Effectiveness of an Intervention to Improve the Adequacy of the Indication of Lipid Lowering Treatment in Primary Prevention: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60,000
- 试验地点
- 2
- 主要终点
- percentage of participants with increase of the adequacy of lipid-lowering prescription
研究概览
简要总结
OBJECTIVE: To evaluate the impact of an intervention addressed to health professionals to improve the adequacy of lipid-lowering prescription in primary prevention of cardiovascular disease and reducing expenditure in this respect.
DESIGN: a cluster randomized clinical trial, not blind; Data were obtained from medical records and other primary care databases.
SETTING: 279 primary health care teams in Catalonia (Spain), centers managed by Catalan Health Institute (ICS)
SUBJECTS: Population from 35 to 74 years, free of cardiovascular disease, who have been started on lipid-lowering therapy during 2 consecutive years of study.
INTERVENTION: Practitioners in the intervention group may have access, whenever they want and through the computerized medical record program, to personalized information on their assigned patients who have started treatment of cardiovascular primary prevention with lipid-lowering. This information is updated monthly for 12 consecutive months.Information will be presented in two different and complementary ways to each practitioner: asynchronous information (the patient is not present when the practitioner receives the information) and synchronous information (the patient is present when the practitioner receives the information).
VARIABLES:
- Primary Outcomes are:
- Variable RETIRA: new lipid-lowering treatments initiated during the year prior to the intervention, seen as inadequate and withdrawn during the intervention period.
- Variable EVITA: New lipid-lowering treatments started during the intervention period and considered as inadequate.
- Secondary Outcomes are:
- Variable COST: total cost of the inadequate new lipid-lowering treatments.
- Variable RECORD: recording of the cardiovascular risk.
2.Other variables:
- Principal: intervention/control group assignment of health professional.
- Patient variables: demographic and clinical.
- Professional variables: quality of care indicators.
STATISTICAL ANALYSIS: Descriptive analysis, agreggated at health professional level, will be performed and subsequently multilevel analysis techniques will be used to estimate the effect of intervention according to hierarchic data structure and, in particular, patient variables effect.
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
- 35 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Population from 35 to 74 years
- •Free of cardiovascular disease
- •Start on lipid-lowering therapy during 2 consecutive years of study
排除标准
- •Previous treatment with lipid-lowering
- •History of cardiovascular disease
结局指标
主要结局
percentage of participants with increase of the adequacy of lipid-lowering prescription
时间窗: up to 24 months
The primary outcome is the improvement in the appropriateness of prescribing of lipid-lowering therapy in primary prevention as recommended by the guide clinical practice intervention in the Institut Català de la Salut compared with clinical practice group. To answer the main objective of the study, two dependent variables were calculated: * Variable RETIRA: new lipid-lowering treatments initiated during the year prior to the intervention, seen as inadequate and withdrawn during the intervention period * Variable EVITA: New lipid-lowering treatments started during the intervention period and considered as inadequate
次要结局
- percentage of patients with cardiovascular risk register in the clinical records of patients(up to 24 months)
- Change from baseline in the total cost of the lipid-lowering treatments prescribed during the study period(baseline, months 24)