Randomized Controlled Trial of Pharmacist-led Medication Review With Follow-up on Cardiovascular Older Adult Patients in Primary Care. POLARIS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 340
- 试验地点
- 2
- 主要终点
- Incremental Cost-Effectiveness ratio (ICEr)
研究概览
简要总结
Hypothesis: Medication Review with follow-up can improve clinical, health related quality of life and economic outcomes. To prove this hypothesis a cluster randomized controlled trial will be held in primary care centres of the public health system of Chile. Patients of the cardiovascular disease prevention program, older than 65 years and with poly pharmacy (more than 5 drugs) will be recruited. Control group will receive usual care and the intervention arm will have medication review consultations by a pharmacist every 4 months for one year. Clinical interventions will be made with physician authorisation. Participating pharmacist will be trained in cardiovascular prevention pharmacotherapy in the elderly, interview skills and educational techniques. A practice change facilitator will assist the pharmacist in any matters regarding the methodology and will asses barriers and facilitators to the implementation of the medication review with follow-up service. A personalised plan will be developed for every pharmacist. Clinical outcomes (blood pressure, HbA1c, LDL cholesterol, overall cardiovascular risk, among others), number of medications, adherence rate and health-related quality of life will be evaluated. A cost-utility analysis will be made through the health ministry of Chile perspective.
详细描述
This study was approved by the ethics committee from the Metropolitan Southeastern health service and the University of Technology Sydney (UTS)'s Human Research Ethics Committee (HREC). All patients are compelled to sign an informed consent document before the first interview, explaining that they can leave the study whenever they want without punishment or justification. All data will be coded and stored without any personal information, to comply with the Chilean law 19,628 for protection of personal data and 20,584 for rights and duties of the patients.
Sample size and losses
Sample size was calculated with data from the pilot study conducted between March and July of 2017. The effect size was determined by the reduction of CHD risk (0.324). Cluster size was of 24, clustering effect of 1.57, control-intervention relationship of 1:1, with an 80% of statistical power and type I error of 5%. A 20% attrition rate was assumed. With this data the calculated sample size was 576, with 288 patients and 11-12 clusters in each study group.
In addition, primary care centers will recruit participants following the proportion of older adults (OA) in the Cardiovascular disease care program (PSCV in spanish) of each one . If a center gathers more than 10% of the total population, that center must recruit 10% of the sample in that group.
Study structure
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
- Single (Participant)
盲法说明
Each participant will sign an informed consent, without knowing that there is another group of patients.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 or older.
- •Polypharmacy, defined as five or more chronic prescribed medications.
- •Independent or independent at risk, classified by the chilean scale of autonomy for older adults (EFAM in spanish).
- •Included in the Cardiovascular Primary Care Program.
排除标准
- •Low Cardiovascular Disease Risk (CVDR).
- •Participants of the pilot study.
- •Risk of dependency or dependent by the EFAM.
结局指标
主要结局
Incremental Cost-Effectiveness ratio (ICEr)
时间窗: 12 months
Calculated by the difference in costs between groups, divided by the difference in effects.
Quality of Life (QoL) by visual analog scale (VAS)
时间窗: 12 months.
Measured by the EuroQol-5D-3L VAS test, where 0 is the worst and 100 is the best possible health status by personal perception.
Quality of Life (QoL) by 5 dimensions.
时间窗: 12 months
Measured by the EuroQol-5D-3L five dimension test. Each dimension will be presented individually.
Patients with controlled hypertension, type-2 diabetes or dyslipidemia
时间窗: 12 months
Proportion of patients with controlled diseases by the chilean government treatment goals. Results will be presented for each disease as Odds ratio for achieving goals in control and intervention group.
次要结局
- ACR (albumin-creatinine ratio)(12 months)
- Serum electrolytes(12 months)
- Glomerular filtration rate (GFR)(12 months)
- Blood pressure (SBP and DBP).(12 months)
- Lipid profile(12 months)
- Fasting glycemia (FG)(12 months)
- Glycated hemoglobin (HbA1c)(12 months)
- Costs of the interventions(12 months)
研究者
Cristián Plaza
Director
Pontificia Universidad Catolica de Chile