children who report sensitivity to chlorhexidine products Children who report allergy to dogs or sensitivity to dog allergen
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meghan F Davis, DVM PhD
Phone
410-614-8283
Email
mdavis65@jhu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kaitlin Waite, DVM
Email
kwaite2@jhu.edu
Facility Information:
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghan F Davis, DVM PhD
Phone
410-614-8283
Email
mdavis65@jhu.edu
First Name & Middle Initial & Last Name & Degree
Meghan Davis, DVM PhD
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Kubrak, RRT-NPS; CCRC
First Name & Middle Initial & Last Name & Degree
Ron Rubenstein, MD PhD
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Donnely
Email
donnellye4@chop.edu
First Name & Middle Initial & Last Name & Degree
Clement Ren, MD MBA

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant meta-data will be linked to microbiome sequencing results and deposited to NCBI.
IPD Sharing Time Frame
Data will become available at the time of first publication of the sequencing results.
IPD Sharing Access Criteria
There are no specific access criteria instituted by the study. Access will be controlled by NCBI.

Learn more about this trial

Animal-Assisted Visitation Program Chlorhexidine Trial

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