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

19 avril 2018 mis à jour par: Amelie von Saint Andre-von Arnim, Seattle Children's Hospital

Family Assisted Severe Febrile Illness Therapy (FASTER) 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

182

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Kenya
      • Nairobi, Kenya
        • Kenyatta National Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

2 mois à 12 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: 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.
Comparateur actif: 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.
Autre: 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.
Aucune intervention: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Healthcare provider assessment rate of patient
Délai: First 24 hrs after enrollment
Number of assessments of study patient by nurses or doctors within the 24 hrs intervention period
First 24 hrs after enrollment

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Association of number of healthcare provider assessments within 24 hours with survival to discharge.
Délai: First 24 hrs after enrollment
Number of healthcare provider assessments will be associated with survival to discharge.
First 24 hrs after enrollment
Association of number of healthcare provider assessments within 24 hours with hospital length of stay.
Délai: First 24 hrs after enrollment
Number of healthcare provider assessments will be associated with hospital length of stay.
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).
Délai: First 24 hrs after enrollment
Number of healthcare provider assessments will be associated with need for transfer to the 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.
Délai: 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.
First 24 hrs after enrollment
Association of number of healthcare provider assessments within 24 hours with number of clinical procedures and interventions performed.
Délai: 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.
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
Délai: 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.
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.
Délai: 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.
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.
Délai: 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.
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
Délai: 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.
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
Délai: 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.
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.
Délai: 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.
First 24 hrs after enrollment

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Seattle Children's Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

8 mai 2017

Achèvement primaire (Réel)

30 novembre 2017

Achèvement de l'étude (Réel)

30 novembre 2017

Dates d'inscription aux études

Première soumission

6 janvier 2018

Première soumission répondant aux critères de contrôle qualité

19 avril 2018

Première publication (Réel)

2 mai 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 mai 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

19 avril 2018

Dernière vérification

1 avril 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 24080017

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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