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

Seattle Children's Healthcare System

Status: Completed

Conditions: Febrile Illness; Critical Illness

Treatments: Other: FASTER Assessment tool

Study type: Interventional

Funder types: Other

Identifiers

NCT03513861

24080017

Details and patient eligibility

About

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.

Enrollment: 182 patients

Sex: All

Ages: 2 months to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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182 participants in 3 patient groups

Aim 1: Parental FASTER tool training

Experimental group

Description:

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.

Treatment:

Other: FASTER Assessment tool

Aim 2: Intervention group

Active Comparator group

Description:

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.

Treatment:

Other: FASTER Assessment tool

Aim 2: Control Group

No Intervention group

Description:

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.