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
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
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
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) 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 |