Evaluation of a Locally Adapted Stroke Unit to Improve Outcomes in Lusaka, Zambia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Proportion of clinical practice guidelines followed during inpatient admission
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Refusal to give informed consent
研究组 & 干预措施
Stroke Unit Arm
All participants in this study will be adults with stroke cared for in the recently implemented stroke unit at the University Teaching Hospital in Lusaka, Zambia. Of note, all adults with stroke admitted to the University Teaching Hospital during the study period will be cared for in the stroke unit regardless of participation participation in this study. However, only those who consent to study participation will have data collected.
干预措施: Stroke Unit (Other)
Pre-Stroke Unit Arm
This arm will consist of a historical cohort of adults with stroke admitted to the University Teaching Hospital in Lusaka, Zambia for the implementation of a stroke unit.
结局指标
主要结局
Proportion of clinical practice guidelines followed during inpatient admission
时间窗: <=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)
Whether or not each individual clinical practice guideline is followed will be tracked each day of the participant's inpatient admission for stroke. The total proportion of clinical practice guidelines followed will then be calculated.
Percentage of 21 Clinical Practice Guidelines Followed During Inpatient Admission
时间窗: <=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)
Whether or not each individual clinical practice guideline is followed will be tracked each day of the participant's inpatient admission for stroke. The percentage of 21 key clinical practice guidelines followed will then be calculated.
次要结局
- 90-day post-discharge mortality(Duration of inpatient hospitalization + 90 days (likely to average < 100 days after enrollment))
- Rate of aspiration pneumonia(<=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))
- Rate of deep vein thrombosis(<=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))
- In-hospital mortality(Duration of inpatient hospitalization ( likely to average <7 days after enrollment ) up to 7 days)
- Functional status at 90-days post-discharge(Duration of inpatient hospitalization + 90 days (likely to average <100 days after enrollment))
- Rate of decubitus ulcers(<=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))
- In-hospital Mortality(Duration of inpatient hospitalization ( likely to average <7 days after enrollment ) up to 7 days)
- 90-day Post-discharge Mortality(90-days (+/- 7 days) post-discharge (likely to average < 100 days after enrollment))
- Functional Status as Measured by the Modified Rankin Scale at 90-days Post-discharge(90-days (+/- 7 days) post-discharge from the index hospitalization)
- Participants With Aspiration Pneumonia(<=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))
- Participants With Decubitus Ulcers(<=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))
- Participants With Deep Vein Thrombosis(<=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))