- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04344418
Harnessing Alternative Resources to Aid Kenyans With Acute Illness (HARAKA-2)
April 12, 2020 updated by: 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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
732
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wangari Waweru-Siika, FRCA
- Phone Number: +254708612258
- Email: wangari.waweru-siika@kellogg.ox.ac.uk
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to diagnosis
Time Frame: 24 hours
|
Difference in median time to diagnosis between nurse-performed FoCUS and usual care.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with cardiorespiratory failure who have a FoCUS exam performed in A&E
Time Frame: 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
Time Frame: 10 months
|
Proportion of patients with cardiorespiratory failure who have a FoCUS
|
10 months
|
Diagnostic accuracy of nurse-performed FoCUS
Time Frame: 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
Time Frame: 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.
Time Frame: 10 months
|
Proportion of novice scanners able to access remote supervision for FoCUS practice.
|
10 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wangari Waweru-Siika, FRCA, Aga Khan University, Nairobi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2020
Primary Completion (Anticipated)
April 30, 2021
Study Completion (Anticipated)
April 30, 2021
Study Registration Dates
First Submitted
April 7, 2020
First Submitted That Met QC Criteria
April 12, 2020
First Posted (Actual)
April 14, 2020
Study Record Updates
Last Update Posted (Actual)
April 14, 2020
Last Update Submitted That Met QC Criteria
April 12, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 31-20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Available on request
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
Available on request
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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