StrokeNCT04011514
Querying Stroke Unit Nursing Interventions in the Emergency Department
An observational study of Stroke and TIA, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The aim of the study is to monitor if specialized stroke nurses as team partners in the ED can reduce hospital acquired infections. The study is designed as pre- post-intervention study in which specialized SU nurses partner with ED nursing staff to asses and screen stroke admissions in the ED. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Dedicated stroke nurse care in ED
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 800 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Sep 2018to 1 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients admitted with a diagnosis of acute stroke or TIA and candidate to specific stroke observation within the following 24 hours minimum. Data for all stroke/TIA patients admitted to the ED at HGH are retrieved during the 3-month baseline and a 3 month intervention observational period during admission and at regular clinical follow-up.
Who may be able to join
- patients referred to the ED at Herlev Hospital with a diagnosis of stroke or TIA from 11 Am to 7 PM
- patients fulfilling one of the following ICD-10 codes at discharge: ICH: I61, cerebral infarction; I63, unspecified: I64, TIA: G45 and a scheduled follow-up appointment at the outpatient clinic Herlev Hospital
Who cannot join
- Patients transferred from other hospitals or stroke units
- Patients elegible for thrombolysis or thrombectomy at time of admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Specialized Stroke Unit Nursing Interventions in the Emergency Department and Their Efficacy on Outcomes and Patient Perceptions of Clinical Care Pathway Coherence
The aim of the study is to monitor if specialized stroke nurses as team partners in the ED can reduce hospital acquired infections. The study is designed as pre- post-intervention study in which specialized SU nurses partner with ED nursing staff to asses and screen stroke admissions in the ED.
Read the detailed description
An intervention study comprised of 1) a primary registry database component and 2) a secondary questionnaire based quantitative evaluation . The intervention study includes a 3-month baseline observational period followed by a 7-month baseline data collection period, a 2-month intervention implementation phase, and a 3-month intervention observational period followed by 7-month intervention data collection period.
An intervention, where dedicated stroke nurses handle acute care of stroke and TIA patient in the ED prior to admission to a dedicated stroke unit will take place in the timeframe of 11-19:00 hrs, 7 days a week. Notably, the intervention is set to be integrated into clinical practice on a permanent basis after end of study.
Data for all stroke patients admitted to the ED at HGH are collected during the 3-month baseline and intervention observational periods. Fulfilment of Danish Stroke Quality Program (DAP) quality indicators is monitored as follows - use of dysphagia screen (GUSS), mobilization within day of ED admission and transfer to SU. Additional nursing interventions monitored in the ED are: Use of nasogastric catheter, use of bladder scan and intermittent catheterization, frequency of temperature monitoring and use of anti-pyretics, acute phase monitoring of blood-pressure every 2 hours, use of Scandinavian Stroke Scale (SSS) score.
Outcomes are monitored in hospital and at visits to the out patient clinic, as well as by registry.
- Being tested
- Dedicated stroke nurse care in ED
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dedicated stroke nurse care in EDBehavioural
A specialized SU nursing team partner with ED nursing staff for timely fulfillment of stroke quality care indicators while awationg admission to a dedicated stroke unit
| Study group | Role | What they receive |
|---|---|---|
| Baseline period | Usual care. Stroke patients admitted to the ED during the 3-month baseline inclusion period. Receives: Behavioral: Dedicated stroke nurse care in ED | |
| Intervention period | Intervention: 2 month implementation period of specialized stroke nurses allocated to ED for nurse specific treatment of stroke patients specific observations and care Receives: Behavioral: Dedicated stroke nurse care in ED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of infections
Incidence of pneumonia and urinary tract infections defined by a combination of clinical symptoms and para-clinical tests.
Measured: 7 days from admission
Secondary outcomes (7)
30-day mortality or recurrent cerebrovascular event
Composite measure of mortality, cerebrovascular or cardiovascular incidence
Measured: 30 days from first admission
Rate of re-admission within 30 days
Number of re-admission for any disease post stroke
Measured: 30 days from first admission
Number of patients with post stroke depression
new onset depression and antidepressant prescriptions within 90 days and 1 year from stroke
Measured: baseline and 90 days and 1 year after admission
Level of 90-day post-stroke dependency
via modified Rankin Scale (mRS) score (0-6, 0=best)
Measured: baseline and 90 days from admission
Mental health
WHO-Five Well-Being index
Measured: within 90 days from admission
Length of stay
Total time of hospital admission
Measured: 90 days from admission
Dependency
Barthel Index
Measured: Within 90 days from admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start28 Sep 2018
- Primary completion21 Sep 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Christina Kruuse, Herlev Hospital
- Investigators
- Christina Kruuse, MD, DMSc, Principal investigator, Department of Neurology, Herlev-Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011514
- Sponsor's protocol ID
- H-17035544
- Status last verified
- Jan 2021
- First submitted
- 20 Oct 2018
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participants data cannot be shared with 3rd parties as these data are protected by danish law.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specialized Stroke Unit Nursing Interventions in the Emergency Department and Their Efficacy on Outcomes and Patient Perceptions of Clinical Care Pathway Coherence
- ClinicalTrials.gov ID
- NCT04011514
- Acronym / sponsor ID
- H-17035544
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 21 Sep 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to monitor if specialized stroke nurses as team partners in the ED can reduce hospital acquired infections. The study is designed as pre- post-intervention study in which specialized SU nurses partner with ED nursing staff to asses and screen stroke admissions in the ED.
Detailed description
An intervention study comprised of 1) a primary registry database component and 2) a secondary questionnaire based quantitative evaluation . The intervention study includes a 3-month baseline observational period followed by a 7-month baseline data collection period, a 2-month intervention implementation phase, and a 3-month intervention observational period followed by 7-month intervention data collection period.
An intervention, where dedicated stroke nurses handle acute care of stroke and TIA patient in the ED prior to admission to a dedicated stroke unit will take place in the timeframe of 11-19:00 hrs, 7 days a week. Notably, the intervention is set to be integrated into clinical practice on a permanent basis after end of study.
Data for all stroke patients admitted to the ED at HGH are collected during the 3-month baseline and intervention observational periods. Fulfilment of Danish Stroke Quality Program (DAP) quality indicators is monitored as follows - use of dysphagia screen (GUSS), mobilization within day of ED admission and transfer to SU. Additional nursing interventions monitored in the ED are: Use of nasogastric catheter, use of bladder scan and intermittent catheterization, frequency of temperature monitoring and use of anti-pyretics, acute phase monitoring of blood-pressure every 2 hours, use of Scandinavian Stroke Scale (SSS) score.
Outcomes are monitored in hospital and at visits to the out patient clinic, as well as by registry.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline period | – | Behavioral: Dedicated stroke nurse care in EDUsual care. Stroke patients admitted to the ED during the 3-month baseline inclusion period. |
| Intervention period | – | Behavioral: Dedicated stroke nurse care in EDIntervention: 2 month implementation period of specialized stroke nurses allocated to ED for nurse specific treatment of stroke patients specific observations and care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted with a diagnosis of acute stroke or TIA and candidate to specific stroke observation within the following 24 hours minimum. Data for all stroke/TIA patients admitted to the ED at HGH are retrieved during the 3-month baseline and a 3 month intervention observational period during admission and at regular clinical follow-up.
Key inclusion criteria (2 listed)
- patients referred to the ED at Herlev Hospital with a diagnosis of stroke or TIA from 11 Am to 7 PM
- patients fulfilling one of the following ICD-10 codes at discharge: ICH: I61, cerebral infarction; I63, unspecified: I64, TIA: G45 and a scheduled follow-up appointment at the outpatient clinic Herlev Hospital
Key exclusion criteria (2 listed)
- Patients transferred from other hospitals or stroke units
- Patients elegible for thrombolysis or thrombectomy at time of admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dedicated stroke nurse care in EDA specialized SU nursing team partner with ED nursing staff for timely fulfillment of stroke quality care indicators while awationg admission to a dedicated stroke unit | Behavioural | Baseline period, Intervention period |
Primary outcome
Incidence of infections
Time frame: 7 days from admission
Incidence of pneumonia and urinary tract infections defined by a combination of clinical symptoms and para-clinical tests.
7 secondary outcomes
30-day mortality or recurrent cerebrovascular event
Time frame: 30 days from first admission
Rate of re-admission within 30 days
Time frame: 30 days from first admission
Number of patients with post stroke depression
Time frame: baseline and 90 days and 1 year after admission
Level of 90-day post-stroke dependency
Time frame: baseline and 90 days from admission
Mental health
Time frame: within 90 days from admission
Length of stay
Time frame: 90 days from admission
Dependency
Time frame: Within 90 days from admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No. Individual participants data cannot be shared with 3rd parties as these data are protected by danish law.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Kruuse, MD, DMSc principal investigator
Department of Neurology, Herlev-Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and TIA, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of infections (time frame: 7 days from admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.