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Completed

NCT Number: NCT05506683

Improving Nighttime Access to Care and Treatment; Part 2- 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. The TMDS will be implemented in three distinct Ghanaian community to evaluate the clinical safety, operational feasibility of implementing,and scalability of the service.

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Key information

Conditions

Pediatric ALL Acute Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

Up to 10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Ambulance Service

Accra, Accra Metropolitan District, GA-143-8975, Ghana

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MotoMeds pediatric telemedicine and medication delivery service (TMDS)

Other

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.

Primary outcomes

  1. The rate of guideline adherence at the call center.

    Time frame: 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 outcomes

  1. The rate of guideline adherence at the household.

    Time frame: 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.

  2. Sensitivity, specificity and congruence of clinical variables

    Time frame: 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.

  3. Participant clinical status at 8-12 days

    Time frame: 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.

Other outcomes

  1. Operational metrics: Duration of initial call and time to arrival at household

    Time frame: 1 hour

    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.

  2. Evaluate qualitative feedback from MotoMeds users

    Time frame: Between 8-12 days

    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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Ghana National Ambulance Service

Registry information

Official study title

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

Acronym: INACT2-G

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 18, 2022
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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