Clinical trial NCT06457048: Zambia Stroke Unit Study
Official title: Evaluation of a Locally Adapted Stroke Unit to Improve Outcomes in Lusaka, Zambia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2024-06-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Outcomes will be compared between a prospective post-intervention cohort enrolled for this study and a historical pre-intervention cohort.
Primary purpose: HEALTH_SERVICES_RESEARCH

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 question\[s\] 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 (alive/dead) 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 (e.g., 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 - i.e. 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 (e.g. 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 Zambia's 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.

Eligibility criteria: Inclusion Criteria:

* Clinically suspected diagnosis of stroke by treating neurologist or imaging-confirmed diagnosis of stroke
* Symptom onset (last known normal) within 7 days of presentation to the University Teaching Hospital in Lusaka, Zambia
* Inpatient admission to the University Teaching Hospital in Lusaka, Zambia

Exclusion Criteria:

* Refusal to give informed consent

Primary outcomes:
measure: Proportion of clinical practice guidelines followed during inpatient admission
timeFrame: <=10 days of inpatient hospitalization for acute stroke (patients will be followed for the first 10 days of hospital admission or until hospital discharge, whichever is first)
Secondary outcomes:
measure: In-hospital mortality
timeFrame: Duration of inpatient hospitalization ( likely to average <7 days after enrollment ) up to 7 days
measure: 90-day post-discharge mortality
timeFrame: Duration of inpatient hospitalization + 90 days (likely to average < 100 days after enrollment)
measure: Functional status at 90-days post-discharge
timeFrame: Duration of inpatient hospitalization + 90 days (likely to average <100 days after enrollment)
measure: Rate of aspiration pneumonia
timeFrame: <=10 days of inpatient hospitalization for acute stroke (patients will be followed for the first 10 days of hospital admission or until hospital discharge, whichever is first)
measure: Rate of decubitus ulcers
timeFrame: <=10 days of inpatient hospitalization for acute stroke (patients will be followed for the first 10 days of hospital admission or until hospital discharge, whichever is first)
measure: Rate of deep vein thrombosis
timeFrame: <=10 days of inpatient hospitalization for acute stroke (patients will be followed for the first 10 days of hospital admission or until hospital discharge, whichever is first)
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: University Teaching Hospital
Study officials:
affiliation: Johns Hopkins University
name: Deanna Saylor, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: