Animal-Assisted Visitation Program Chlorhexidine Trial

Clinical Trial of a Disinfectant Intervention in Therapy Dogs to Combat Hospital-associated Pathogens and Promote Sustainability of Animal-Assisted Visitation Programs

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.

Study Overview

• Status: Recruiting
• Conditions: Methicillin-resistant Staphylococcus Aureus; Pseudomonas Aeruginosa; Clostridium Difficile
• Intervention / Treatment: Drug: Chlorhexidine

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.

• Study Type: Interventional
• Enrollment (Estimated): 412
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Meghan F Davis, DVM PhD; Phone Number: 410-614-8283; Email: mdavis65@jhu.edu
• Study Contact Backup: Name: Kaitlin Waite, DVM; Email: kwaite2@jhu.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Not yet recruiting
      • Johns Hopkins
      • Contact: Meghan F Davis, DVM PhD; Phone Number: 410-614-8283; Email: mdavis65@jhu.edu
      • Principal Investigator: Meghan Davis, DVM PhD
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Not yet recruiting
      • Washington University in St. Louis
      • Principal Investigator: Ron Rubenstein, MD PhD
      • Contact: Christina Kubrak, RRT-NPS; CCRC
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Children's Hospital of Philadelphia
      • Contact: Erin Donnely; Email: donnellye4@chop.edu
      • Principal Investigator: Clement Ren, MD MBA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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.
Experimental: CHX Intervention A; 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).	Drug: Chlorhexidine; 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; Other Names: CHX
Experimental: CHX Intervention B; 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.	Drug: Chlorhexidine; 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; Other Names: CHX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline through intervention completion, an average of 60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline through intervention completion, an average of 60 minutes
Child and Dog Clostridium difficile prevalence	Positivity of child and dog for C. difficile at a session	Baseline to intervention completion, an average of 60 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dog MRSA fur contamination difference	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	Baseline through intervention completion, an average of 60 minutes

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Children's Hospital of Philadelphia; University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: child; chlorhexidine; therapy dog; canine; animal assisted intervention
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pseudomonas Infections; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: R01HD097692 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• 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