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Paramedic - Norwegian Acute Stroke Prehospital Project (ParaNASPP)

Primary Purpose

Stroke, Triage, Paramedic

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
eSTROKE model
Control
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients with suspected acute stroke met by emergency medical services (ambulance and rapid response car)

Sites / Locations

  • Prehospital services - Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

eSTROKE

Control

Arm Description

Conventional prehospital care

Outcomes

Primary Outcome Measures

Positive predictive value (PPV) of the ParaNASPP model to identify patients suffering acute stroke.

Secondary Outcome Measures

Number of patients in hospitalized within the first 4 hours after symptom onset

Full Information

First Posted
October 11, 2019
Last Updated
September 23, 2021
Sponsor
Oslo University Hospital
Collaborators
Norwegian Air Ambulance Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04137874
Brief Title
Paramedic - Norwegian Acute Stroke Prehospital Project
Acronym
ParaNASPP
Official Title
Diagnostics and Triage of Acute Stroke by the National Institute of Stroke Scale (NIHSS) by Paramedics, the ParaNASPP (Paramedic - Norwegian Acute Stroke Prehospital Project) Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 3, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Norwegian Air Ambulance Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main aim of the study is to show that patients with suspected acute stroke met by the emergency medical service and assessed using the eSTROKE model including prehospital NIHSS and a mobile application will identify a higher number of patients with stroke, than those who receive conventional prehospital care.
Detailed Description
Primary aims: In patients with suspected stroke The proportion of patients hospitalized with a suspected acute stroke and discharged with a stroke diagnose is significantly increased using the ParaNASPP model compared with conventional prehospital care Time from onset to hospitalization is significantly reduced with the ParaNASPP model The ParaNASPP model identifies patients eligible for direct transportation for comprehensive stroke center

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Triage, Paramedic, Mobile Application

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
ParaNASPP is a stepped wedge cluster randomized controlled intervention trial (SW-RCT).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
eSTROKE
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Conventional prehospital care
Intervention Type
Diagnostic Test
Intervention Name(s)
eSTROKE model
Other Intervention Name(s)
ParaNASPP
Intervention Description
The eSTROKE model includes an electronic learning module, a full day course with practical teaching of National Institute of Health Stroke Scale and a mobile application which will be used for communication with in-hospital stroke physician
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Conventional prehospital care
Primary Outcome Measure Information:
Title
Positive predictive value (PPV) of the ParaNASPP model to identify patients suffering acute stroke.
Time Frame
On discharge from hospital - typically within 7 days.
Secondary Outcome Measure Information:
Title
Number of patients in hospitalized within the first 4 hours after symptom onset
Time Frame
first 4 hours On admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients with suspected acute stroke met by emergency medical services (ambulance and rapid response car)
Facility Information:
Facility Name
Prehospital services - Oslo University Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35120559
Citation
Bugge HF, Guterud M, Bache KCG, Braarud AC, Eriksen E, Fremstad KO, Ihle-Hansen H, Ingebretsen SH, Kramer-Johansen J, Larsen K, Roislien J, Thorsen K, Toft M, Sandset EC, Hov MR. Paramedic Norwegian Acute Stroke Prehospital Project (ParaNASPP) study protocol: a stepped wedge randomised trial of stroke screening using the National Institutes of Health Stroke Scale in the ambulance. Trials. 2022 Feb 4;23(1):113. doi: 10.1186/s13063-022-06006-4.
Results Reference
derived

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Paramedic - Norwegian Acute Stroke Prehospital Project

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