NCT04011514

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2018

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2018

Completed
9 months until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

April 28, 2021

Status Verified

January 1, 2021

Enrollment Period

3 years

First QC Date

October 20, 2018

Last Update Submit

April 27, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 30-day mortality or recurrent cerebrovascular event

    30 days from first admission

  • Rate of re-admission within 30 days

    30 days from first admission

  • Number of patients with post stroke depression

    baseline and 90 days and 1 year after admission

  • Level of 90-day post-stroke dependency

    baseline and 90 days from admission

  • Mental health

    within 90 days from admission

  • +2 more secondary outcomes

Study Arms (2)

Baseline period

Usual care. Stroke patients admitted to the ED during the 3-month baseline inclusion period.

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

Behavioral: Dedicated stroke nurse care in ED

Interventions

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

Baseline periodIntervention period

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • Patients transferred from other hospitals or stroke units
  • Patients elegible for thrombolysis or thrombectomy at time of admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Herlev-Gentofte Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Christina Kruuse, MD, DMSc

    Department of Neurology, Herlev-Gentofte Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior consultant and faculty supervisor, DMSc, Ph.D.,

Study Record Dates

First Submitted

October 20, 2018

First Posted

July 8, 2019

Study Start

September 28, 2018

Primary Completion

September 21, 2021

Study Completion

November 1, 2021

Last Updated

April 28, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Individual participants data cannot be shared with 3rd parties as these data are protected by danish law.

Locations