- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03645590
Stroke Ready - Ottimizzazione della cura dell'ictus acuto
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
In this study, the participants who received the intervention are a separate group from those analyzed in the outcome measures. Stroke Ready was a multilevel intervention that included a hospital based emergency department optimization component conducted from October 2017 through May 2018 and a community based stroke preparedness intervention conducted from June 2018 through March 2020. The emergency department component focused on improving hospital level acute stroke care processes and did not involve participant enrollment, individual level data collection, or participant level outcomes. Stroke education sessions were offered to community members in quadrant based groups between 2017 and 2020, but this was simply for administrative purposes, not for analytical distinctions among the groups. Demographic information was collected based on workshop educators' perceptions of those in attendance and not taken at the individual level.
Outcome measures about acute stroke treatment rates were collected Flint wide for two different time periods: a preintervention period from July 2010 to September 2017 and a postintervention period from October 2017 to March 2020. The postintervention period was defined based on the initiation of the Stroke Ready intervention in October 2017, corresponding to the start of the emergency department optimization component.
Outcome measure data was not directly related to the intervention, as the intervention was performed among community members and outcomes obtained in people who had a stroke or TIA within time periods before and after the intervention. The workshop data was collected without identifiers at the group level based on perceptions of stroke educators. Baseline data for stroke patients was acquired from the medical record.
Consequently, the information in the Participant Flow and Adverse Events modules only reflects those who attended the community workshops in person or remotely and has no relation to the population addressed in the outcome measures.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Michigan
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Flint, Michigan, Stati Uniti, 48502
- Flint Community
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Descrizione
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Ictus Pronto Intervento comunitario
Abbiamo diviso la comunità di Flint in quattro quadranti.
Concentreremo i nostri workshop e poster su un quadrante, ma non esclusivamente, spostando i quadranti ogni 6 mesi nel corso di due anni.
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L'intervento della comunità Stroke Ready consiste in laboratori educativi facilitati da pari, video musicali sull'ictus e campagne di mass media che includono materiali stampati (ad es.
manifesti, opuscoli), mailer di promozione della salute, annunci radiotelevisivi del servizio sanitario pubblico e il sito Web e la pagina Facebook di Stroke Ready.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Utilization of Thrombolysis Among Ischemic Stroke and Transient Ischemic Attack (TIA) Patients
Lasso di tempo: Data for this outcome was from county-wide medical records from July 2010 through September 2017 (pre-intervention) and from October 2017 through March 2020 (post-intervention, defined by initiation of the emergency department optimization component).
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Proportion of Tissue Plasminogen Activator (tPA) treatment utilization among ischemic stroke and TIA patients in pre vs. post intervention periods in all Genesee county hospitals.
This is a distinct group of county-wide patients who may or may not include any individuals who received the workshop intervention.
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Data for this outcome was from county-wide medical records from July 2010 through September 2017 (pre-intervention) and from October 2017 through March 2020 (post-intervention, defined by initiation of the emergency department optimization component).
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percent of Stroke and TIA Patients Who Arrive to the Emergency Department by Ambulance
Lasso di tempo: Data was gathered retrospectively from the medical record for Flint stroke or TIA patients from October 2017 through March 2020, following initiation of the Stroke Ready intervention.
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Stroke and TIA patient arrival by EMS in Pre vs. Post Intervention periods
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Data was gathered retrospectively from the medical record for Flint stroke or TIA patients from October 2017 through March 2020, following initiation of the Stroke Ready intervention.
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Lesli Skolarus, MD, University of Michigan
Pubblicazioni e link utili
Pubblicazioni generali
- Robles MC, Springer MV, Corches CL, Burke JF, Lin CC, Oliver A, Skolarus LE. Stroke Ready Very Brief Intervention Improves Immediate Postintervention Stroke Preparedness. Circ Cardiovasc Qual Outcomes. 2020 Dec;13(12):e006643. doi: 10.1161/CIRCOUTCOMES.120.006643. Epub 2020 Nov 26. No abstract available.
- Skolarus LE, Sales AE, Zimmerman MA, Corches CL, Landis-Lewis Z, Robles MC, McBride AC, Rehman N, Oliver A, Islam N, Springer MV, O'Brien A, Bailey S, Morgenstern LB, Meurer WJ, Burke JF. Stroke Ready: a multi-level program that combines implementation science and community-based participatory research approaches to increase acute stroke treatment: protocol for a stepped wedge trial. Implement Sci. 2019 Mar 7;14(1):24. doi: 10.1186/s13012-019-0869-3.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- U01MD010579 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .