Enhancing Pediatric Acute Care Through Adaptive E-Learning and In-Person Skills Practice in Tanzania

NCT06635733 | Not Yet Recruiting

• 2 other identifiers: 1R21TW012612-01A1-20251R21TW012612-01A1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate whether the integration of in-person skills practice (ISP) with an adaptive e-learning platform can improve refresher learning progress (RLP) among healthcare providers in pediatric care settings in Tanzania. The main questions it aims to answer are: Can healthcare providers who participate in ISP sessions facilitated by clinical champions achieve greater improvements in refresher learning progress (RLP)? Will providers in the intervention group demonstrate improved metacognition and practical skill performance compared to those in the control group? Researchers will compare healthcare providers using the ISP digital platform (Rhapsode Capable™) to providers using paper-based ISP to see if the digital platform results in significantly higher RLP and fewer skill-based errors. Participants will: Complete adaptive e-learning modules focused on pediatric care topics (e.g., newborn resuscitation, severe malnutrition). Participate in ISP sessions where clinical champions provide feedback and assess performance.

Conditions

Newborn Resuscitation; Severe Malnutrition; Severe Malaria; Severe Pneumonia; Severe Dehydration; In-Service Training; Computer-Assisted Instruction; Simulation Training

Keywords

Pediatric acute care; Newborn resuscitation; Severe malnutrition in children; Severe malaria treatment; Severe dehydration management; Pediatric pneumonia care; In-person skills practice (ISP); Adaptive e-learning for healthcare providers; Clinical skills training in low-resource settings; Health provider education; Clinical champions; Tanzania healthcare providers; Pediatric emergency training; Blended learning in pediatric care; Refresher learning progress (RLP); Cluster randomized controlled trial (RCT); Rhapsode Capable™ platform; Skills assessment in pediatric care; Continuous professional development (CPD) for healthcare providers

Outcome Measures

Primary Outcomes (1)

• Median Refresher Learning Progress (RLP) Among Providers

  The percentage of refresher learning modules completed by healthcare providers with an initial learning progress (ILP) score of 95% or greater, who also complete at least one In-Person Skills Practice (ISP) session per month. The RLP will be measured as the progress in refresher module completion and adherence to ISP sessions, indicating the effectiveness of combining adaptive e-learning with in-person skills practice.

  16 (Pilot) or 32 (repilot) weeks from baseline to study completion. Each participant's progress will be tracked weekly throughout the 16/32-week intervention period.

Secondary Outcomes (4)

• Improvement in Metacognition (Conscious Competence)

  Assessed at baseline, 16 weeks(pilot only), and 32 weeks (repilot only) after intervention start.

• Total ISP Score Improvement

  Assessed after each ISP session and summarized at 16 (pilot) or 32 (repilot) weeks after intervention start.

• Reduction in Common ISP Errors

  Errors tracked throughout ISP sessions over the 16 or 32-week intervention period.

• Proportion of Healthy Providers (HPs)

  Assessed monthly and summarized at 16 or 32 weeks after intervention start.

Study Arms (2)

Intervention Group (Rhapsode Capable™ Platform)

EXPERIMENTAL

Participants (healthcare providers) in this group will receive the PACE adaptive learning modules and participate in In-Person Skills Practice (ISP) sessions facilitated by clinical champions. The ISP sessions will be managed using the Rhapsode Capable™ platform, which allows for scheduling, real-time performance feedback, and tracking of progress. The intervention is designed to enhance pediatric care competencies by blending adaptive e-learning with structured, feedback-driven skills practice.

Behavioral: Rhapsode Capable™ Platform (Intervention Group)

Control Group (Paper-based ISP)

ACTIVE COMPARATOR

Participants (healthcare providers) in this group will also receive the same PACE adaptive learning modules and participate in In-Person Skills Practice (ISP) sessions facilitated by clinical champions. However, ISP sessions will be conducted using paper-based assessments. Clinical champions will manually track performance, provide feedback, and schedule sessions using paper forms. The control group will not have access to real-time digital feedback or automated progress tracking.

Behavioral: Paper-based ISP (Control Group)

Interventions

Rhapsode Capable™ Platform (Intervention Group) BEHAVIORAL

Participants in the intervention group will use the Rhapsode Capable™ platform to facilitate In-Person Skills Practice (ISP) sessions. The platform allows for scheduling ISP sessions, providing real-time performance feedback, and tracking progress. The platform integrates with the PACE adaptive learning modules, which cover pediatric acute care topics. The goal is to improve skills retention and performance in pediatric care through a blended learning approach.

Intervention Group (Rhapsode Capable™ Platform)

Paper-based ISP (Control Group) BEHAVIORAL

Participants in the control group will also receive In-Person Skills Practice (ISP) sessions facilitated by clinical champions, but without the use of the digital platform. The ISP sessions will be tracked and scheduled using paper-based assessments. Feedback will be provided verbally or manually, and progress will be documented using paper forms. Both groups will receive the same PACE adaptive learning modules, but the method of ISP implementation differs between the groups.

Control Group (Paper-based ISP)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthcare providers actively involved in pediatric care at one of the selected healthcare centers.
• Completion of core Pediatric Acute Care Education (PACE) adaptive learning modules prior to study participation.
• Willingness to participate in In-Person Skills Practice (ISP) sessions.
• Ability to engage with either the Rhapsode Capable™ platform (intervention group) or paper-based ISP methods (control group).
• Minimum proficiency in written and spoken English.

You may not qualify if:

• Healthcare providers not involved in pediatric or newborn clinical care at the time of recruitment.
• Providers unable or unwilling to attend ISP sessions facilitated by clinical champions.
• Individuals with no prior engagement in the PACE program.
• Providers with significant technological barriers that prevent the use of the Rhapsode Capable™ platform (for the intervention group only).

Sponsors & Collaborators

• Stanford University: lead
• Catholic University of Health and Allied Sciences: collaborator
• London School of Hygiene and Tropical Medicine: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Catholic University of Health and Allied Sciences

Mwanza, Tanzania

Location

MeSH Terms

Conditions

Malnutrition; Malaria; Pneumonia; Dehydration; Child Nutrition Disorders; Cephalopelvic Disproportion

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Peter A Meaney, MD MPH

  Stanford University

  PRINCIPAL INVESTIGATOR

• Adolfine Hokororo, MD

  Catholic University of Health and Allied Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanston Ndosi, MD

CONTACT

‭255 754 399 038‬; hanstonndosi@gmail.com

Shelby Burk

CONTACT

650-704-2186‬; shelbyb@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Pediatric Critical Care

Model Details: The study is a cluster randomized controlled trial (RCT) where healthcare providers are assigned to either the intervention group, which uses the Rhapsode Capable™ platform for in-person skills practice (ISP) scheduling, feedback, and assessment, or the control group, which follows paper-based ISP. Both groups receive the same Pediatric Acute Care Education (PACE) adaptive learning content, but the method of ISP differs between groups.

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: January 6, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The IPD will be made available starting 6 months after publication of the primary study results and will be available for a period of 5 years from that date.
• Access Criteria: Access to the shared IPD will be granted to researchers who submit a formal request with a scientifically sound proposal for secondary analyses. Proposals will be reviewed by the study team members, data access committee, and access will be granted via a secure data-sharing platform. Researchers will be required to sign a data use agreement ensuring the protection of participant confidentiality and adherence to ethical use of the data.

Locations

TA (1)