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临床试验/NCT03241498
NCT03241498已完成不适用

GP Practice Based Pharmacist Input to Medicines Optimisation

Queen's University, Belfast1 个研究点 分布在 1 个国家目标入组 356 人开始时间: 2016年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
356
试验地点
1
主要终点
Number of unplanned hospital admissions

研究概览

简要总结

The study is a United Kingdom (UK) based multi-centre study which will evaluate the impact of a medication optimisation intervention (delivered in GP practices by pharmacists to patients at risk of medication related problems), on healthcare resource utilisation and patient outcomes. Pharmacists in 4 areas across the UK (3 in England and 1 in Northern Ireland) will engage with patients, thought to be at a higher risk of medication related problems, within their GP practice in order to help identify areas for improvement

详细描述

Drug therapy is growing more complex as patients increasingly suffer from a number of co-morbidities. Accordingly, in clinical medicine, a wide range of medication related problems may arise (1). A medication related problem (MRP) is defined as "an event or circumstance involving drug therapy that actually or potentially interferes with desired health outcomes" (2). These problems have been found to lead to more hospital admissions and thus increase the cost of healthcare provision (3, 4). For instance, Winterstein et al. carried out a meta-analysis of research in this area which showed that 7.1% of hospital admissions were attributable to a drug related problem, of which 59% appeared avoidable (5). Moreover, a large study in the United Kingdom showed that these admissions cost the National Health Service (NHS) up to £466 million annually, which is 0.59% of the British health care budget (6).

Medication related problems (MRPs) remain a serious concern particularly in primary care settings. A recent UK study found that one in 20 prescription items in general practice included an error, affecting 1 in 8 patients. Although the majority of these errors were described as being either mild or moderate in severity, 1 in 550 of all prescription items contained an error determined to be severe (7). In addition, significant medication wastage has been found within general practice settings in England with an estimated £300 million worth of prescribed medications being wasted each year in primary and community care (8). Optimisation of drug therapy and prevention of MRPs can reduce health care expenditure, potentially save lives and enhance patient quality of life (9-13).

Medicines optimisation is defined as 'a person-centred approach to safe and effective medicines use, to ensure people obtain the best possible outcomes from their medicines. Medicines optimisation applies to people who may or may not take their medicines effectively. Shared decision-making is an essential part of evidence-based medicine, seeking to use the best available evidence to guide decisions about the care of the individual patient, taking into account their needs, preferences and values' (14, 15, 16).

Medicines optimisation requires more patient engagement and professional collaboration within health and social care settings. It focuses on actions taken by all health and social care practitioners. To support the medicines optimisation agenda a guide on medicines optimisation has been produced by The Royal Pharmaceutical Society (RPS) the aim of which is to help patients make the most of their medicines (17). This guide involves four key principles for medicines optimisation in order to achieve improved patient outcomes (16). These principles are as follows:

(i) Aim to understand the patient's experience (ii) Evidence based choice of medicines (iii) Ensure medicines use is as safe as possible (iv) Make medicines optimisation part of routine practice

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
Single (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

入选标准

  • Patients are included in the study if they have any of the following:
  • Have had at least 1 unplanned hospital admission or 2 or more accident and emergency department (A&E) attendances in the previous 12 months.
  • Prescribed ≥ 6 regular oral/systemic, long term medicines.
  • Has ≥ 2 long-term chronic conditions.

排除标准

  • Patient is residing in a nursing home or a care home.
  • Patient is considered unable to give written informed consent e.g. Alzheimer's disease.
  • Palliative care patients.
  • Patient has had ≥ 4 unplanned admissions to hospital in the previous 6 months.
  • Patient is participating in another intervention research project within the practice.

结局指标

主要结局

Number of unplanned hospital admissions

时间窗: Recruitment - 6 months post intervention

Number of unplanned admissions to hospital over the follow-up period will be collected for both control and intervention patients

Number of A&E attendances

时间窗: Recruitment - 6 months post intervention

Number of attendance to the A\&E department over the follow-up period will be collected for both control and intervention patients

Number of GP consultations

时间窗: Recruitment - 6 months post intervention

Number of unplanned consultations with the patient's GP over the follow-up period will be collected for both control and intervention patients

次要结局

  • Beliefs about medicines questionnaire (BMQ)(Recruitment - 6 months post intervention)
  • Patient laboratory data relevant to medications being received(Recruitment - 6 months post intervention)
  • Number of medication related problems(Recruitment - 6 months post intervention)
  • Medication appropriateness index (MAI) score(Recruitment - 6 months post intervention)
  • Health-related quality of life (HRQOL)(Recruitment - 6 months post intervention)
  • Medication Adherence report scale (MARS)(Recruitment - 6 months post intervention)
  • Patient satisfaction with GP services(Recruitment - 6 months post intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James McElnay

Professor

Queen's University, Belfast

研究点 (1)

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