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

19 april 2018 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

182

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Kenia
      • Nairobi, Kenia
        • Kenyatta National Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

2 maanden tot 12 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: 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.
Actieve vergelijker: 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.
Ander: 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.
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Healthcare provider assessment rate of patient
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Association of number of healthcare provider assessments within 24 hours with survival to discharge.
Tijdsspanne: 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.
Tijdsspanne: 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).
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Seattle Children's Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

8 mei 2017

Primaire voltooiing (Werkelijk)

30 november 2017

Studie voltooiing (Werkelijk)

30 november 2017

Studieregistratiedata

Eerst ingediend

6 januari 2018

Eerst ingediend dat voldeed aan de QC-criteria

19 april 2018

Eerst geplaatst (Werkelijk)

2 mei 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 mei 2018

Laatste update ingediend die voldeed aan QC-criteria

19 april 2018

Laatst geverifieerd

1 april 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 24080017

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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