Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05730452
Status:
RECRUITING
Last Update Posted:
2023-02-15
First Post:
2022-12-09
Brief Title:
Smart Discharges to Improve Post-discharge Health Outcomes in Children
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Smart Discharges to Improve Post-discharge Health Outcomes in Children A Prospective Before-after Study With Staggered Implementation
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In Uganda about 5 of children discharged after hospitalization for a serious infection will die in the weeks after returning home Doctors and parents are often unaware of this period of vulnerability and are poorly equipped to identify or handle this critical situation This project builds on past work to develop and evaluate models and technology to predict before discharge an individual childs risk of recurrent illness as well as to provide additional post-discharge support to at-risk children This study seeks to evaluate the effect of a novel Smart Discharges approach on childhood mortality and health seeking behaviour
Detailed Description:
PURPOSE
Our purpose is to conduct an interventional cohort study to evaluate the impact of the Smart Discharges approach to discharge care on pediatric post-discharge mortality
HYPOTHESIS
Our Smart Discharges approach will improve post-discharge health seeking and reduce post-discharge mortality
JUSTIFICATION
With an improved understanding of risk and an ability to determine risk at the bedside a Smart Discharge program will ensure optimized resource allocation focusing on children most in need of limited resources Such programs in precision public health can not only save lives and resources but are much more likely to be scalable in economically strained environments
OBJECTIVES
The objective of this study is to determine whether a individualized risk-based approach to improving pediatric discharges will reduce 6-month post-discharge mortality among children admitted with suspected sepsis
The study has two objectives each corresponding to a phase
1 Phase I An observational period with enrolled patients acting as controls Furthermore this cohort will be used to update refine and validate previously developed models for post-discharge mortality to be used during Phase II
2 Phase II An interventional period to evaluate the effectiveness of a Smart Discharge program on mortality and post-discharge health seeking
RESEARCH DESIGN
This will be a two-phase study Phase I is a multi-site prospective observational cohort study while Phase II is a multi-site prospective interventional cohort study This prospective study will be conducted from March 2017 to January 2024 The study will enroll 5700 children under five years of age 2700 6 months of age 3000 6-60m of age in Phase I non-interventional and an equal number 5700 of children during phase II interventional phase for a total of 11600 children
STATISTICAL ANALYSIS
Our prior work has shown that the 6-month post-discharge mortality rate is 5 Our preliminary work has also suggested that our expected mortality benefit will be between 25 and 30 relative risk reduction Assuming a relative risk reduction of 225 we would need to enroll 5250 children per arm We thus will conservatively aim to enroll 5700 per arm to account for losses to follow-up
All analyses will be conducted using R 422 Vienna Austria httpwwwR-projectorg External model validation will be conducted using the Phase I cohort on the previously developed Smart Discharge Model The Smart Discharge Model will then be updated to include data from the Phase I cohort Final prediction models will be developed separately for children 6m of age and for children 6m - 5 years of age with an area under the ROC curve analysis used to assess the overall performance of the final models For the final model in older children 6m - 5y the risk cut-off will be chosen based on the sensitivity and specificity ensuring a sensitivity of 80 initial derived model sensitivity was 82 The final sensitivity and specificity will be reported along with positive and negative predictive values based on the overall mortality rate and the mortality rates of each site For the model in younger children the same approach will be used but ensuring the sensitivity is at least 85 due to an expected higher mortality rate among younger children The separation of ages has been determined to be the optimal approach for these models
To evaluate the effectiveness of the intervention a cox-proportional hazards regression on the time to post-discharge mortality will be used including the year of discharge as a covariate to account for potential trends in mortality unrelated to the intervention Additional potentially confounding variables will be identified based on a combination of pre-existing and expert knowledge and univariate analysis of potential confounders on outcomes A final multivariable model will be used to determine the adjusted effect of the Smart Discharge intervention Interrupted time series which use segmented regression modeling to determine the effect of the intervention after controlling for pre- and post-intervention time trends will also be used to account for potential pre-intervention trends in mortality
Our purpose is to conduct an interventional cohort study to evaluate the impact of the Smart Discharges approach to discharge care on pediatric post-discharge mortality
HYPOTHESIS
Our Smart Discharges approach will improve post-discharge health seeking and reduce post-discharge mortality
JUSTIFICATION
With an improved understanding of risk and an ability to determine risk at the bedside a Smart Discharge program will ensure optimized resource allocation focusing on children most in need of limited resources Such programs in precision public health can not only save lives and resources but are much more likely to be scalable in economically strained environments
OBJECTIVES
The objective of this study is to determine whether a individualized risk-based approach to improving pediatric discharges will reduce 6-month post-discharge mortality among children admitted with suspected sepsis
The study has two objectives each corresponding to a phase
1 Phase I An observational period with enrolled patients acting as controls Furthermore this cohort will be used to update refine and validate previously developed models for post-discharge mortality to be used during Phase II
2 Phase II An interventional period to evaluate the effectiveness of a Smart Discharge program on mortality and post-discharge health seeking
RESEARCH DESIGN
This will be a two-phase study Phase I is a multi-site prospective observational cohort study while Phase II is a multi-site prospective interventional cohort study This prospective study will be conducted from March 2017 to January 2024 The study will enroll 5700 children under five years of age 2700 6 months of age 3000 6-60m of age in Phase I non-interventional and an equal number 5700 of children during phase II interventional phase for a total of 11600 children
STATISTICAL ANALYSIS
Our prior work has shown that the 6-month post-discharge mortality rate is 5 Our preliminary work has also suggested that our expected mortality benefit will be between 25 and 30 relative risk reduction Assuming a relative risk reduction of 225 we would need to enroll 5250 children per arm We thus will conservatively aim to enroll 5700 per arm to account for losses to follow-up
All analyses will be conducted using R 422 Vienna Austria httpwwwR-projectorg External model validation will be conducted using the Phase I cohort on the previously developed Smart Discharge Model The Smart Discharge Model will then be updated to include data from the Phase I cohort Final prediction models will be developed separately for children 6m of age and for children 6m - 5 years of age with an area under the ROC curve analysis used to assess the overall performance of the final models For the final model in older children 6m - 5y the risk cut-off will be chosen based on the sensitivity and specificity ensuring a sensitivity of 80 initial derived model sensitivity was 82 The final sensitivity and specificity will be reported along with positive and negative predictive values based on the overall mortality rate and the mortality rates of each site For the model in younger children the same approach will be used but ensuring the sensitivity is at least 85 due to an expected higher mortality rate among younger children The separation of ages has been determined to be the optimal approach for these models
To evaluate the effectiveness of the intervention a cox-proportional hazards regression on the time to post-discharge mortality will be used including the year of discharge as a covariate to account for potential trends in mortality unrelated to the intervention Additional potentially confounding variables will be identified based on a combination of pre-existing and expert knowledge and univariate analysis of potential confounders on outcomes A final multivariable model will be used to determine the adjusted effect of the Smart Discharge intervention Interrupted time series which use segmented regression modeling to determine the effect of the intervention after controlling for pre- and post-intervention time trends will also be used to account for potential pre-intervention trends in mortality
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| F21-05597 | OTHER_GRANT | None | None |
| F17-02096 | OTHER_GRANT | None | None |
| F17-02096 | OTHER_GRANT | Thrasher Research Fund | None |