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

Telemedicine Clinical Trial

— INACT4-H  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05480930
• Other study ID #: IRB202201220
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2022
• Est. completion date: June 2025

Study information

• Verified date: May 2023
• Source: University of Florida
• Contact: Molly B Klarman, MPH
• Phone: 509 4600-7486
• Email: mklarman[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Pediatrics
• Telemedicine

Intervention

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

Locations

Country	Name	City	State
Haiti	CV Foundation	Gressier	Ouest

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

Haiti, 

Outcome

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).

External Links

•   MotoMeds TMDS website at the University of Florida