Emergencies Clinical Trial
— MADLADOfficial title:
Machine Learning Assisted Differentiation of Low Acuity Patients at Dispatch: A Randomized Controlled Trial
NCT number | NCT04757194 |
Other study ID # | SVLC001 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | February 1, 2021 |
Est. completion date | March 1, 2025 |
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
Status | Recruiting |
Enrollment | 2700 |
Est. completion date | March 1, 2025 |
Est. primary completion date | March 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Uppsala University Hospital | Uppsala | |
Sweden | Västmanland hospital Västerås | Västerås | Västmanland |
Lead Sponsor | Collaborator |
---|---|
Uppsala University Hospital | Region Västmanland |
Sweden,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of RCS where the first available ambulance was dispatched to the patient with the highest National Early Warning Score (NEWS). | 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 | Difference in composite outcome measure score between patients with immediate vs. delayed response. | 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 | |
Secondary | Difference in National Early Warning Score (NEWS) between patients with immediate vs. delayed response. | Per primary outcome | Upon ambulance response (Within 8 hours of dispatch) |
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