Submission date
05/11/2015
Registration date
05/11/2015
Last edited
30/11/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Background and study aims
A stroke is a serious condition where the blood supply to a part of the brain is cut off, usually by a blood clot blocking an artery or a bleed (haemorrhage). The majority of strokes are ischemic strokes. Ischemic strokes happen when the arteries that supply the brain with oxygen (carotid arteries) become narrowed or blocked, causing severely reduced blood flow (ischemia). As we age, a gradual build-up of a sticky substance called plaque can build-up in one or both of the carotid arteries. When there is a lot of plaque, particularly with a rough or irregular surface, blood clots can develop, depriving the brain of oxygen and leading to an acute ischemic stroke (AIS). This can lead to irreversible damage to the brain and long-term disability if not treated quickly. Thrombolysis, also known as “clot busting”, is a drug treatment that breaks down clots, helping to restore the blood supply to the brain. The quicker this treatment is given, the better the patient’s chance of recovery. Unfortunately, many patients do not receive thrombolysis quickly enough, as the decision to give it relies on specialist assessments, which take place after they have been admitted to hospital. Quicker access to important stroke treatments such as thrombolysis is needed, and paramedics may be able to play a more important role. Paramedic acute stroke treatment assessment (PASTA) is a new care pathway in which paramedics perform an enhanced role in stroke assessment. This involves taking down more information about the patient, providing a structured handover of stroke information to medical professionals and assistance with urgent tasks when they arrive at the hospital with the patient. The aim of this study is to find out whether implementing PASTA could have a beneficial effect on patients’ long-term recovery from an acute stroke.

Who can participate?
Adults who have suffered an acute stroke, and have been assessed by a study paramedic within 4 hours.

What does the study involve?
Study participants receive either the PASTA pathway or usual emergency stroke care, according to the paramedic who attends their emergency call. Before the start of the study, paramedics are randomly allocated to provide the PASTA pathway or to continue with usual emergency stroke care. Participants are also asked to undergo a telephone interview or to complete a postal questionnaire at 90 days after stroke. This records details about recovery after stroke, including any help required with day to day activities, and rehabilitation received since discharge from hospital.

What are the possible benefits and risks of participating?
The PASTA pathway may improve recovery, but this is not yet proven. There may be no benefits to individuals who take part in the study, however, it is hoped that care for future stroke patients will be improved as a result of this research. There are no notable risks of participating.

Where is the study run from?
North East England, North West England and Wales (UK)

When is the study starting and how long is it expected to run for?
November 2015 to April 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Rachel Lakey

Study website

Contact information

Type

Scientific

Contact name

Dr Rachel Lakey

ORCID ID

Contact details

Newcastle Clinical Trials Unit
1-4
Claremont Terrace
Newcastle upon Tyne
NE2 4AE
United Kingdom

Additional identifiers

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Secondary identifying numbers

20052

Study information

Scientific title

Paramedic Acute Stroke Treatment Assessment (PASTA)

Acronym

PASTA

Study hypothesis

The aim of this study is to determine the clinical-and cost-effectiveness of an enhanced Paramedic Acute Stroke Treatment Assessment (PASTA) pathway.

Ethics approval(s)

National Research Ethics Service Committee North East - Newcastle & North Tyneside 1, 09/11/2015, ref: 15/NE/0309

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Other

Study type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Stroke; Subtopic: Acute Care; Disease: In hospital study, Community study

Intervention

Participants will randomly receive either the Paramedic Acute Stroke Treatment Assessment (PASTA) pathway or usual emergency stroke care, according to the paramedic that attends their emergency call. The PASTA pathway is a care pathway where paramedics perform an enhanced role in stroke assessment including additional pre-hospital information collection, structured handover of stroke information at hospital and assistance with urgent tasks on hospital arrival.

Intervention type

Other

Primary outcome measure

Current primary outcome measure as of 18/12/2019:
Treatment with intravenous thrombolysis on the day of hospital admission assessed by examining medical records

Previous primary outcome measure:
Dependency measured using the modified Rankin Scale (mRS) at 90 days after stroke.

