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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pediatric ALL, Acute Disease

Intervention / Treatment
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* Other: MotoMeds pediatric telemedicine and medication delivery service (TMDS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MotoMeds users (parent/chid participant pairs)<br> | Other: MotoMeds pediatric telemedicine and medication delivery service (TMDS)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Healthcare Access, Nighttime