A Cluster Randomized Trial Evaluating the Effect of a Multifaceted Intervention to Increase Evidence Based Strategies Usage for Cardiovascular Prevention.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,623
- 主要终点
- Adherence to evidence based therapies
研究概览
简要总结
The purpose of the study is assess the impact of a multifaceted quality improvement intervention in adherence to evidence based therapies prescription (according to local guidelines) for cardiovascular prevention in high risk patients in 12 months.
详细描述
The quality improvement strategy being assessed in this study will be applied to the healthcare team, thus any intervention that is not well established in the literature will not be prescribed to the patients. Thus, this trial does not imply any additional risk for patients.
Furthermore, if this strategy is proved to be effective, it may be offered as a new clinical practice that might benefit brazilian patients.
BRIDGE-CV consists of a quality improvement project by the incorporation of evidence based interventions in public and private hospitals in Brazil. The chosen setting is cardiovascular prevention in high risk patients since cardiovascular diseases represent the major cause of death in Brazil.
It will be developed a cluster randomized trial, where hospitals will be allocated to receive or not the multifaceted intervention.
The patients will be followed for 12 months in order to assess if the multifaceted intervention can increase the evidence based prescriptions. If this is the case, this tool package may be offered as a quality improvement intervention for all hospitals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 40 years old, with manifested atherothrombotic diseases ( coronary artery disease, stroke or transient ischemic attack, or peripheral artery disease)
排除标准
- •Patients from institutions that don't provide the Institutional Authorization Term, as well as patients that withdraw Inform Consent for Data Collection.
- •Patients with a history of atrial fibrillation or that at the discretion of the physician needs anticoagulation, will be excluded.
研究组 & 干预措施
Control
Clusters randomized to the control group will keep their usual practice standards. Patient screening will be performed at the outpatient clinics and primary care centers. Both groups must complete the following forms: "Admission", "06 months", and "12 months". Data collection will be performed from medical records by an independent professional not involved in patient care. Furthermore, study coordinator and data collectors from the sites, when asked, must provide appropriate documents for adjudication purposes.
Intervention
Educational multifaceted intervention can increase the evidence based prescriptions. If this is the case, this tool package may be offered as a quality improvement intervention for all hospitals. Health care professionals from each institution one being a physician (acting as a local leader) and the other being a research nurse (acting as a case manager) must attend the training course for high cardiovascular risk patients that will take place at HCor.
干预措施: Quality Improvement Intervention (Behavioral)
结局指标
主要结局
Adherence to evidence based therapies
时间窗: 12 months
Adherence to evidence based therapies ( aspirin/antiplatelets , lipid lowering agents(statins) and ACE inhibitors/ARB) in an "all or none" model for patients without contra indication in a period of 12 months.
次要结局
- LDL < 70mg/dL in 12 months(12 months)
- LDL < 100mg/dL in 12 months(12 months)
- Adherence to ACE inhibitors or ARBs(12 Months)
- Adherence to Antiplatelets(12 months)
- Composite Outcome of Major Cardiovascular Events(12 months)
- Blood Pressure < 140 x 90 mmHg(12 months)
- Adherence to evidence based therapies(six and twelve months)
- Adherence to Lipid Lowering Agents (Statins)(12 months)
- Adherence to Beta Blockers(12 months)
- Blood Pressure < 120 mmHg(12 months)
- Smoke Cessation Education(12 Months)
研究者
Instituto de Pesquisa
Otavio Berwanger
Hospital do Coracao