Use of App for Stroke Assessment VS Standard Level of Care During Prehospital Stroke Assessment (STRAPP)

November 1, 2024 updated by: Naestved Hospital

In Denmark, 12,000 people experience a stroke every year. It is the fourth largest cause of death, and costs 4,6 billion Danish crowns in healthcare expenses and lost work income. It is also the leading cause of acquired disability for adults. Pre-hospital recognition of stroke is paramount to ensure fast and correct treatment for patients, in turn leading to better outcomes for patients. As the advanced treatment for ischemic stroke, thrombolysis and thrombectomy, is time-sensitive, even short delays in recognition and treatment can have a large effect on the individual stroke patient.

Paramedics on scene have only a few tools to assist them in recognizing stroke, where clinical scales such as the National Institutes of Health Stroke Scale (NIHSS), Face Arm Speech Time (FAST) or Prehospital Stroke Score (PRESS ) are most commonly used. Despite the use of such instruments, patients with stroke still go unrecognized, and as a result, the unrecognized patient might not be hospitalized, be hospitalized in a hospital without stroke facilities or be hospitalized too late for advanced treatment. Lower quality of communication between paramedics and the stroke centre significantly increases prehospital on-scene time. In a consensus statement from the European Academy of Neurology (EAN) and the European Stroke Organisation (ESO), training paramedics to recognise symptoms of all stroke types was strongly recommended. This study aims to explore whether trained paramedics using a mobile application with NIHSS and video communication to the in-hospital stroke physician may improve triage of acute stroke patients. This intervention will be compared to paramedics using standard procedure and communication through regular channels. It is hypothesized that the number of patients brought to the emergency department with suspected acute stroke and discharged with a stroke diagnosis is significantly higher in the app-group (intervention) compared to standard prehospital model (control).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

1. Background 1.1 Stroke In Denmark, 12,000 people experience a stroke every year. It is the fourth largest cause of death, and costs 4,6 billion Danish crowns in healthcare expenses and lost work income. It is also the leading cause of acquired disability for adults.

Pre-hospital recognition of stroke is paramount to ensure fast and correct treatment for patients, in turn leading to better outcomes for patients. As the advanced treatment for ischemic stroke, thrombolysis and thrombectomy, is time-sensitive, even short delays in recognition and treatment can have a large effect on the individual stroke patient. Paramedics on scene have only a few tools to assist them in recognizing stroke, where clinical scales such as the National Institutes of Health Stroke Scale (NIHSS), Face Arm Speech Time (FAST) or Prehospital Stroke Score (PRESS ) are most commonly used. Despite the use of such instruments, patients with stroke still go unrecognized, and as a result, the unrecognized patient might not be hospitalized, be hospitalized in a hospital without stroke facilities or be hospitalized too late for advanced treatment.

A combination of early prehospital identification of stroke, triage to the right level of care and improvement of in-hospital measures to reduce door-to-needle time may result in more patients receiving acute treatment. Lower quality of communication between paramedics and the stroke centre significantly increases prehospital on-scene time. In a consensus statement from the European Academy of Neurology (EAN) and the European Stroke Organisation (ESO), training paramedics to recognise symptoms of all stroke types was strongly recommended.

This study aims to explore whether trained paramedics using a mobile application with NIHSS and digital communication may improve triage of acute stroke patients and ensure the standardised transfer of critical patient data to the in-hospital stroke physician. This intervention will be compared to paramedics using standard procedure with PRESS and communication through regular channels.

Investigators hypothesize that the number of patients brought to the emergency department (ED) with suspected acute stroke and discharged with a stroke diagnosis is significantly higher in the app-group (intervention) compared to standard prehospital model (control).

