A Study of the Efficacy of the Code Stroke in Spain

Stroke, Acute Clinical Trial

— QICS  

Official title:

Indicators for Quality Assessment of Hospitalized Ischemic Stroke Patients. A Study of the Efficacy of the Code Stroke in Spain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02647957
• Other study ID #: 489/2015
• Status: Not yet recruiting
• Phase: N/A
• First received: December 26, 2015
• Last updated: January 6, 2016
• Start date: January 2016
• Est. completion date: April 2016

Study information

• Verified date: January 2016
• Source: Universidad Miguel Hernandez de Elche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministerio de Sanidad, Servicios Sociales e Igualdad
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• acute ischemic stroke in-patients

Exclusion Criteria:

• Patients who refuse participate

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Procedure:
• Code Stroke
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.

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Universidad Miguel Hernandez de Elche	Hospital Complejo Hospitalario de Jaén, Hospital General San Jorge, Hospital Serranía de Ronda, Hospital Universitario de Navarra, Hospital Universitario Ramon y Cajal, Hospital Virgen de la Concha

References & Publications (1)

Alvarez Sabín J, Molina C, Abilleira S, Montaner J, García 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month	Yes
Secondary	Patient satisfaction	Patient Satisfaction Scale	1 month	No
Secondary	Patient engage	Health literacy Scale	1 month	No
Secondary	response capacity	Response time for the initial evaluation and treatment	1 day	No
Secondary	Treatment adequacy: Intravenous trombolysis treatment	Intravenous trombolysis treatment applied in eligible ischemic stroke patients	1 month	Yes
Secondary	Patient safety. Complications in the recombinant tissue plasminogen activator treatment after tromobysis	Recombinant tissue plasminogen activator complication rates	1 month	Yes
Secondary	Mortality rates of the Intravenous trombolysis treatment	Mortality rates of the Intravenous trombolysis treatment when applied in eligible ischemic stroke patients	1 month	Yes