Secondary outcome measures

Current secondary outcome measures as of 18/12/2019:
1. Stroke severity measured by the National Institute of Health Stroke Scale in the medical records at 24 h after thrombolysis
2. Medical complications at 24 h after thrombolysis by examining medical records
3. Dependency assessed using the modified Rankin Scale at discharge from hospital and 90 days after stroke
4. Discharge destination at discharge from hospital assessed by examining medical records
5. Assistance with activities of daily living required at discharge from hospital assessed by examining medical records and at 90 days after stroke by participant interview
6. Residence at 90 days after stroke assessed by examining medical records and participant interview

Previous secondary outcome measures:
1. Stroke severity measured by the National Institute of Health Stroke Scale at 24 hours after thrombolysis
2. Medical complications at 24 hours after thrombolysis
3. Dependency (mRS), discharge destination and assistance with activities of daily living required, at discharge from hospital
4. Residence and assistance with activities of daily living required at 90 days after stroke

Overall study start date

01/01/2015

Overall study end date

30/04/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Paramedics allocated to delivering the PASTA pathway will be asked to deliver this to the following patients:
1. Aged 18 years and over.
2. Face Arm Speech Test (FAST) positive or any presentation of new focal neurological symptoms which indicate acute stroke in the paramedic's clinical judgement.
3. Within 4 hours of last known to be without new stroke symptoms in the paramedic’s judgement.
4. Admission to a study hospital

Patients will be identified and approached about enrolment in the study after arrival at hospital. Patients approached about enrolment will meet the following criteria:
1. Travelled to hospital with a study paramedic
2. Aged 18 years and over
3. Hospital specialist diagnosis of stroke
4. Within 4 hours of stroke onset (onset time determined by the hospital stroke team) when assessed by the study paramedic

Participant type(s)

Patient

Age group

Adult

Lower age limit

18 Years

Sex

Both

Target number of participants

Planned Sample Size: 3640; UK Sample Size: 3640; Description: The sample sixe is 3640 patients (1820 participants per group)

Total final enrolment

1214

Participant exclusion criteria

Not meeting the inclusion criteria

Recruitment start date

01/12/2015

Recruitment end date

30/04/2018

Locations

Countries of recruitment

England, United Kingdom

Study participating centre

Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust

Sponsor details

1st floor
Regent's Point
Regent Farm Road
Newcastle Upon Tyne
NE3 3HD
England
United Kingdom

Sponsor type

Hospital/treatment centre

Website

ROR

https://ror.org/05p40t847

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The study will be presented at national and international conferences and submitted for publication in peer reviewed journals.

2019 results presented at the European Stroke Organisation Conference in https://eso-wso-conference.org/wp-content/uploads/sites/42/2019/05/PASTA.pdf

Intention to publish date

01/07/2020

Individual participant data (IPD) Intention to share

No

IPD sharing plan

Not provided at time of registration

IPD sharing plan summary

Not provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 12/02/2019 Yes No
Results article results 01/07/2020 15/04/2020 Yes No
Results article economic results 16/03/2021 17/03/2021 Yes No
Abstract results 22/05/2019 30/11/2022 No No
Protocol (other) V2 31/10/2017 30/11/2022 No No
Results article 01/05/2022 30/11/2022 Yes No
HRA research summary 28/06/2023 No No

Additional files

Editorial Notes

30/11/2022: Protocol, results and abstract added. 17/03/2021: Publication reference added. 15/04/2020: The following changes have been made: 1. Publication reference added. 2. The total final enrolment number has been added from the reference. 18/12/2019: The following changes have been made: 1. The primary outcome measures have been changed. 2. The secondary outcome measures have been changed. 3. The intention to publish date has been changed from 31/12/2019 to 01/07/2020. 07/11/2019: Conference presentation slides added to publication and dissemination plan. 14/02/2019: Publication reference added.