Condition category
Circulatory System
Date applied
28/02/2020
Date assigned
02/03/2020
Last edited
06/03/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Stroke is a devastating disease, as the leading cause of severe physical disability. Ischemic stroke is the most common form of stroke; and is treatable with medical treatment and a new minimally invasive surgical procedure. These treatments can transform lives, but minutes matter for improving outcomes. The research objectives are focused on increasing the proportion of ischemic stroke patients receiving treatment, and improving the efficiency of treatment.

In Canada, healthcare is administered within provincial boundaries; this presents a particular challenge in Atlantic Canada due to small populations and the lack of locally available medical specialists. We aim to overcome these care barriers to ensure that all stroke patients have access to efficient treatment based on their clinical presentation, not on system restrictions. We will employ an Improvement Collaborative intervention. It has been used successfully in health care to implement improvements across multiple hospitals. This intervention uses the Model for Improvement adopted from Industrial Engineering, which employs alternating face-to-face workshops and action periods to test and implement changes at local hospitals.

Who can participate?
Health professionals enrolled to participate in the improvement collaborative.

What does the study involve?
The workshops involve sharing information with hospital teams and facilitation of cross-site learning. Additionally, operations research in simulation will be employed to ensure that the health system can adequately support the changes.

What are the possible benefits and risks of participating?
The potential benefit for patients experiencing ischemic stroke is profound. It is anticipated that 10-20% of ischemic stroke patients will have improved outcomes, which means that up to 550 more patients each year in Atlantic Canada can return to their homes with no or little disability, and utilize much less rehabilitation and long-term care services.

Where is the study run from?
Queen Elizabeth II Health Sciences Centre (Canada)

When is the study starting and how long is it expected to run for?
July 2020 to February 2023

Who is funding the study?
Canadian Institutes of Health Research

Who is the main contact?
Dr Noreen Kamal
Noreen.Kamal@dal.ca

Trial website

Contact information

Type

Scientific

Primary contact

Dr Noreen Kamal

ORCID ID

http://orcid.org/0000-0001-5957-2183

Contact details

Dalhousie University
5269 Morris Street
Room 100
PO Box 15000
Halifax
B3H 4R2
Canada
+1 (902) 494-3293
Noreen.Kamal@dal.ca

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

ACTEAST001

Study information

Scientific title

Atlantic Canada Together Enhancing Acute Stroke Treatment

Acronym

ACTEAST

Study hypothesis

The intervention will increase the proportion of ischemic stroke patients that receive either alteplase or EVT by 5%

Ethics approval

Approval pending, Nova Scotia Health Authority (Centre for Clinical Research, 118-5790 University Avenue, Halifax, NS, B3H 1V7, Canada; +1 902-473-6846; ShelleyL.MacDonald@nshealth.ca), ref: n/a

Study design

Stepped wedge interventional non-randomized

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Ischemic stroke

Intervention

The evaluation of this improvement intervention will be conducted through a Stepped Wedge Trial (SWT). In the SWT, all sites will be assigned to a group or cluster. Each cluster will go through the intervention at different times. Prior to going through the intervention, all clusters are in the control phase, while after the intervention, all clusters will have the intervention fully implemented. The intervention will be 6 months in length.

Teams from all hospitals that treat stroke patients (typically called Primary and Comprehensive Stroke Centres) will be recruited to participate in the Improvement Collaborative intervention. The teams will be comprised of approximately 5 interdisciplinary healthcare professionals.
Recruitment will be conducted through a Site Enrolment Form. Once we receive the form from a site, a consent form will be sent to each individual to sign. The efforts to improve the proportion of patients that receive treatment and improve the treatment times will be led by these individuals. Essentially, the intervention will be carried out by these hospital teams.
Data for all ischemic stroke patients that receive treatment will be included in the analysis from NS, NB, PEI and NL. However, no new treatment is being trialled in this study. Only improvement of access and efficiency of treatment will be evaluated.
Participants for each enrolled hospital site will work with an interdisciplinary team who are also participants in this study. They will do the following:
• Complete a pre-Collaborative online questionnaire prior to attending the Learning Sessions
• Attend two face-to-face Learning Sessions (workshops)
• Carry out changes to improve access and efficiency of acute stroke treatment at their hospital as planned during the Learning Sessions
• Ensure that de-identified acute stroke data is submitted to the research team for each ischemic stroke patient that received treatment (alteplase and/or EVT) at their site. This will be done by only one person on their team
• Assist to organize a large meeting at their hospital with frontline staff when the 1-3 members of the research team carry out their site visit
• Participate in interviews and focus group after the Collaborative is completed (6 months after the first Learning Session)

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Proportion of ischemic stroke patients treated with alteplase and endovascular thrombectomy using data from the Discharge Abstract Database at the end of the data collection periods.

Secondary outcome measures

Measures are obtained from chart audits at the end of the data collection periods:
1. Door to needle time (time from arrival to start of alteplase treatment)
2. Proportion of all ischemic stroke patients discharged home
3. Proportion of all treated (alteplase or EVT) ischemic stroke patients discharged home
4. Hospital length of stay for all ischemic stroke patients
5. Hospital length of stay for all treated (alteplase or EVT) ischemic stroke patients
6. Door-in-door-out times (time from hospital arrival to departure) for all patients transferred for EVT
7. Door to groin puncture time (time from arrival to groin puncture) for all EVT treated patients
8. First medical contact to needle time (time from 911 call to start of alteplase treatment)
9. First medical contact to groin puncture (time from 911 call to start of EVT procedure)

Overall trial start date

01/03/2020

Overall trial end date

28/02/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Enrolled to participate in the improvement collaborative
2. Involved with acute stroke care of ischemic stroke patients

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/07/2020

Recruitment end date

01/02/2022

Locations

Countries of recruitment

Canada

Trial participating centre

Queen Elizabeth II Health Sciences Centre
1276 South Park Street
Halifax
B3H 3A6
Canada

Sponsor information

Organisation

Dalhousie University

Sponsor details

PO Box 15000
Halifax
B3H 4R2
Canada
+1 (902) 494-3293
Noreen.Kamal@dal.ca

Sponsor type

University/education

Website

https://www.dal.ca

Funders

Funder type

Government

Funder name

Canadian Institutes of Health Research

Alternative name(s)

Instituts de Recherche en Santé du Canada, CIHR, IRSC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Canada

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

01/10/2023

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/03/2020: Uploaded protocol version 1.0 01 March 2020 (not peer reviewed). 02/03/2020: Trial’s existence confirmed by Canadian Institutes of Health Research.