Clinical trial NCT05506683: Improving Nighttime Access to Care and Treatment; Part 2- Ghana
Official title: Pilot Implementation of a Nighttime Telemedicine and Medication Delivery Service to Increase Access to Pre-emergency Pediatric Care in Ghana
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric ALL
Acute Disease
Keywords: Telemedicine
Healthcare Access
Nighttime
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Ghana National Ambulance Service
First posted: 2022-08-18
Enrollment: 1365
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: The rate of guideline adherence at the call center.
timeFrame: 1 day
Secondary outcomes:
measure: The rate of guideline adherence at the household.
timeFrame: 1 day
measure: Sensitivity, specificity and congruence of clinical variables
timeFrame: 1 day
measure: Participant clinical status at 8-12 days
timeFrame: Between 8-12 days
Other outcomes:
measure: Operational metrics: Duration of initial call and time to arrival at household
timeFrame: 1 hour
measure: Evaluate qualitative feedback from MotoMeds users
timeFrame: Between 8-12 days
Locations:
city: Accra
country: Ghana
facility: National Ambulance Service
state: Accra Metropolitan District
Study officials:
affiliation: University of Florida
name: Torben K Becker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flaherty KE, Klarman MB, Cajusma Y, Schon J, Exantus L, Beau de Rochars VM, 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):1063-1071. doi: 10.4269/ajtmh.21-1068. Print 2022 Apr 6.
citation: 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.