NCT04757194

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,499

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

3.8 years

First QC Date

February 3, 2021

Last Update Submit

January 7, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Difference in composite outcome measure score between patients with immediate vs. delayed response.

    Up to 30 days

  • Difference in National Early Warning Score (NEWS) between patients with immediate vs. delayed response.

    Upon ambulance response (Within 8 hours of dispatch)

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Diagnostic Test: openTriage - Alitis algorithm

Control

NO INTERVENTION

Ambulance dispatch per standard of care

Interventions

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

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Västmanland hospital Västerås

Västerås, Västmanland County, Sweden

Location

Uppsala University Hospital

Uppsala, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 31834920BACKGROUND
  • 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.

    PMID: 32198303BACKGROUND

Related Links

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hans Blomberg, MD, PhD

    Uppsala University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Analyst masked to treatment group allocation in final analysis. Outcomes extracted algorithmically from databases.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Groups of patients experiencing a resource constrained situation randomized 1:1 at time of inclusion to control/intervention arms
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 17, 2021

Study Start

February 1, 2021

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

January 8, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Individual level data available upon reasonable request to authors after publication

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
Upon publication
Access Criteria
Researchers with ethics board approved research plan

Locations