Querying Stroke Unit Nursing Interventions in the Emergency Department

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.

Study Overview

• Status: Unknown
• Conditions: Stroke; TIA
• Intervention / Treatment: Behavioral: Dedicated stroke nurse care in 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 Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Department of Neurology, Herlev-Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Baseline period; Usual care. Stroke patients admitted to the ED during the 3-month baseline inclusion period.	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
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day mortality or recurrent cerebrovascular event	Composite measure of mortality, cerebrovascular or cardiovascular incidence	30 days from first admission
Rate of re-admission within 30 days	Number of re-admission for any disease post stroke	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	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)	baseline and 90 days from admission
Mental health	WHO-Five Well-Being index	within 90 days from admission
Length of stay	Total time of hospital admission	90 days from admission
Dependency	Barthel Index	Within 90 days from admission

Collaborators and Investigators

• Sponsor: Herlev Hospital
• Collaborators: University of Copenhagen

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 28, 2018
• Primary Completion (ANTICIPATED): September 21, 2021
• Study Completion (ANTICIPATED): November 1, 2021

Study Registration Dates

• First Submitted: October 20, 2018
• First Submitted That Met QC Criteria: July 4, 2019
• First Posted (ACTUAL): July 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Stroke; Emergencies
• Other Study ID Numbers: H-17035544

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participants data cannot be shared with 3rd parties as these data are protected by danish law.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No