Clinical trial NCT03513861: Family Assisted Severe Febrile Illness Therapy for Critically-ill Kenyan Children
Official title: Family Assisted Severe Febrile Illness Therapy (FASTER) for Critically-ill Kenyan Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Febrile Illness
Keywords: Low and Middle Income Countries
Limited resource settings
Early warning signs
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2018-05-02
Enrollment: 182
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Healthcare provider assessment rate of patient
timeFrame: First 24 hrs after enrollment
Secondary outcomes:
measure: Association of number of healthcare provider assessments within 24 hours with survival to discharge.
timeFrame: First 24 hrs after enrollment
measure: Association of number of healthcare provider assessments within 24 hours with hospital length of stay.
timeFrame: First 24 hrs after enrollment
measure: Association of number of healthcare provider assessments within 24 hours with need of patient transfer to the pediatric ICU (PICU).
timeFrame: First 24 hrs after enrollment
measure: Association of number of healthcare provider assessments within 24 hours with need of patient transfer from the acute room to the regular pediatric ward.
timeFrame: First 24 hrs after enrollment
measure: Association of number of healthcare provider assessments within 24 hours with number of clinical procedures and interventions performed.
timeFrame: First 24 hrs after enrollment
measure: 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
timeFrame: First 24 hrs after enrollment
measure: 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.
timeFrame: First 24 hrs after enrollment
measure: Initial PEWS and change in PEWS score over 24 hrs in intervention vs control group will be correlated with mortality.
timeFrame: First 24 hrs after enrollment
measure: Proportion of concordant FASTER assessments between parents and research team for Aim 1 patients and Aim 2 intervention group patients
timeFrame: First 24 hrs after enrollment
measure: 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
timeFrame: First 24 hrs after enrollment
measure: Association of parental level of education with correct parental severity of illness level assessment compared to research team assessments in intervention group patients.
timeFrame: First 24 hrs after enrollment
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Kenyatta National Hospital
Study officials:
References:
citation: von Saint Andre-von Arnim AO, Kumar RK, Clark JD, Wilfond BS, Nguyen QP, Mutonga DM, Zimmerman JJ, Oron AP, Walson JL. Family-Assisted Severity of Illness Monitoring for Hospitalized Children in Low-Resource Settings-A Two-Arm Interventional Feasibility Study. Front Pediatr. 2022 May 23;10:804346. doi: 10.3389/fped.2022.804346. eCollection 2022.
citation: von Saint Andre-von Arnim AO, Kumar RK, Oron AP, Nguyen QP, Mutonga DM, Zimmerman J, Walson JL. Feasibility of Family-Assisted Severity of Illness Monitoring for Hospitalized Children in Low-Income Settings. Pediatr Crit Care Med. 2021 Feb 1;22(2):e115-e124. doi: 10.1097/PCC.0000000000002582.