An interventional study of paper-based clinical decision support (dCDS) tool and digital clinical decision support (dCDS) tool in Telemedicine and Pediatrics, sponsored by University of Florida. Recruiting at 1 site in Haiti. Open to participants aged Up to 10 Years. Per ClinicalTrials.gov, last updated 2025-06-30.
Sponsored by University of Florida · Not applicable, Interventional, and Other
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.
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.
University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
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Inclusion criteria for child, parent/guardian participants:
Exclusion criteria for child, parent/guardian participants:
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
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
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.
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.
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.
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).
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
Plan to share: Yes — The investigator will share a de-identified data set in a data depository such as Dryad.
Supporting information: 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.
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