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

ConditionsTelemedicine Pediatrics

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeUp to 10

SponsorUniversity of Florida

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

No consent

Trial design

Design model

Crossover

Treatments tested in this trial

paper-based clinical decision support (dCDS) tool
Other intervention
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
Other intervention
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.

Treatment groups

7,124 Participants

are divided into 2 treatment groups

Group A: paper-based clinical decision support toolActive comparator 1 intervention

Group B: digital clinical decision support (dCDS) toolExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Secondary outcomes

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

All families will receive a follow-up call at 10 days post initial call to MotoMeds. The family will be asked about the clinical status of the child with regards to the initial medical complaint (resolved, better, same, worse, died).

Time frame

10 days

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

Call duration is defined as the time elapsed from once the provider starts consulting the patient (filling out the case report form or face sheet) until the provider finishes the assessment and has communicated the treatment plan to the caller (prior to the consent process). The mean call duration while using the paper CDS will be compared to the mean call duration while using the digital CDS tool.

Time frame

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).

Time to medication delivery is defined as the time from once the provider starts consulting the patient (filling out the case report form or face sheet) until the driver (or driver and provider) arrives at the patient's home for delivery. The mean time to delivery while using the paper CDS will be compared to the mean time to delivery while using the digital CDS tool.

Time frame

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

Other outcomes

Change in provider guideline adherence rates at the household 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 household 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.

Time frame

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

Qualitative feedback from TMDS providers

Qualitative feedback from the provider perspective framed with respect to content, usability of the user-interface (e.g., haptic vs typed data entry, navigation), satisfaction and technical challenges (connectivity, malfunctions, inter-operability).

Time frame

Approximately 1 hour

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

Fogarty International Center of the National Institute of Health

Collaborator

Source ClinicalTrials.gov

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