Pilot Implementation of a Nighttime Telemedicine and Medication Delivery Service to Increase Access to Pre-emergency Pediatric Care in Ghana
Phase: NA
Conditions: Pediatric ALL, Acute Disease
Sponsor: University of Florida

Pilot Implementation of a Nighttime Telemedicine and Medication Delivery Service to 
Increase Access to Pre-emergency Pediatric Care in Ghana 
 
NCT05506683 
 
April 4, 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

University of Florida IRB-01 
Protocol:  
1.     Project Title: Pilot Implementation of a Nighttime Telemedicine and Medication 
Delivery Service to Increase Access to Pre-emergency Pediatric Care in Ghana 
Subtitle: Improving Nighttime Access to Care and Treatment (INACT2-G) 
2.     Investigator(s): 
·  Torben K. Becker, MD PhD (UF PI) 
·  Eric J. Nelson, MD PhD (UF Co-Investigator) 
·  Katelyn E. Flaherty (UF Co-Investigator) 
·  Molly Klarman, MPH (UF Co-Investigator) 
·  Ahmed N. Zakariah, MD, MPM, EMBA, MPhil, FGCS (Ghana Co-Investigator) 
·  Maxwell Osei-Ampofo, MBChB, MBA, MPH, FGCS (Ghana Co-Investigator) 
·  Taiba Afaa Jibril, MD (Ghana Co-Investigator) 
·  Nathanael Smith, MD (Boston Medical Center Co-Investigator; Dr. Smith will teach 
EMTs, access identifiable data for the purpose of analyses) 
3.     Abstract 
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, especially in low- and middle- income countries (LMICs). In response, our team has 
designed a telemedicine and medication delivery service (TMDS) called MotoMeds to 
overcome barriers to seeking care. We target the nighttime period when barriers to accessing 
care are highest. Our strategic plan is to design, deploy and evaluate MotoMeds through the 
improving nighttime access to care and treatment (INACT) studies. The TMDS was initially 
deployed in Haiti and now will be evaluated for generalizability and portability in Ghana. In 
Ghana, we have initiated a formative needs assessment (INACT1-G) to inform the design and 
approach of the pilot implementation of the TMDS (INACT2-G). The study objectives are to 
assess clinical safety and logistical feasibility. The study population is an urban slum 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 travelling to the household to perform an exam and deliver protocoled 
medications for cases within the delivery zone. Eligibility criteria includes patient participants 
aged 0-10 years old with medical problem, parent/guardian participants calling on behalf of a 
patient participant, and TMDS staff aged 18 years and older. Written consent/assent will be 
obtained from patient and parent/guardian participants receiving a household visit. 
Parent/guardian participants who do not receive a household visit and TMDS staff will be 

