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Family Assisted Severe Febrile Illness Therapy for Critically-ill Kenyan Children (FASTER)

19 kwietnia 2018 zaktualizowane przez: Amelie von Saint Andre-von Arnim, Seattle Children's Hospital

Family Assisted Severe Febrile Illness Therapy (FASTER) for Critically-ill Kenyan Children

The purpose of this pilot study is to improve inpatient monitoring of severely-ill children admitted to the hospital in low resource settings at Kenyatta National Hospital in Nairobi, Kenya. Given the high ratio of patients to medical staff in these settings, the lack of reliable patient monitoring tools, and the high rate of early inpatient mortality, we will prospectively train parents as monitoring aids of their hospitalized children. Early recognition and intervention in critical illness is important to avoid (further) organ failure. Parents will be taught how to assess their child's mental status, work of breathing and capillary refill time which will inform a 3-point severity of illness scale. The severity of illness will be conveyed by the parents to the medical staff via color-coded flag system. The goal is to increase the healthcare provider patient reassessment rate according to patients' level of severity to assist in early recognition and treatment of patients' deterioration.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

182

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Kenia
      • Nairobi, Kenia
        • Kenyatta National Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

2 miesiące do 12 lat (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Admitted to Kenyatta National Hospital with severe febrile illness which includes presumed malaria, sepsis or septic shock, pneumonia, meningitis or encephalitis
  • Available adult caregiver
  • Enrollment within the first 8 hours of admission to the pediatric ward (modified to 16 hrs later)

Exclusion Criteria:

  • Primary cause of admission is major bleed or hemorrhagic shock, severe trauma or burn, major surgery, known congenital heart disease
  • Previous study enrollment
  • No available adult caregiver
  • Caregiver unable to give informed consent
  • Caregiver not proficient in English or Swahili

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie sekwencyjne
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Aim 1: Parental FASTER tool training
The goal is to see whether the child's parent/ guardian can be trained in overall severity of illness assessment using the FASTER Tool, to match the performance of a professional.
Inny: FASTER Assessment tool
The FASTER assessment tool consists of monitoring mental status, respiratory distress and capillary refill time by parents of children admitted to the hospital with febrile illness. Parents in the intervention group are asked to monitor their child hourly with the FASTER tool and signal severity of illness to the healthcare team via color coded flag system. Number of healthcare provider - patient reassessments will be compared in intervention and control group.
Aktywny komparator: Aim 2: Intervention group
The intervention group parents will be taught the FASTER assessment tool. Intervention group parents will each be asked to monitor their own hospitalized child hourly using the FASTER assessment tool, and put up color-coded flags indicating severity of illness to the healthcare team. Parents will record the frequency of healthcare provider assessments of their child over the 24 hour intervention period.
Inny: FASTER Assessment tool
The FASTER assessment tool consists of monitoring mental status, respiratory distress and capillary refill time by parents of children admitted to the hospital with febrile illness. Parents in the intervention group are asked to monitor their child hourly with the FASTER tool and signal severity of illness to the healthcare team via color coded flag system. Number of healthcare provider - patient reassessments will be compared in intervention and control group.
Brak interwencji: Aim 2: Control Group
The control group parents will not be taught the FASTER assessment tool. Hence they will not be involved in monitoring their child, nor signaling severity of their child's illness per color-coded flag system. Control group parents will record the frequency of healthcare provider assessments of their child over the 24 hrs enrollment period.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Healthcare provider assessment rate of patient
Ramy czasowe: First 24 hrs after enrollment
Number of assessments of study patient by nurses or doctors within the 24 hrs intervention period
First 24 hrs after enrollment

