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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-08

Study Completion Date

2017-11-30

Brief Summary

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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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Detailed Description

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Conditions

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Critical Illness Febrile Illness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

FASTER Assessment tool

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

FASTER Assessment tool

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

2 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No