A Study of the Efficacy of the Code Stroke in Spain

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02647957

Acronym

QICS

Enrollment

240

Registered

2016-01-06

Start date

2016-01-31

Completion date

2016-04-30

Last updated

2016-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Acute

Keywords

acute ischemic stroke, quality

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.

Interventions

PROCEDURECode 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

* acute ischemic stroke in-patients

Exclusion criteria

* Patients who refuse participate

Design outcomes

Primary

Measure	Time frame	Description
Recovery rate of the Intravenous trombolysis treatment	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

Measure	Time frame	Description
Patient engage	1 month	Health literacy Scale
response capacity	1 day	Response time for the initial evaluation and treatment
Patient satisfaction	1 month	Patient Satisfaction Scale
Patient safety. Complications in the recombinant tissue plasminogen activator treatment after tromobysis	1 month	Recombinant tissue plasminogen activator complication rates
Mortality rates of the Intravenous trombolysis treatment	1 month	Mortality rates of the Intravenous trombolysis treatment when applied in eligible ischemic stroke patients
Treatment adequacy: Intravenous trombolysis treatment	1 month	Intravenous trombolysis treatment applied in eligible ischemic stroke patients

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026