E-PRIME dla dzieci z problemami medycznymi (E-PRIME)
Ulepszona opieka podstawowa dzięki telezdrowiu dla dzieci ze złożonymi problemami medycznymi
Children with medical complexity (CMC) have very high needs for health and support services. CMC have very rare diseases that involve multiple organ systems. As a result, all CMC have multiple chronic conditions and need care from many specialists and services. While there are important benefits to the child and family in living at home, the continuing need for complex medical care places a profound burden on caregivers. Telehealth has long been considered a potential solution to barriers in access to care for children. The purpose of this research is to test whether telehealth can help pediatric primary care providers (PCPs) as they treat, monitor, and manage children with medical complexity (CMC). Additionally, it is to reduce caregiver and child burden as well as improve care coordination between multiple providers.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
The specific aims of this study are to: compare the effectiveness of Enhanced Primary Care via Telehealth (E-PRIME) verses usual care in improving child-level appointment and outcome measures; compare the effectiveness of (E-PRIME) verses usual care in reducing caregiver stress and improving caregiver satisfaction in primary care and care coordination services; evaluate how acceptable, appropriate, and feasible E-PRIME is from the perspective of practice providers and staff, and caregivers. Telehealth has long been considered a potential solution to barriers in access to care for children. The purpose of this research is to test whether telehealth can help pediatric primary care providers (PCPs) as they treat, monitor, and manage children with medical complexity (CMC). Additionally, it is to reduce caregiver and child burden as well as improve care coordination between multiple providers.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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North Carolina
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Winston-Salem, North Carolina, Stany Zjednoczone, 27157
- Wake Forest University Health Sciences
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Less than 18 years of age on the date of enrollment (date consented)
- Presence of a chronic condition, defined as a health condition expected to last ≥ 12 months
- Complexity of the condition, defined as needing ongoing care with 4 sub-specialists/ services OR dependent on ≥ 1 technology (e.g. gastrostomy, tracheostomy, oxygen, ventilator, etc.)
Exclusion Criteria:
- CMC whose permanent address is outside of the state of North Carolina
- CMC at a long-term care facility
- CMC who are wards of the state, except when the caregiver is a legal guardian and can consent
- CMC whose caregivers do not speak English or Spanish
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: Delayed Enhanced Primary Care (E-PRIME) Group
Children will receive usual care before receiving E-PRIME intervention. |
Usual Care: Interdisciplinary complex care teams help coordinate appointments, facilitate communication between the many specialist providers involved in the child's care, support families, assist with practical needs, and are available as a resource (as consultants) for Primary Care Physicians (PCPs) to care for Children with Medical Complexity (CMC). The complex care teams in tertiary care children's hospital is the focus for providing comprehensive care for CMC. Enhanced Primary Care: The E-PRIME team will support the CMC and their caregivers with navigating the patient access portal and how to use the video visit platform for the telehealth visits. The physician or nurse of the E-PRIME team will create clinical summaries about CMC's visit to specialists and hospital and share this health information about CMC with his/her PCP to help the PCP provide care for CMC at home. A team of telehealth experts will help PCPs in using telehealth in their practice.
Inne nazwy:
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Eksperymentalny: Early Enhanced Primary Care (E-PRIME) Group
Subjects of this arm will receive E-PRIME intervention at the start of enrollment. |
The intervention has the following components: (A) The staff of the E-PRIME team will support the CMC and their caregivers with navigating the patient access portal and how to use the video visit platform for the telehealth visits. (B) The physician or nurse of the E-PRIME team will create clinical summaries about CMC's visit to specialists and hospital and share this health information about CMC with his/her PCP to help the PCP provide care for CMC at home. (C) A team of telehealth experts will help PCPs in using telehealth in their practice.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of Days Outside the Home (DOH)
Ramy czasowe: Baseline
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Number of hospital days + ER visit days + number of in-person appointments / child year |
Baseline
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Number of Days Outside the Home (DOH)
Ramy czasowe: Year 1
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Number of hospital days + ER visit days + number of in-person appointments / child year |
Year 1
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of Hospitalizations
Ramy czasowe: Year 1
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Number of hospitalizations/100-child years in the two groups. Number of hospitalizations during the observation period will be counted and the rate will be calculated as: [Number of hospitalizations/ observation period in years]*100. Planned admissions (i.e. elective surgeries, procedures, treatments, etc.) will be excluded. |
Year 1
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Number of Emergency Room (ER) visits
Ramy czasowe: Year 1
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Number of ER visits |
Year 1
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Number of Hospital Days
Ramy czasowe: Year 1
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Number of hospital days/observation period in years |
Year 1
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Appointment Completion Rate
Ramy czasowe: Year 1
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Proportion of scheduled appointments that were completed |
Year 1
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Change in Caregiver Burden scores
Ramy czasowe: Month 19
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Caregiver burden will be measured using the 15-item Impact on Family Scale- Revised which as 15 items and 4 domains - financial, family/social, personal strain, and mastery. Scores will range from 15 to 60. The higher the score the greater the impact. |
Month 19
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Change in Caregiver Satisfaction with coordination of care scores
Ramy czasowe: Month 19
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Caregiver satisfaction with coordination of care will be compared between the two groups and measured by the Family Experiences with Coordination of Care survey. Scores will range from 0 to 100 and each item will be measured independently. Higher scores indicate better care (i.e. care plans, coordination, visit summary content, etc.) |
Month 19
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Współpracownicy i badacze
Współpracownicy
Śledczy
- Główny śledczy: Savithri Nageswaran, MD, Wake Forest University Health Sciences
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
Inne numery identyfikacyjne badania
- IRB00102234
- TE-2022C3-30607 (Inny identyfikator: PCORI)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
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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