OPERAM: OPtimising thERapy to Prevent Avoidable Hospital Admissions in the Multimorbid Older People: a Cluster Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,009
- 试验地点
- 7
- 主要终点
- Patients with confirmed DRA after discharge from the index hospitalisation
研究概览
简要总结
The objective of this Randomised Controlled Trial (RCT) is to evaluate whether the Systematic Tool to Reduce Inappropriate Prescribing (STRIP) including STRIP assistant (STRIPA) implemented by an appropriately qualified team will lead to an improvement in clinical and economic outcomes among patients aged 70 years and more with multimorbidity and polypharmacy.
详细描述
Background:
Drug-related morbidity and mortality is an increasing problem in European healthcare systems. Multimorbidity, polypharmacy and old age are important risk factors for drug-related hospital admissions (DRA). The reported incidence of DRAs in the elderly may be as high as 30% of all acute cases, and about half of DRAs are likely to be preventable. They are mainly related to prescribing problems and non-compliance with drug regimens. A significant proportion of healthcare costs are spent on unnecessary interventions and inappropriate medications. The Systematic Tool to Reduce Inappropriate Prescribing (STRIP) is a structured method to perform a medication review to optimise pharmacotherapy.
Design:
European multi-centre, cluster randomised, controlled trial of people aged 70 years or older, with multimorbidity and polypharmacy, being on an ambulatory visit or on a hospital stay in one of the four participating centres in Ireland, Belgium, Switzerland and the Netherlands. A cluster is defined around a treating physician, i.e. the treating physician is randomised and defines the allocation of his patients. Clusters of patients will be randomised to the intervention arm receiving STRIP for optimising therapy or to the control arm undergoing usual clinical care. The patients of physicians who are allocated to the intervention group will undergo a systematic drug review and pharmacotherapy optimisation by a physician and a pharmacist using STRIP, including the STRIPA software. That provides the research team with a recommendation of changes in the patient's medication. Based on STRIPA recommendation and agreement on changes to the patients' pharmacotherapy between the team of the research physician and pharmacist and the prescribing physician, will the patient receive structured counselling about his/her medication; general practitioners will receive a report. Patients will be further followed for 1 year with follow-up phone calls after 2, 6 and 12 months. For the purpose of this trial, all hospitalisations during follow-up of participants will be adjudicated to assess their relationship to adverse drug events.
Objectives:
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, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People 70 years of age or older
- •Multimorbidity: 3 or more coexistent chronic conditions defined by 3 distinct International Classification of Diseases (ICD-10) codes with an estimated duration of 6 months or more or based on a clinical decision
- •Polypharmacy i.e. five or more different regular drugs (defined as authorised medications with registration numbers) for more than 30 days.
- •In inpatient: Estimated minimal length of stay within the cluster is sufficient to apply the intervention
- •If outpatient: prescribing physician has GP function and has a planned appointment to conduct intervention
排除标准
- •Inability to provide informed consent or to obtain informed consent from a proxy for patients with cognitive impairment
- •Direct admission to palliative care (< 24h after admission)
- •Has passed or will pass a systematic structured drug review during this hospitalisation or within the last two months
结局指标
主要结局
Patients with confirmed DRA after discharge from the index hospitalisation
时间窗: 12 months
The primary outcome is defined as the first confirmed DRA after discharge from the index hospitalisation within a period of 12 months. Confirmation of a drug-related hospital admission will be assessed by an independent and blinded adjudication committee (per site). Prolongation of the index hospitalisation and prolongation of any following hospitalisations will not be adjudicated for drug-relatedness. Adjudication is done according to specific guidelines.
次要结局
- Number of survivors(12 months)
- Number of patients with a serious adverse event(12 months)
- Number of cancer deaths(12 months)
- Patients' degree of poly-pharmacy(12 months)
- Number of patients with hospitalisations(12 months)
- Number of patients with falls(12 months)
- Patients' quality of life(12 months)
- Patients' level of pain/discomfort(12 months)
- Patients' drug compliance(12 months)
- Number of clinically significant drug-drug interactions(2 months)
- Number of drug underuse(2 months)
- Patients' basic activities of daily living(12 months)
- Number of drug overuse(2 months)
- Number of potentially inappropriate medications(2 months)