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

NCT05480930 | Recruiting

• 2 other identifiers: IRB202201220R21TW012332
• Study Type: interventional
• Target: 7,124
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Telemedicine; Pediatrics

Keywords

digital clinical decision support

Outcome Measures

Primary Outcomes (1)

• Change in provider guideline adherence rates at the call center between use of the paper and digital clinical decision support tools (CDS).

  We will evaluate the change in rates of provider guideline adherence at the call center between the 16 month period (minus 2 week wash out) where the existing paper CDS tools are used and the 16 month period (minus 2 week wash out) where the new digital CDS tools are used. Guideline adherence will be measured using the following features of the assessment and plan; severity determination and danger signs, provider household visit determination, and antibiotic and zinc prescriptions.

  Two 16 month intervention periods less the 2 week wash out.

Secondary Outcomes (3)

• Enumeration of clinical status of participants at 10-day follow up

  10 days

• Change in call duration between use of the paper and digital clinical decision support tools (CDS).

  From time incoming call is answered until treatment plan has been explained (approximately 10 to 20 minutes).

• Change in time to medication delivery between use of the paper and digital clinical decision support tools (CDS).

  From time incoming call is answered until medication is delivered to the participant's home (approximately 45-120 minutes).

Other Outcomes (2)

• Change in provider guideline adherence rates at the household between use of the paper and digital clinical decision support tools (CDS).

  Two 16 month intervention periods less the 2 week wash out.

• Qualitative feedback from TMDS providers

  Approximately 1 hour

Study Arms (2)

paper-based clinical decision support tool

ACTIVE COMPARATOR

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

Other: paper-based clinical decision support (dCDS) tool

digital clinical decision support (dCDS) tool

EXPERIMENTAL

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

Other: digital clinical decision support (dCDS) tool

Interventions

paper-based clinical decision support (dCDS) tool 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.

paper-based clinical decision support tool

digital clinical decision support (dCDS) tool 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.

digital clinical decision support (dCDS) tool

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• No consent

Sponsors & Collaborators

• University of Florida: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

CV Foundation

Gressier, Ouest, HT-6160, Haiti

RECRUITING

Related Links

• MotoMeds TMDS website at the University of Florida

MeSH Terms

Interventions

Equipment and Supplies

Study Officials

• Eric J Nelson, MD PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Molly B Klarman, MPH

CONTACT

509 4600-7486; mklarman@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 29, 2022
• Study Start: September 27, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 30, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will likely be made available within 1 year of the conclusion of the study.
• Access Criteria: The de-identified dataset will be deposited in a publicly available data depository such as Dryad.

Locations

HA (1)