Improving Nighttime Access to Care and Treatment (Part 2)

Completed

• Conditions: Acute Diarrhea; Acute Respiratory Infection; Acute Febrile Illness
• Interventions: Other: MotoMeds Healthline- illness assessment and treatment recommendation for non-emergent cases by telephone

• Registration Number: NCT03943654
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-05-07
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-09
• Study Start: 2019-09-09
• Primary Completion: 2021-01-19
• Study Completion: 2021-01-19
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 391

Inclusion Criteria

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

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Exclusion Criteria

• emergent illness (danger signs present)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children who are identified as having danger signs	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.
Children living within study delivery area w/o danger signs	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 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.
Children living outside study delivery area w/o danger signs	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Determinants that correlate with seeking care at a medical facility	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.

Trial Locations

Locations (1)

University of Florida Public Health Research Laboratory; 🇭🇹 Gressier, Ouest, Haiti