Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635733
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Enhancing Pediatric Acute Care Through Adaptive E-Learning and In-Person Skills Practice in Tanzania
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Cluster Randomized Controlled Trial of the Pediatric Acute Care Education PACE Program Combining Adaptive E-Learning with In-Person Skills Practice in Tanzania
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PACE
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 eg newborn resuscitation severe malnutrition
Participate in ISP sessions where clinical champions provide feedback and assess performance
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 eg newborn resuscitation severe malnutrition
Participate in ISP sessions where clinical champions provide feedback and assess performance
Detailed Description:
This study is a cluster randomized controlled trial RCT aimed at assessing the effectiveness of integrating In-Person Skills Practice ISP sessions facilitated by clinical champions into the existing Pediatric Acute Care Education PACE adaptive e-learning program The study is designed to evaluate whether this blended learning approach can enhance the refresher learning progress RLP improve practical clinical skills and increase metacognition conscious competence among healthcare providers responsible for pediatric care in Tanzania
Study Design
The trial will randomize four healthcare centers into two groups an intervention group where providers use the Rhapsode Capable platform for ISP and a control group where providers receive paper-based ISP Both groups will receive the same core content from the PACE adaptive learning modules
The intervention group will utilize the Rhapsode Capable digital platform for ISP which provides scheduling skill tracking and real-time feedback on performance The control group will follow a similar protocol but feedback and skill tracking will be done manually using paper forms Clinical champions will facilitate all ISP sessions in both groups providing structured guidance peer support and real-time feedback
This trial will use a mixed-methods approach including quantitative assessments learning progress scores ISP scores and qualitative data collection Focus Group Discussions and In-Depth Interviews to gather insights into the barriers and facilitators of ISP integration into the PACE program
Study Procedures
1 Intervention Group
Healthcare providers will complete core PACE adaptive e-learning modules focusing on pediatric care topics like newborn resuscitation severe malnutrition severe malaria and respiratory conditions
Providers will participate in ISP sessions facilitated by clinical champions using the Rhapsode Capable platform These sessions will provide an opportunity for providers to practice critical clinical skills with real-time feedback and scoring
The platform will track provider progress enabling personalized feedback based on performance scheduling of future sessions and consistency of practice
2 Control Group
Providers will complete the same core PACE adaptive e-learning modules ISP sessions will be conducted using paper-based assessments facilitated by clinical champions Feedback will be provided verbally during sessions and scores will be recorded manually
Quality Assurance Procedures
To ensure data integrity and consistent delivery of the intervention several quality assurance measures will be implemented
Data Validation Data entered into the Rhapsode Capable platform for the intervention group will undergo automated validation checks for consistency range and completeness For the control group the PACE coordinator will perform weekly reviews of paper forms and cross-check them against participant logs
Site Monitoring Clinical champions and the study coordinator will conduct regular site visits to monitor compliance with ISP protocols data collection and participant engagement
Source Data Verification SDV Random checks of paper-based ISP assessments will be compared with original session records to verify accuracy and completeness
Standard Operating Procedures SOPs The study will adhere to detailed SOPs for each aspect of the trial including participant recruitment ISP facilitation data management and reporting of adverse events
Data Management
Data Collection Data will be collected via the Rhapsode Capable platform for the intervention group and manual paper forms for the control group All data will be transferred to the secure REDCap database for analysis
Data Checks A dedicated PACE coordinator will regularly perform data checks to compare ISP scores ensure participant progression and resolve any discrepancies in the dataset
Data Dictionary A detailed data dictionary will be maintained outlining each variable its source coding system and any range limits This will include information about ISP performance scores learning progress metrics demographic data and survey results
Sample Size
The trial will enroll 90 healthcare providers 45 in the intervention group and 45 in the control group After accounting for a potential dropout rate of up to 10 it is expected that 80 providers will complete the full study protocol This sample size is calculated based on anticipated differences in the primary outcome RLP and allows for detection of significant differences between the two groups with a power of 80 at a significance level of 005
Plan for Missing Data
A comprehensive plan for managing missing data will be implemented
Imputation Methods Missing data will be addressed using multiple imputation techniques if the missing data exceeds 5 In cases where data is missing completely at random MCAR a complete case analysis will be conducted
Handling Data Inconsistency Any inconsistent or out-of-range data will be flagged during weekly data checks and verified by clinical champions or the PACE coordinator
Statistical Analysis
The primary analysis will focus on comparing the median refresher learning progress RLP between the intervention and control groups Statistical significance will be determined using the Wilcoxon rank-sum test to account for the non-parametric distribution of data A two-sided alpha of 005 will be used for hypothesis testing
The secondary analyses will include
Changes in metacognition conscious competence using generalized estimating equations GEE to account for repeated measures over time
ISP scores between intervention and control groups using mixed-effects linear regression models adjusting for baseline ISP scores
Trends in common errors observed during ISP sessions The trial will also conduct an exploratory analysis of the qualitative data collected through Focus Group Discussions FGDs and In-Depth Interviews IDIs This data will be analyzed using thematic analysis focusing on participant feedback regarding the ease of ISP integration the perceived value of clinical champions and any barriers encountered during the study
Registry Information
Registry Procedures To maintain data accuracy and ensure consistent participant monitoring the PACE program will include
On-site Audits Routine on-site audits will be conducted to verify data accuracy and adherence to ISP protocols
Data Entry Audits Manual data entry for the control group will be reviewed weekly by the PACE coordinator and discrepancies will be addressed immediately
Monitoring Plan Weekly educator dashboard summaries will be provided to clinical champions highlighting provider progress and any outstanding ISP tasks
Ethical Considerations
This study has been approved by the Institutional Review Boards IRBs of the Catholic University of Health and Allied Sciences CUHAS Stanford University and London School of Hygiene and Tropical Medicine LSHTM Ethical concerns such as data confidentiality and informed consent have been thoroughly addressed and all participants will be able to withdraw from the study at any point without penalty
Conclusion
The results of this study will provide critical insights into the effectiveness of integrating adaptive e-learning with in-person skills practice to improve pediatric care in low-resource settings If successful the findings could lead to the implementation of scalable blended learning strategies to improve healthcare outcomes for children in sub-Saharan Africa
Study Design
The trial will randomize four healthcare centers into two groups an intervention group where providers use the Rhapsode Capable platform for ISP and a control group where providers receive paper-based ISP Both groups will receive the same core content from the PACE adaptive learning modules
The intervention group will utilize the Rhapsode Capable digital platform for ISP which provides scheduling skill tracking and real-time feedback on performance The control group will follow a similar protocol but feedback and skill tracking will be done manually using paper forms Clinical champions will facilitate all ISP sessions in both groups providing structured guidance peer support and real-time feedback
This trial will use a mixed-methods approach including quantitative assessments learning progress scores ISP scores and qualitative data collection Focus Group Discussions and In-Depth Interviews to gather insights into the barriers and facilitators of ISP integration into the PACE program
Study Procedures
1 Intervention Group
Healthcare providers will complete core PACE adaptive e-learning modules focusing on pediatric care topics like newborn resuscitation severe malnutrition severe malaria and respiratory conditions
Providers will participate in ISP sessions facilitated by clinical champions using the Rhapsode Capable platform These sessions will provide an opportunity for providers to practice critical clinical skills with real-time feedback and scoring
The platform will track provider progress enabling personalized feedback based on performance scheduling of future sessions and consistency of practice
2 Control Group
Providers will complete the same core PACE adaptive e-learning modules ISP sessions will be conducted using paper-based assessments facilitated by clinical champions Feedback will be provided verbally during sessions and scores will be recorded manually
Quality Assurance Procedures
To ensure data integrity and consistent delivery of the intervention several quality assurance measures will be implemented
Data Validation Data entered into the Rhapsode Capable platform for the intervention group will undergo automated validation checks for consistency range and completeness For the control group the PACE coordinator will perform weekly reviews of paper forms and cross-check them against participant logs
Site Monitoring Clinical champions and the study coordinator will conduct regular site visits to monitor compliance with ISP protocols data collection and participant engagement
Source Data Verification SDV Random checks of paper-based ISP assessments will be compared with original session records to verify accuracy and completeness
Standard Operating Procedures SOPs The study will adhere to detailed SOPs for each aspect of the trial including participant recruitment ISP facilitation data management and reporting of adverse events
Data Management
Data Collection Data will be collected via the Rhapsode Capable platform for the intervention group and manual paper forms for the control group All data will be transferred to the secure REDCap database for analysis
Data Checks A dedicated PACE coordinator will regularly perform data checks to compare ISP scores ensure participant progression and resolve any discrepancies in the dataset
Data Dictionary A detailed data dictionary will be maintained outlining each variable its source coding system and any range limits This will include information about ISP performance scores learning progress metrics demographic data and survey results
Sample Size
The trial will enroll 90 healthcare providers 45 in the intervention group and 45 in the control group After accounting for a potential dropout rate of up to 10 it is expected that 80 providers will complete the full study protocol This sample size is calculated based on anticipated differences in the primary outcome RLP and allows for detection of significant differences between the two groups with a power of 80 at a significance level of 005
Plan for Missing Data
A comprehensive plan for managing missing data will be implemented
Imputation Methods Missing data will be addressed using multiple imputation techniques if the missing data exceeds 5 In cases where data is missing completely at random MCAR a complete case analysis will be conducted
Handling Data Inconsistency Any inconsistent or out-of-range data will be flagged during weekly data checks and verified by clinical champions or the PACE coordinator
Statistical Analysis
The primary analysis will focus on comparing the median refresher learning progress RLP between the intervention and control groups Statistical significance will be determined using the Wilcoxon rank-sum test to account for the non-parametric distribution of data A two-sided alpha of 005 will be used for hypothesis testing
The secondary analyses will include
Changes in metacognition conscious competence using generalized estimating equations GEE to account for repeated measures over time
ISP scores between intervention and control groups using mixed-effects linear regression models adjusting for baseline ISP scores
Trends in common errors observed during ISP sessions The trial will also conduct an exploratory analysis of the qualitative data collected through Focus Group Discussions FGDs and In-Depth Interviews IDIs This data will be analyzed using thematic analysis focusing on participant feedback regarding the ease of ISP integration the perceived value of clinical champions and any barriers encountered during the study
Registry Information
Registry Procedures To maintain data accuracy and ensure consistent participant monitoring the PACE program will include
On-site Audits Routine on-site audits will be conducted to verify data accuracy and adherence to ISP protocols
Data Entry Audits Manual data entry for the control group will be reviewed weekly by the PACE coordinator and discrepancies will be addressed immediately
Monitoring Plan Weekly educator dashboard summaries will be provided to clinical champions highlighting provider progress and any outstanding ISP tasks
Ethical Considerations
This study has been approved by the Institutional Review Boards IRBs of the Catholic University of Health and Allied Sciences CUHAS Stanford University and London School of Hygiene and Tropical Medicine LSHTM Ethical concerns such as data confidentiality and informed consent have been thoroughly addressed and all participants will be able to withdraw from the study at any point without penalty
Conclusion
The results of this study will provide critical insights into the effectiveness of integrating adaptive e-learning with in-person skills practice to improve pediatric care in low-resource settings If successful the findings could lead to the implementation of scalable blended learning strategies to improve healthcare outcomes for children in sub-Saharan Africa
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None