Implementing International Standards of Practice in A Low Resource Country by Blended Training Modules to Improve Stroke Care
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background: Lack of proper stroke care delivery leads to poor patient outcomes in middle- and low-income countries that can be improved by implementation of international standards. We aim to determine feasibility of implementing stroke core measures and training through blended learning modules in resource poor countries to improve stroke outcomes.
Methods: The project will be conducted across four hospitals in Pakistan in three phases. First stage will include retrospective collection of data for the preceding 4 weeks from start. In stage II, 3 months data will be collected before implementation of core measures. The stepwise training of staff will begin simultaneously, and data will continue to be collected. In stage III by the end of 3 months of stage II, core measures will be implemented as standard of care and patients will be enrolled for another 3 months. Outcomes measures will be successful implementation of the stroke care model as measured by survey done at the end and patient outcomes including in-hospital complication rates, length of hospital stay, patient and caregiver education, mRS at 3 months after discharge, post discharge complications and re-stroke rate. Data will be compared against published data from Pakistan and between patients in the first and last 3 months of the project. Statistical analyses will include appropriate mixed-effects multivariate regression models (i.e., linear and logistic) to model the relationship between clinical measures and patient safety. Degree of correlation across each symptom predictor will be measured. This study will not involve thrombolytic therapy or thrombectomy. However, the study will not provide any hindrance to implementation of such therapy and will not include such patients in analysis.
Discussion: At least one third of stroke survivors in Pakistan die due to recurrent vascular events and complications of stroke in absence of core measures. Prevention practices and stroke care are significantly underutilized in low- and middle-income countries but can be improved most efficiently by improving care delivering process without additional burden on resources by following American Heart Association "Get With The Guidelines" Stroke (GWTG-Stroke) program, Royal College of Physicians UK and European Guidelines, regardless of thrombolysis or thrombectomy. This feasibility study aims to develop a multidisciplinary comprehensive stroke team model with gradual integration of staff training, nursing care, therapy and patient education.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Punjab
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Rawalpindi, Punjab, Pakistán, 46000
- Fauji Foundation Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
Acute onset of Symptoms in the last 24 hours suggestive of stroke Age > 18 years Ischemic or hemorrhagic stroke
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Exclusion Criteria:
Presenting after 24 hours of onset of symptoms Alternate explanation for presenting symptoms (stroke mimics) Family (Surrogate Decision Maker) or next of kin/ patient refusal for participation Transfer of care from another department or hospital Care needed in another department (e.g, ICU, other department) GCS (Glasgow Coma Scale) below 5 or End of life care initiated TIA (Transient Ischemic Attack)
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Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Retrospective 3 months cohort (admitted stroke patients)
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Prospective pre-implementation "standard of core care quality measures" cohort
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Prospective post-implementation "standard of core care quality measures" cohort
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Post Core Measure Delivery
Periodo de tiempo: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
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• Primary outcome measure will be successful implementation of the stroke care model as measured by survey done at the end assessing engagement and ability to continue the program in future and ability to implement the program across institutions.
This will be measured by the NIHSS training, stroke education, awareness of core measures, the regularity of following the core measure and data collection.
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From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Modified Rankin Scale
Periodo de tiempo: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 days
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Modified Rankin Scale is a 6 point disability scale from 0-6, and a greater score means worse outcome.
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From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 days
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New ischemic stroke or Transient Ischemic Attack:
Periodo de tiempo: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 days
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From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 days
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Hemorrhagic transformation:
Periodo de tiempo: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 days
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From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 days
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Intracranial hemorrhage:
Periodo de tiempo: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 days
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From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 days
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Death
Periodo de tiempo: From date of inclusion in the study until the date of discharge
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From date of inclusion in the study until the date of discharge
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FUI/CTR/2020/8
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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