Improving Nighttime Access to Care and Treatment (Part 2)

Acute Respiratory Infection Clinical Trial

— INACT2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03943654
• Other study ID #: IRB201802920 -N
• Secondary ID: DP5OD019893
• Status: Completed
• Start date: September 9, 2019
• Est. completion date: January 19, 2021

Study information

• Verified date: July 2022
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 391
• Est. completion date: January 19, 2021
• Est. primary completion date: January 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Diarrhea
• Acute Febrile Illness
• Acute Respiratory Infection
• Diarrhea
• Respiratory Tract Infections

Intervention

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.

Locations

Country	Name	City	State
Haiti	University of Florida Public Health Research Laboratory	Gressier	Ouest

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	National Institutes of Health (NIH), Universite d'Etat d'Haiti

Country where clinical trial is conducted

Haiti, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Begins when the healthline call is placed and ends once the nurse has completed the household visit; approximately 1-3 hours.
Secondary	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.	Begins when the healthline call is placed and ends 8-12 days later.

External Links

•   Eric Nelson Research Program at UF