Impulsar los recursos para el cuidado de la traqueostomía en el hogar (BREATHE)
Impulsar los recursos y el empoderamiento de los cuidadores para la atención de la traqueostomía en el hogar: un ensayo aleatorizado pragmático
The goal of this trial is to advance the understanding of how to best support caregivers of children with tracheostomies who are caring for their child at home. The main questions it aims to answer are:
- What are the best ways to support caregivers post-discharge with both medical and nonmedical decisions about resuming life, work, and family activities, while safely caring for their child with a tracheostomy at home?
- How can the investigators leverage existing technology to facilitate communication between inpatient and outpatient care teams to better support needs of pediatric patients and caregivers post-discharge?
Caregiver participants will be randomly assigned to receive Trach Me Home (gold standard discharge program) or Trach Me Home with additional components. Caregiver participants will complete three surveys over the course of 6 months. Researchers will see if caregivers in the Trach Me Home with additional components report lower caregiver burden at 4 weeks post discharge (primary outcome) and fewer hospital readmissions at 6 months than those in Trach Me Home arm.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study is focused on a rare and medically complex population of children with tracheostomies. The study is a Type I hybrid effectiveness-implementation study using a pragmatic randomized trial at six participating sites. The goal of this trial is to advance the understanding of how to best support caregivers of children with tracheostomies who are caring for their child at home. The main question[s] it aims to answer are:
- What are the best ways to support caregivers post-discharge with both medical and nonmedical decisions about resuming life, work, and family activities, while safely caring for their child with a tracheostomy at home?
- How can the investigators leverage existing technology to facilitate communication between inpatient and outpatient care teams to better support needs of pediatric patients and caregivers post-discharge?
Caregiver participants will randomly assigned to the Comparator arm (gold standard discharge program) or to the Intervention arm (gold standard program with other components). Caregiver participants will complete three surveys over the course of 6 months. The investigators will test two main hypotheses: the Intervention arm will have (1) significantly lower caregiver burden at 4 weeks post discharge (primary outcome) and (2) significantly lower readmissions or emergency room visits at 6 months post discharge than the Comparator arm.
The investigators will also survey pediatricians of participating patients at 6 months post discharge and examine whether intervention arm pediatricians have higher satisfaction with discharge communication than those in comparator arm.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
California
-
La Jolla, California, Estados Unidos, 92093
- University of San Diego Rady Children's Hospital
-
-
Maryland
-
Silver Spring, Maryland, Estados Unidos, 20910
- Children's National Medical Center, Children's Research Institute
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
-
-
Minnesota
-
Minneapolis, Minnesota, Estados Unidos, 55404
- Children's Hospitals and Clinics of Minnesota
-
-
Ohio
-
Cincinnati, Ohio, Estados Unidos, 45229
- Cincinnati Children's Hospital Medical Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 19146
- Children's Hospital of Philadelphia
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Lead or primary adult caregiver (18 or older) of infants or children (0-17 years old) with tracheostomy who are planning for discharge to home, including children who are dependent on ventilator
Exclusion Criteria:
- Patients transferred to other hospital or facility (and/or not discharged to home during study period)
- Primary caregiver unable to read or write in English, Spanish, Mandarin, or Arabic
- Not residing in the U.S. for at least 12 months after discharge
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Active Comparator Caregivers
TrachMeHome program delivered in the hospital including education, skills training and case management for caregivers |
The Trach Me Home discharge program includes caregiver education, skills training and case management. |
|
Experimental: Intervention Caregivers
Trach Me Home and Trach Plus with additional education, outpatient care team communication and social support for caregivers. |
The Trach Me Home discharge program includes caregiver education, skills training and case management. The Trach Plus program includes education, social support, and outreach to outpatient care team. |
|
Comparador activo: Active Comparator Physicians
Primary care physicians' of the enrolled participant's child receiving discharge communication |
