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Animal-Assisted Visitation Program Chlorhexidine Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04171817
Recruitment Status : Not yet recruiting
First Posted : November 21, 2019
Last Update Posted : November 21, 2019
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
University of Pennsylvania
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

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.

Condition or disease Intervention/treatment Phase
Methicillin-resistant Staphylococcus Aureus Clostridium Difficile Pseudomonas Aeruginosa Drug: Chlorhexidine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 412 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Clinical Trial of a Disinfectant Intervention in Therapy Dogs to Combat Hospital-associated Pathogens and Promote Sustainability of Animal-Assisted Visitation Programs
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : May 1, 2023


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 Name: 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 Name: CHX




Primary Outcome Measures :
  1. Child MRSA exposure [ Time Frame: Baseline through intervention completion, an average of 60 minutes ]
    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 :
  1. Child Pseudomonas aeruginosa exposure [ Time Frame: Baseline through intervention completion, an average of 60 minutes ]
    Pseudonomonas 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.

  2. Child and Dog Clostridium difficile prevalence [ Time Frame: Baseline to intervention completion, an average of 60 minutes ]
    Positivity of child and dog for C. difficile at a session


Other Outcome Measures:
  1. Dog MRSA fur contamination difference [ Time Frame: Baseline through intervention completion, an average of 60 minutes ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04171817


Contacts
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Contact: Meghan F Davis, DVM PhD 410-614-8283 mdavis65@jhu.edu
Contact: Kaitlin Waite, DVM kwaite2@jhu.edu

Locations
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United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21205
Contact: Meghan F Davis, DVM PhD    410-614-8283    mdavis65@jhu.edu   
Principal Investigator: Meghan Davis, DVM PhD         
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Contact: Christina Kubrak         
Contact: Erin Donnely         
Principal Investigator: Ron Rubenstein, MD PhD         
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Children's Hospital of Philadelphia
University of Pennsylvania
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT04171817    
Other Study ID Numbers: R01HD097692 ( U.S. NIH Grant/Contract )
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant meta-data will be linked to microbiome sequencing results and deposited to NCBI.
Supporting Materials: Study Protocol
Time Frame: Data will become available at the time of first publication of the sequencing results.
Access Criteria: There are no specific access criteria instituted by the study. Access will be controlled by NCBI.

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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
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
therapy dog
canine
animal assisted intervention
chlorhexidine
child
Additional relevant MeSH terms:
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Pseudomonas Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents