Improving Nighttime Access to Care and Treatment; Part 2- Ghana (INACT2-G)

Pilot Implementation of a Nighttime Telemedicine and Medication Delivery Service to Increase Access to Pre-emergency Pediatric Care in Ghana

Globally, leading causes of death among children one month to 5 years old are pneumonia, diarrheal disease and malaria which are treatable early in the disease-course with low-cost medications. However, these diseases can progress to emergencies when access to care is delayed. In response, a telemedicine and medication delivery service (TMDS) was designed to improve nighttime access to pediatric care and treatment. Over 9-months, the TMDS will be implemented in a Ghanaian community to evaluate the clinical safety and operational feasibility of implementing the service.

Study Overview

• Status: Recruiting
• Conditions: Acute Disease; Pediatric ALL
• Intervention / Treatment: Other: MotoMeds pediatric telemedicine and medication delivery service (TMDS)

Detailed Description

Globally, leading causes of death among children one month to 5 years old are pneumonia, diarrheal disease and malaria which are treatable early in the disease-course with low-cost medications. However, these diseases can progress to emergencies when access to care is delayed. In response, a telemedicine and medication delivery service (TMDS) called MotoMeds was designed to overcome barriers to seeking care. MotoMeds targets the nighttime period when barriers to accessing care are highest. The TMDS was initially deployed in Haiti and will now be evaluated for generalizability and portability in Ghana.

The study objectives are to assess clinical safety and logistical feasibility of the TMDS. The study population is an urban resource-constrained area within Accra and the enrollment period is nine months. The workflow consists of parents/guardians calling the TMDS on their child's behalf, Emergency Medical Technicians (EMTs) referring severe cases to emergency services, EMTs performing a phone assessment for non-severe cases, and EMTs traveling to the child's household to perform an in-person exam, rapid diagnostic testing for malaria where indicated as per protocol, and to deliver protocolized medications for cases within a predefined delivery zone.

EMTs and the protocols/guidelines used are supervised by Ghanaian and US physicians.

Clinical safety and feasibility of the TMDS will be evaluated using patient and logistical metrics.

• Study Type: Interventional
• Enrollment (Estimated): 1365
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ghana
  • Accra Metropolitan District
    • Accra, Accra Metropolitan District, Ghana, GA-143-8975
      • Recruiting
      • National Ambulance Service
      • Contact: Katie E Flaherty, BS; Phone Number: 025-792-0072; Email: flahertyk@ufl.edu
      • Principal Investigator: Ahmed N Zakariah, MD, MPM, EMBA
      • Sub-Investigator: Maxwell Osei-Ampofo, MBChB, MBA, MPH
      • Sub-Investigator: Taiba Afaa Jibril, MD

Participation Criteria

Eligibility Criteria

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

Description

Child Participant Inclusion Criteria:

• Child ≤ 10 years
• Has an acute medical problem
• Provides written assent (if 10 years and receives a household visit)

Child Participant Exclusion Criteria:

• Child > 10 years
• Child does not have an acute medical problem
• Medical problem involves physical trauma or mental health
• Refusal of written assent (if 10 years and receives a household visit)

Parent/Guardian Participant Inclusion Criteria:

• Calls MotoMeds during operating hours
• Parent/guardian of a patient participant meeting inclusion criteria
• Adult (18 years or older)
• Provides written consent (household visit) or a waiver of documentation of consent (no household visit)

Parent/Guardian Participant Exclusion Criteria:

• Age < 18 years
• No written consent or waiver of documentation of consent
• Corresponding child does not meet inclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MotoMeds users (parent/chid participant pairs)

Other: MotoMeds pediatric telemedicine and medication delivery service (TMDS); The intervention is use of a pediatric TMDS. Eligible children experiencing acute illness are examined over the phone by EMTs who follow a set of clinical guidelines to triage, assess, and develop treatment plans for participants. To evaluate the TMDS and as a safety measure EMTs will also examine most participants in-person a their homes following the phone exam.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of guideline adherence at the call center.	Establish the rates of provider adherence to the TMDS clinical guidelines while performing assessments and generating treatment plans at the call center. Points of non-adherence will include severity assessments, missed danger signs and non-indicated or missed antibiotic prescriptions.	Entire 9 month study period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of guideline adherence at the household.	Establish the rates of provider adherence to the TMDS clinical guidelines while performing assessments and generating treatment plans at the household. Points of non-adherence will include severity assessments, missed danger signs and non-indicated or missed antibiotic prescriptions.	Full 9 month study period
Sensitivity, specificity and congruence of clinical variables	Determine sensitivity and specificity of each clinical variable at the call center using the in-person exam at the household as the reference standard. Establish congruence between call center and in-person assessment in terms of severity categorization, danger signs, disease type, and treatment plans.	Full 9 month study period
Participant clinical status at 8-12 days	Determine the clinical status of participants 8-12 days following their initial contact with the TMDS. Participant families will report the status (recovered, better, same, worse, died) to TMDS staff during a follow-up phone call.	Between 8-12 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operational metrics: Duration of initial call and time to arrival at household	Measure call duration, defined as the time elapsed from first contact between a parent/guardian and a MotoMeds call center provider until the patient's treatment plan has been relayed. Measure time to arrival at household, defined as the time elapsed from first contact between a parent/guardian and a MotoMeds call center provider until the MotoMeds team arrives at the participant's household. Data will be analyzed against benchmarks set in formative research.	Full 9 month study period
Evaluate qualitative feedback from MotoMeds users	Parent/guardian feedback will be collected on the clinical and quality aspects of the TMDS. Both quantitative and qualitative data will be analyzed to identify strengths and weaknesses of the TMDS design.	Full 9 month study period

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Ghana National Ambulance Service
• Investigators: Principal Investigator: Torben K Becker, MD, PhD, University of Florida

Publications and helpful links

General Publications

• Flaherty KE, Klarman MB, Cajusma Y, Schon J, Exantus L, de Rochars VMB, Baril C, Becker TK, Nelson EJ. A Nighttime Telemedicine and Medication Delivery Service to Avert Pediatric Emergencies in Haiti: An Exploratory Cost-Effectiveness Analysis. Am J Trop Med Hyg. 2022 Feb 21;106(4):1063-71. doi: 10.4269/ajtmh.21-1068. Online ahead of print.
• Flaherty KE, Zakariah AN, Vescio VA, Osei-Ampofo M, Mahama MN, Agongo V, Becker TK. The state of emergency medical technician education in Ghana. Afr J Emerg Med. 2020 Sep;10(3):107-110. doi: 10.1016/j.afjem.2020.01.009. Epub 2020 Mar 7.

Helpful Links

• MotoMeds website

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: August 17, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 18, 2022

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Telemedicine; Healthcare Access; Nighttime
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Acute Disease
• Other Study ID Numbers: IRB202201648

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified individual participant data (IDP) will be made publicly available through a data depository such as Dryad.
• IPD Sharing Time Frame: The de-identified IDP will likely be made available within 1 year of the conclusion of the study and will remain available indefinitely.
• IPD Sharing Access Criteria: The de-identified IDP will be publicly available.

Drug and device information, study documents

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