Telemedicine Clinical Trial
— INACT4-HOfficial title:
Novel Approach to Improve Patient Care and Diarrheal Disease Research Using Mobile Technology in Haiti
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.
Status | Recruiting |
Enrollment | 2660 |
Est. completion date | June 2025 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 10 Years |
Eligibility | Inclusion criteria for child, parent/guardian participants: - 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 for child, parent/guardian participants: - No consent |
Country | Name | City | State |
---|---|---|---|
Haiti | CV Foundation | Gressier | Ouest |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
Haiti,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | Two 16 month intervention periods less the 2 week wash out. | |
Other | 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). | Approximately 1 hour | |
Primary | 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 | 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). | 10 days | |
Secondary | 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. | From time incoming call is answered until treatment plan has been explained (approximately 10 to 20 minutes). | |
Secondary | 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. | From time incoming call is answered until medication is delivered to the participant's home (approximately 45-120 minutes). |
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