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

NCT06672757 | Not Yet Recruiting DMC

• 1 other identifier: p-2024-17207
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Stroke, Acute

Keywords

NIHSS; Paramedic

Outcome Measures

Primary Outcomes (1)

• Prehospital recognition of stroke

  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 Outcomes (3)

• Time on scene

  From enrollment to the admission upto 6 hours

• Door-to-scanner time

  From enrollment to the admission upto 12 hours

• Change in 90-day neurological outcome measured by the modified rankin scale (mRS)

  90 days after admission

Study Arms (2)

Intervention with NIHSS certification and use of app

EXPERIMENTAL

All paramedics who have been NIHSS certified wil be enrolled in this arm. Intervention

Device: CV_AID

Control - standard operating procedure

NO INTERVENTION

Paramedics will remain in this arm until they have been NIHSS certified

Interventions

CV_AID DEVICE

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

Also known as: Education of paramedics

Intervention with NIHSS certification and use of app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A. Suspected stroke by paramedic or dispatcher

You may not qualify if:

• 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

Sponsors & Collaborators

• Naestved Hospital: lead

Study Sites (1)

Emergency Medical Services

Næstved, DK-4700, Denmark

Location

Related Publications (19)

• Gude MF, Blauenfeldt RA, Behrndtz AB, Nielsen CN, Speiser L, Simonsen CZ, Johnsen SP, Kirkegaard H, Andersen G. The Prehospital Stroke Score and telephone conference: A prospective validation. Acta Neurol Scand. 2022 May;145(5):541-550. doi: 10.1111/ane.13580. Epub 2022 Jan 13.

  PMID: 35023151 BACKGROUND

• Duvekot MHC, Venema E, Rozeman AD, Moudrous W, Vermeij FH, Biekart M, Lingsma HF, Maasland L, Wijnhoud AD, Mulder LJMM, Alblas KCL, van Eijkelenburg RPJ, Buijck BI, Bakker J, Plaisier AS, Hensen JH, Lycklama A Nijeholt GJ, van Doormaal PJ, van Es ACGM, van der Lugt A, Kerkhoff H, Dippel DWJ, Roozenbeek B; PRESTO investigators. Comparison of eight prehospital stroke scales to detect intracranial large-vessel occlusion in suspected stroke (PRESTO): a prospective observational study. Lancet Neurol. 2021 Mar;20(3):213-221. doi: 10.1016/S1474-4422(20)30439-7. Epub 2021 Jan 7.

  PMID: 33422191 BACKGROUND

• Price CI, Shaw L, Islam S, Javanbakht M, Watkins A, McMeekin P, Snooks H, Flynn D, Francis R, Lakey R, Sutcliffe L, McClelland G, Lally J, Exley C, Rodgers H, Russell I, Vale L, Ford GA. Effect of an Enhanced Paramedic Acute Stroke Treatment Assessment on Thrombolysis Delivery During Emergency Stroke Care: A Cluster Randomized Clinical Trial. JAMA Neurol. 2020 Jul 1;77(7):840-848. doi: 10.1001/jamaneurol.2020.0611.

  PMID: 32282015 BACKGROUND

• Guterud M, Fagerheim Bugge H, Roislien J, Kramer-Johansen J, Toft M, Ihle-Hansen H, Bache KG, Larsen K, Braarud AC, Sandset EC, Ranhoff Hov M. Prehospital screening of acute stroke with the National Institutes of Health Stroke Scale (ParaNASPP): a stepped-wedge, cluster-randomised controlled trial. Lancet Neurol. 2023 Sep;22(9):800-811. doi: 10.1016/S1474-4422(23)00237-5.

  PMID: 37596006 BACKGROUND

• Viereck S, Moller TP, Iversen HK, Christensen H, Lippert F. Medical dispatchers recognise substantial amount of acute stroke during emergency calls. Scand J Trauma Resusc Emerg Med. 2016 Jul 7;24:89. doi: 10.1186/s13049-016-0277-5.

  PMID: 27388490 BACKGROUND

• Walter S, Audebert HJ, Katsanos AH, Larsen K, Sacco S, Steiner T, Turc G, Tsivgoulis G. European Stroke Organisation (ESO) guidelines on mobile stroke units for prehospital stroke management. Eur Stroke J. 2022 Mar;7(1):XXVII-LIX. doi: 10.1177/23969873221079413. Epub 2022 Feb 9.

  PMID: 35300251 BACKGROUND

• Chiu LQ, Quek DYJ, Salihan RB, Ng WM, Othman RB, Lee CH, Oh DCT. ACT-FAST: a quality improvement project to increase the percentage of acute stroke patients receiving intravenous thrombolysis within 60 minutes of arrival at the emergency department. Singapore Med J. 2021 Sep;62(9):476-481. doi: 10.11622/smedj.2020040. Epub 2020 Mar 31.

  PMID: 32227791 BACKGROUND

• Saver JL. Time is brain--quantified. Stroke. 2006 Jan;37(1):263-6. doi: 10.1161/01.STR.0000196957.55928.ab. Epub 2005 Dec 8.

  PMID: 16339467 BACKGROUND

• Rudd AG, Bladin C, Carli P, De Silva DA, Field TS, Jauch EC, Kudenchuk P, Kurz MW, Laerdal T, Ong M, Panagos P, Ranta A, Rutan C, Sayre MR, Schonau L, Shin SD, Waters D, Lippert F. Utstein recommendation for emergency stroke care. Int J Stroke. 2020 Jul;15(5):555-564. doi: 10.1177/1747493020915135. Epub 2020 Mar 29.

