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Completed

NCT Number: NCT02647957

A Study of the Efficacy of the Code Stroke in Spain

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).

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Key information

Conditions

Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • acute ischemic stroke in-patients

Exclusion criteria

  • Patients who refuse participate

Treatment and study plan

Code Stroke

Procedure

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 outcomes

  1. 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

  1. Patient satisfaction

    Time frame: 1 month

    Patient Satisfaction Scale

  2. Patient engage

    Time frame: 1 month

    Health literacy Scale

  3. response capacity

    Time frame: 1 day

    Response time for the initial evaluation and treatment

  4. Treatment adequacy: Intravenous trombolysis treatment

    Time frame: 1 month

    Intravenous trombolysis treatment applied in eligible ischemic stroke patients

  5. Patient safety. Complications in the recombinant tissue plasminogen activator treatment after tromobysis

    Time frame: 1 month

    Recombinant tissue plasminogen activator complication rates

  6. Mortality rates of the Intravenous trombolysis treatment

    Time frame: 1 month

    Mortality rates of the Intravenous trombolysis treatment when applied in eligible ischemic stroke patients

Sponsors and collaborators

Lead sponsor

Universidad Miguel Hernandez de Elche

Other

Collaborators

  • Hospital General San Jorge
  • Hospital Serranía de Ronda
  • Hospital Universitario Ramon y Cajal
  • Hospital Virgen de la Concha
  • Hospital of Jaen
  • Hospital of Navarra

Registry information

Official study title

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

Acronym: QICS

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 6, 2016
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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