Zwiększanie zasobów na opiekę nad tracheostomią w domu (BREATHE)
Zwiększanie zasobów i wzmacnianie pozycji opiekunów w zakresie opieki nad trachą w domu: pragmatyczna, randomizowana próba
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
California
-
La Jolla, California, Stany Zjednoczone, 92093
- University of San Diego Rady Children's Hospital
-
-
Maryland
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Silver Spring, Maryland, Stany Zjednoczone, 20910
- Children's National Medical Center, Children's Research Institute
-
-
Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02114
- Massachusetts General Hospital
-
-
Minnesota
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Minneapolis, Minnesota, Stany Zjednoczone, 55404
- Children's Hospitals and Clinics of Minnesota
-
-
Ohio
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Cincinnati, Ohio, Stany Zjednoczone, 45229
- Cincinnati Children's Hospital Medical Center
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-
Pennsylvania
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19146
- Children's Hospital of Philadelphia
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-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: 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. |
|
Eksperymentalny: 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. |
|
Aktywny komparator: 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. |
|
Eksperymentalny: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Caregiver Burden
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Medical Complications Associated with Tracheostomy
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of readmissions
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Karen Sepucha, PhD, Massachusetts General Hospital
- Główny śledczy: Christopher Hartnick, MD, Massachusetts Eye and Ear Infirmary / Massachusetts General Hospital
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2023P001695
- IHS-2022C1-26100 (Inny numer grantu/finansowania: Patient Centered Outcomes Research Institute (PCORI))
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu 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.
Ramy czasowe udostępniania 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.
Kryteria dostępu do udostępniania IPD
Researchers may access the data through the PCORI-designated repository (ICPSR's website) once it is made available.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ANALITYCZNY_KOD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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