offered a waiver of documentation of consent. Estimated enrollment is up to 1,365 child and 
parent/guardian participant pairs, 15 call center EMTs, 10 delivery drivers, and 3 on-call 
physicians. Clinical safety will be evaluated through guideline adherence, congruence analysis 
between call center and in-person assessments, and clinical status at 10 days. Feasibility will 
be evaluated in terms of logistical data, parent/guardian feedback, and TMDS staff feedback.  
4.     Background 
4.1 Pediatric health and healthcare. Pneumonia, diarrheal disease, and malaria are the first, 
second, and third leading causes of mortality for children between one month and 5 years of 
age globally1. Oral amoxicillin for bacterial pneumonia, oral rehydration solution for 
dehydration from diarrheal disease, and artesunate-amodiaquine for malaria can reduce 
mortality rates by 32%, 93% and 99.7%, respectively2, 3, 4. However, these treatments are most 
effective when administered early after symptoms start 5, 6, which is difficult when healthcare 
access is limited, especially at night. Delayed treatment, especially in children, can result in 
rapid progression to an emergent state5, 6. In LMICs emergency care is considerably more 
difficult to access and more expensive than pre-emergency care7; thus emergencies must be 
prevented in order to decrease pediatric mortality. The WHO/UNICEF action plan for Ending 
Preventable Child Deaths calls for innovation within the domains of “delivery strategies, 
overcoming barriers to interventions and better ways for implementation”8. 
Since the COVID-19 pandemic, telemedicine has gained accelerated interest as an innovative 
approach to improve access to care9, 10. By improving clinician efficiency and accessibility, 
telemedicine has the potential to overcome workforce as well as distance barriers11, 12. 
Successful pediatric use cases in LMICs include a virtual clinic for pediatric ambulatory 
surgical patients in Egypt13 and a telemedicine service for pediatric cancer and blood disorders 
in the Caribbean14. However, the need for physical assessments limits what can be 
accomplished via telemedicine alone15. A systematic review of interventions for improving 
access to healthcare for children under 5 in LMICs found “delivery of services close to home” 
was one of two interventions that was consistently associated with increased healthcare 
utilization16. Accordingly, community health worker programs (CHWPs) continue to gain 
prevalence17, 18, 19. CHWPs train community leaders to deliver healthcare resources directly to 
households in their neighborhood. These programs have been found to decrease both disease 
prevalence and mortality in LMICs 20, 21. However, such programs are largely limited to the 
daytime22.  
The rise and success of community paramedicine programs exemplifies the potential of 24-7 
telemedicine and medication delivery services. Community paramedicine is an evolving 
healthcare model in which EMTs operate in expanded roles to provide primary care to low-
resource communities. The scope of community paramedicine practice varies by settings but 
often includes education, vaccination, and basic medication/fluid administration. Community 
paramedicine programs have been shown to effectively decrease emergency department visits 
through the provision of preventative and chronic care services in high income countries23, 24.  
The potential for telemedicine and medication delivery services to avert emergencies through 
the provision of acute care services in LMICs remains to be realized.    

4.2 Health and healthcare in Ghana. The Ghanaian pediatric population could benefit from 
improved acute cares services. The Ghanaian National Ambulance Service (NAS), a 
nationwide Emergency Medical Services (EMS) agency, works to provide timely emergency 
care 25, 26. The NAS has prioritized EMS through the development of a Paramedic & 
Emergency Care Training School, operation of 297 EMS stations, and purchase of 307 new 
ambulances25.However, the endeavor has exposed unanticipated costs that limit sustainability 
and scalability27, 28. Both NAS personnel and the Ghanaian public express concern over NAS 
resources and response28, 29. Currently a major challenge is how to prevent and manage pre-
emergency cases that consume resources intended for emergencies30. 
To meet this need, Ghana Health Services manages a robust network of CHWPs31. CHWPs 
have worked under the National Expanded Programme on Immunisation (EPI) to increase 
complete vaccination coverage for children 12-23 months from 85% in 1998 to 95% in 201432. 
Further, CHWPs have been found to be instrumental in treating pediatric acute illnesses such 
as pneumonia, diarrhea, and malaria in Accra and Northern Ghana33; however, progress is 
insufficient.  
Ghana‘s U5M rate is 48 per 1,000 live births34 with malaria, acute respiratory illness, and 
diarrheal disease accounting for 20%, 13%, and 8% of the U5M rate, respectively35. Pediatric 
care in Ghana is compromised by a low level of general health education, shortage of 
healthcare personnel, and limited pediatric health facilities36. The ratio of medical doctors to 
population is 1: 9,43437. The 2014 Demographic and Health Survey found 43% of adult 
women–many mothers–were dissatisfied with primary care services38.   
4.3 Clinical considerations in Ghana. The high burden of malaria poses unique challenges to 
assessing and treating pediatric patients with fever. Conventional and point of care diagnostics 
play an important role. With respect to malaria, diagnostic modalities include polymerase 
chain reaction, smear microscopy, and rapid diagnostic testing. While polymerase chain 
reaction and smear microscopy are more sensitive than rapid diagnostic testing the need for 
conventional laboratory capabilities limits their use in point-of-care testing in low-resource 
settings. Performance metrics for rapid diagnostic testing vary widely up to 98% sensitivity 
and 92% specificity39. With respect to acute respiratory infection, diagnostic modalities 
include imaging, lung function tests, culture, and polymerase chain reaction. Rates of 
coinfection among outpatient febrile children under 10 in Tanzania were found to be frequent, 
with viral and bacterial co-infection being most common, but also co-infection of parasitic and 
bacterial and/or viral origin40. However, rates of single agent as well as dual agent infections in 
our study population are unknown. 
4.4 Feasibility Studies. Interventions must be assessed for feasibility to determine whether 
scaling and comprehensive evaluations are justified41. Feasibility studies focus on development 
of implementation strategies and refinement of research methods42, 43. Feasibility studies may 
be fixed–rigid in design–or flexible–allowing for changes during the course of the study44. 
Conventional feasibility metrics for healthcare interventions include demand45, 
implementation46, integration41, adherence47, cost-effectiveness48, clinical safety49, and 
acceptability50. However, there exists little guidance pertaining to feasibility thresholds. 
Rather, the theory and application of feasibility thresholds is widely questioned with the only 

consensus being that feasibility thresholds must be determined realistically with attention to 
circumstance44, 51.  
5.     Specific Aims: 
Aim I: Assess the clinical safety of a nighttime TMDS in a prospective cohort pilot study of 
pediatric patients 10 years and younger. Paired exams will be performed at the call center 
(virtual) and at the household (in-person).  
• The primary objectives are to determine the rate of guideline adherence at the call center 
(primary outcome measure) and household as well as evaluate congruence between call 
center and in-person assessment and determine clinical status at follow-up at 8-12 days. 
Aim II: Evaluate the feasibility of the TMDS model with respect to patients.  
• 
Logistical data on patient workflow will be collected (duration of call, time to delivery). 
Data will be analyzed against benchmarks set in formative research (call duration < 25 
minutes and time to delivery < 2 hours). 
• Parent/guardian feedback will be collected on the clinical, cost and quality aspects of the 
TMDS. Both quantitative and qualitative data will be analyzed to identify strengths and 
weaknesses of the TMDS design.  
Aim III: Evaluate the feasibility of the TMDS model from the perspective of the staff. 
• Data will be obtained from EMTs, drivers and on-call physician participants by 
questionnaires and focus groups. Domains of inquiry are clinical decision making, 
formulation of medications, communication with team members and households, and 
opportunities for improvement.  
• 
Data will be transcribed, evaluated for themes using an inductive code, and summarized 
for strengths and weaknesses of the TMDS design. 
 
 

6. Research Plan: 
6.1 Definitions 
ARI: Acute respiratory infection defined as the presence of fever and cough.  
EMT: Emergency medical technician trained to provide emergency medical services.  
Household (HH): A group of two or more individuals living in the same structure and share 
at least one daily meal 
INACT: Improving Nighttime Access to Care and Treatment. 
INACT1-H: Survey assessment in Haiti 
INACT2-H: Initial TMDS implementation in Haiti 
INACT1-G: Survey assessment in Ghana 
INACT2-G: TMDS implementation in Ghana 
RDT: Rapid diagnostic test.  
Telemedicine and Medication Delivery Service (TMDS): A service offering phone-based 
assessments and treatment plans as well as household medication delivery. 
6.2 Study design: Prospective cohort study (pilot). 
6.3 Population The population of this study will include residents in or approximate to the 
adjacent communities of Jamestown and Usshertown within Greater Accra (Figure 1). 
Jamestown and Usshertown are urban communities together known as Ga Mashie or Old 
Accra. Due to word of mouth, participants residing outside the study area may contact the 
TMDS; they will receive advice without corresponding delivery/household visits.  
Accra Metropolitan, the District in which Jamestown and Usshertown are located, has a 
youthful population; approximately 20% of the population is under the age of 10. Ghana‘s 
under-5 mortality rate is 48 per 1,000 live births34, with 57.1% of the population having 
access to satisfactory primary care38. Ghana ranks 133 out of 180 on the Flourishing Index52. 
6.4 Recruitment The TMDS (e.g. 
‘MotoMeds nighttime healthcare 
for children’) will be advertised to 
targeted communities within the 
study area. It will be promoted 
through flyers in an incremental 
manner at health facilities, 
schools, religious institutions, etc. 
as a service for families needing 
access to non-emergent healthcare 
for children 10 years and younger 
during the night. Messaging will 
clarify that the TMDS is a pilot 
initiative with a 9-month trial 
 
Figure 1. Approximate study area comprised of 
Jamestown and Usshertown 

period. In addition, audio messaging (radio and public announcements) may occur; content 
will be similar to that in the written advertisements. Ghana Health Services and local health 
promoters may assist with advertising efforts. Participants from INACT1-G (survey 
assessment, ongoing) will be actively notified of the service by phone; INACT1-G 
participants are consented to a 1-year follow-up period and/or follow-up until the post-study 
analysis has finished. 
6.5 Inclusion criteria and enrollment estimates  
6.5.1 Patient participant 
Inclusion criteria: 
1. Patient must be 10 years of 
age or younger  
2. Has a medical problem 
3. Provides written assent (10 
years and household visit). 
Exclusion Criteria: 
1. Patient older than 10 years 
2. Does not have a medical 
problem. 
3. Medical problem involves 
physical trauma or mental 
health.  
4. Refusal of assent (10 years 
and household visit). 
6.5.2 Parent/guardian participants 
Inclusion criteria: 
1. Calls MotoMeds during operating hours 
2. Parent/guardian of a patient participant meeting inclusion criteria 
3. Provides written consent (household visit) or waiver of consent of documentation (no 
household visit). 
Exclusion Criteria: 
5. No consent/waiver of documentation of consent 
6. Corresponding child participant does not meet inclusion criteria 
Enrollment estimates: Enrollment will be determined by the number of eligible patient and 
parent/guardian participants that contact MotoMeds call center. Based on staff capacity, 
advertising will be controlled to target 3-5 patients per night. As such, a minimum of 819 
and a maximum of 1365 patient and parent/guardian participant pairs will be enrolled. We 
estimate that loss of follow up at 8-12 days will be 10% (Figure 2). Repeat patients within 
 
Figure 2. CONSORT recruitment, enrollment, and 
analysis figure for patient participants. 

30 days will be excluded from analysis; other repeat patients will be considered unique 
participants. 
6.5.3 TMDS staff participants. 
Inclusion criteria: 
1. Age 18 years and older. 
2. TMDS staff member. 
Enrollment estimates: Call center EMT enrollment is estimated to be 5 to 15. Driver 
enrollment is estimated to be 5 to 10. On-call physician enrollment is estimated to be 1 to 3.  
6.6 Consent/Assent 
6.6.1 Patient participants receiving a household visit 
Written assent will be obtained from patient participants aged 10 years. Participants unable 
to sign may assent via fingerprint. Explanation of informed assent procedures may be 
obtained in English (official language of Ghana) or another locally spoken language (ex: 
Ga) in which the EMT obtaining consent and the participant providing consent are fluent as 
is common research practice in Ghana given that the Ga language is seldom written (see 
Gamada Letter of Support).  
6.6.2 Parent/guardian participants receiving a household visit 
Written consent to participate will be obtained in English from the parent/guardian of each 
patient who receives a household visit; all genders, including pregnant mothers will be 
included. Participants unable to sign may consent via fingerprint. Explanation of informed 
consent procedures may be obtained in English (official language of Ghana) or another 
locally spoken language (ex: Ga) in which the EMT obtaining consent and the participant 
providing consent are fluent as is common research practice in Ghana (see Gamada Letter of 
Support). 
6.6.3 Parent/guardian participants not receiving a household visit 
For parent/guardian participants that are not receiving a household visit due to danger signs 
present, met capacity, or failed/declined delivery, a waiver of documentation of consent will 
be presented at the time of the initial call or at the time of the follow-up call (either 24-hour 
or at the 8-12-day follow-up call). The rationale for the waiver of documentation of consent 
is that the survey questions pose no more than minimal risk and written consent is not 
logistically feasible. Explanation of informed consent procedures may be obtained in 
English (official language of Ghana) or another locally spoken language (ex: Ga) in which 
the EMT obtaining consent and the participant providing consent are fluent as is common 
research practice in Ghana (see Gamada Letter of Support). 
6.6.4 TMDS staff participating in questionnaire/focus group 

A waiver of documentation of consent to participate will be obtained in English from 
MotoMeds staff members. The rational is 
that staff focus groups are likely to be 
performed over Zoom or a similar video-
conferencing software.  
6.7 Workflow. The call center will operate 
during the nighttime (exact hours will be 
determined from INACT1-G). Staffing 
will be elastic to the needs of the call 
center case volume. If there are multiple 
calls at one time, the call center will be 
staffed to field 1-2 calls at a time. If the 
call volume is greater than expected, the 
calls will be placed on hold until a call 
center EMT is available. If the 
delivery/household visit volume is greater 
than the capacity to respond, the 
contingency plan is as follows: A 
restriction (‘cap’) will be activated such 
that no more than 3 participants can be waiting for a delivery at one time. If there are more 
than 3 participants waiting, the participants will receive advice by phone and will not 
receive a delivery/household visit. These cases will be recorded as study data. If volume 
consistently exceeds the planned capacity, the number of staff (EMTs and drivers) will be 
increased as funding allows.  
Call intake will be managed by the HIPAA-compliant call center software Twilio and case 
dispatch will be managed by the Beacon Crisis Response. Dispatch alerts via Beacon will 
include the caller’s name, phone number, location, as well as patient complaints; Beacon is 
also HIPAA-compliant. 
Severe cases, certain fever cases and cases with unsuccessful deliveries will be contacted by 
phone within 24 hours (maximum of 2 attempts over the course of another 24 hours) and all 
participants will be contacted (maximum of 3 attempts) at 8-12 days to ascertain disposition, 
if additional care was sought, and qualitative feedback about the service. Responses will be 
recorded on paper forms and/or directly into REDCap.  
Focus groups with TMDS staff will be performed to determine service usability and 
acceptability from an operational perspective.  
6.8 Clinical procedures. The clinical guidelines will adhere to Ghanaian and WHO 
standards of care and have been developed in collaboration with Ghanaian and US 
government experts in malaria. During each call it will be disclosed that the call center 
objectives are to provide pre-emergency health support and conduct research to improve 
nighttime access to standard of care. To identify emergency cases, triage will occur at the 
level of the call center EMT (mild, moderate, and severe, see clinical guideline appendix) 
and leverage WHO derived danger signs for life-threatening illness. If the EMT identifies a 
 
Figure 3. MotoMeds Workflow. Follow-up 
calls will be placed within a range of 8-12 
days. 

danger sign at the call center or household and thus triages the case as severe, the EMT will 
advise the patient to seek care at a medical facility and will offer to refer the patient to NAS 
emergency dispatch (for an ambulance to be dispatched if so desired by the caller).  
The clinical guidelines define the clinical scope of the TMDS (also discussed above in the 
inclusion criteria section). This study is being conducted in an area with high pediatric 
morbidity and mortality from malaria. Our approach is to follow WHO standards of ‘test 
and treat’. Febrile patients will all be tested with a commercial RDT for malaria. RDT 
positive patients will be treated with antimalarials. Caregivers of RDT negative patients who 
do not have another source of their fever will receive a next-day follow-up phone call.  
A follow-up call will be placed within 24 hours for severe cases and for those mild/moderate 
cases with a fever without source and a negative RDT as described above. If a case is triaged 
as mild or moderate (no danger signs identified), local EMTs will conduct a phone-based 
assessment. If the patient household is outside the delivery zone, consult alone will be 
provided as a clinical case; the data from these encounters will not be recorded as study 
data, given that these patients represent a different patient population. Therefore, they will 
not receive a waiver of informed consent or follow-up call. If the household is inside the 
delivery zone (Jamestown/Usshertown), the EMT will generate a treatment plan and 
medications/fluids will be delivered to the household. A follow-up call will be placed at 8-
12 days, ideally at 10 days. In the INACT2-G pilot study, all patient participants will receive 
a paired in-person exam at a household visit. 
The clinical approach will be standardized across EMTs at the call center and at the 
household. Standardization will occur through paper and/or digital guideline generation for 
the common chief complaints identified in INACT1-G. Each call center assessment will 
produce a treatment plan that may include direction to seek emergency care, clinic follow-
up, fluids, and/or basic medications (see clinical guideline appendix). The clinical guidelines 
and workflow (Figure 3) were localized to standards of practice (e.g. selection of guideline-
recommended antimalarial medications) and epidemiology (high malaria burden).  
Neither the ability to receive care nor the type of care will be affected by the decision to 
participate in the study. If a family declines to consent to inclusion in the research study, 
evaluation/care will be provided as outlined in the clinical guidelines. The data from this 
encounter will not be recorded as study data. 
All household medication/fluid deliveries will be accompanied by an EMT with the intent 
that the medication handoff will happen after the EMT examines the patient and any 
necessary adjustments to the treatment plan are made. If patients are excluded from 
participation in the study, standard of care information will be conveyed and/or indications 
for seeking emergency care. The data from this interaction will not be recorded as study 
data. 
6.9 Testing.  
Malaria: Rapid diagnostic tests will be used to evaluate malaria as a source of fever in all 
febrile patients; febrile is defined as parent/guardian report of fever at the call center or 
household or objectively measured fever at the household visit. EMTs trained in rapid 

