Pilot of a Complex Intervention to Improve Initial Medication Adherence to Cardiovascular and Diabetes Treatments in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 605
- 试验地点
- 10
- 主要终点
- Rate of clinical registries related to diabetes mellitus II
研究概览
简要总结
This pilot study aims to test the feasibility of the following effectiveness and cost-effectiveness evaluation using Real-World Data.
详细描述
A cluster non-randomised pilot study with an embedded process evaluation was carried out to test the feasibility of the definitive cluster randomised controlled trial (cRCT). The cRCT will aim to evaluate the effectiveness and cost-effectiveness of the Initial Medication Adherence (IMA) intervention in comparison to usual care, to increase initiation of pharmacological treatments for CVD and diabetes (antihypertensive drugs, hypolipidemic drugs, antiplatelet drugs, and insulin and oral antidiabetics) prescribed in Primary Care (PC).
The pilot study was conducted in five PC centres (PCC) in Catalonia (Spain), two were assigned to the control group and three to the intervention group. There were two target participants, the implementation targeted professionals (general practitioners (GP), nurses, and community pharmacists), and the population targeted by the intervention, PC patients.
The IMA intervention provided healthcare professionals with the knowledge, skills, and tools to help the patient make an informed and shared decision with the GP to initiate a new CVD or diabetes treatment. Professionals were trained on the problem of non-initiation, communication skills, health literacy, and the use of decision aids (leaflets, website).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
PC patients: Patients from the intervention PCCs received the IMA intervention but were not aware of the group they were assigned to.
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
- •Primary healthcare professionals and pharmacists who:
- •Agree to participate in the pilot study.
- •Primary care patients who:
- •Are prescribed a new treatment of cardiovascular disease o diabetes by a GP who participates in the clinical trial.
- •Are >18 years old.
- •Do not reject to participate.
排除标准
- 未提供
结局指标
主要结局
Rate of clinical registries related to diabetes mellitus II
时间窗: 5 months before and after recruitment
Rate of registries recorded five months before and after the prescription of: * Glycated haemoglobin * Glomerular filtrate * Blood glucose
Rate of clinical registries related to cardiovascular risk
时间窗: 5 months before and after recruitment
Rate of registries recorded five months before and after the prescription of: • REGICOR
Rate of clinical registries related to dyslipidemia
时间窗: 5 months before and after recruitment
Rate of registries recorded five months before and after the prescription of: * Total colesterol * HDL cholesterol * LDL colesterol
Rate of clinical registries related to hypertension
时间窗: 2 months before and after recruitment
Rate of registries recorded one to two months before and after the prescription of: * Systolic blood pressure * Diastolic blood pressure
Rate of use of services
时间窗: 5 months before and after recruitment
Rate of use of services recorded five months before and after the prescription of: * Visits to primary care (nurse, GP) * Referrals to secondary care * Productivity losses (sick leave days) * Outpatient diagnostic tests
次要结局
- Outliers registries(5 months before and after recruitment)
- Missing registries(5 months before and after recruitment)
- Active diagnosis registry(5 months before and after recruitment)
研究者
Maria Rubio-Valera
Head of Quality and Patient Safety
Fundació Sant Joan de Déu