Clinical trial NCT03943654: Improving Nighttime Access to Care and Treatment (Part 2)
Official title: Novel Approach to Improve Patient Care and Diarrheal Disease Research Using Mobile Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Diarrhea
Acute Respiratory Infection
Acute Febrile Illness
Keywords: Telemedicine
Diarrhea
Diarrhoea
mHealth
Healthline
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Universite d'Etat d'Haiti
First posted: 2019-05-09
Enrollment: 391
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* age of patient must be 10 years or younger
* patient must reside inside the study delivery area
* consent/assent to participate

Exclusion Criteria:

* emergent illness (danger signs present)

Primary outcomes:
measure: Congruence between phone and in person clinical assessment.
timeFrame: Begins when the healthline call is placed and ends once the nurse has completed the household visit; approximately 1-3 hours.
Secondary outcomes:
measure: Determinants that correlate with seeking care at a medical facility
timeFrame: Begins when the healthline call is placed and ends 8-12 days later.
Other outcomes:
Locations:
city: Gressier
country: Haiti
facility: University of Florida Public Health Research Laboratory
state: Ouest
Study officials:
affiliation: University of Florida
name: Eric Nelson, MD PHD
role: PRINCIPAL_INVESTIGATOR
References: