Improving Nighttime Access to Care and Treatment; Part 2- Ghana (INACT2-G)
Primary Purpose
Pediatric ALL, Acute Disease
Status
Recruiting
Phase
Not Applicable
Locations
Ghana
Study Type
Interventional
Intervention
MotoMeds pediatric telemedicine and medication delivery service (TMDS)
Sponsored by
About this trial
This is an interventional health services research trial for Pediatric ALL focused on measuring Telemedicine, Healthcare Access, Nighttime
Eligibility 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 Exclusion Criteria:
- Age < 18 years
- No written consent or waiver of documentation of consent
- Corresponding child does not meet inclusion criteria
Sites / Locations
- National Ambulance ServiceRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MotoMeds users (parent/chid participant pairs)
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05506683
First Posted
August 17, 2022
Last Updated
September 8, 2023
Sponsor
University of Florida
Collaborators
Ghana National Ambulance Service
1. Study Identification
Unique Protocol Identification Number
NCT05506683
Brief Title
Improving Nighttime Access to Care and Treatment; Part 2- Ghana
Acronym
INACT2-G
Official Title
Pilot Implementation of a Nighttime Telemedicine and Medication Delivery Service to Increase Access to Pre-emergency Pediatric Care in Ghana
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Ghana National Ambulance Service
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric ALL, Acute Disease
Keywords
Telemedicine, Healthcare Access, Nighttime
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1365 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MotoMeds users (parent/chid participant pairs)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
MotoMeds pediatric telemedicine and medication delivery service (TMDS)
Intervention Description
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 Outcome Measure Information:
Title
The rate of guideline adherence at the call center.
Description
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.
Time Frame
Entire 9 month study period.
Secondary Outcome Measure Information:
Title
The rate of guideline adherence at the household.
Description
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.
Time Frame
Full 9 month study period
Title
Sensitivity, specificity and congruence of clinical variables
Description
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.
Time Frame
Full 9 month study period
Title
Participant clinical status at 8-12 days
Description
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.
Time Frame
Between 8-12 days
Other Pre-specified Outcome Measures:
Title
Operational metrics: Duration of initial call and time to arrival at household
Description
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.
Time Frame
Full 9 month study period
Title
Evaluate qualitative feedback from MotoMeds users
Description
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.
Time Frame
Full 9 month study period
10. Eligibility
Sex
All
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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 Exclusion Criteria:
Age < 18 years
No written consent or waiver of documentation of consent
Corresponding child does not meet inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torben K Becker, MD, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Ambulance Service
City
Accra
State/Province
Accra Metropolitan District
ZIP/Postal Code
GA-143-8975
Country
Ghana
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie E Flaherty, BS
Phone
025-792-0072
Email
flahertyk@ufl.edu
First Name & Middle Initial & Last Name & Degree
Ahmed N Zakariah, MD, MPM, EMBA
First Name & Middle Initial & Last Name & Degree
Maxwell Osei-Ampofo, MBChB, MBA, MPH
First Name & Middle Initial & Last Name & Degree
Taiba Afaa Jibril, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified individual participant data (IDP) will be made publicly available through a data depository such as Dryad.
IPD Sharing Time Frame
The de-identified IDP will likely be made available within 1 year of the conclusion of the study and will remain available indefinitely.
IPD Sharing Access Criteria
The de-identified IDP will be publicly available.
Citations:
PubMed Identifier
35189597
Citation
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.
Results Reference
background
PubMed Identifier
32923318
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.
Results Reference
background
Links:
URL
http://motomeds.org
Description
MotoMeds website
Learn more about this trial
Improving Nighttime Access to Care and Treatment; Part 2- Ghana
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