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

Pediatric ALL Clinical Trial

— INACT2-G  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05506683
• Other study ID #: IRB202201648
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2022
• Est. completion date: January 2025

Study information

• Verified date: December 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. Over 9-months, the TMDS will be implemented in a Ghanaian community to evaluate the clinical safety and operational feasibility of implementing the service.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1365
• Est. completion date: January 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Disease
• Pediatric ALL

Intervention

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.

Locations

Country	Name	City	State
Ghana	National Ambulance Service	Accra	Accra Metropolitan District

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Ghana National Ambulance Service

Country where clinical trial is conducted

Ghana, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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

External Links

•   MotoMeds website