Strategies To Improve Appropriate Prescribing In Heart Failure Patients. Assessment of the Effectiveness of an Integrated Clinical Pathway Between Cardiology and Primary Care Physicians to Implement Pharmacological Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- achievement of ≥ 50% of the target dose either for beta-blockers (12.5mg b.i.d. for carvedilol, 5mg u.i.d for bisoprolol) or for ACE-inhibitors or angiotensin-receptor blockers in patients in whom beta-blockers are contraindicated
研究概览
简要总结
The purpose of the study is to assess whether primary care physicians may uptitrate recommended drug therapies in stable heart failure patients if educational material and specialist support including phone or mail consultation are provided
详细描述
Heart failure is highly prevalent, particularly in elderly subjects, and costly, mainly because of the high rate of recurrent hospital admissions. Although guideline-recommended treatments, such as beta-blockers and renin-angiotensin inhibitors, are effective on both mortality and morbidity, these drugs are very often underprescribed or used at lower doses than those shown to be beneficial in clinical trials, particularly in the primary care setting, for fear of adverse events. Although referral to specialist services may improve prescription of recommended drugs and doses achieved, frequent consultations may be unfeasible and costly.The study is designed to assess whether active specialist support and educational material improve the prescription process for heart failure patients in primary care
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a confirmed diagnosis of heart failure wih depressed systolic function (left ventricular ejection fraction <40% in the previous 6 months).
- •stable NYHA class II-III
- •a clinical indication to implement drug therapy with betablockers and/or renin-angiotensin system inhibitors and current dose <50% of the target dose
排除标准
- •NYHA class IV or clinically unstable
- •cardiac surgery or cardiac resynchronization therapy planned within the following 6 months
- •discharged to a rehabilitation unit refusal or impossibility to present to outpatient visits
结局指标
主要结局
achievement of ≥ 50% of the target dose either for beta-blockers (12.5mg b.i.d. for carvedilol, 5mg u.i.d for bisoprolol) or for ACE-inhibitors or angiotensin-receptor blockers in patients in whom beta-blockers are contraindicated
时间窗: 12 weeks
次要结局
- achievement of ≥ 50% of the target dose of both beta-blockers and ACE-inhibitors or angiotensin-receptor blockers(12 weeks)
- proportion of patients who started drug uptitration by week 12 expressed as N° patients in whom therapy was uptitrated by their primary care physician/N° randomized patients(12 weeks)
- all cause death, hospital admissions, emergency room visits; changes in quality of life by SF12, a generic questionnaire(12 weeks)
- value of DRG reimbursement for hospital admissions and specialist visits(12 weeks)