- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00958958
Brazilian Intervention to Increase Evidence Usage in Practice - Acute Coronary Syndromes (BRIDGE)
Phase 1: An observational study (registry) will be conducted which will objectively document the ACS clinical practice in Brazilian public hospitals, and identify the important barriers for the evidence usage incorporation in the clinical practice.
Phase 2: A Cluster randomized clinical trial in which public hospital will be randomized to receive or not a multifaceted strategy in order to increase evidence based therapy in clinical practice.
연구 개요
상세 설명
STUDY POPULATION:
Patients with thoracic pain who the emergency department physician suspects of ACS and plans start a treatment for this issue; It will be excluded patients transferred of others institutions with 12 hours of symptoms.
PROGRAM:
There are multifaceted Interventions Including
- Distribution of educational materials
- Case manager: Use of a trained person who works in the hospital and will be responsible to assure that all interventions were used
- Reminders: specific information that is designed or intended to prompt a health professional to recall information (patient bracelets, labels, posters, pocket cards, checklists).
- Practical training
ENDPOINTS:
Phase 1 Primary outcome; patient who've received interventions based on evidence proportion informed by the indicators; Phase 2
Primary outcome:
Increase of prescription of evidence based treatment in clinical practice Secondary outcome Total mortality and major cardiovascular events
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
SP
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São Paulo, SP, 브라질, 04005-000
- Hospital do Coracao
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Patient Eligibility criteria
Inclusion Criteria:
- Patients with thoracic pain who the emergency department physician suspects of ACS and plans start a treatment for this issue
Exclusion Criteria:
- Patients transferred from others institutions within 12 hours of the symptoms
Cluster Eligibility Criteria
- National Public Hospitals with emergency department. A cluster can be one hospital with emergency department, or 2 or more hospitals (for example: 1 emergency hospital and 1 general hospital which receive the patients to perform PCI).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: Quality improvement program
There are multifaceted Interventions for the clinic hospital team Including
|
There are multifaceted Interventions Including
|
|
간섭 없음: Hospital standard treatment
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Phase 1: patient who've received interventions based on evidence proportion informed by the indicators
기간: 9 months
|
9 months
|
|
Phase 2: increase of prescription of evidence based treatment in clinical practice
기간: 6 months
|
6 months
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Total mortality and major cardiovascular events
기간: 6 months
|
6 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Otávio Berwanger, PhD, Hospital do Coracao
간행물 및 유용한 링크
일반 간행물
- Berwanger O, Guimaraes HP, Laranjeira LN, Cavalcanti AB, Kodama AA, Zazula AD, Santucci EV, Victor E, Tenuta M, Carvalho V, Mira VL, Pieper KS, Weber B, Mota LH, Peterson ED, Lopes RD; Bridge-Acs Investigators. Effect of a multifaceted intervention on use of evidence-based therapies in patients with acute coronary syndromes in Brazil: the BRIDGE-ACS randomized trial. JAMA. 2012 May 16;307(19):2041-9. doi: 10.1001/jama.2012.413.
- Berwanger O, Guimaraes HP, Laranjeira LN, Cavalcanti AB, Kodama A, Zazula AD, Santucci E, Victor E, Flato UA, Tenuta M, Carvalho V, Mira VL, Pieper KS, Mota LH, Peterson ED, Lopes RD; BRIDGE-ACS. A multifaceted intervention to narrow the evidence-based gap in the treatment of acute coronary syndromes: rationale and design of the Brazilian Intervention to Increase Evidence Usage in Acute Coronary Syndromes (BRIDGE-ACS) cluster-randomized trial. Am Heart J. 2012 Mar;163(3):323-29, 329.e1. doi: 10.1016/j.ahj.2012.02.004.
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
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. .