An observational study in Acute Diarrhea, Acute Respiratory Infection and Acute Febrile Illness, sponsored by University of Florida. Completed at 1 site in Haiti. Open to participants aged Up to 10 Years. Per ClinicalTrials.gov, last updated 2022-07-20.
Sponsored by University of Florida · Observational
Children in resource-limited settings who develop illness at night are often isolated from pre-emergency care, resulting in progression to an emergency because families are forced to wait until morning to seek care. This is especially true in Haiti based on needs assessments (INACT Part 1; INACT1) surrounding access to healthcare. This study (INACT Part 2; INACT2) seeks to improve access to care by establishing a health hotline (healthline) and mobile pharmacy for families with children who become ill at nighttime. The healthline will be staffed by medical professionals and will provide phone based assessment and treatment recommendations based on standard of care practices according to Haitian and WHO guidelines. The healthline will focus on pre-emergency patients (those without danger signs as defined by WHO guidelines). Emergent patients will be advised to bypass the healthline and seek immediate care at the nearest medical facility. In the event that a non-emergent patient requires access to basic medications or fluids and is logistically accessible, the mobile pharmacy service will be offered.
The specific aims of the study are as follows: Aim I. Evaluate congruence between healthline assessment over the phone and in-person assessment of participants (patients using the healthline) 10 years of age and younger. The investigators hypothesize that in-person assessments based on WHO guidelines will be discordant with those made by the healthline because the physical aspects of the call-center assessment will be performed by an untrained parent/ guardian. The study focuses on acute diarrheal disease (ADD) and acute respiratory illness (ARI) but is not exclusive to these two chief complaints. Aim II: Identify determinants that correlate with seeking care at a medical facility over the 8-12 day follow up period after the initial call. The findings from this study will determine if a healthline model is a safe and accurate method of providing high quality access to nighttime healthcare, averting the progression of non-emergent cases to emergencies.
877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.
This study's enrollment of 391 is above the median of 248 across 103 observational studies indexed under Diarrhea.
Browse Diarrhea studies →University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
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The healthine service will be advertised to residents in or approximate to a 5Km radius centered around the healthline office, which is in the community of La Reserve, Gressier, Haiti. There are approximately 12,632 households in this area covering 79 sq km.
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Exclusion Criteria:
Families who call the healthline service about a sick child (no danger signs) and live within the mobile pharmacy delivery area will receive illness assessments and treatment recommendations over the phone. Immediately following calls a nurse will conduct household visits to complete in-person assessments of the children. Illness progression will be tracked with a 8-12 day follow up call. The phone and in-person assessments will be compared to evaluate safety and accuracy of the healthline.
Other: MotoMeds Healthline- illness assessment and treatment recommendation for non-emergent cases by telephone
Families who call the healthline service about a sick child (no danger signs) and live outside the delivery area will receive illness assessments and treatment recommendations over the phone. Illness progression will be tracked with a 8-12 day follow up call.
Other: MotoMeds Healthline- illness assessment and treatment recommendation for non-emergent cases by telephone
Families who call the healthline service about a sick child and who are identified as having a danger sign will be directed to the nearest medical facility. Illness progression will be tracked with a 8-12 day follow up call.
Other: MotoMeds Healthline- illness assessment and treatment recommendation for non-emergent cases by telephone
The healthline uses a series of questions (based off of the WHO Integrated Management of Childhood Illness guidelines) asked to the parent of a sick child over the phone to remotely triage and assess the child's illness and then provide a treatment recommendation. MotoMeds is the accompanying motorcycle delivery service for basic medication delivery at nighttime.
Congruence between phone and in person clinical assessment.
The responses parents give over the phone describing the child's illnesses will be compared to the routine clinical exam that the nurse performs in person. Clinical assessment features include vital signs, signs of work of breathings, and signs of dehydration per WHO and APP guidelines.
Time frame: Begins when the healthline call is placed and ends once the nurse has completed the household visit; approximately 1-3 hours.
Determinants that correlate with seeking care at a medical facility
A follow up call will be placed 8-12 days after the initial healthline call to investigate factors associated with seeking care at a medical facility after the initial call to the heathline service.
Time frame: Begins when the healthline call is placed and ends 8-12 days later.
Plan to share: No
Ran from Sep 2019 to primary completion in Jan 2021, 16 months.
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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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