Querying Stroke Unit Nursing Interventions in the Emergency Department

Stroke Clinical Trial

Official title:

Specialized Stroke Unit Nursing Interventions in the Emergency Department and Their Efficacy on Outcomes and Patient Perceptions of Clinical Care Pathway Coherence

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04011514
• Other study ID #: H-17035544
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Emergencies
• Stroke
• TIA

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