Multiple Intervention and AUdit in Renal Diseases to Optimize Care: the MAURO Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 788
- 试验地点
- 1
- 主要终点
- A composite renal and cardiovascular (CV) end point, i.e. >30% decrease in the GFR, dialysis, transplantation, death or CV event.
研究概览
简要总结
Test whether the intensive intervention improves renal and cardiovascular outcomes in patients with chronic renal insufficiency.
Test whether a multi-method intensive intervention including clinical Audit improves adherence to a series of quality indicators relevant to hypertension control, proteinuria, treatment of dyslipidemia, anemia, calcium and phosphate alterations in patients with chronic renal insufficiency.
详细描述
Background:
Guidelines are currently promoted as a means for linking evidence based medicine to clinical practice and for reducing variation in clinical practice (1). However, there is ample evidence that implementation of evidence-based recommendations for prevention and management of renal disease progression and associated cardiovascular complications remain largely unsatisfactory (2). Deficiencies exist in the treatment of dyslipidemia and hypertension, inadequate use of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers as well as in the treatment of anemia and of alterations in calcium and phosphate metabolism (2). Furthermore patients with diabetes mellitus infrequently receive recommended treatment for elevated glycosylated haemoglobin levels, hypertension, and dyslipidemia.
The importance of interventions to increase adherence to practice guidelines and to improve disease control is now widely perceived. However, little is known about the relative effectiveness of different implementation strategies. Fresh research is required to develop and validate practical strategies for improving the provision of evidence-based medicine in nephrology clinics. In particular, studies addressing multiple common, chronic conditions which simultaneously affect the population of patients with chronic renal insufficiency are now felt as of primary importance. The study was approved by Ethical Committees of all Nephrology Units participating into the MAURO study.
Specific hypotheses:
This study is designed as a clinical trial aimed at assessing whether a quality improvement intervention is more effective than standard care for improving adherence to a series of quality indicators relevant to the prevention of renal disease progression and associated cardiovascular complications. The multi-method quality improvement intervention (intensive intervention) adds telephone and e-mail contacts (for quality improvement facilitation) and audits to the approach of periodic guideline dissemination used in standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Creatinine >1.5 -4.0 mg/dL (males) and >1.3-3.5 mg/dL (females).
- •Age range :18 - 75 years
排除标准
- •Transplanted
- •Affected by cancer or diseases in the terminal phase
- •Non acute or rapidly evolving renal diseases.
结局指标
主要结局
A composite renal and cardiovascular (CV) end point, i.e. >30% decrease in the GFR, dialysis, transplantation, death or CV event.
时间窗: 3 years
次要结局
- The primary renal unit-level outcome is the percentage of performance targets achieved. The primary patient-level outcome is the percentage of patients for whom the recommended process measures occurs.(3 years)
研究者
Carmine Zoccali
Prof.
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy