Managing Appropriate Prescribing in Primary Care COPD Patients With Comorbidities: Evaluation of the Desktop Helper (Number 10) in a Pragmatic Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Percentage of COPD patients with one or more 'medication-comorbidity clashes'
研究概览
简要总结
Objective: Reducing inappropriate medications for primary care COPD patients with comorbidities ('medication-comorbidity clashes'), by evaluation of the Desktop Helper (number 10) in a pragmatic cluster randomized controlled trial.
Study design: A four-arm pragmatic cluster randomized controlled trial (cluster RCT), which will be conducted in GP practices in the Netherlands. In the cluster RCT, the control condition (arm 1: care as usual) will be compared with three intervention arms (i.e. arm 2: the 'Desktop Helper (number 10)' , arm 3: an e-learning module, and arm 4: the 'Desktop Helper (number 10)' accompanied by the e-learning module). At baseline and at 26 weeks of follow-up, a data-extraction of comorbidities and prescribed medications will be obtained from the EMR of participating GP practices.
Study population: Primary care patients with COPD who have 1 or more comorbidities and who are prescribed one or more medications.
Intervention (if applicable): Clinical rules to remediate 'medication-comorbidity clashes' as outlined in the 'Desktop Helper (number 10)'. These clinical rules will be implemented in the EMR to enable the identification of patients with 'medication-comorbidity clashes'. In addition, e-learning about these 'medication-comorbidity clashes' will be offered depending on the treatment arm of the trial.
Main study parameters/endpoints: The number of 'medication-comorbidity clashes'.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
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 patients with COPD aged 18 years and older with one or more (co)morbidities.
- •A clinical GP diagnosis of COPD (ICPC code R95 (emphysema/COPD).
- •Presence of one or more of the following (co)morbidities: Glaucoma (ICPC code F93*), Kidney failure / renal insufficiency (ICPC code: U99.01), Tuberculosis (ICPC code: A70, R70), Diabetes (ICPC code: T90, A91.05), Pneumonia (ICPC code: R81, R81.01), Osteoporosis/osteopenia (ICPC code: L95, L95.02, L95.01), Prostate symptoms (ICPC code: Y06, U05.02), Atrium fibrillation (ICPC code: K78, K79, K80, K84.02, K04, K05), Bronchiectasis (ICPC code: R91, R91.02) and Asthma (ICPC code: R96, R96.02)
排除标准
- •Have end-stage COPD or a life expectancy < 6 months
- •If they underwent a systematic medication review aimed at reducing inappropriate prescribing. Systematic refers to a collaboration with a pharmacist and the adoption of Beers, STOPP and or START criteria.
结局指标
主要结局
Percentage of COPD patients with one or more 'medication-comorbidity clashes'
时间窗: 26 weeks
The primary outcome of the study is the percentage of COPD patients with one or more 'medication-comorbidity clashes' (i.e. undesired interactions between medications for COPD and comorbid conditions).
次要结局
- Percentages of patients with one or more inappropriately prescribed medication(26 weeks)