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出境医 / 临床实验 / Querying Stroke Unit Nursing Interventions in the Emergency Department

Querying Stroke Unit Nursing Interventions in the Emergency Department

Study Description
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.

Study Design
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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 21, 2021
Estimated Study Completion Date : November 1, 2021
Arms 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
Outcome Measures
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. Number of patients with 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. Level of 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


Eligibility Criteria
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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
Contacts and Locations

Locations
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Denmark
Department of Neurology, Herlev-Gentofte Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
University of Copenhagen
Investigators
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Principal Investigator: Christina Kruuse, MD, DMSc Department of Neurology, Herlev-Gentofte Hospital
Tracking Information
First Submitted Date October 20, 2018
First Posted Date July 8, 2019
Last Update Posted Date April 28, 2021
Actual Study Start Date September 28, 2018
Estimated Primary Completion Date September 21, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 4, 2019) 		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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 24, 2021)
  • 30-day mortality or recurrent cerebrovascular event [ Time Frame: 30 days from first admission ]
    Composite measure of mortality, cerebrovascular or cardiovascular incidence
  • Rate of re-admission within 30 days [ Time Frame: 30 days from first admission ]
    Number of re-admission for any disease post stroke
  • Number of patients with 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
  • Level of 90-day post-stroke dependency [ Time Frame: baseline and 90 days from admission ]
    via modified Rankin Scale (mRS) score (0-6, 0=best)
  • Mental health [ Time Frame: within 90 days from admission ]
    WHO-Five Well-Being index
  • Length of stay [ Time Frame: 90 days from admission ]
    Total time of hospital admission
  • Dependency [ Time Frame: Within 90 days from admission ]
    Barthel Index
Original Secondary Outcome Measures
 (submitted: July 4, 2019)
  • 30-day mortality or recurrent cerebrovascular event [ Time Frame: 30 days from first admission ]
    Composite measure of mortality, cerebrovascular or cardiovascular incidence
  • Rate of re-admission within 30 days [ Time Frame: 30 days from first admission ]
    Number of re-admission for any disease post stroke
  • 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
  • 90-day post-stroke dependency [ Time Frame: baseline and 90 days from admission ]
    via modified Rankin Scale (mRS) score (0-6, 0=best)
  • Mental health [ Time Frame: within 90 days from admission ]
    WHO-Five Well-Being index
  • Length of stay [ Time Frame: 90 days from admission ]
    Total time of hospital admission
  • Dependency [ Time Frame: Within 90 days from admission ]
    Barthel Index
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • 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
Study Groups/Cohorts
  • Baseline period
    Usual care. Stroke patients admitted to the ED during the 3-month baseline inclusion period.
    Intervention: 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
    Intervention: Behavioral: Dedicated stroke nurse care in ED
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: July 4, 2019) 		800
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 1, 2021
Estimated Primary Completion Date September 21, 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT04011514
Other Study ID Numbers H-17035544
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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.
Responsible Party Christina Kruuse, Herlev Hospital
Study Sponsor Herlev Hospital
Collaborators University of Copenhagen
Investigators
Principal Investigator: Christina Kruuse, MD, DMSc Department of Neurology, Herlev-Gentofte Hospital
PRS Account Herlev Hospital
Verification Date January 2021

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