Posílení zdrojů pro péči o tracheostomii doma (BREATHE)
Posílení zdrojů a zmocnění pečovatele pro péči o průdušnici doma: Pragmatická randomizovaná zkouška
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
California
-
La Jolla, California, Spojené státy, 92093
- University of San Diego Rady Children's Hospital
-
-
Maryland
-
Silver Spring, Maryland, Spojené státy, 20910
- Children's National Medical Center, Children's Research Institute
-
-
Massachusetts
-
Boston, Massachusetts, Spojené státy, 02114
- Massachusetts General Hospital
-
-
Minnesota
-
Minneapolis, Minnesota, Spojené státy, 55404
- Children's Hospitals and Clinics of Minnesota
-
-
Ohio
-
Cincinnati, Ohio, Spojené státy, 45229
- Cincinnati Children's Hospital Medical Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Spojené státy, 19146
- Children's Hospital of Philadelphia
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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. |
|
Experimentální: 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. |
|
Aktivní komparátor: 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. |
|
Experimentální: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Caregiver Burden
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Medical Complications Associated with Tracheostomy
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of readmissions
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Karen Sepucha, PhD, Massachusetts General Hospital
- Vrchní vyšetřovatel: Christopher Hartnick, MD, Massachusetts Eye and Ear Infirmary / Massachusetts General Hospital
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2023P001695
- IHS-2022C1-26100 (Jiné číslo grantu/financování: Patient Centered Outcomes Research Institute (PCORI))
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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.
Časový rámec sdílení 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.
Kritéria přístupu pro sdílení IPD
Researchers may access the data through the PCORI-designated repository (ICPSR's website) once it is made available.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ANALYTIC_CODE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .