Animal-Assisted Visitation Program Chlorhexidine Trial

Clostridium Difficile Clinical 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04171817
• Other study ID #: R01HD097692
• Status: Recruiting
• Phase: Phase 4
• Start date: May 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: June 2023
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: Meghan F Davis, DVM PhD
• Phone: 410-614-8283
• Email: mdavis65[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 412
• Est. completion date: December 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile
• Methicillin-resistant Staphylococcus Aureus
• Pseudomonas Aeruginosa
• Pseudomonas Infections

Intervention

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

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Children's Hospital of Philadelphia, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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