Family Assisted Severe Febrile Illness Therapy (FASTER) for Critically-ill Kenyan Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Seattle Children's Hospital
- Enrollment
- 182
- Locations
- 1
- Primary Endpoint
- Healthcare provider assessment rate of patient
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 2 Months to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: FASTER Assessment tool (Other)
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.
Intervention: FASTER Assessment tool (Other)
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.
Outcomes
Primary Outcomes
Healthcare provider assessment rate of patient
Time Frame: First 24 hrs after enrollment
Number of assessments of study patient by nurses or doctors within the 24 hrs intervention period
Secondary Outcomes
- Association of number of healthcare provider assessments within 24 hours with survival to discharge.(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).(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.(First 24 hrs after enrollment)
- Association of number of healthcare provider assessments within 24 hours with number of clinical procedures and interventions performed.(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(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.(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.(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(First 24 hrs after enrollment)
- Association of number of healthcare provider assessments within 24 hours with hospital length of stay.(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(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.(First 24 hrs after enrollment)
Investigators
Amelie von Saint Andre-von Arnim
Assistant Professor
Seattle Children's Hospital