- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03645590
Stroke Ready - 급성 뇌졸중 치료 최적화
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Michigan
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Flint, Michigan, 미국, 48502
- Flint Community
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 뇌졸중 준비 커뮤니티 개입
우리는 Flint 커뮤니티를 4개의 사분면으로 나누었습니다.
우리는 워크숍과 포스터를 2년 동안 6개월마다 사분면을 이동하면서 하나의 사분면에 집중할 것입니다.
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Stroke Ready 커뮤니티 개입은 동료가 진행하는 교육 워크숍, Stroke 뮤직 비디오, 인쇄 자료(예:
포스터, 브로슈어), 건강 홍보 우편물, 라디오/텔레비전 공중 보건 서비스 발표, Stroke Ready 웹사이트 및 Facebook 페이지.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Utilization of Thrombolysis Among Ischemic Stroke and Transient Ischemic Attack (TIA) Patients
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percent of Stroke and TIA Patients Who Arrive to the Emergency Department by Ambulance
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Lesli Skolarus, MD, University of Michigan
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .