Improving Nighttime Access to Care and Treatment (Part 2)

NCT ID: NCT03943654

Last Updated: 2022-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

391 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-09

Study Completion Date

2021-01-19

Brief Summary

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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

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Conditions

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Acute Diarrhea Acute Respiratory Infection Acute Febrile Illness

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

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

Intervention Type 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

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.

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

Intervention Type 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 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.

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

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)
Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Universite d'Etat d'Haiti

OTHER

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Nelson, MD PHD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida Public Health Research Laboratory

Gressier, Ouest, Haiti

Site Status

Countries

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Haiti

References

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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.

Reference Type DERIVED
PMID: 38191203 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36528053 (View on PubMed)

Related Links

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https://nelson.research.pediatrics.med.ufl.edu

Eric Nelson Research Program at UF

Other Identifiers

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DP5OD019893

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB201802920 -N

Identifier Type: -

Identifier Source: org_study_id

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