1.1.1 Incidence and mortality In Denmark, 17.647 patients were registered in 2020 with the diagnosis of Stroke and Transient ischemic attack (TIA) according to the national Danish stroke database DanStroke. Costs of Stroke are expected to increase by 44% by 2040 in Europe. A major part of stroke costs is due to post-stroke need of care due to loss of independency. Acute Stroke revascularization treatment using medical thrombolysis or mechanical endovascular treatment is a critical time-dependent situation as increasing time from symptom onset to start of treatment increases independency for patients post-stroke. Every minute there is a loss of approximately 2 MIO brain cells, hence the term "Time is Brain", and corresponds to more loss of independency in clinical outcome with increasing time from onset of symptoms

1.2 Prehospital assessment of patients with suspected stroke 1.2.1 The potential importance of prehospital assessment A combination of early prehospital identification of stroke, triage to the right level of care and improvement of in-hospital measures to reduce door-to-needle time may result in more patients receiving acute treatment. Lower quality of communication between paramedics and stroke centre significantly increases prehospital on-scene time. As mentioned, the European Academy of Neurology (EAN) and the European Stroke Organisation (ESO) strongly recommend training paramedics to recognise symptoms of all stroke types.

1.3 Current evidence concerning videoassisted prehospital assessment of patients with suspected stroke 1.3.1 Randomized clinical trials PubMed was searched with the search terms "prehospital stroke scales", "prehospital NIHSS", "non-physician NIHSS", "prehospital stroke assessment", "NIHSS in LVO", and "mobile stroke units". The focus was on studies reporting randomised controlled trials, stepped-wedge cluster randomised trials, clinical trials, and cohort studies as well as systematic reviews and meta-analyses of prehospital stroke care. A recent randomised trial, the ParaNASPP trial explored prehospital NIHSS as a common language in the acute stroke chain. This trial showed that introducing prehospital NIHSS with direct communication to the stroke physician, improved care by reducing in-hospital time to CT and by increasing prehospital identification of patients with low NIHSS and subtle symptoms. However, it did not increase diagnostic accuracy.

Another study, the PASTA trial, explored the implementation of a structured protocol and checklists for paramedic stroke assessment to increase thrombolytic rates in a randomised control design. The PASTA checklist was based on structured handover and clinical assessment with a face, arm, speech, time (FAST) test, and concluded that paramedic training in FAST alone did not significantly influence treatment rate. These prehospital stroke scales are usually modified versions of the National Institutes of Health Stroke Scale (NIHSS) and their main purpose is to enable identification of patients with large vessel occlusions (LVOs), eligible for endovascular thrombectomy.

In the PRESTO trial, Duvecot et al. compared the accuracy of eight prehospital stroke scales in detecting LVOs. Since LVOs occur in at most 30% of the general stroke population, most patients have non-LVO stroke with a heterogeneous symptom presentation. The NIHSS is the scale of choice for identification of both LVO and non-LVO strokes. Our literature search did not find any prehospital studies focusing on non-LVO symptoms in minor to moderate strokes. Several in-hospital conducted cohort and inter-rater agreement studies on the NIHSS have shown high levels of agreement when used by non-physicians. No studies considered whether prehospital NIHSS could be implemented in a large-scale prehospital system; however, promising results were presented in cohort studies from the helicopter emergency medical service and mobile stroke units. The prehospital NIHSS studies had poor methodological robustness because of their small sample size and non-randomised design.

1.5 Current practice Currently, paramedics meeting a patient with suspected stroke assess the patients with the PRESS-scale and when deemed necessary the comprehensive stroke centre is contacted, and a teleconference between paramedics and the attending neurologist is initiated. In case of suspected and prehospitally confirmed stroke suspicion, the patient is transported to the comprehensive stroke centre in Roskilde for further evaluation and treatment.

If a stroke is identified at the hospital, it is registered in The Danish Stroke Registry (DanStroke).

Study Type

Interventional

Enrollment (Estimated)

1200

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

Study Contact Backup

Study Locations

  • Denmark
      • Naestved, Denmark, DK-4700
        • Emergency Medical Services
        • Contact:
        • Contact:
        • Contact:
          • Stig NF Blomberg, MSC, PHD
        • Contact:
          • Helle C Christensen, MD, PHD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • A. Suspected stroke by paramedic or dispatcher

Exclusion Criteria:

  • Technical issues (ie. the telephone does not work, the app does not work).
  • Patients who are incarcerated
  • Patients seen by a physician prior to assessment by paramedics.
  • Subarachnoid Haemorrhage strokes

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention with NIHSS certification and use of app
All paramedics who have been NIHSS certified wil be enrolled in this arm. Intervention
Device: CV_AID

Upon arrival at the scene, the paramedic utilizes a mobile app with an integrated camera to aid in conducting the National Institutes of Health Stroke Scale (NIHSS) assessment. The app assists in scoring the patient's responses according to NIHSS criteria to determine the severity of stroke symptoms.

If the app assessment indicates a high likelihood of stroke, transport can be initiated without a conference with the neurovascular centre. The app shares the recorded NIHSS assessment and video of the patient with the neurovascular centre for review.

While en route, the paramedic confer with the neurovascular centre to discuss the patient's condition and determine appropriate course of action. If the neurovascular centre decides not to treat the patient, transport can be diverted to the nearest hospital.

The paramedic documents all assessment findings, interventions, and communications related to the stroke patient in the patient care record. U

Other Names:
  • Education of paramedics
No Intervention: Control - standard operating procedure
Paramedics will remain in this arm until they have been NIHSS certified

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prehospital recognition of stroke
Time Frame: From enrollment to patient admission upto 6 hours
The primary outcome will be prehospital recognition of stroke by paramedics, quantified as the proportion of patients discharged with a final stroke diagnosis who are accepted for stroke evaluation by the neurologist at the neurovascular centre.
From enrollment to patient admission upto 6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time on scene
Time Frame: From enrollment to the admission upto 6 hours
Time spent on-scene is a key metric for the evaluation of prehospital health services. Less time spent on scene is directly correlated with time to hospital admittance, presuming correct triage of the patient. As this study introduces a potential delaying factor in the use of an app and the performance of a full NIHSS evaluation, this metric is key to evaluating whether this new initiative is a net positive for patients with stroke.
From enrollment to the admission upto 6 hours
Door-to-scanner time
Time Frame: From enrollment to the admission upto 12 hours
Investigators theorise that the availability of a reliable NIHSS score as well as the video material from the evaluation of the patient will enable the neurologist at the neurovascular centre to make faster assessment, which could lead to reduced door-to-scanner times.
From enrollment to the admission upto 12 hours
Change in 90-day neurological outcome measured by the modified rankin scale (mRS)
Time Frame: 90 days after admission

The 90-day neurological outcome is important, as this outcome reflects the degree of disability experienced by the patient, and thereby the recovery from stroke. If this study leads to faster and more accurate diagnoses and treatment, investigators to see this reflected in the 90 day-neurological outcome.

Neurological outcome is measured by the modified rankin scale (mRS), a clinical scale to measure the degree of disability or dependence in daily activities of people who have had a stroke or other neurological diseases. It ranges from 0 (no symptoms) to 6 (death). The mRS is the standard scale for evaluating the patients degree of disability post-stroke, and is available as part of the DanStroke registry data for all patients.
90 days after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Naestved Hospital

Investigators

  • Principal Investigator: Helle C Christensen, MD, PHD, Region Zealand Prehospital Center, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

October 29, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

August 31, 2024

First Submitted That Met QC Criteria

November 1, 2024

First Posted (Estimated)

November 4, 2024

Study Record Updates

Last Update Posted (Estimated)

November 4, 2024

Last Update Submitted That Met QC Criteria

November 1, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • p-2024-17207

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be completely anonymized according to Danish law before analysis. Due to Danish data regulations, data is not publically available, but access to the registry data used in this project can be applied for by appropriate official channels. Anonymised data from the app can be made available upon reasonable request after the publication of the results.

All relevant project-related documents will be made available upon reasonable request. Data will be available for any research purpose to all interested parties who have approval from an independent review committee and who have a methodological sound proposal as determined by the steering committee of the current project. Interested parties will be able to request the project specific data by contacting the principal investigator, and registry data by appropriate official channels.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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