search
Back to results

A Study of the Efficacy of the Code Stroke in Spain (QICS)

Primary Purpose

Stroke, Acute

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Code Stroke
Sponsored by
Universidad Miguel Hernandez de Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke, Acute focused on measuring acute ischemic stroke, quality

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • acute ischemic stroke in-patients

Exclusion Criteria:

  • Patients who refuse participate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Group A

    Group B

    Arm Description

    Hospital using Code Stroke

    Hospital not using Code Stroke

    Outcomes

    Primary Outcome Measures

    Recovery rate of the Intravenous trombolysis treatment
    Number of patients showing an adequate recovery after Intravenous trombolysis treatment as assessed by the criteria of the Quality Indicator Board of the German Stroke Registers Study Group and the National Sentinel Audit of Stroke.

    Secondary Outcome Measures

    Patient satisfaction
    Patient Satisfaction Scale
    Patient engage
    Health literacy Scale
    response capacity
    Response time for the initial evaluation and treatment
    Treatment adequacy: Intravenous trombolysis treatment
    Intravenous trombolysis treatment applied in eligible ischemic stroke patients
    Patient safety. Complications in the recombinant tissue plasminogen activator treatment after tromobysis
    Recombinant tissue plasminogen activator complication rates
    Mortality rates of the Intravenous trombolysis treatment
    Mortality rates of the Intravenous trombolysis treatment when applied in eligible ischemic stroke patients

    Full Information

    First Posted
    December 26, 2015
    Last Updated
    May 10, 2016
    Sponsor
    Universidad Miguel Hernandez de Elche
    Collaborators
    Hospital Universitario Ramon y Cajal, Hospital Serranía de Ronda, Hospital Universitario de Navarra, Hospital Virgen de la Concha, Hospital of Jaen, Hospital General San Jorge
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02647957
    Brief Title
    A Study of the Efficacy of the Code Stroke in Spain
    Acronym
    QICS
    Official Title
    Indicators for Quality Assessment of Hospitalized Ischemic Stroke Patients. A Study of the Efficacy of the Code Stroke in Spain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Miguel Hernandez de Elche
    Collaborators
    Hospital Universitario Ramon y Cajal, Hospital Serranía de Ronda, Hospital Universitario de Navarra, Hospital Virgen de la Concha, Hospital of Jaen, Hospital General San Jorge

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Code Stroke is a system for the rapid identification, pre-notification and transport of acute ischemic stroke patients. The objective of this study was to define quality indicators and to compare treatment outcomes in hospitals where Code Stroke has been implemented and hospitals without the use of Code Stroke (control patients).
    Detailed Description
    In a first step qualitative technique has been conducted to define treatment quality indicators of acute ischemic stroke patients. In a second step a prospective study is conducted to collect data of 240 inpatients from two groups of hospitals. Two hospitals applying Code Stroke (N= 120) and four hospitals non-applying Code Stroke procedure (N=120). A consecutive sampling method will be conducted. Inclusion criteria: acute ischemic stroke patients treated in the hospitals during the field study. The referral to the hospital could be from primary care, Emergency Unit of other hospital. Patients will enroll after inform consent. A Singer-blind- research method will applied. Quality indicators defined in the first phase will be applied and comparisons will be realized using ANOVA.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Acute
    Keywords
    acute ischemic stroke, quality

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Non-Randomized
    Enrollment
    240 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Description
    Hospital using Code Stroke
    Arm Title
    Group B
    Arm Type
    No Intervention
    Arm Description
    Hospital not using Code Stroke
    Intervention Type
    Procedure
    Intervention Name(s)
    Code Stroke
    Intervention Description
    Apply a protocol called Code Stroke that involves the entire care chain from emergency teams outpatient specialists of Neurology, Internal Medicine, Radiology or Intensitivos Care, among other hospital areas.
    Primary Outcome Measure Information:
    Title
    Recovery rate of the Intravenous trombolysis treatment
    Description
    Number of patients showing an adequate recovery after Intravenous trombolysis treatment as assessed by the criteria of the Quality Indicator Board of the German Stroke Registers Study Group and the National Sentinel Audit of Stroke.
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Patient satisfaction
    Description
    Patient Satisfaction Scale
    Time Frame
    1 month
    Title
    Patient engage
    Description
    Health literacy Scale
    Time Frame
    1 month
    Title
    response capacity
    Description
    Response time for the initial evaluation and treatment
    Time Frame
    1 day
    Title
    Treatment adequacy: Intravenous trombolysis treatment
    Description
    Intravenous trombolysis treatment applied in eligible ischemic stroke patients
    Time Frame
    1 month
    Title
    Patient safety. Complications in the recombinant tissue plasminogen activator treatment after tromobysis
    Description
    Recombinant tissue plasminogen activator complication rates
    Time Frame
    1 month
    Title
    Mortality rates of the Intravenous trombolysis treatment
    Description
    Mortality rates of the Intravenous trombolysis treatment when applied in eligible ischemic stroke patients
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: acute ischemic stroke in-patients Exclusion Criteria: Patients who refuse participate

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    10604170
    Citation
    Alvarez Sabin J, Molina C, Abilleira S, Montaner J, Garcia F, Alijotas J. ["Stroke code". Shortening the delay in reperfusion treatment of acute ischemic stroke]. Med Clin (Barc). 1999 Oct 23;113(13):481-3. Spanish.
    Results Reference
    result

    Learn more about this trial

    A Study of the Efficacy of the Code Stroke in Spain

    We'll reach out to this number within 24 hrs