Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Querying Stroke Unit Nursing Interventions in the Emergency Department

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04011514
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Christina Kruuse, Herlev Hospital

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.

Condition or disease Intervention/treatment
Stroke TIA 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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Specialized Stroke Unit Nursing Interventions in the Emergency Department and Their Efficacy on Outcomes and Patient Perceptions of Clinical Care Pathway Coherence
Actual Study Start Date : September 28, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : December 1, 2019

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




Primary Outcome Measures :
  1. Incidence of infections [ Time Frame: 7 days from admission ]
    Incidence of pneumonia and urinary tract infections defined by a combination of clinical symptoms and para-clinical tests.


Secondary Outcome Measures :
  1. 30-day mortality or recurrent cerebrovascular event [ Time Frame: 30 days from first admission ]
    Composite measure of mortality, cerebrovascular or cardiovascular incidence

  2. Rate of re-admission within 30 days [ Time Frame: 30 days from first admission ]
    Number of re-admission for any disease post stroke

  3. Post stroke depression [ Time Frame: baseline and 90 days and 1 year after admission ]
    new onset depression and antidepressant prescriptions within 90 days and 1 year from stroke

  4. 90-day post-stroke dependency [ Time Frame: baseline and 90 days from admission ]
    via modified Rankin Scale (mRS) score (0-6, 0=best)

  5. Mental health [ Time Frame: within 90 days from admission ]
    WHO-Five Well-Being index

  6. Length of stay [ Time Frame: 90 days from admission ]
    Total time of hospital admission

  7. Dependency [ Time Frame: Within 90 days from admission ]
    Barthel Index



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011514


Contacts
Layout table for location contacts
Contact: Christina R Kruuse, MD, PhD 38681233 ckruuse@dadlnet.dk
Contact: Lene Koldborg, Nurse 38689070 lene.koldborg@regionh.dk

Locations
Layout table for location information
Denmark
Department of Neurology, Herlev-Gentofte Hospital Recruiting
Herlev, Denmark, 2730
Contact: Christina Kruuse, MD, DMSc    +4538681233      
Sponsors and Collaborators
Herlev Hospital
University of Copenhagen
Investigators
Layout table for investigator information
Principal Investigator: Christina Kruuse, MD, DMSc Department of Neurology, Herlev-Gentofte Hospital

Layout table for additonal information
Responsible Party: Christina Kruuse, Senior consultant and faculty supervisor, DMSc, Ph.D.,, Herlev Hospital
ClinicalTrials.gov Identifier: NCT04011514     History of Changes
Other Study ID Numbers: H-17035544
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participants data cannot be shared with 3rd parties as these data are protected by danish law.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Emergencies
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes