Critical IllnessFASTERNCT03513861
Family Assisted Severe Febrile Illness Therapy for Critically-ill Kenyan Children
A study testing FASTER Assessment tool in people with Critical Illness and Febrile Illness, run by Seattle Children's Hospital at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 12 years
- Conditions the study is for
- Critical Illness, Febrile Illness
- What is being tested?
- FASTER Assessment tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteKenya
- Study dates
- 8 May 2017to 30 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Critical Illness, Febrile Illness
- Being tested
- FASTER Assessment tool
- Keywords
- Low and Middle Income Countries, Limited resource settings, Early warning signs
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FASTER Assessment toolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Aim 1: Parental FASTER tool training | Experimental | 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. Receives: Other: FASTER Assessment tool |
| Aim 2: Intervention group | Active comparator | 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. Receives: Other: FASTER Assessment tool |
| Aim 2: Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare provider assessment rate of patient
Number of assessments of study patient by nurses or doctors within the 24 hrs intervention period
Measured: First 24 hrs after enrollment
Secondary outcomes (11)
Association of number of healthcare provider assessments within 24 hours with survival to discharge.
Number of healthcare provider assessments will be associated with survival to discharge.
Measured: First 24 hrs after enrollment
Association of number of healthcare provider assessments within 24 hours with hospital length of stay.
Number of healthcare provider assessments will be associated with hospital length of stay.
Measured: 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).
Number of healthcare provider assessments will be associated with need for transfer to the PICU.
Measured: 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.
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.
Measured: First 24 hrs after enrollment
Association of number of healthcare provider assessments within 24 hours with number of clinical procedures and interventions performed.
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.
Measured: 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
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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.
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.
Measured: First 24 hrs after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start8 May 2017
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amelie von Saint Andre-von Arnim, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513861
- Sponsor's protocol ID
- 24080017
- Acronym
- FASTER
- Status last verified
- Apr 2018
- First submitted
- 6 Jan 2018
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
von Saint Andre-von Arnim AO, Kumar RK, Clark JD, Wilfond BS, Nguyen QP, Mutonga DM, Zimmerman JJ, Oron AP, Walson JL. Family-Assisted Severity of Illness Monitoring for Hospitalized Children in Low-Resource Settings-A Two-Arm Interventional Feasibility Study. Front Pediatr. 2022 May 23;10:804346. doi: 10.3389/fped.2022.804346. eCollection 2022.
PubMed 35676898von Saint Andre-von Arnim AO, Kumar RK, Oron AP, Nguyen QP, Mutonga DM, Zimmerman J, Walson JL. Feasibility of Family-Assisted Severity of Illness Monitoring for Hospitalized Children in Low-Income Settings. Pediatr Crit Care Med. 2021 Feb 1;22(2):e115-e124. doi: 10.1097/PCC.0000000000002582.
PubMed 33031354
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Assisted Severe Febrile Illness Therapy (FASTER) for Critically-ill Kenyan Children
- ClinicalTrials.gov ID
- NCT03513861
- Acronym / sponsor ID
- FASTER / 24080017
- Conditions
- Critical Illness, Febrile Illness
- Keywords
- Low and Middle Income Countries, Limited resource settings, Early warning signs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 8 May 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 2 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aim 1: Parental FASTER tool training | Experimental | Other: FASTER Assessment toolThe 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. |
| Aim 2: Intervention group | Active comparator | Other: FASTER Assessment toolThe 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. |
| Aim 2: Control Group | No intervention | –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. |
Who may qualify
- Ages
- 2 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FASTER Assessment toolThe 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. | Other | Aim 1: Parental FASTER tool training, Aim 2: Intervention group |
Primary outcome
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
11 secondary outcomes
Association of number of healthcare provider assessments within 24 hours with survival to discharge.
Time frame: First 24 hrs after enrollment
Association of number of healthcare provider assessments within 24 hours with hospital length of stay.
Time frame: 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).
Time frame: 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.
Time frame: First 24 hrs after enrollment
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Derived from this study: PubMed 35676898von Saint Andre-von Arnim AO, Kumar RK, Clark JD, Wilfond BS, Nguyen QP, Mutonga DM, Zimmerman JJ, Oron AP, Walson JL. Family-Assisted Severity of Illness Monitoring for Hospitalized Children in Low-Resource Settings-A Two-Arm Interventional Feasibility Study. Front Pediatr. 2022 May 23;10:804346. doi: 10.3389/fped.2022.804346. eCollection 2022.
- Derived from this study: PubMed 33031354von Saint Andre-von Arnim AO, Kumar RK, Oron AP, Nguyen QP, Mutonga DM, Zimmerman J, Walson JL. Feasibility of Family-Assisted Severity of Illness Monitoring for Hospitalized Children in Low-Income Settings. Pediatr Crit Care Med. 2021 Feb 1;22(2):e115-e124. doi: 10.1097/PCC.0000000000002582.
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FASTER Assessment tool in people with Critical Illness and Febrile Illness, run by Seattle Children's Hospital at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare provider assessment rate of patient (time frame: First 24 hrs after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03513861, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.