- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04757194
Machine Learning Assisted Differentiation of Low Acuity Patients at Dispatch (MADLAD)
Machine Learning Assisted Differentiation of Low Acuity Patients at Dispatch: A Randomized Controlled Trial
BACKGROUND:
At Emergency Medical Dispatch (EMD) centers, Resource Constrained Situations (RCS) where there are more callers requiring an ambulance than there are available ambulances are common. At the EMD centers in Uppsala and Västmanland, patients experiencing these situations are typically assigned a low-priority response, are often elderly, and have non-specific symptoms. Machine learning techniques offer a promising but largely untested approach to assessing risks among these patients.
OBJECTIVES:
To establish whether the provision of machine learning-based risk scores improves the ability of dispatchers to identify patients at high risk for deterioration in RCS.
DESIGN:
Multi-centre, parallel-grouped, randomized, analyst-blinded trial.
POPULATION:
Adult patients contacting the national emergency line (112), assessed by a dispatch nurse in Uppsala or Västmanland as requiring a low-priority ambulance response, and experiencing an RCS.
OUTCOMES:
Primary:
1. Proportion of RCS where the first available ambulance was dispatched to the patient with the highest National Early Warning Score (NEWS) score
Secondary:
- Difference in composite risk score consisting of ambulance interventions, emergent transport, hospital admission, intensive care, and mortality between patients receiving immediate vs. delayed ambulance response during RCS.
- Difference in NEWS between patients receiving immediate vs. delayed ambulance response during RCS.
INTERVENTION:
A machine learning model will estimate the risk associated with each patient involved in the RCS, and propose a patient to receive the available ambulance. In the intervention arm only, the assessment will be displayed in a user interface integrated into the dispatching system.
TRIAL SIZE:
1500 RCS each consisting of multiple patients randomized 1:1 to control and intervention arms
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Uppsala, Sweden
- Uppsala University Hospital
-
-
Västmanland
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Västerås, Västmanland, Sweden
- Västmanland hospital Västerås
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Identification of a resource constrained situation by ambulance director (i.e., 2 or more patients awaiting an ambulance response)
- Assigned priority 2A or 2B (Low-priority ambulance response) by dispatch nurse call-taker
- Valid Swedish personal identification number collected at dispatch
- Age >= 18 years
Exclusion Criteria:
- Relevant calls received more than 30 minutes apart
- Logistical factors (eg. the patients' geographical locations) affect the ambulance assignment decision
- On scene risk factors (eg. a patient is outdoors and risks hypothermia) or risk mitigators (eg. healthcare staff already on-scene with a patient) affect the ambulance assignment decision
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Calculation of risk assessment score by machine learning algorithm and display of risk assessment information to dispatch nurses.
Staff encouraged but not required to comply with suggested ranking.
|
A machine learning algorithm (Gradient boosting) applied to structured data collected in the Alitis Clinical Decision Support system, patient demographics, and free-text notes.
|
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No Intervention: Control
Ambulance dispatch per standard of care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of RCS where the first available ambulance was dispatched to the patient with the highest National Early Warning Score (NEWS).
Time Frame: Upon ambulance response (Within 8 hours of dispatch)
|
NEWS is a widely used and well-validated scoring algorithm based on objective patient vital signs, which are not causally dependent on the outcomes used to train the machine learning models investigated in this study.
NEWS values will be based on the first set of vital signs obtained by ambulance nurses upon making contact with the patient.
NEWS is measured on a 0-21 scale, with higher values corresponding to patients at higher risk for deterioration.
|
Upon ambulance response (Within 8 hours of dispatch)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in composite outcome measure score between patients with immediate vs. delayed response.
Time Frame: Up to 30 days
|
This measure investigates a composite score consisting of the outcomes used to train the machine learning models. The composite score is generated by identifying the following patient outcomes and assigning the corresponding weights: Abnormal intitial Arway/Breathing/Circulation findings by ambulance crew (4) Emergent (lights and sirens) transport to the hospital (2) Provision of prehospital interventions (1) Admission to in-patient care or mortality within 30 days (1) This results in a score from 0-8, with higher scores representing more |
Up to 30 days
|
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Difference in National Early Warning Score (NEWS) between patients with immediate vs. delayed response.
Time Frame: Upon ambulance response (Within 8 hours of dispatch)
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Per primary outcome
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Upon ambulance response (Within 8 hours of dispatch)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hans Blomberg, MD, PhD, Uppsala University Hospital
Publications and helpful links
General Publications
- Spangler D, Hermansson T, Smekal D, Blomberg H. A validation of machine learning-based risk scores in the prehospital setting. PLoS One. 2019 Dec 13;14(12):e0226518. doi: 10.1371/journal.pone.0226518. eCollection 2019.
- Spangler D, Edmark L, Winblad U, Collden-Benneck J, Borg H, Blomberg H. Using trigger tools to identify triage errors by ambulance dispatch nurses in Sweden: an observational study. BMJ Open. 2020 Mar 19;10(3):e035004. doi: 10.1136/bmjopen-2019-035004.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SVLC001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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