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

Patrocinadores

Patrocinador principal: Johns Hopkins Bloomberg School of Public Health

Colaborador: Children's Hospital of Philadelphia
University of Pennsylvania
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Fuente Johns Hopkins Bloomberg School of Public Health
Resumen breve

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.

Descripción detallada

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.

Estado general Not yet recruiting
Fecha de inicio January 1, 2020
Fecha de Terminación May 1, 2023
Fecha de finalización primaria November 1, 2022
Fase Phase 4
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Child MRSA exposure Baseline through intervention completion, an average of 60 minutes
Resultado secundario
Medida Periodo de tiempo
Child Pseudomonas aeruginosa exposure Baseline through intervention completion, an average of 60 minutes
Child and Dog Clostridium difficile prevalence Baseline to intervention completion, an average of 60 minutes
Inscripción 412
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Chlorhexidine

Descripción: 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

Otro nombre: CHX

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 3 Years

Edad máxima: 17 Years

Voluntarios Saludables: No

Contacto general

Apellido: Meghan F Davis, DVM PhD

Teléfono: 410-614-8283

Email: [email protected]

Ubicación
Instalaciones: Contacto: Investigador:
Johns Hopkins | Baltimore, Maryland, 21205, United States Meghan F Davis, DVM PhD 410-614-8283 [email protected] Meghan Davis, DVM PhD Principal Investigator
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania, 19104, United States Christina Kubrak Ron Rubenstein, MD PhD Principal Investigator
Ubicacion Paises

United States

Fecha de verificación

November 2019

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 3
Grupo de brazo

Etiqueta: Control

Tipo: No Intervention

Descripción: 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.

Etiqueta: CHX Intervention A

Tipo: Experimental

Descripción: 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).

Etiqueta: CHX Intervention B

Tipo: Experimental

Descripción: 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.

Datos del paciente Yes
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Descripción del modelo de intervención: 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.

Propósito primario: Prevention

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov