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Completed

NCT Number: NCT03513861

Family Assisted Severe Febrile Illness Therapy 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.

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Key information

Conditions

Critical Illness Disease Attributes Febrile Illness Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

2 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kenyatta National Hospital

Nairobi, Kenya

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FASTER Assessment tool

Other

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.

Primary outcomes

  1. 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

  1. Association of number of healthcare provider assessments within 24 hours with survival to discharge.

    Time frame: First 24 hrs after enrollment

    Number of healthcare provider assessments will be associated with survival to discharge.

  2. Association of number of healthcare provider assessments within 24 hours with hospital length of stay.

    Time frame: First 24 hrs after enrollment

    Number of healthcare provider assessments will be associated with hospital length of stay.

  3. Association of number of healthcare provider assessments within 24 hours with need of patient transfer to the pediatric ICU (PICU).

    Time frame: First 24 hrs after enrollment

    Number of healthcare provider assessments will be associated with need for transfer to the PICU.

  4. Association of number of healthcare provider assessments within 24 hours with need of patient transfer from the acute room to the regular pediatric ward.

    Time frame: 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.

  5. Association of number of healthcare provider assessments within 24 hours with number of clinical procedures and interventions performed.

    Time frame: 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.

  6. 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

    Time frame: 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.

  7. 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.

    Time frame: 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.

  8. Initial PEWS and change in PEWS score over 24 hrs in intervention vs control group will be correlated with mortality.

    Time frame: 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.

  9. Proportion of concordant FASTER assessments between parents and research team for Aim 1 patients and Aim 2 intervention group patients

    Time frame: 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.

  10. 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

    Time frame: 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.

  11. Association of parental level of education with correct parental severity of illness level assessment compared to research team assessments in intervention group patients.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Registry information

Official study title

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

Acronym: FASTER

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 2, 2018
Registry last updated
May 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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