Acute Disease, Pediatric ALL
Conditions
Keywords
Telemedicine, Healthcare Access, Nighttime
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.
Interventions
OTHERMotoMeds 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.
Sponsors
Ghana National Ambulance Service
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 10 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Operational metrics: Duration of initial call and time to arrival at household | 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. |
| Evaluate qualitative feedback from MotoMeds users | 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. |
Countries
Ghana
Outcome results
None listed