Improving Nighttime Access to Care and Treatment; Part 4-Haiti (INACT4-H)

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.

Study Overview

• Status: Recruiting
• Conditions: Telemedicine; Pediatrics
• Intervention / Treatment: Other: paper-based clinical decision support (dCDS) tool; Other: digital clinical decision support (dCDS) tool

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.

• Study Type: Interventional
• Enrollment (Estimated): 2660
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Molly B Klarman, MPH; Phone Number: 509 4600-7486; Email: mklarman@ufl.edu

Study Locations

• Haiti
  • Ouest
    • Gressier, Ouest, Haiti, HT-6160
      • Recruiting
      • CV Foundation
      • Contact: Molly Klarman, MPH; Phone Number: 509 4600-7486; Email: mklarman@ufl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: paper-based clinical decision support tool; Providers at the TMDS will use the existing paper-based clinical decision support tools to consult/examine patients.	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.
Experimental: digital clinical decision support (dCDS) tool; Providers at the TMDS will use the new digital clinical decision support (dCDS) tool to consult/examine patients.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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).
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).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Eric J Nelson, MD PhD, University of Florida

Publications and helpful links

Helpful Links

• MotoMeds TMDS website at the University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2022
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: digital clinical decision support
• Other Study ID Numbers: IRB202201220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigator will share a de-identified data set in a data depository such as Dryad.
• IPD Sharing Time Frame: The data will likely be made available within 1 year of the conclusion of the study.
• IPD Sharing Access Criteria: The de-identified dataset will be deposited in a publicly available data depository such as Dryad.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No