Clinical trial NCT05480930: Improving Nighttime Access to Care and Treatment; Part 4-Haiti
Official title: Novel Approach to Improve Patient Care and Diarrheal Disease Research Using Mobile Technology in Haiti
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Telemedicine
Pediatrics
Keywords: digital clinical decision support
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
First posted: 2022-07-29
Enrollment: 2660
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study is an interrupted time series trial where the pre-intervention period will employ existing paper clinical decision support tools and the intervention period will employ a new digital clinical decision support tool. A small fraction of participants will participate in both the pre-intervention and post-intervention periods but most will only participate in one.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in provider guideline adherence rates at the call center between use of the paper and digital clinical decision support tools (CDS).
timeFrame: Two 16 month intervention periods less the 2 week wash out.
Secondary outcomes:
measure: Enumeration of clinical status of participants at 10-day follow up
timeFrame: 10 days
measure: Change in call duration between use of the paper and digital clinical decision support tools (CDS).
timeFrame: From time incoming call is answered until treatment plan has been explained (approximately 10 to 20 minutes).
measure: Change in time to medication delivery between use of the paper and digital clinical decision support tools (CDS).
timeFrame: From time incoming call is answered until medication is delivered to the participant's home (approximately 45-120 minutes).
Other outcomes:
measure: Change in provider guideline adherence rates at the household between use of the paper and digital clinical decision support tools (CDS).
timeFrame: Two 16 month intervention periods less the 2 week wash out.
measure: Qualitative feedback from TMDS providers
timeFrame: Approximately 1 hour
Locations:
city: Gressier
country: Haiti
facility: CV Foundation
state: Ouest
Study officials:
affiliation: University of Florida
name: Eric J Nelson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: