Impact of Medications Review on Potentially Inappropriate Medications and Clinical Outcomes Among Hospitalized Older Adults: A Randomized Controlled Trial (REVMED RCT) Protocol
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Number of potentially inappropriate medications
研究概览
简要总结
The goal of this randomized controlled trial is to assess the effectiveness of a pharmacist-led medication review using the locally developed Malaysian Potentially Inappropriate Prescribing Screening tool in Older Adults (MALPIP), an explicit criteria in hospitalized older adults. The main questions it aims to answer are:
- The effectiveness of the intervention in reducing the number of PIMs and chronic medications after discharge
- The impact of the intervention on quality of life, falls events, emergency department visits, readmissions and survivals
Researchers will compare the control group to see if there is corresponding changes to the outcomes specified above.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 60 years and above
- •Taking more than five regular drugs
- •Having at least one chronic medical condition
- •Ability to understand and speak Malay, English, or Mandarin language
排除标准
- •Admitted for end-of-life care
- •Diagnosed with terminal illness
- •Diagnosed with active cancer
- •Participated in another drug trial
- •Refused or unable to give consent
- •Visited the Emergency Department without admission to ward
- •Readmitted and have been previously enrolled in the trial
研究组 & 干预措施
Intervention
In the intervention group, the clinical pharmacist will apply the MALPIP criteria on all the admission and discharge medications. The pharmacists can access the full MALPIP list at https://sites.google.com/moh.gov.my/malpip/home.
The intervention will consist of 4 steps: i) pharmacist review using MALPIP criteria to detect PIM, ii) discussion with doctors for deprescribing decision iii) discussion with patients and documentation of shared decision iv) follow up patients at 6, 12, and 18 months.
Pharmacists will perform the reviewing and checking by themselves and discuss the suggestions with doctors during daily medical ward rounds. The attending doctors will decide whether to deprescribe based-on pharmacists suggestions. Then, the pharmacists will discuss the deprescribing proposal with the patients and record the decision.
干预措施: MALPIP criteria (Other)
Control
In the control arm, pharmacists, patients and doctors are not purposefully blinded but are not aware of the intervention (i.e. the MALPIP tool). Designated pharmacist at the control sites identifies patients who match the eligibility requirements and enroll them into the trial after obtaining consent.
Patients in the control arm will receive routine care and support that they entitled to from the medical team and clinical pharmacists. Preadmission medication will be reconciled by a clinical pharmacist using the standard procedures, including medication history assessment form (CP1), pharmacotherapy review (CP2) and the clinical pharmacy report form (CP3).
结局指标
主要结局
Number of potentially inappropriate medications
时间窗: Admission up to 18 months
Number of chronic medications
时间窗: Admission up to 18 months
次要结局
未报告次要终点
研究者
Shaun Lee Wen Huey
Professor
Monash University