Zambia Stroke Unit Study
NCT Number: NCT06457048
Acronym: ZASUS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: OTHER: Stroke Unit
Sponsor: Johns Hopkins University
Collaborators: National Institutes of Health (NIH)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08
Completion Date: 2025-11
Locations: University Teaching Hospital, Lusaka, 00000, Zambia

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.

Primary Outcome Measures: Proportion of clinical practice guidelines followed during inpatient admission, 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., <=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 Outcome Measures: In-hospital mortality, Proportion of patients who die during the inpatient hospitalization for acute stroke, Duration of inpatient hospitalization ( likely to average <7 days after enrollment ) up to 7 days|90-day post-discharge mortality, Proportion of patients who survive the inpatient hospitalization but die within 90 days of discharge as assessed by telephone call, Duration of inpatient hospitalization + 90 days (likely to average < 100 days after enrollment)|Functional status at 90-days post-discharge, Proportion of patients with Modified Rankin Scale (mRS) \<2 vs mRS \>=2 at 90-days post-discharge. mRS will be measured using the telephone version of the modified Rankin Scale and the study team will include all patients (not just those who survived the initial hospitalization) in this outcome.Score range from 0 to 6, with higher scores indicating greater disability., Duration of inpatient hospitalization + 90 days (likely to average <100 days after enrollment)|Rate of aspiration pneumonia, Aspiration pneumonia will be defined as \>=4 of the following criteria: fever (temperature \>38°C), tachypnea (respiratory rate \>20), hypoxemia (oxygen saturation \<92%), cough, rhonchi, witnessed aspiration event, initiation of antibiotics for clinically suspected aspiration pneumonia, leukocytosis (WBC \>10,000) on complete blood count (CBC) or opacity on chest X-ray. These criteria will be assessed daily for the first 10 days of admission or until discharge, whichever comes first., <=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 decubitus ulcers, Presence or absence of decubitus ulcers will be assessed daily with a skin exam for the first ten days of inpatient hospitalization or until hospital discharge, whichever occurs first., <=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, Proportion of patients diagnosed with a deep vein thrombosis confirmed on ultrasound during the first 10 days of hospitalization or until hospital discharge, whichever comes first., <=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)