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Improving Nighttime Access to Care and Treatment (Part 2)

Novel Approach to Improve Patient Care and Diarrheal Disease Research Using Mobile Technology

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03943654
Acronym
INACT2
Enrollment
391
Registered
2019-05-09
Start date
2019-09-09
Completion date
2021-01-19
Last updated
2022-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Diarrhea, Acute Febrile Illness, Acute Respiratory Infection

Keywords

Telemedicine, Diarrhea, Diarrhoea, mHealth, Healthline

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.

Interventions

OTHERMotoMeds 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.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Universite d'Etat d'Haiti
CollaboratorOTHER
University of Florida
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
No minimum to 10 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Congruence between phone and in person clinical assessment.Begins when the healthline call is placed and ends once the nurse has completed the household visit; approximately 1-3 hours.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.

Secondary

MeasureTime frameDescription
Determinants that correlate with seeking care at a medical facilityBegins when the healthline call is placed and ends 8-12 days later.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.

Countries

Haiti

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026