Improving Nighttime Access to Care and Treatment; Part 2- Ghana

Not Applicable

Recruiting

• Conditions: Acute Disease; Pediatric ALL
• Interventions: Other: MotoMeds pediatric telemedicine and medication delivery service (TMDS)

• Registration Number: NCT05506683
• Lead Sponsor: University of Florida

Brief Summary

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. The TMDS will be implemented in three distinct Ghanaian community to evaluate the clinical safety, operational feasibility of implementing,and scalability of the service.

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 children in Accra and Tamale. 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 Timeline

• Study First Submitted: 2022-08-17
• Study First Submitted QC: 2022-08-17
• Study First Posted: 2022-08-18
• Study Start: 2022-11-16
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-23
• Primary Completion: 2024-08
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1365

Inclusion Criteria

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

Child Participant

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MotoMeds users (parent/chid participant pairs)	MotoMeds pediatric telemedicine and medication delivery service (TMDS)	-

Primary Outcome Measures

Name	Time	Method
The rate of guideline adherence at the call center.	1 day	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.

Secondary Outcome Measures

Name	Time	Method
Sensitivity, specificity and congruence of clinical variables	1 day	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.
Participant clinical status at 8-12 days	Between 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.
The rate of guideline adherence at the household.	1 day	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.

Trial Locations

Locations (1)

National Ambulance Service; 🇬🇭 Accra, Accra Metropolitan District, Ghana