Prehospital Management of Stroke Patients by Emergency Medical Services

NCT02191514 | Completed

• 1 other identifier: EMS-2014-SV-01
• Study Type: observational
• Target: 2,653
• Locations: 1 country
• Sites: 1

Brief Summary

Annually 12.000 people i Denmark suffer from a stroke. Treatment for ischemic stroke is available, but only 12% of stroke patients receive it. The treatment is only available within a time frame of 4,5 hours from symptom onset, thus the Emergency Medical Services (EMS) is essential to fast and effective stroke treatment. The aim of this study is:

1. 1.To establish the rate of recognition of stroke symptoms by healthcare personnel in the EMD, ultimately aiming at optimizing performance, and identifying barriers for a fast and correct EMS-response.
2. 2.To assess prehospital time consumption by ambulance personnel on the scene of a stroke, create a baseline for future comparison and generate explorative hypotheses for forthcoming interventions.

Conditions

Stroke

Keywords

Prehospital; EMS; EMD; Stroke; Dispatch

Outcome Measures

Primary Outcomes (4)

• The rate of acute stroke recognized by the EMD during the emergency call (sensitivity).

  01.01.2012 - 12.31.2013 (up to 24 months)

• Time from dispatch to ambulance arrival at the scene of accident in stroke fast track patients.

  Up to 6 month period after collection of registration forms (expected 01.01.2015-06.30.2015)

• Time on scene by EMS in stroke fast track patients (on-scene-time).

  Up to 6 month period after collection of registration forms (expected 01.01.2015-06.30.2015)

• Time from departure from the scene of the accident to arrival at the stroke centre in stroke fast track patients.

  Up to 6 month period after collection of registration forms (expected 01.01.2015-06.30.2015)

Secondary Outcomes (6)

• Final diagnoses(ICD-10), in patients with a dispatch code of stroke, but another final diagnosis (false positive).

  01.01.2012 - 12.31.2013 (up to 24 months)

• Dispatch codes, in patients with a final diagnosis of acute stroke, but another dispatch code (false negative).

  01.01.2012 - 12.31.2013 (up to 24 months)

• The positive predictive values of stroke recognition by healthcare personnel at the EMD.

  01.01.2012 - 12.31.2013 (up to 24 months)

• The proportion of patients with a final diagnosis of stroke, who accessed the healthcare system through the EMS.

  01.01.2012 - 12.31.2013 (up to 24 months)

• Prehospital time compared to in-hospital time in stroke fast track patients.

  Up to 6 month period after collection of registration forms (expected 01.01.2015-06.30.2015)

Other Outcomes (9)

• On-scene-time in relation to time-point of performing 12-lead ECG

  Up to 12 months.

• On-scene-time in relation to quality of communication during prenotification of the stroke centre.

  Up to 12 months.

• On-scene-time in relation to ambulance operator

  Up to 12 months.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of patients suffering from a stroke in the Capital Region of Denmark. The Capital Region of Denmark is home to 1,8 mio. people and covers an area of 2.568 km². The regions has 24-hour fast track stroke service divided at 2 hospitals, with alternate 24-hour shifts.

You may qualify if:

• All patients are included if registered in Danish Stroke Registry with an ICD-10 code of stroke (haemorrhagic and ischemic - I61 and I63-64.9), in the National Patient Registry with an ICD-10 code of TIA (Transient Ischemic Attack - G45.9) or in the Emergency Medical Services-database with a dispatch code of suspected stroke (A.26.03, A.26.04) from the 2-year period 01-01-2012 - 12-31-2013.

You may not qualify if:

• Patients are excluded if the Danish personal identification number is not available in either database. If the patient has been directly referred to the hospital by their general practitioner without the use of a EMS transport, or they have presented themselves in the emergency room, they will not be registered in the EMS database.
• Part 2.
• Patients with suspected stroke where the EMS has been in contact with fast track stroke service at the stroke centre are included.
• Incomplete forms will be excluded.
• Part 3.
• All patients with a Danish personal identification number, referred to one of the two regional stroke centres, during a 6-month period will be included. The 6 month period will begin after the above mentioned 500 registration form has been collected, to avoid bias.
• none

Sponsors & Collaborators

• Emergency Medical Services, Capital Region, Denmark: lead
• University of Copenhagen: collaborator
• Bispebjerg Hospital: collaborator
• Glostrup University Hospital, Copenhagen: collaborator
• TrygFonden, Denmark: collaborator

Study Sites (1)

EMS Copenhagen

Copenhagen, Ballerup, 2750, Denmark

Location

Related Publications (6)

• Jauch EC, Saver JL, Adams HP Jr, Bruno A, Connors JJ, Demaerschalk BM, Khatri P, McMullan PW Jr, Qureshi AI, Rosenfield K, Scott PA, Summers DR, Wang DZ, Wintermark M, Yonas H; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Peripheral Vascular Disease; Council on Clinical Cardiology. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Mar;44(3):870-947. doi: 10.1161/STR.0b013e318284056a. Epub 2013 Jan 31.

  PMID: 23370205 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

• Tong D, Reeves MJ, Hernandez AF, Zhao X, Olson DM, Fonarow GC, Schwamm LH, Smith EE. Times from symptom onset to hospital arrival in the Get with the Guidelines--Stroke Program 2002 to 2009: temporal trends and implications. Stroke. 2012 Jul;43(7):1912-7. doi: 10.1161/STROKEAHA.111.644963. Epub 2012 Apr 26.

  PMID: 22539544 BACKGROUND

• Lin CB, Peterson ED, Smith EE, Saver JL, Liang L, Xian Y, Olson DM, Shah BR, Hernandez AF, Schwamm LH, Fonarow GC. Emergency medical service hospital prenotification is associated with improved evaluation and treatment of acute ischemic stroke. Circ Cardiovasc Qual Outcomes. 2012 Jul 1;5(4):514-22. doi: 10.1161/CIRCOUTCOMES.112.965210. Epub 2012 Jul 10.

  PMID: 22787065 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Freddy Lippert, MD, CEO

  Emergency Medical Services, Capital Region, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: July 16, 2014
• Study Start: July 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: January 5, 2016

Record last verified: 2016-01

Locations

DK (1)