- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02647957
A Study of the Efficacy of the Code Stroke in Spain (QICS)
Indicators for Quality Assessment of Hospitalized Ischemic Stroke Patients. A Study of the Efficacy of the Code Stroke in Spain
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- acute ischemic stroke in-patients
Exclusion Criteria:
- Patients who refuse participate
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Group A
Hospital using 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.
|
|
Ingen indgriben: Group B
Hospital not using Code Stroke
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Recovery rate of the Intravenous trombolysis treatment
Tidsramme: 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.
|
1 month
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient satisfaction
Tidsramme: 1 month
|
Patient Satisfaction Scale
|
1 month
|
|
Patient engage
Tidsramme: 1 month
|
Health literacy Scale
|
1 month
|
|
response capacity
Tidsramme: 1 day
|
Response time for the initial evaluation and treatment
|
1 day
|
|
Treatment adequacy: Intravenous trombolysis treatment
Tidsramme: 1 month
|
Intravenous trombolysis treatment applied in eligible ischemic stroke patients
|
1 month
|
|
Patient safety. Complications in the recombinant tissue plasminogen activator treatment after tromobysis
Tidsramme: 1 month
|
Recombinant tissue plasminogen activator complication rates
|
1 month
|
|
Mortality rates of the Intravenous trombolysis treatment
Tidsramme: 1 month
|
Mortality rates of the Intravenous trombolysis treatment when applied in eligible ischemic stroke patients
|
1 month
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 489/2015
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .