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Improving Nighttime Access to Care and Treatment; Part 4-Haiti

NCT ID: NCT05480930

Last Updated: 2025-06-30

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

RECRUITING

Clinical Phase

NA

Total Enrollment

7124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-27

Study Completion Date

2027-09-30

Brief Summary

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Children in resource-limited settings who develop illness at night are often isolated from care, resulting in progression to an emergency. A telemedicine and medication delivery service (TMDS) is a viable healthcare delivery option to bridge the gap in nighttime care. This interrupted time series study (pre/post) will evaluate a digital clinical decision-support (dCDS) tool. The objective is to assess if the tool is associated with an improvement in guideline adherence by TMDS providers.

Detailed Description

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Acute respiratory infection and diarrheal disease are the two leading causes of pediatric death between 1 month and 5 years of age globally. These common problems have well-established low-cost treatments. However, these treatments are most effective when administered early which is difficult in resource-limited settings, especially at night. Based on five years of formative NIH-funded research, the team has built a Telemedicine and Medication Delivery Service (TMDS) in Haiti to improve nighttime access to care and treatment for children called MotoMeds. The strategic plan is to design, deploy and evaluate MotoMeds by conducting four clinical studies titled Improving Nighttime Access to Care and Treatment (INACT1/2/3/4) in Haiti. INACT1-H was a needs assessment (2018-2019), INACT2-H was a pre-pilot deployment of MotoMeds that compared the congruence of clinical assessments at the call-center to in-person household assessments by providers (2019-2020), and INACT3-H was a pilot of a scalable model of MotoMeds that had provider assessment only at the call-center for most non-severe cases and had provider assessment at both the call-center and household for some non-severe/ moderate cases. In addition, the central call center serviced a geographically distant delivery zone, demonstrating proof of concept for a fully scaled model. INACT4-H will evaluate a digital clinical decision support (dCDS) tool designed for use at a pediatric TMDS in an interrupted time series study. The pre-intervention is use of the existing paper CDS tool and the intervention is use of the dCDS tool. This initiative is significant because it uses telemedicine and medication delivery to address one of the most fundamental challenges in pediatrics early access to pediatric healthcare.

Conditions

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Telemedicine Pediatrics

Keywords

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digital clinical decision support

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

This study is an interrupted time series trial where the pre-intervention period will employ existing paper clinical decision support tools and the intervention period will employ a new digital clinical decision support tool. A small fraction of participants will participate in both the pre-intervention and post-intervention periods but most will only participate in one.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Participants who are consulted/examined by telephone only will be masked to which arm they are participating in. Participants who are consulted/examined in-person will not be explicitly informed of the study arm but will be able to observe if the provider is using paper forms or an electronic device.

Study Groups

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paper-based clinical decision support tool

Providers at the TMDS will use the existing paper-based clinical decision support tools to consult/examine patients.

Group Type ACTIVE_COMPARATOR

paper-based clinical decision support (dCDS) tool

Intervention Type OTHER

The paper based clinical decision support tools currently employed at the TMDS that are used to triage, assess and generate treatment plans for pediatric patients.

digital clinical decision support (dCDS) tool

Providers at the TMDS will use the new digital clinical decision support (dCDS) tool to consult/examine patients.

Group Type EXPERIMENTAL

digital clinical decision support (dCDS) tool

Intervention Type OTHER

The intervention is a digitized version of the paper based clinical decision support tools currently employed at the TMDS that are used to triage, assess and generate treatment plans for pediatric patients.

Interventions

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paper-based clinical decision support (dCDS) tool

The paper based clinical decision support tools currently employed at the TMDS that are used to triage, assess and generate treatment plans for pediatric patients.

Intervention Type OTHER

digital clinical decision support (dCDS) tool

The intervention is a digitized version of the paper based clinical decision support tools currently employed at the TMDS that are used to triage, assess and generate treatment plans for pediatric patients.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children 10 years of age or younger with an acute illness
* Parent/guardian contacts the TMDS in regards to the illness during hours of operation
* Parental/guardian agreement to a waiver of documentation of consent when contact is by phone only OR written consent/assent at the household from the parent/guardian and child (7yrs and older) for participants who receive a household visit.

Exclusion Criteria

* No consent
Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fogarty International Center of the National Institute of Health

NIH

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 J Nelson, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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CV Foundation

Gressier, Ouest, Haiti

Site Status RECRUITING

Countries

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Haiti

Central Contacts

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Molly B Klarman, MPH

Role: CONTACT

Phone: 509 4600-7486

Email: [email protected]

Facility Contacts

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Molly Klarman, MPH

Role: primary

Related Links

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

MotoMeds TMDS website at the University of Florida

Other Identifiers

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R21TW012332

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB202201220

Identifier Type: -

Identifier Source: org_study_id