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

NCT05506683 | Completed

• 1 other identifier: IRB202201648
• Study Type: interventional
• Target: 1,239
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric ALL; Acute Disease

Keywords

Telemedicine; Healthcare Access; Nighttime

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Secondary Outcomes (3)

• The rate of guideline adherence at the household.

  1 day

• Sensitivity, specificity and congruence of clinical variables

  1 day

• Participant clinical status at 8-12 days

  Between 8-12 days

Other Outcomes (2)

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

  1 hour

• Evaluate qualitative feedback from MotoMeds users

  Between 8-12 days

Study Arms (1)

MotoMeds users (parent/chid participant pairs)

EXPERIMENTAL

Other: MotoMeds pediatric telemedicine and medication delivery service (TMDS)

Interventions

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.

MotoMeds users (parent/chid participant pairs)

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child ≤ 10 years
• Has an acute medical problem
• Provides written assent (if 10 years and receives a household visit)

You may not qualify if:

• 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)
• Calls MotoMeds during operating hours
• Adult (18 years or older)
• Provides written consent (household visit) or a waiver of documentation of consent (no household visit)
• Age \< 18 years
• No written consent or waiver of documentation of consent

Sponsors & Collaborators

• University of Florida: lead
• Ghana National Ambulance Service: collaborator

Study Sites (1)

National Ambulance Service

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

Location

Related Publications (3)

• Flaherty KE, Klarman MB, Cajusma Y, Schon J, Exantus L, Beau de Rochars VM, 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):1063-1071. doi: 10.4269/ajtmh.21-1068. Print 2022 Apr 6.

  PMID: 35189597 BACKGROUND

• 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.

  PMID: 32923318 BACKGROUND

• Flaherty KE, Mahama MN, Klarman MB, Anane-Binfoh NA, Patel MD, Smith NJ, Osei-Ampofo M, Mathelier M, Nelson EJ, Zakariah AN, Afaa TJ, Becker TK. Applying the ADAPT guidance to implement a telemedicine and medication delivery service in a malaria-endemic setting: A prospective cohort study. Trop Med Int Health. 2025 Mar;30(3):181-192. doi: 10.1111/tmi.14081. Epub 2025 Jan 16.

  PMID: 39815954 DERIVED

Related Links

• MotoMeds website

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Acute Disease

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Torben K Becker, MD, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 18, 2022
• Study Start: November 16, 2022
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: September 25, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• 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.
• Access Criteria: The de-identified IDP will be publicly available.

Locations

GH (1)