The Trach Me Home discharge program includes caregiver education, skills training and case management. |
|
Experimental: Intervention Physicians
Primary care physicians' of the enrolled participant's child receiving outpatient care team communication prior to discharge |
The Trach Me Home discharge program includes caregiver education, skills training and case management. The Trach Plus program includes education, social support, and outreach to outpatient care team. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Caregiver Burden
Periodo de tiempo: 4 weeks post-discharge
|
Pediatric Tracheostomy Health Status Instrument (PTHSI) Caregiver burden subscale, total scores range from 0-68. Higher scores indicate higher burden. |
4 weeks post-discharge
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Medical Complications Associated with Tracheostomy
Periodo de tiempo: 6 months post-discharge
|
4-item modified Medical Complications Associated with Tracheostomy (MCAT) measure that includes 4 caregiver reported items to assess the total number of urgent medical visits, emergency room and readmissions for tracheostomy-related issues. Items are summed and scores start at 0 and there is no upper limit. Higher total numbers are worse. |
6 months post-discharge
|
|
6-month Readmission Rate
Periodo de tiempo: 6 months post-discharge
|
Percentage with one or more emergency room visits or hospital readmissions as documented in the electronic health record within 6 months of discharge. |
6 months post-discharge
|
|
Frequency of pediatrician communication
Periodo de tiempo: 6 months post-discharge
|
Percentage of pediatrician-specific communication with inpatient team prior to and/or shortly after discharge documented in electronic medical record or by pediatrician report. |
6 months post-discharge
|
|
Primary care pediatrician satisfaction
Periodo de tiempo: 6 months post-discharge
|
Clinician reported satisfaction with discharge communication scored from 0-100, higher scores indicate higher satisfaction with discharge communication. |
6 months post-discharge
|
|
Medical Complications Associated with Tracheostomy
Periodo de tiempo: 4 weeks post-discharge
|
4-item modified Medical Complications Associated with Tracheostomy (MCAT) measure that includes 4 caregiver reported items to assess the total number of urgent medical visits, emergency room and readmissions for tracheostomy-related issues. Items are summed and scores start at 0 and there is no upper limit. Higher total numbers are worse. |
4 weeks post-discharge
|
|
Caregiver Burden
Periodo de tiempo: 6 months post-discharge
|
Pediatric Tracheostomy Health Status Instrument (PTHSI) Caregiver burden subscale, total scores range from 0-68. Higher scores indicate higher burden. |
6 months post-discharge
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of readmissions
Periodo de tiempo: 6 months post discharge
|
The total number of electronic health record documented emergency room visits and hospital admissions will be collected, with higher numbers being worse (indicating more readmissions). |
6 months post discharge
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Karen Sepucha, PhD, Massachusetts General Hospital
- Investigador principal: Christopher Hartnick, MD, Massachusetts Eye and Ear Infirmary / Massachusetts General Hospital
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2023P001695
- IHS-2022C1-26100 (Otro número de subvención/financiamiento: Patient Centered Outcomes Research Institute (PCORI))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
To promote research replicability, transparency and future use of the data, de-identified data sets will be created and will be available, by request, to outside researchers.
The Data Package (comprised of the de-identified Analyzable Data Set, Full Protocol, metadata, data dictionary, full statistical analysis plan, and analytic code from the project) will be deposited in the Patient-Centered Outcomes Research Institute's Data Repository at the ICPSR. Participant information sheets for the study will indicate that de-identified information will be deposited in an open access service to promote use of the data by other researchers. No information that contains identifiers or that could be used to link an individual to the data will be included in the de-identified data set. No data will be provided from qualitative transcripts as this may lead to identifying information about participants. However, codes abstracted from qualitative transcripts may be made available.
Marco de tiempo para compartir IPD
After study results have been published, about 1 year after the end of the funded grant period, the study materials and de-identified data will be placed on an open access service such as ICPSR where they will be available indefinitely.
Criterios de acceso compartido de IPD
Researchers may access the data through the PCORI-designated repository (ICPSR's website) once it is made available.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .