Effectiveness of a Public Campaign to Increase Stroke Awareness in Reducing Prehospital Delay
Cluster Randomized Controlled Trial to Assess the Effectiveness of a Population-based Educational Campaign on Stroke Symptom Recognition in Reducing Pre-hospital Delay
The starting hypothesis is that a multilevel educational campaign, specifically developed for the local community, can increase public stroke awareness and reduce pre-hospital delay.
The effectiveness of such intervention will be evaluated according to a cluster randomized, stepped wedged design. The clusters are the four communities of the Area Vasta Emilia Nord, AVEN (Parma, Piacenza, Modena e Reggio Emilia). As analysis Units, we will consider the patients consecutively admitted to the six participating hospitals throughout the study period, for suspected stroke or transitory ischemic attack (TIA).
연구 개요
상세 설명
After a baseline 3 month period, the educational campaign will be sequentially launched in the four communities over four 3 month periods, according to a computer-generated list. The comparison will be the"usual care".
Primary outcome measures: The proportion of patients arriving at the Emergency Department (ED) with suspected stroke or TIA within two hours.
Secondary outcome measures: the proportion of patients with confirmed stroke or TIA diagnosis; the proportion of ischemic stroke patients evaluated for recominanat Tissue Plasminogen Activator (rTPA) therapy; the proportion of patients treated with rTPA; time interval between arrival at the ED and CT scan; for patients treated with rTPA, time interval between arrival at the ED and therapy initiation (door to needle time); death and disability (assessed as modified Rankin Score 3-5) at 1 and 3 month from stroke onset.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Fidenza, 이탈리아, 43016
- AUSL Parma
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Modena, 이탈리아
- Ospedale Civile S. Agostino Estense-Baggiovara-AUSL Modena
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Parma, 이탈리아, 43100
- University Hospital of Parma
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Piacenza, 이탈리아
- Ospedale Guglielmo di Siliceto-AUSL Piacenza
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Reggio Emilia, 이탈리아
- Arcispedale Santa Maria Nuova of Reggio Emilia
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients consecutively admitted to the six participating hospitals for suspected stroke or transitory ischemic attack (TIA), defined as abrupt onset of focal or generalized neurologic deficit of vascular origin.
Exclusion Criteria:
- No information available on the time of stroke onset.
- No informed consent from patient or caregiver
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 제어
평소 케어
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Information on stroke usually delivered at the community level.
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실험적: Intervention
Educational campaign
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Multilevel educational campaign on stroke sympton recognition and the need for calling the Emergency Services
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of early admission
기간: Time interval from stroke onset to arrival at the Emergency Department
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Proportion of patients arriving to the Emergency Department with suspected stroke or TIA within two hours
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Time interval from stroke onset to arrival at the Emergency Department
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Poor outcome at 1 month
기간: 1 month from stroke onset
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Death or disability (modified Rankin Scale 3-6)at 1 month
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1 month from stroke onset
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Poor outcome at 3 months
기간: 3 months from stroke onset
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Death or disability (modified Rankin Scale 3-6) at 3 months
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3 months from stroke onset
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Rate of thrombolysis
기간: Up to 4 hours and 30 minutes from stroke onset
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Proportion of patients given thrombolysis
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Up to 4 hours and 30 minutes from stroke onset
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Rate of thrombolysis activation
기간: Up to 3 hours from stroke onset
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Proportion of patients evaluated for thrombolysis
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Up to 3 hours from stroke onset
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Delay in CT scan
기간: Up to 12 hours from admission at the ED
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Time interval between arrival at the Emergency Department and CT scan
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Up to 12 hours from admission at the ED
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Door to needle time
기간: Up to 4 hours and 30 minutes from stroke onset
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Time interval between arrival at the ED and thrombolysis initiation
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Up to 4 hours and 30 minutes from stroke onset
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공동 작업자 및 조사자
수사관
- 수석 연구원: Licia Denti, MD, Parma University Hospital
간행물 및 유용한 링크
일반 간행물
- Denti L, Caminiti C, Scoditti U, Zini A, Malferrari G, Zedde ML, Guidetti D, Baratti M, Vaghi L, Montanari E, Marcomini B, Riva S, Iezzi E, Castellini P, Olivato S, Barbi F, Perticaroli E, Monaco D, Iafelice I, Bigliardi G, Vandelli L, Guareschi A, Artoni A, Zanferrari C, Schulz PJ. Impact on Prehospital Delay of a Stroke Preparedness Campaign: A SW-RCT (Stepped-Wedge Cluster Randomized Controlled Trial). Stroke. 2017 Dec;48(12):3316-3322. doi: 10.1161/STROKEAHA.117.018135. Epub 2017 Nov 3.
- Caminiti C, Schulz P, Marcomini B, Iezzi E, Riva S, Scoditti U, Zini A, Malferrari G, Zedde ML, Guidetti D, Montanari E, Baratti M, Denti L; Educazione e Ritardo di Ospedalizzazione (E.R.O.I) study group. Development of an education campaign to reduce delays in pre-hospital response to stroke. BMC Emerg Med. 2017 Jun 24;17(1):20. doi: 10.1186/s12873-017-0130-9.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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