Essential Acute Stroke Care in Low Resource Settings: a Pilot studY

Study Overview
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Brief Summary
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An investigator-initiated, evaluator-blinded, prospective, multi centre, before-and-after, effectiveness-implementation hybrid design study to assess the feasibility of essential acute stroke care in a low resource setting

Detailed Description
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This is a multicentre, before and after, effectiveness-implementation hybrid study design with blinded outcome assessment. Patients admitted to the participating hospitals will be managed under usual care conditions for three months (control arm). This will be followed by the training of the doctors and nurses in those hospitals on essential acute stroke care management. Patient management for the following three months after the training (intervention) will then be assessed to evaluate its impact on the care and clinical outcome of the patients.

Official Title
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Essential Acute Stroke Care in Low Resource Settings: a Pilot Study

Conditions
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Acute Stroke

Intervention / Treatment
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* Other: Acute stroke care Intervention arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (age ≥18 years) A clinical or imaging-based diagnosis of acute stroke (ischemic or haemorrhagic) within 72 hours of stroke symptom onset Provision of written informed consent Subjects in observational, natural history and/or epidemiological studies not involving an intervention are eligible. Exclusion Criteria: Patients who have undergone intravenous thrombolysis or mechanical thrombectomy Patients who are planned for transfer to the intensive care unit Subarachnoid haemorrhage Participation in an interventional medical investigation or clinical trial currently or within the past 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: A before and after, effectiveness-implementation hybrid study design with blinded outcome assessment will be conducted. This type 1 effectiveness-implementation hybrid design will test the essential acute stroke care management plan and secondarily gather data to inform subsequent research trials
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Usual care to be provided to patients as per hospital guidelines for 3 months | |
| Other: Intervention arm<br>The intervention consists of training and education of the site staff about the treatment protocol for the different components of the management plan will be provided on two occasions. This intervention will run for 3 months. Refresher training will be given monthly during the intervention. | Other: Acute stroke care Intervention arm<br>* Training and education of the site staff about the treatment protocol for the different components of the management plan will be provided on two occasions. The aim of these sessions will be to educate stroke champions and other site staff on the management protocols. Available training resources will be accessed (including online materials) and simulation training will be used. New skills such as dysphagia assessment will be emphasized based on existing knowledge and competencies. After training, staff will have another assessment (Post-test) in order to determine whether they have been adequately trained and are able to adhere to the essential acute stroke care management plan. A standardised Power Point presentation and accompanying handouts will be made available for further use in the ward. Refresher training will be provided monthly during the intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Primary Outcome Measure: Adherence to the predefined components of the essential acute stroke care management plan Adherence will be expressed as all or none measure and is defined as the proportion of patients who receive all the components of acute stroke care management for which the patient is eligible. Adherence will also be expressed as a composite measure, which is defined as the total number of eligible components performed divided by the total number of components for which the patient was eligible. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death or disability | Death or disability as measured by Modified Rankin Scale (mRS) at 30 days. The mRS is a disability scale that ranges from 0 (no symptoms) to 6 (death). | 30 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Ischemic stroke, hemorrhagic stroke, stroke package