Effectiveness and Cost-effectiveness of the Initial Medication Adherence Intervention: Cluster-randomized Controlled Trial and Economic Model
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 4,153
- 试验地点
- 24
- 主要终点
- Rate of Initiation
研究概览
简要总结
The purpose of this study is to assess the effectiveness and the cost-effectiveness of the Initial Medication Adherence (IMA) Intervention.
详细描述
A pragmatic cluster randomised control trial will be conducted to evaluate the effectiveness of the IMA intervention in comparison to usual care, in the increase of initiation of medicines for CVD and diabetes (antihypertensive, lipid-lowering, antidiabetic and antiplatelet medications) prescribed in Primary Care (PC). The impact of the IMA intervention on secondary adherence and clinical indicators will be evaluated.
A multicenter pragmatic RCT, with cluster allocation and 2 parallel branches (IMA intervention vs. usual care) based on health records or RWD will be conducted.
PC centres' personnel, including general practitioners (GP), nurses and community pharmacists, from different areas around Catalonia (Spain), will be cluster randomised 1:1 into intervention and control groups, stratified according to the type of PC centre, either rural or urban and taking into consideration the size and localization of the PC centre and the main predictors of non-initiation (socioeconomic status, mean age, % immigrant population of the PC centre).
The IMA intervention will provide clinicians with knowledge, skills and tools to help the patient make an informed decision. PC centre personnel in the intervention group will receive training on medication non-initiation, communication abilities, health literacy, shared decision making and the use of support tools such as leaflets and the IMA website.
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
- Double (Participant, Investigator)
盲法说明
Participant: The randomization is conducted at the primary care centre level. Patients from intervention areas will receive enhanced care but will not be aware of the group assigned.
Investigator: Data analysists will not have information on which group is the intervention group when conducting the analysis.
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 Care health professionals and pharmacists who:
- •Agree to participate in the clinical trial and process evaluation.
- •Attend the training course
- •Are not plannig to be on sick leave during the study period (e.g. maternity leave).
- •Patients who:
- •Are prescribed a new treatment of cardiovascular disease o diabetes by a doctor who participates in the clinical trial.
- •Are >18 years old
- •Do not reject to participate
排除标准
- 未提供
研究组 & 干预措施
Initial Medication Adherence (IMA) intervention
General practitioners (GP) will apply the IMA intervention to all patients receiving a new prescription for treatment of cardiovascular disease or diabetes. Following the IMA intervention, nurses and community pharmacists will offer information support in line with the information provided by the GP.
干预措施: Initial Medication Adherence (IMA) (Behavioral)
Usual care
Patients will receive the usual care when being prescribed a new prescription for treatment of cardiovascular disease or diabetes. Nurses and community pharmacists will be asked to also provide usual care to those patients.
干预措施: Usual care (Other)
结局指标
主要结局
Rate of Initiation
时间窗: 1 month and 3 months after recruitment
Patients who receive a new prescription (a prescription is considered new if there is no previouos prescription from the same group in the previous 6 months) will be considered initiators if they fill-up their prescription in the community pharmacy. Prescription and dispensation databases will be compared to classify prescriptions as initiated and non-initiated.
次要结局
- Reduction of Cardiovascular Risk(1 year after recruitment)
- Rate of adherence(1 year after recruitment)
研究者
Maria Rubio-Valera
Head of Quality and Patient Safety
Parc Sanitari Sant Joan de Déu