diagnostic testing will perform the test at the household. A positive malarial RDT will be 
used to initiate anti-malarial treatment. A finger prick will be performed with a retractable 
safety lancet, up to 0.5 ml of blood will be collected in a capillary/collection tube and 
spotted onto the RDT.  
6.10 Outcome Measures.  
6.10.1 Aim I (clinical safety). Establish rate of guideline adherence at the call center 
(primary outcome measure) and household. Determine sensitivity and specificity of each 
clinical variable 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. Determine clinical status at 8-12 
days. Since evaluation of guideline adherence and congruence between the call center and 
household are part of the research question itself, and because clinical equipoise can exist 
beyond what can be reflected in written guidelines, small deviations from guidelines based 
on the clinical facts of the case are not considered protocol violations. Violations that led to 
an adverse or severe adverse effect will be reported as further specified in this study 
protocol. 
6.10.2 Aim II (feasibility from patient perspective). Logistical data on patient workflow 
will be collected (duration of call, time to delivery). Parent/guardian feedback will be 
collected on the clinical, cost and quality aspects of the TMDS.  
6.10.3 Aim III (feasibility from staff perspective). Domains of inquiry are clinical 
decision making, formulation of medications, communication with team members and 
households, and unanticipated opportunities for improvement.  
6.11 Data collection. During the initial call, study staff will capture household contact 
information, details of the illness assessment and treatment recommendations from all 
callers meeting inclusion criteria. During the home visit the EMT will capture details of the 
in-person illness assessment and physical exam that includes anthropometric measurements 
(MUAC), vital signs, and/or RDT results. During the follow-up call, study staff will capture 
information on illness progression, outcome, and service feedback. During staff focus 
groups, a third party will capture staff opinions relating to service operations. 
Data collection instruments will include paper screening forms and paper case report forms, 
digital data collection forms (e.g. REDCap; see data collection instruments) and zoom 
recordings. Data collected on participants that refuse consent (e.g. initial call center data) 
will be kept to enumerate rates of study exclusion and reasons for refusal of consent; the 
data will be excluded from analysis and will be maintained confidentially. Data may be 
collected up to 12 days after the initial call. Participants may be contacted by phone for 
clarifications up to 365 days after the initial call. Paper documents will only be accessed by 
trained clinical and study personnel and will be secured in a locked cabinet in Ghana. These 
documents will be scanned and uploaded onto a UF secure server. 
6.12 Sample size calculation. The enrollment is based on TMDS census over the study 
period which is estimated to be 819 patient participants. Determination of the effect size of 
guideline adherence at the call center is the primary outcome. If the call center treatment 

