Ambulance transport direct to the stroke unit instead of transport to an emergency department
| ISRCTN | ISRCTN12104897 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12104897 |
| Secondary identifying numbers | 2014/8 |
- Submission date
- 08/04/2022
- Registration date
- 19/04/2022
- Last edited
- 18/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
A stroke is a serious life-threatening medical condition that happens when the blood supply to part of the brain is cut off. It is a time-sensitive condition and one of the major causes of death and illness worldwide. In Sweden, the yearly incidence of stroke is about 30,000, with a mean age of 75 years, and most patients with stroke need ambulance care. Research and guidelines recommend that care and rehabilitation at a stroke unit should take place immediately in the event of a stroke to improve the recovery of patients. However, for patients with low priority (i.e., not eligible for thrombolysis or thrombectomy), there are delays in the emergency department for CT examination and physical/occupational therapist assessment at a stroke unit. Time to treatment is important and has resulted in more effective prehospital care among these patients. Thus, fast tracks have been developed with the aim of performing a CT scan of the brain as rapidly as possible and transporting the patients directly from the ambulance to the stroke unit, bypassing the emergency department (ED). Although it seems reasonable to assume that transporting the patients from the ambulance directly to a stroke unit is beneficial, there is a lack of evidence of the impact of such a fast track on the early chain of care and on the outcomes. Furthermore, both are considered legitimate standards of care. The aim of this study is to compare direct admission to the stroke unit by ambulance and transport to the ED in terms of time to clinical examination, length of hospital stay and activities of daily living at 3 months.
Who can participate?
Patients aged over 18 years with suspected stroke and cared for by ambulance services in the Region of Halland
What does the study involve?
Participants are randomly allocated by the ambulance nurse before arrival at the hospital to either be directly admitted to the stroke unit by ambulance (DASA) or to be transported to the emergency department (ED). The DASA group are transported directly to the stroke unit and a stroke nurse performs blood tests and sends a referral to the radiology department for CT examination. The neurologist, occupational therapist and physical therapist perform an examination and acute care/rehabilitation. The ED group are transported to the ED. The patient is prioritized according to the guidelines. An ED nurse carries out blood tests and an ECG. The patient is placed in an examination room or a corridor along with other patients to wait for an examination by a physician. Following examination by the physician, the patient is transported to the radiology department for CT examination and then back to the ED. In the ED, the patient waits for the decision about treatment. Thereafter, the ED nurse reports the patient to the stroke unit, and the patient is moved to the stroke unit.
To investigate if direct admission to the stroke unit by ambulance instead of transport to the emergency department have impact on time to clinical examination, length of hospital stay and ADL at 3 months.
What are the possible benefits and risks of participating?
A possible disadvantage of participation may be that patients do not take part in the emergency department's broad competence if they are randomized to direct admission. At the same time, it can be an advantage to see a doctor directly with a focus on stroke if the patients are subject to direct admission. In both cases, accepted assessment tools are used to support the doctor's initial treatment. Patients who are admitted directly avoid any waiting time at the emergency department.
Where is the study run from?
Halland Hospital and the ambulance services in Region Halland (Sweden)
When is the study starting and how long is it expected to run for?
January 2016 to August 2018
Who is funding the study?
Halland Hospital and the Department of Prehospital Care in Region of Halland (Sweden)
Who is the main contact?
