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Completed

NCT Number: NCT03943654

Improving Nighttime Access to Care and Treatment (Part 2)

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.

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Key information

Age range

Up to 10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida Public Health Research Laboratory

Gressier, Ouest, Haiti

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MotoMeds Healthline- illness assessment and treatment recommendation for non-emergent cases by telephone

Other

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.

Primary outcomes

  1. Congruence between phone and in person clinical assessment.

    Time frame: 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 outcomes

  1. Determinants that correlate with seeking care at a medical facility

    Time frame: Begins 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institutes of Health (NIH)
  • Universite d'Etat d'Haiti

Registry information

Official study title

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

Acronym: INACT2

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 9, 2019
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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