plan adheres to the clinical guidelines for 86% of cases (data from INACT2-H), then a 
sample size of 819 (1.5 patients per night) will estimate guideline adherence to within a 95% 
confidence interval of +/- 2.4%. 
6.13 Staffing and Training. The TMDS will be staffed by Ghanaian medical professionals 
including physicians and Advanced EMTs. On-call physicians with experience in pediatrics 
will provide supervision of guidelines and care. Consults will be flexible to mode of 
communication as to local standards of care; this may involve modes of communication 
beyond voice (e.g. images, video). If these modes are used, they will always occur with 
direct end-to-end encryption and they will not be saved nor used as research data. This 
flexibility prioritizes safety and yet respects protected health information. The staff will be 
trained on this distinction. All EMTs will have completed a minimum of 2 years of medical 
education at the NAS Paramedic and Emergency Care Training School or an equivalent 
institution. They will receive incoming calls, conduct phone assessments following standard 
of care guidelines, and make treatment recommendations. They will also perform consent 
and in-person assessments during home visits and will complete follow-up calls. Advanced 
EMTs will not make independent decisions but rather act within the scope of pre-defined 
clinical guidelines and/or consult on-call physicians. Trained local motorcycle taxi drivers 
will be contracted to deliver any needed medications, drive study EMTs to and from home 
visits. All staff members will be trained in occupational safety measures and human research 
protections. Staff members will receive training specific to this study, the clinical guidelines 
and study procedures by the PI and CIs and will undergo an assessment by the PI/CIs prior 
to being cleared for participation at the TMDS. They will receive on-going supervision by 
the PI/CIs and a NAS paramedic supervisor who completed paramedic-level training in the 
United States. 
6.14 Incentives. No monetary benefits will be offered for participation in this study. 
6.15 Costs. There is no cost for families to participate in this study and/or receive care.  
6.16 Study endpoint and timeline Advertisement of the call center and outreach will begin 
in the month prior to starting the service. Enrollment will take place over 9 months 
(estimated November 2022 to July 2023). If the minimum enrollment of 819 patients is 
reached before 9 months, enrollment will continue for the full 9 months to assess 
sustainability. No more than 2000 patients will be screened/enrolled without subsequent IRB 
approval. If the minimum enrollment is not reached by 9 months, the enrollment period will 
be extended to a maximum of 15 months. IRB approval will be requested for further 
extension beyond 15 months. Primary analysis may continue up to 5 years after study 
conclusion. See data collection section for duration of enrollment per participant. 
6.17 Data Security Paper-based survey forms will be handled by staff trained in the 
protections of personal health information; forms will be stored in a locked cabinet in 
Ghana. Data collected electronically will use a HIPAA compliant survey tool (e.g. REDCap 
and server). All devices will be password protected and encrypted. The de-identification 
plan for data publication is as follows: Names and phone numbers will be removed. Each 
case will be given a de-identified number that will be used to link the data sources. Upon 
publication, these ID numbers will be removed and replaced with a random generated 

number and there will be no key to link the files. De-identified data will be shared with the 
USAID.  
6.18 Data Analysis 
Data will be aggregated with REDCap and analyzed in R. Statistical support will be 
provided by the UF Clinical and Translational Science Institute.  
Quantitative data will be analyzed using frequentist statistics, which will include using 
proportions for categorical variables, median and interquartile ranges for quantitative 
variables, effect size, sensitivity/specificity calculations, interrater agreement (e.g. Cohen’s 
kappa). Qualitative data will be transcribed, coded to evaluate themes, and summarized to 
identify opportunities for improvement. 
6.19 Limitations 
Low sample size. Household visits at nighttime are logistically challenging, therefore the 
study area must be limited in size to ensure safety and efficiency. The size of the study 
area dictates the population eligible for enrollment. Prior to commencing the intervention, 
it is difficult to assess whether the designated study area will provide adequate call 
volume to reach enrollment. We will address this limitation through active advertisement.  
Enrollment biases. The intervention is intended to provide pre-emergency care to children 
who are experiencing a health problem during nighttime hours.  Due to the lack of 
affordable, qualified healthcare options in the study area, households who could 
potentially visit a health center during the day may wait until nighttime to take advantage 
of the call center service.  This could bias our understanding of the nighttime healthcare 
needs and call center functionality.  
Geographic bias. The call center will be advertised as a service for households in a specific 
geographic area.  In Ghana, boundaries at the community level (US equivalent to 
neighborhoods) are not officially defined and the address system is based on proximity to 
landmarks. As a result, it is possible that some callers outside of the study area could be 
enrolled or some callers inside the study area could be excluded, although the former is 
more likely to occur.  While a ‘fuzzy radius’ impacts logistics, we do not anticipate this to 
impact the primary outcomes. 
Limited scope. The study is designed to evaluate congruence of phone vs in-person 
assessments for non-emergent patients. Emergent patients will be advised to seek care 
immediately.  The exclusion of emergency patients limits the scope and generalizability 
of the study to the full spectrum of EMS services. In-person data on emergent patients 
will not be obtained in this study.  
Limited diagnostic ability. The study is designed to provide acute care at the community 
level; thus, it is not possible for gold standard diagnostics such as microscopy and PCR to 
directly inform individual treatment plans. For malaria, in lieu of microscopy, point-of-
care rapid diagnostic testing may be used for diagnosis.  
7. Data Safety Monitoring Committee   