Markus Lingman
Markus.Lingman@regionhalland.se
Contact information
Scientific
Lasarettsvägen
Halmstad
302 33
Sweden
| Phone | +46 (0)35131000 |
|---|---|
| Markus.Lingman@regionhalland.se |
Scientific
Allegatan.1
Borås
50190
Sweden
| Phone | +46 (0)708436467 |
|---|---|
| Glenn.larsson@hb.se |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Direct admission to the stroke unit by ambulance services: a randomized controlled trial comparing two prehospital emergency care pathways and time to clinical examinations, lengths of stay and activities of daily living |
| Study acronym | DASA |
| Study objectives | Direct admission to a stroke ward by ambulance compared with a standard pathway via the emergency department decreases activities of daily living (ADL) dependence. |
| Ethics approval(s) | Approved 16/09/2014, Regional Ethical Review Board in Lund, Sweden Dnr 2014/534. Sandgatan.1, 223 50 Lund, Sweden; +46 (0)46 222 00 00; no email provided), 2014/8 |
| Health condition(s) or problem(s) studied | Stroke |
| Intervention | Patients assessed with a suspicion of stroke and triaged to level yellow or green (low acuity) according to the Rapid Emergency Triage and Treatment System are randomized using a closed, opaque envelope by the ambulance nurse before arrival to the hospital to either direct admission to the stroke unit by ambulance (DASA) or transport to the emergency department (ED). The patients who are randomized to the DASA group are transported directly to the stroke unit and a stroke nurse performs blood tests and sends a referral to the radiology department for CT examination. Thereafter, the neurologist, occupational therapist and physical therapist perform an examination and acute care/rehabilitation. Patients randomized to the ED are transported to the ED. The patient is prioritized according to the RETTS and ED guidelines. An ED nurse carries out blood tests and an ECG. The patient is placed in an examination room or a corridor along with other patients to wait for examination by a physician. Following examination by the physician, the patient is transported to the radiology department for CT examination and then back to the ED. In the ED, the patient waits for the decision about treatment. Thereafter, the ED nurse reports the patient to the stroke unit, and the patient is moved to the stroke unit. |
| Intervention type | Other |
| Primary outcome measure | Independent in activities of daily living (ADL), mobility, going to the toilet and dressing was measured using patient reported outcome measurements before and three months after the stroke and collected from the Swedish Stroke Registry. |
| Secondary outcome measures | 1. Time in minutes was measured from arrival to admission to stroke unit 2. Time in minutes was measured from arrival to neurologist assessment at stroke unit 3. Time in minutes was measured from arrival to start of computed tomography 4. The number of patients assessed by physical/occupational therapist within 24 h of admission 5. Length of hospital stay was measured in days from arrival to discharge from hospital |
| Overall study start date | 12/01/2016 |
| Completion date | 31/08/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 210 patients, with 105 patients in each group |
| Total final enrolment | 2112 |
| Key inclusion criteria | 1. Patients with a suspected stroke >18 years old and acute onset of a neurological deficit, such as a sudden problem speaking or sudden weakness in the face, arm, or leg 2. Low priority (yellow or green) according to the Rapid Emergency Triage and Treatment System (RETTS) 3. Monday through Friday between 08.00 h and 16.00 h |
| Key exclusion criteria | 1. Patients who met the criteria for stroke alerts and candidates for i.v. thrombolysis, symptoms for <4 h 2. Plasma glucose of >25 mmol/l 3. Wound damage that needs to be saturated 4. Seizures associated with the disease 5. Diarrhoea or vomiting in the last 48 h |
| Date of first enrolment | 15/01/2016 |
| Date of final enrolment | 24/08/2018 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Halmstad
30185
Sweden
Sponsor information
Hospital/treatment centre
Lasarettsgatan
Halmstad
30233
Sweden
| Phone | +46 (0)35131000 |
|---|---|
| regionen@regionhalland.se | |
| Website | http://www.regionhalland.se/hallandssjukhushalmstad |
"ROR" |
https://ror.org/04faw9m73 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 15/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The data can be provided after contact with Glenn Larsson, Glenn.larsson@hb.se. Participant-level data is only available if the request is compliant with the related regulatory framework of the European Union and Sweden. Therefore all requests will be treated individually regarding the type of data and availability. |
Editorial Notes
18/08/2022: The intention to publish date was changed from 01/07/2022 to 15/12/2022.
19/04/2022: Trial's existence confirmed by Swedish Ethical Review Authority (Etikprövningsmyndigheten)
