Improving Nighttime Access to Care and Treatment (Part 2)

NCT03943654 | Completed

• 2 other identifiers: IRB201802920 -NDP5OD019893
• Study Type: observational
• Target: 391
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Diarrhea; Acute Respiratory Infection; Acute Febrile Illness

Keywords

Telemedicine; Diarrhea; Diarrhoea; mHealth; Healthline

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Determinants that correlate with seeking care at a medical facility

  Begins when the healthline call is placed and ends 8-12 days later.

Study Arms (3)

Children living within study delivery area w/o danger signs

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.

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

Children living outside study delivery area w/o danger signs

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.

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

Children who are identified as having danger signs

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.

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

Interventions

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.

Children living outside study delivery area w/o danger signs; Children living within study delivery area w/o danger signs; Children who are identified as having danger signs

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• emergent illness (danger signs present)

Sponsors & Collaborators

• University of Florida: lead
• National Institutes of Health (NIH): collaborator
• Universite d'Etat d'Haiti: collaborator

Study Sites (1)

University of Florida Public Health Research Laboratory

Gressier, Ouest, Haiti

Location

Related Publications (2)

• Klarman MB, Chi X, Cajusma Y, Flaherty KE, Capois AC, Dofine MDV, Exantus L, Friesen J, Beau de Rochars VM, Becker T, Baril C, Gurka MJ, Nelson EJ. Development and evaluation of a clinical guideline for a paediatric telemedicine service in a low-resource setting. BMJ Paediatr Open. 2024 Jan 8;8(1):e002164. doi: 10.1136/bmjpo-2023-002164.

  PMID: 38191203 DERIVED

• Klarman MB, Flaherty KE, Chi X, Cajusma Y, Capois AC, Vladimir Dofine MD, Exantus L, Friesen J, Beau de Rochars VM, Baril C, Gurka MJ, Becker TK, Nelson EJ. Implementation of a Pediatric Telemedicine and Medication Delivery Service in a Resource-limited Setting: A Pilot Study for Clinical Safety and Feasibility. J Pediatr. 2023 Jun;257:113304. doi: 10.1016/j.jpeds.2022.12.005. Epub 2022 Dec 14.

  PMID: 36528053 DERIVED

Related Links

• Eric Nelson Research Program at UF

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples and nasal swabs will be collected.

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Nelson, MD PHD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 9, 2019
• Study Start: September 9, 2019
• Primary Completion: January 19, 2021
• Study Completion: January 19, 2021
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

HA (1)