Similar to the iteration of this study that was conducted in Haiti, this study is considered 
minimal risk and a DSMC is not required, unless instructed by the IRB.  
A Medical Advisory Committee consisting of Ghanian and University of Florida physicians 
specializing in emergency medicine, prehospital medicine, infectious disease, and pediatrics 
will be convened. The Medical Advisory Committee will receive biweekly email updates 
including case summaries and relevant medical questions for discussion.  
Severe adverse events will be reported per protocols of the Ghana Health Service Ethics 
Review Committee and the UF IRB. SAE will be defined as: Any event that results in death, 
significant disability, incapacity, and/or life-threatening situation that developed after 
enrollment of any patient within the enrollment period (enrollment to the 8-12 day follow-up 
call). In the event of an SAE, the paramedic supervisor, on-call physicians (primary and 
secondary), and study director will be notified immediately. NAS leadership and UF leadership 
(PIs) will be notified the following morning. The leadership will review the situation, dispatch 
a team to conduct an on-site review/verbal autopsy of the case, and notify the clinical advisory 
committee. A verbal report will be made to the Ghana IRB within 3 days per their 
requirements. A preliminary written report will be submitted to both the Ghana IRB and the 
USA (UF) IRB within five days, as well as the clinical advisory committee. After IRB review 
and recommendations, a final report will be submitted. The study will continue, be amended, 
suspended or terminated based on this review process. Given high rates of morbidity and 
mortality among the participant population34 and prior research that found the mortality rate in 
an INACT2 TMDS model in Haiti to be one in 391 participants (0.2%)53, we anticipate in a 
population of 891 enrollment participants there will be two mortalities. The threshold for 
suspending the study for review will be 2 mortalities per two hundred patients enrolled (1%). 
 
8. Possible Discomforts and Risks  
Discomforts and risks. 
1.  Breach of confidentiality. 
2.  Caller may understate severity of symptoms.  A caller may understate the severity of a 
patient’s symptoms, either intentionally or unintentionally, leading to an enrollment 
that does not meet inclusion criteria.  This may result in a delay of seeking immediate 
care for a true emergency. 
3.  Financial cost. Seeking care at night at established health facilities is expensive. If we 
conservatively recommend seeking emergency care but the patient does not have an 
emergency, this will create unnecessary financial burden for the family. 
Efforts to minimize risk. 
1.  To address risk of breach of confidentiality, paper-based data collection will be 
minimized and when possible, secure electronic-based data collection tools will be 
used (REDCap). All staff will be trained in the protections of personal information 
as well as protections of human subjects research. All paper-based documents will 

be maintained in a locked cabinet in a secure building with keyed-access limited to 
study leadership. 
2.  To minimize understating disease severity, the guidelines for diverting callers directly 
to a healthcare facility will adhere to established guidelines (e.g. WHO IMCI). The 
approach will draw on best practices to interrogate callers and have scripts that ask 
clear dichotomous questions. The study data will be monitored to determine the 
concordance between phone and household assessments. 
3.  When directing callers to seek immediate care at a medical facility, study staff will be 
clear that they are providing qualified recommendations based on the relayed 
information, but the final decision is the responsibility of the family. Given the 
conservative approach, we acknowledge that a small percentage of families may 
experience unnecessary cost exposure which is weighed against the benefit of likely 
reducing overall morbidity and mortality.   
9.     Possible Benefits   
Direct:  
The primary direct benefit to study participants is access to qualified healthcare during 
nighttime hours, when alternative healthcare options are scarce.  
Indirect: 
The service may decompress high morning caseloads at area hospital and clinics by 
addressing urgent care needs overnight. 
The study has potential to benefit the larger regional, national, and international 
communities, as it could lead to a sustainable option for nighttime pre-emergent 
healthcare.  
10.  Conflict of Interest  
None.  The study investigators and affiliates hold no patents or stock in related technologies.  
 
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