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Association of number of healthcare provider assessments within 24 hours with survival to discharge.
Ramy czasowe: First 24 hrs after enrollment
Number of healthcare provider assessments will be associated with survival to discharge.
First 24 hrs after enrollment
Association of number of healthcare provider assessments within 24 hours with hospital length of stay.
Ramy czasowe: First 24 hrs after enrollment
Number of healthcare provider assessments will be associated with hospital length of stay.
First 24 hrs after enrollment
Association of number of healthcare provider assessments within 24 hours with need of patient transfer to the pediatric ICU (PICU).
Ramy czasowe: First 24 hrs after enrollment
Number of healthcare provider assessments will be associated with need for transfer to the PICU.
First 24 hrs after enrollment
Association of number of healthcare provider assessments within 24 hours with need of patient transfer from the acute room to the regular pediatric ward.
Ramy czasowe: First 24 hrs after enrollment
Number of healthcare provider assessments will be associated with need for patient transfer from the acute room that provides closer monitoring to regular pediatric ward.
First 24 hrs after enrollment
Association of number of healthcare provider assessments within 24 hours with number of clinical procedures and interventions performed.
Ramy czasowe: First 24 hrs after enrollment
Number of healthcare provider assessments will be associated with the number of clinical procedures performed on patients. Invasive clinical procedures include, but are not limited to lumbar puncture, thoracentesis, abscess drainage). Interventions included are blood transfusion given; antibiotics or antimalarials given; fluid bolus given.
First 24 hrs after enrollment
Association of number of healthcare provider assessments within 24 hours with the change in Pediatric Early Warning Score (PEWS) between time of enrollment and 24 hour time point
Ramy czasowe: First 24 hrs after enrollment
Number of healthcare provider assessments will be associated with the change in patients' PEWS score between time of enrollment and 24 hrs status post enrollment. The bedside PEWS is measured by 6 components, including heart rate, systolic blood pressure, capillary refill time, respiratory rate, oxygen saturation, respiratory effort and oxygen therapy. The score ranges between zero to 24 point, with 24 point representing the highest severity level.
First 24 hrs after enrollment
Initial PEWS and change in PEWS from enrollment to 24 hrs in intervention vs control group will be correlated with the need for patients requiring transfer to PICU.
Ramy czasowe: First 24 hrs after enrollment
The goal of this outcome is to see if patients with equivalent levels of illness severity in both intervention and control group, exhibit differences in need for transfer to the intensive care unit.
First 24 hrs after enrollment
Initial PEWS and change in PEWS score over 24 hrs in intervention vs control group will be correlated with mortality.
Ramy czasowe: First 24 hrs after enrollment
The goal of this outcome is to see if patients with equivalent levels of illness severity in both intervention and control group, exhibit differences in mortality.
First 24 hrs after enrollment
Proportion of concordant FASTER assessments between parents and research team for Aim 1 patients and Aim 2 intervention group patients
Ramy czasowe: First 24 hrs after enrollment
The goal of this outcome is to assess the accuracy of the parental FASTER assessments compared to the gold standard which is the research team's FASTER assessment.
First 24 hrs after enrollment
Correlation of PEWS score with Research team's FASTER tool assessments for Aim 1 patients and in both control and intervention group for Aim 2 patients
Ramy czasowe: First 24 hrs after enrollment
The bedside PEWS is measured by 6 components, including heart rate, systolic blood pressure, capillary refill time, respiratory rate, oxygen saturation, respiratory effort and oxygen therapy. The score ranges between zero to 24 point, with 24 point representing the highest severity level.
First 24 hrs after enrollment
Association of parental level of education with correct parental severity of illness level assessment compared to research team assessments in intervention group patients.
Ramy czasowe: First 24 hrs after enrollment
This outcome will assess if level of parental education has an impact on the correct use of the FASTER tool. There are up to 24 separate parental FASTER assessments and 4 research team assessments per patient. Parental and research team assessment have to occur within 1 hr of one another to qualify for comparison.
First 24 hrs after enrollment

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Seattle Children's Hospital

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

8 maja 2017

Zakończenie podstawowe (Rzeczywisty)

30 listopada 2017

Ukończenie studiów (Rzeczywisty)

30 listopada 2017

Daty rejestracji na studia

Pierwszy przesłany

6 stycznia 2018

Pierwszy przesłany, który spełnia kryteria kontroli jakości

19 kwietnia 2018

Pierwszy wysłany (Rzeczywisty)

2 maja 2018

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

2 maja 2018

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

19 kwietnia 2018

Ostatnia weryfikacja

1 kwietnia 2018

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 24080017

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na FASTER Assessment tool

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Warunki

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Lokalizacje

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