Skip to main content
Clinical Trials/NCT05480930
NCT05480930
Recruiting
Not Applicable

Novel Approach to Improve Patient Care and Diarrheal Disease Research Using Mobile Technology in Haiti

University of Florida1 site in 1 country7,124 target enrollmentSeptember 27, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Telemedicine
Sponsor
University of Florida
Enrollment
7124
Locations
1
Primary Endpoint
Change in provider guideline adherence rates at the call center between use of the paper and digital clinical decision support tools (CDS).
Status
Recruiting
Last Updated
10 months ago

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 27, 2022
End Date
September 1, 2027
Last Updated
10 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

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).

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

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.

Secondary Outcomes

  • 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).)

Study Sites (1)

Loading locations...

Similar Trials