Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05997420
Status:
RECRUITING
Last Update Posted:
2024-01-31
First Post:
2023-08-10
Brief Title:
Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up ASTROS
Status:
RECRUITING
Status Verified Date:
2024-08
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:
ASTROS
Brief Summary:
The Adapting a Sepsis Transition and Recovery Program for Optimal Scale Up ASTROS study is an effectiveness-implementation hybrid design The effectiveness evaluation is designed as a multiple interrupted time series mITS analysis to test the impact of implementing an adapted Sepsis Transition and Recovery STAR program on enhancing post sepsis outcomes in new hospital settings
Detailed Description:
Approximately 14 million survivors of sepsis life-threatening organ dysfunction due to infection are discharged from US hospitals annually facing high rates of long-term mortality and morbidity as well as incurring high costs to healthcare systems To improve outcomes and address disparities this study developed a multicomponent Sepsis Transition and Recovery STAR intervention that leverages real-time advanced analytics to identify high-risk patients who are most likely to benefit from sepsis-specific transitional support STAR is a 90-day nurse-navigator-led program designed to facilitate transitionrecovery after sepsis hospitalization Navigators provide disease education help patients overcome medical-system barriers to recommended care and bridge gaps in service that serve as points of failure for complex sepsis patients STAR specifically targets delivery of best-practice post-sepsis care including i medication optimization ii screening for new impairments iii anticipationmitigation of risk for health deterioration and iv palliative care when appropriate STAR is the only intervention to date supported by randomized controlled trial evidence to improve outcomes for sepsis survivors
Despite rigorous data supporting STAR program effectiveness in its initial context there are significant differences in healthcare infrastructure and resources at different sites that require careful adaptation prior to implementation to retain effectiveness More research is needed to identify STARs core functions ie the subset of an interventions features that are causally related to outcomes to be distinguished from features that may be adapted without compromising interventions effectiveness and may enhance effectiveness by promoting proficientconsistent use in new contexts study the implementation process and evaluate STAR performance in new contexts The goal of this project is to examine strategies to optimize the STAR program to fit well in other settings
Despite rigorous data supporting STAR program effectiveness in its initial context there are significant differences in healthcare infrastructure and resources at different sites that require careful adaptation prior to implementation to retain effectiveness More research is needed to identify STARs core functions ie the subset of an interventions features that are causally related to outcomes to be distinguished from features that may be adapted without compromising interventions effectiveness and may enhance effectiveness by promoting proficientconsistent use in new contexts study the implementation process and evaluate STAR performance in new contexts The goal of this project is to examine strategies to optimize the STAR program to fit well in other settings
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 |
|---|---|---|---|
| 7056-SP | OTHER_GRANT | The Duke Endowment | None |