Harnessing Alternative Resources to Aid Kenyans With Acute Illness

NCT ID: NCT04344418

Last Updated: 2020-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 732 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2021-04-30

Brief Summary

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.

Detailed Description

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.

Conditions

Cardiorespiratory Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Nurse-performed Focused cardiac ultrasound (FoCUS)

Intervention Type: DEVICE

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.

Interventions

Nurse-performed Focused cardiac ultrasound (FoCUS)

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.

Intervention Type: DEVICE

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 KNH and AKUHN

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oxford

OTHER

Sponsor Role: collaborator

Kenyatta National Hospital

OTHER_GOV

Sponsor Role: collaborator

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Wangari Waweru-Siika

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wangari Waweru-Siika, FRCA

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Central Contacts

Wangari Waweru-Siika, FRCA

Role: CONTACT

wangari.waweru-siika@kellogg.ox.ac.uk

+254708612258

Other Identifiers

31-20

Identifier Type: -

Identifier Source: org_study_id