Optimizing PharmacoTherapy In the Multimorbid Elderly in Primary CAre: a Cluster Randomized Controlled Trial (the OPTICA Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 323
- 试验地点
- 1
- 主要终点
- Patients' medication appropriateness, as measured by two complementary co-primary outcomes: Co-primary outcome #1: change in the Medication Appropriateness Index (MAI)
研究概览
简要总结
The objective of this randomized controlled trial (RCT) is to evaluate whether the Systematic Tool to Reduce Inappropriate Prescribing (STRIP), put into practice through the STRIP Assistant (STRIPA) and implemented by general practitioners (GPs), will lead to an improvement in clinical and economic outcomes in patients aged 65 or older with multimorbidity and polypharmacy.
详细描述
Background:
Policy makers face many challenges, when they plan health care systems to meet the needs of the fast growing elderly population. More than 60% of the elderly suffer from multiple chronic conditions (multimorbidity - commonly defined as ≥3 chronic diseases) and get multiple drugs (polypharmacy - commonly defined as ≥5 regular medications). Multimorbid patients are often excluded from randomized controlled trials (RCT) and consequently most prescribing guidelines address diseases in isolation. Consequently, there is inappropriate prescribing, which results in diminished health states and lower quality of life of the patients.
Older patients usually rely on their general practitioners (GPs) to manage their medications. However, GPs often have limited time to adapt polypharmacy. Reviewing medications and understanding their interactions based on a list of diagnoses and drugs is complex and time consuming. Furthermore, due to the increase of patients with multimorbidity and polypharmacy, medication review especially in patients with many drugs is often neglected. Pilot data from the Netherlands showed that a software-assisted method, called STRIPA, was effective for optimizing pharmacotherapy in primary care. Through the OPTICA trial this tool will now be tested in the Swiss primary care context.
Study design:
The OPTICA trial is a single-site cluster randomized controlled trial (RCT), which will be conducted at the Institute for Primary Health Care of the University of Bern (BIHAM). All study-related tasks will be performed centrally at the BIHAM except for patient recruitment and use of the STRIPA, as these two tasks will be performed in participating GP offices.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The OPTICA study is partially blinded, with blinding being implemented as follows:
- Due to the nature of the study intervention participating GPs (care providers) cannot be blinded.
- Patients remain blinded. They will not be informed to which treatment arm their GP is allocated to, in order to minimize performance and other reporting biases. Despite this, they receive a "high-level description" of the study question and the study procedures.
- Data collection for primary and secondary outcome analyses will be conducted by blinded study team members.
- Outcome adjudication (MAI and AOU assessment) will be performed by blinded study team members.
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
- •Being a regular patient of participating GP
- •Age: 65 years of age or older
- •Multimorbidity: 3 or more coexistent chronic conditions defined by 3 distinct International Classification in Primary Care -2 (ICPC-2) codes defined as chronic (O'Halloran et al., 2004) with an estimated duration of 6 months or more, or based on a clinical decision supported by Pharmacost Groups (PCG) for chronic conditions in an algorithm from FIRE
- •Polypharmacy: Use of five or more different regular drugs (defined as authorized medications with registration numbers) for more than 30 days before signing the informed consent form
排除标准
- •Inability to provide informed consent from a patient or to obtain informed consent from a proxy for patients with cognitive impairment
- •If the patient is already participating in the a different interventional study
研究组 & 干预措施
STRIPA intervention
GPs in the intervention group will perform a STRIPA analysis for each of their 8-10 patients after the recruitment of the patient into the OPTICA trial, so that the results can be discussed in the next consultation and a shared decision-making can be performed.
STRIPA is a structured method to perform pharmacotherapy optimization. The STRIPA intervention in the OPTICA trial consists of 4 steps:
- recording medication and diagnoses in STRIPA (upload from data from the 'Family medicine ICPC Research using Electronic medical records' (FIRE) database)
- structured drug review through the GP based on the STRIPA with the integrated STOPP/START criteria
- shared decision-making between GP and patient with possible adaptation of the recommendation
- follow-up through study team
干预措施: STRIPA intervention (Device)
Sham intervention
Patients in the control group will receive a sham intervention, which consists of a usual medication review by their GP as well as a shared decision making of the latter.
干预措施: Sham intervention (Other)
结局指标
主要结局
Patients' medication appropriateness, as measured by two complementary co-primary outcomes: Co-primary outcome #1: change in the Medication Appropriateness Index (MAI)
时间窗: 12 months
Medication Appropriateness Index (MAI), assessed at baseline as well as at the 6 and 12 months follow-ups for each chronic medication of the patient. The 10 item version of the MAI will be used, but the cost-effectiveness item will be excluded. The MAI score for each medication will range from 0 to 17.
Patients' medication appropriateness, as measured by two complementary co-primary outcomes: Co-primary outcome #2: change in the Assessment of Underutilization (AOU)
时间窗: 12 months
Assessment of Underutilization (AOU), assessed for each of the patients' chronic conditions at baseline as well as at the 6 and 12 months follow-ups. For each chronic condition of the patient, the assessors decided whether there is i) no omission, ii) marginal omission, or iii) omission of indicated medication.
次要结局
- Cost-effectiveness of the STRIPA intervention(12 months)
- Patients' degree of polypharmacy(12 months)
- Patients' quality of life measured by 5-level version of the European Quality of Life-5 Dimensions questionnaire (EQ-5D), including pain/discomfort.(12 months)
- Amount of informal care received by patients(12 months)
- Survival(12 months)
- Patients' Quality-adjusted life years (QALYs)(12 months)
- Patients' degree of underprescribing, as measured by the Assessment of Underutilization(12 months)
- Patients' falls and fractures(12 months)
- Amount of formal care received by patients(12 months)
- Percentage of recommendations accepted by general practitioners (GPs)(12 months)
- Patient's willingness to deprescribe(Baseline)
- Patients' medical costs(12 months)
- Patients' degree of overprescribing, as measured by the Medication Appropriateness Index (MAI)(12 months)
- Percentage of recommendations rejected by general practitioners (GPs)(12 months)