Clinical trial NCT04344418: Harnessing Alternative Resources to Aid Kenyans With Acute Illness
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiorespiratory Failure
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: University of Oxford
name: Kenyatta National Hospital
First posted: 2020-04-14
Enrollment: 732
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 2-cluster stepped wedge clinical feasibility trial
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Time to diagnosis
timeFrame: 24 hours
Secondary outcomes:
measure: Number of patients with cardiorespiratory failure who have a FoCUS exam performed in A&E
timeFrame: 10 months
measure: Proportion of patients with cardiorespiratory failure who have a FoCUS exam performed in A&E
timeFrame: 10 months
measure: Diagnostic accuracy of nurse-performed FoCUS
timeFrame: 10 months
measure: Number of FoCUS protocol components suitable for inclusion in a local FoCUS curriculum
timeFrame: 10 months
measure: Proportion of novice scanners able to access remote supervision for FoCUS practice.
timeFrame: 10 months
Other outcomes:
Locations:
Study officials:
affiliation: Aga Khan University
name: Wangari Waweru-Siika, FRCA
role: PRINCIPAL_INVESTIGATOR
References: