Clinical trial NCT04011514: Querying Stroke Unit Nursing Interventions in the Emergency Department
Official title: Specialized Stroke Unit Nursing Interventions in the Emergency Department and Their Efficacy on Outcomes and Patient Perceptions of Clinical Care Pathway Coherence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
TIA
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2019-07-08
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of infections
timeFrame: 7 days from admission
Secondary outcomes:
measure: 30-day mortality or recurrent cerebrovascular event
timeFrame: 30 days from first admission
measure: Rate of re-admission within 30 days
timeFrame: 30 days from first admission
measure: Number of patients with post stroke depression
timeFrame: baseline and 90 days and 1 year after admission
measure: Level of 90-day post-stroke dependency
timeFrame: baseline and 90 days from admission
measure: Mental health
timeFrame: within 90 days from admission
measure: Length of stay
timeFrame: 90 days from admission
measure: Dependency
timeFrame: Within 90 days from admission
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Neurology, Herlev-Gentofte Hospital
Study officials:
affiliation: Department of Neurology, Herlev-Gentofte Hospital
name: Christina Kruuse, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References: