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

About this trial
This is an interventional health services research trial for Stroke, Acute focused on measuring acute ischemic stroke, quality
Eligibility Criteria
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
NCT ID
NCT02647957
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
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
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A Study of the Efficacy of the Code Stroke in Spain
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