  PMID: 32223543 BACKGROUND

• Wardlaw JM, del Zoppo G, Yamaguchi T. Thrombolysis for acute ischaemic stroke. Cochrane Database Syst Rev. 2000;(2):CD000213. doi: 10.1002/14651858.CD000213.

  PMID: 10796329 BACKGROUND

• Berge E, Whiteley W, Audebert H, De Marchis GM, Fonseca AC, Padiglioni C, de la Ossa NP, Strbian D, Tsivgoulis G, Turc G. European Stroke Organisation (ESO) guidelines on intravenous thrombolysis for acute ischaemic stroke. Eur Stroke J. 2021 Mar;6(1):I-LXII. doi: 10.1177/2396987321989865. Epub 2021 Feb 19.

  PMID: 33817340 BACKGROUND

• Johnsen SP, Ingeman A, Hundborg HH, Schaarup SZ, Gyllenborg J. The Danish Stroke Registry. Clin Epidemiol. 2016 Oct 25;8:697-702. doi: 10.2147/CLEP.S103662. eCollection 2016.

  PMID: 27843349 BACKGROUND

• Kobayashi A, Czlonkowska A, Ford GA, Fonseca AC, Luijckx GJ, Korv J, de la Ossa NP, Price C, Russell D, Tsiskaridze A, Messmer-Wullen M, De Keyser J. European Academy of Neurology and European Stroke Organization consensus statement and practical guidance for pre-hospital management of stroke. Eur J Neurol. 2018 Mar;25(3):425-433. doi: 10.1111/ene.13539. Epub 2018 Jan 12.

  PMID: 29218822 BACKGROUND

• Drenck N, Viereck S, Baekgaard JS, Christensen KB, Lippert F, Folke F. Pre-hospital management of acute stroke patients eligible for thrombolysis - an evaluation of ambulance on-scene time. Scand J Trauma Resusc Emerg Med. 2019 Jan 9;27(1):3. doi: 10.1186/s13049-018-0580-4.

  PMID: 30626404 BACKGROUND

• Berglund A, Svensson L, Sjostrand C, von Arbin M, von Euler M, Wahlgren N; HASTA Collaborators; Engerstrom L, Hojeberg B, Kall TB, Mjornheim S, Engqvist A. Higher prehospital priority level of stroke improves thrombolysis frequency and time to stroke unit: the Hyper Acute STroke Alarm (HASTA) study. Stroke. 2012 Oct;43(10):2666-70. doi: 10.1161/STROKEAHA.112.652644. Epub 2012 Aug 9.

  PMID: 22879096 BACKGROUND

• Mulder MJHL, Jansen IGH, Goldhoorn RB, Venema E, Chalos V, Compagne KCJ, Roozenbeek B, Lingsma HF, Schonewille WJ, van den Wijngaard IR, Boiten J, Albert Vos J, Roos YBWE, van Oostenbrugge RJ, van Zwam WH, Majoie CBLM, van der Lugt A, Dippel DWJ; MR CLEAN Registry Investigators. Time to Endovascular Treatment and Outcome in Acute Ischemic Stroke: MR CLEAN Registry Results. Circulation. 2018 Jul 17;138(3):232-240. doi: 10.1161/CIRCULATIONAHA.117.032600. Epub 2018 Mar 26.

  PMID: 29581124 BACKGROUND

• Lees KR, Bluhmki E, von Kummer R, Brott TG, Toni D, Grotta JC, Albers GW, Kaste M, Marler JR, Hamilton SA, Tilley BC, Davis SM, Donnan GA, Hacke W; ECASS, ATLANTIS, NINDS and EPITHET rt-PA Study Group; Allen K, Mau J, Meier D, del Zoppo G, De Silva DA, Butcher KS, Parsons MW, Barber PA, Levi C, Bladin C, Byrnes G. Time to treatment with intravenous alteplase and outcome in stroke: an updated pooled analysis of ECASS, ATLANTIS, NINDS, and EPITHET trials. Lancet. 2010 May 15;375(9727):1695-703. doi: 10.1016/S0140-6736(10)60491-6.

  PMID: 20472172 BACKGROUND

• Skajaa N, Adelborg K, Horvath-Puho E, Rothman KJ, Henderson VW, Casper Thygesen L, Sorensen HT. Nationwide Trends in Incidence and Mortality of Stroke Among Younger and Older Adults in Denmark. Neurology. 2021 Mar 30;96(13):e1711-e1723. doi: 10.1212/WNL.0000000000011636. Epub 2021 Feb 10.

  PMID: 33568547 BACKGROUND

• Bhatt A. International Council for Harmonisation E6(R2) addendum: Challenges of implementation. Perspect Clin Res. 2017 Oct-Dec;8(4):162-166. doi: 10.4103/picr.PICR_124_17.

  PMID: 29109932 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Helle C Christensen, MD, PHD

  Region Zealand Prehospital Center, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stig NF Blomberg, MSC, PHD

CONTACT

+4560144875; sblom@regionsjaelland.dk

Helle C Christensen, MD, PHD

CONTACT

+4531101990; hcli@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped wedge

Study Record Dates

• First Submitted: August 31, 2024
• First Posted: November 4, 2024
• Study Start: October 29, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)