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Clinical Trials/NCT02647957
NCT02647957
Completed
Not Applicable

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

Universidad Miguel Hernandez de Elche0 sites240 target enrollmentJanuary 2016
ConditionsStroke, Acute

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke, Acute
Sponsor
Universidad Miguel Hernandez de Elche
Enrollment
240
Primary Endpoint
Recovery rate of the Intravenous trombolysis treatment
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
April 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

José Joaquín Mira

Professor

Universidad Miguel Hernandez de Elche

Eligibility Criteria

Inclusion Criteria

  • acute ischemic stroke in-patients

Exclusion Criteria

  • Patients who refuse participate

Outcomes

Primary Outcomes

Recovery rate of the Intravenous trombolysis treatment

Time Frame: 1 month

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 Outcomes

  • Patient satisfaction(1 month)
  • Mortality rates of the Intravenous trombolysis treatment(1 month)
  • Treatment adequacy: Intravenous trombolysis treatment(1 month)
  • Patient engage(1 month)
  • response capacity(1 day)
  • Patient safety. Complications in the recombinant tissue plasminogen activator treatment after tromobysis(1 month)

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