Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457048
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-07
Brief Title:
Zambia Stroke Unit Study
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Evaluation of a Locally Adapted Stroke Unit to Improve Outcomes in Lusaka Zambia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
ZASUS
Brief Summary:
The goal of this clinical trial is to evaluate the impact of a locally adapted stroke unit on outcomes of adults with stroke in Zambia The main questions to answer are Does provision of evidence-based stroke care improve after implementation of a stroke unit at the University Teaching Hospital in Zambia Do patients cared for in a locally adapted stroke unit at the University Teaching Hospital in Zambia have better in-hospital and post-discharge outcomes that similar patients who were not cared for in the stroke unit The investigators will collect data on the types of care participants receive during hospitalization and vital status alivedead at the time of hospital discharge and at 90-days post-discharge Researchers will compare patients enrolled in this study to a historical group of adults with stroke cared for at the same hospital prior to implementation of the stroke unit
Detailed Description:
The overarching goal of this project is to evaluate the uptake and impact of locally relevant feasible and generalizable stroke systems of care developed for the University Teaching Hospital UTH in Lusaka Zambia using the Adopt-Contextualize-Adapt framework in order to improve stroke-related outcomes Zambia is a country of 20 million people in southern Africa where stroke is the eighth leading cause of death However stroke is not a problem unique to Zambia Stroke is the second leading cause of adult disability and mortality worldwide More than 75 of stroke-related morbidity and mortality occur in low- and middle-income countries LMICs and stroke prevalence in sub-Saharan Africa SSA is among the highest in the world Yet most stroke literature to date has been developed in high-income settings and its results applied to LMICs without adequate consideration of biological ethnic cultural and contextual differences Diverse populations and settings in LMICs including Zambia necessitate evaluating unique risk factors treatment strategies and systems of care in order to develop locally relevant interventions to improve stroke-related outcomes
While acute stroke interventions eg tissue plasminogen activator endovascular therapies have improved outcomes indirect advances in stroke care have had a broader impact Implementation of standardized systems of stroke care - ie stroke units - has led to secondary gains in stroke-related outcomes regardless of whether patients receive acute interventions Compared to alternative care models inpatient stroke unit care is associated with substantial reductions in death dependency and institutionalized care In LMICs with limited access to specialists neuroimaging and acute stroke interventions standardized systems of stroke care have not been instituted including across Zambia and much of SSA Absence of standardized systems of care likely accounts for higher rates of poor functional outcomes and mortality compared to higher-income settings
Developing systems of stroke care in Zambia may improve stroke outcomes even in the absence of acute stroke interventions Yet simply instituting stroke clinical practice guidelines CPGs developed in high-income settings is unlikely to be successful without attention to differences in resource availability health systems and local contextual factors Differences in biology eg younger age higher rates of HIV and rheumatic heart disease differing risk factors may also necessitate changes to stroke care delivery As such development of systems of stroke care in Zambia offers the promise of substantially improving stroke outcomes but must be done in a way in which stroke biology as well as cultural patient provider and health systems factors are carefully considered during the design and implementation process
Prior research characterized stroke care practices and stroke-related outcomes at the University Teaching Hospital UTH in Zambia More recently contextualized locally relevant stroke CPGs were developed for UTH using the systematic guideline adaptation process of the Adopt-Contextualize-Adapt framework These have recently been implemented as part of Zambias first stroke unit This project will assess the impact of local stroke CPGs on CPG adherence stroke quality measures QMs and mortality through a post-intervention cohort of 300 adults with stroke In this cohort CPG uptake and in-hospital and post-discharge mortality will be measured and compared to a historical pre-intervention cohort of adults with stroke admitted to UTH before stroke unit implementation If effective results could potentially be applied across SSA thereby improving outcomes for millions of people with stroke
While acute stroke interventions eg tissue plasminogen activator endovascular therapies have improved outcomes indirect advances in stroke care have had a broader impact Implementation of standardized systems of stroke care - ie stroke units - has led to secondary gains in stroke-related outcomes regardless of whether patients receive acute interventions Compared to alternative care models inpatient stroke unit care is associated with substantial reductions in death dependency and institutionalized care In LMICs with limited access to specialists neuroimaging and acute stroke interventions standardized systems of stroke care have not been instituted including across Zambia and much of SSA Absence of standardized systems of care likely accounts for higher rates of poor functional outcomes and mortality compared to higher-income settings
Developing systems of stroke care in Zambia may improve stroke outcomes even in the absence of acute stroke interventions Yet simply instituting stroke clinical practice guidelines CPGs developed in high-income settings is unlikely to be successful without attention to differences in resource availability health systems and local contextual factors Differences in biology eg younger age higher rates of HIV and rheumatic heart disease differing risk factors may also necessitate changes to stroke care delivery As such development of systems of stroke care in Zambia offers the promise of substantially improving stroke outcomes but must be done in a way in which stroke biology as well as cultural patient provider and health systems factors are carefully considered during the design and implementation process
Prior research characterized stroke care practices and stroke-related outcomes at the University Teaching Hospital UTH in Zambia More recently contextualized locally relevant stroke CPGs were developed for UTH using the systematic guideline adaptation process of the Adopt-Contextualize-Adapt framework These have recently been implemented as part of Zambias first stroke unit This project will assess the impact of local stroke CPGs on CPG adherence stroke quality measures QMs and mortality through a post-intervention cohort of 300 adults with stroke In this cohort CPG uptake and in-hospital and post-discharge mortality will be measured and compared to a historical pre-intervention cohort of adults with stroke admitted to UTH before stroke unit implementation If effective results could potentially be applied across SSA thereby improving outcomes for millions of people with stroke
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