TelemedicineINACT4-HNCT05480930
Improving Nighttime Access to Care and Treatment; Part 4-Haiti
A study testing paper-based clinical decision support (dCDS) tool and digital clinical decision support (dCDS) tool in people with Telemedicine and Pediatrics, run by University of Florida at 1 site in Haiti.
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. Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Telemedicine, Pediatrics
- What is being tested?
- paper-based clinical decision support (dCDS) tool and digital clinical decision support (dCDS) tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,124 participants
- Where
- 1 siteHaiti
- Study dates
- 27 Sep 2022to Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- No consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Haiti1 site, 1 recruiting
- Recruiting
CV Foundation
Gressier, Ouest, HT-6160
Molly Klarman, MPH, 509 4600-7486, mklarman@ufl.edu
About this study
Official 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.
Read the 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.
- Conditions
- Telemedicine, Pediatrics
- Being tested
- paper-based clinical decision support (dCDS) tool, digital clinical decision support (dCDS) tool
- Keywords
- digital clinical decision support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paper-based clinical decision support (dCDS) toolOther
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) toolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| paper-based clinical decision support tool | Active comparator | Providers at the TMDS will use the existing paper-based clinical decision support tools to consult/examine patients. Receives: Other: paper-based clinical decision support (dCDS) tool |
| digital clinical decision support (dCDS) tool | Experimental | Providers at the TMDS will use the new digital clinical decision support (dCDS) tool to consult/examine patients. Receives: Other: digital clinical decision support (dCDS) tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two 16 month intervention periods less the 2 week wash out.
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: From time incoming call is answered until medication is delivered to the participant's home (approximately 45-120 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start27 Sep 2022
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7,124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Eric J Nelson, MD PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480930
- Sponsor's protocol ID
- IRB202201220
- Other IDs
- R21TW012332
- Acronym
- INACT4-H
- Status last verified
- Jun 2025
- First submitted
- 19 Jul 2022
- Last updated
- 30 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigator will share a de-identified data set in a data depository such as Dryad.