Clinical trial NCT04171817: 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
Overall status: RECRUITING
Phase: PHASE4
Conditions: Methicillin-resistant Staphylococcus Aureus
Clostridium Difficile
Pseudomonas Aeruginosa
Keywords: therapy dog
canine
animal assisted intervention
chlorhexidine
child
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
name: University of Pennsylvania
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-11-21
Enrollment: 412
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Child MRSA exposure
timeFrame: Baseline through intervention completion, an average of 60 minutes
Secondary outcomes:
measure: Child Pseudomonas aeruginosa exposure
timeFrame: Baseline through intervention completion, an average of 60 minutes
measure: Child and Dog Clostridium difficile prevalence
timeFrame: Baseline to intervention completion, an average of 60 minutes
Other outcomes:
measure: Dog MRSA fur contamination difference
timeFrame: Baseline through intervention completion, an average of 60 minutes
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Meghan F Davis, DVM, PhD
role: PRINCIPAL_INVESTIGATOR
References: