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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04011514
Other study ID # H-17035544
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 28, 2018
Est. completion date November 1, 2021

Study information

Verified date January 2021
Source Herlev Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 800
Est. completion date November 1, 2021
Est. primary completion date September 21, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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 Exclusion criteria: - Patients transferred from other hospitals or stroke units - Patients elegible for thrombolysis or thrombectomy at time of admission

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Dedicated stroke nurse care in ED
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

Locations

Country Name City State
Denmark Department of Neurology, Herlev-Gentofte Hospital Herlev

Sponsors (2)

Lead Sponsor Collaborator
Herlev Hospital University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of infections Incidence of pneumonia and urinary tract infections defined by a combination of clinical symptoms and para-clinical tests. 7 days from admission
Secondary 30-day mortality or recurrent cerebrovascular event Composite measure of mortality, cerebrovascular or cardiovascular incidence 30 days from first admission
Secondary Rate of re-admission within 30 days Number of re-admission for any disease post stroke 30 days from first admission
Secondary Number of patients with post stroke depression new onset depression and antidepressant prescriptions within 90 days and 1 year from stroke baseline and 90 days and 1 year after admission
Secondary Level of 90-day post-stroke dependency via modified Rankin Scale (mRS) score (0-6, 0=best) baseline and 90 days from admission
Secondary Mental health WHO-Five Well-Being index within 90 days from admission
Secondary Length of stay Total time of hospital admission 90 days from admission
Secondary Dependency Barthel Index Within 90 days from admission
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