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Harnessing Alternative Resources to Aid Kenyans With Acute Illness (HARAKA-2)

12 de abril de 2020 actualizado por: Dr. Wangari Waweru-Siika, Aga Khan University

Impact of Nurse-Led Focused Cardiac Ultrasound Versus Usual Care on Time to Diagnosis in Adults With Cardiorespiratory Failure: A Two-Cluster Stepped Wedge Clinical Feasibility Trial

Kenya does not have enough experts to perform heart scans in patients who are very sick and in need of urgent intervention. The purpose of this research is to find out whether training Kenyan nurses to perform basic heart scans would shorten the time it takes to know whether the heart and lungs are working normally in very sick patients, to guide treatment. Patients will be placed into one of two groups: One group will have a quick scan of the heart and lungs carried out by trained nurses to see how well these organs are working, in addition to receiving the normal care offered at the hospital. The other group will receive the normal care offered in the hospital only and will not have a scan performed by these nurses. The time it takes to make a diagnosis between the two groups will then be compared. Should the group that has heart scans by nurses be found to spend less time waiting for a diagnosis to be made, more nurses in Kenya will be trained to provide this service, to minimise delays in our emergency departments.

Descripción general del estudio

Descripción detallada

Echocardiography is a useful, non-invasive diagnostic tool in time-critical emergencies. A national shortage of cardiologists and of doctors in Kenya however further compounds the problem of insufficient staff for emergency care and of any capacity building efforts. To achieve the goals of Sustainable Development Goal Number 3 (SDG-3) and realise the government's vision of universal healthcare for all, alternatives to the human resource challenge are key. Modifying the Scope of Practice of Kenyan nurses is one possible solution. Task-shifting traditionally cardiologist roles such as focused cardiac ultrasound (FoCUS) could shorten the time it takes to make a diagnosis in patients with cardiorespiratory failure of likely cardiac origin, making prolonged turnaround times in our public facilities a thing of the past. Our overarching aim is to harness the power of nurses doing FoCUS. The central hypothesis of this work is that in patients with cardiorespiratory failure, a nurse-led FoCUS-guided service would shorten time to diagnosis, supporting interventions and improving outcomes among the critically ill. Insight into potential barriers and enablers for the implementation of a nurse-performed FoCUS service in Kenya is crucial for the success of such a service redesign.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

732

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

Any one of:

  • Systolic blood pressure <90 millimetres of mercury (mmHg)
  • Mean arterial pressure (MAP)<65 millimetres of mercury (mmHg)
  • Shock index >1 (heart rate/systolic blood pressure)
  • Respiratory rate > 30 breaths/minute
  • Oxygen saturations <94%
  • Arterial oxygen partial pressure (paO2) <60 millimetres of mercury (mmHg)
  • Arterial carbon dioxide partial pressure (paCO2) >50 millimetres of mercury(mmHg)

Exclusion Criteria:

  • Trauma
  • Pregnancy
  • Patients requiring immediate life-saving interventions eg cardiopulmonary resuscitation (CPR) or defibrillation

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Diagnóstico
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación Secuencial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Usual care
The control arm will consist of usual care ie a combination of physical examination, lab tests and imaging. The need for a formal echocardiographic evaluation by a cardiologist or cardiac sonographer in patients assigned to the control arm will be at the discretion of the clinical teams, as is usual care at the Kenyatta National Hospital (KNH) and Aga Khan University Hospital Nairobi (AKUHN). A diagnosis will be selected based on the same pre-defined checklist and the time the diagnosis is made recorded.
The control arm will consist of usual care ie a combination of physical examination, lab tests and imaging. The need for a formal echocardiographic evaluation by a cardiologist or cardiac sonographer in patients assigned to the control arm will be at the discretion of the clinical teams, as is usual care at KNH and AKUHN
Experimental: Nurse-performed focused cardiac ultrasound (FoCUS)
The experimental arm will consist of nurse-performed FoCUS for patients with cardiorespiratory failure. A FoCUS-trained nurse will perform a FoCUS examination within 30 minutes of triage by the triage clinician. The Philips Lumify® handheld ultrasound device (HUD) with a phased array probe will be used and studies limited to a maximum of 10 minutes each. A presumptive diagnosis will then be selected by the nurse from a FoCUS checklist based on pre-defined thresholds for each FoCUS target condition and the time the diagnosis is made recorded. Additional imaging and lab tests may be requested at the discretion of the clinical team but the FoCUS nurses will be blinded to the results of these.
A FoCUS-trained nurse will perform a FoCUS examination within 30 minutes of triage by the triage clinician. The Philips Lumify® handheld ultrasound device (HUD) with a phased array probe will be used and studies limited to a maximum of 10 minutes each. A presumptive diagnosis will then be selected by the nurse from a FoCUS checklist based on pre-defined thresholds for each FoCUS target condition and the time the diagnosis is made recorded. Additional imaging and lab tests may be requested at the discretion of the clinical team but the FoCUS nurses will be blinded to the results of these.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to diagnosis
Periodo de tiempo: 24 hours
Difference in median time to diagnosis between nurse-performed FoCUS and usual care.
24 hours

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of patients with cardiorespiratory failure who have a FoCUS exam performed in A&E
Periodo de tiempo: 10 months
Number of patients with cardiorespiratory failure who have a FoCUS
10 months
Proportion of patients with cardiorespiratory failure who have a FoCUS exam performed in A&E
Periodo de tiempo: 10 months
Proportion of patients with cardiorespiratory failure who have a FoCUS
10 months
Diagnostic accuracy of nurse-performed FoCUS
Periodo de tiempo: 10 months
Sensitivity and specificity of novice FoCUS compared to a reference standard (cardiologist opinion)
10 months
Number of FoCUS protocol components suitable for inclusion in a local FoCUS curriculum
Periodo de tiempo: 10 months
Number of FoCUS protocol components suitable for inclusion in a local FoCUS curriculum
10 months
Proportion of novice scanners able to access remote supervision for FoCUS practice.
Periodo de tiempo: 10 months
Proportion of novice scanners able to access remote supervision for FoCUS practice.
10 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Wangari Waweru-Siika, FRCA, Aga Khan University, Nairobi

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Anticipado)

1 de junio de 2020

Finalización primaria (Anticipado)

30 de abril de 2021

Finalización del estudio (Anticipado)

30 de abril de 2021

Fechas de registro del estudio

Enviado por primera vez

7 de abril de 2020

Primero enviado que cumplió con los criterios de control de calidad

12 de abril de 2020

Publicado por primera vez (Actual)

14 de abril de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de abril de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

12 de abril de 2020

Última verificación

1 de abril de 2020

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 31-20

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan IPD

Available on request

Marco de tiempo para compartir IPD

6 months after publication

Criterios de acceso compartido de IPD

Available on request

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • CÓDIGO_ANALÍTICO
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Usual care

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