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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date June 2023
Source Uppsala University Hospital
Contact Hans Blomberg, MD, PhD
Email hans.blomberg@akademiska.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
openTriage - Alitis algorithm
A machine learning algorithm (Gradient boosting) applied to structured data collected in the Alitis Clinical Decision Support system, patient demographics, and free-text notes.

Locations

Country Name City State
Sweden Uppsala University Hospital Uppsala
Sweden Västmanland hospital Västerås Västerås Västmanland

Sponsors (2)

Lead Sponsor Collaborator
Uppsala University Hospital Region Västmanland

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

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

Outcome

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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