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临床试验/NCT03110471
NCT03110471已完成不适用

Nurse-led Medicines' Monitoring in Care Homes: a Process Evaluation of the Impact and Sustainability of the West Wales Adverse Drug Reaction (WWADR) Profile and Pharmacist Involvement

Swansea University10 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年3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
60
试验地点
10
主要终点
Number of Participants With Adverse Drug Reactions (ADRs) Treated

研究概览

简要总结

Lay Summary:

The investigators have shown in randomised controlled trials and observation studies that structured nurse-led medicines' monitoring using the WWADR Profile benefits patients, for example, by reducing pain and sedation and identifying high risk cardiovascular conditions. The investigators now aim to understand what is needed to sustain implementation of the WWADR Profile in routine practice and explore future directions.

The participants of the investigators previous research, 5 newly recruited care homes, and stakeholders - care home managers, carers, healthcare professionals, and service users - will be asked to contribute interviews, observations and reflective diaries/ accounts. The investigators are interested in their experiences of medication use, medication management, adverse effects and barriers and facilitators of medicine monitoring, and how electronic devices can enhance nurse-led monitoring.

详细描述

Background:

Between 1 in 4 and 1 in 25 people benefit from their prescribed medicines (Schork 2015). However, adverse drug reactions (ADRs, known as side effects) occur in 7.8% (7.2-8.4%) patients in community (or ambulatory) care (Hakkarainen et al 2013). Most of these are preventable (Hakkarainen et al 2013, NICE 2015). Adverse drug events (ADE), which include ADRs and under-prescribing, and medicines' mismanagement are responsible for 8% of healthcare spend in the USA, $213bn (Aitkin & Valkova 2013) and 9.5% of direct costs in Sweden.

The West Wales ADR Profiles for medicines' monitoring has improved quality of care by reducing the prescription of mental health medicines and identifying and addressing previously unsuspected adverse effects, such as coupled beats and severe hypertension (Jordan 2002, et al 2002), infections (Gabe el al 2014), chest pain and valproate-induced pancreatitis (Jones et al 2016), and, in care homes, drug-induced Parkinson's (Jordan et al 2014), pain, nausea and behaviour problems (Jordan et al 2015). The investigators now need to know how the intervention can embed in practice and governance frameworks, and benefit from pharmacist involvement and new monitoring devices.

Aims and objectives:

The investigators aim to explore

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 105 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • • Not well enough to participate, as screened by their nurses;
  • Aged <18;
  • Receiving active palliative care.
  • Professionals
  • Inclusion criteria
  • Involved in the provision of care for service users described above
  • Willing to participate in the study
  • Exclusion criteria
  • Not involved with service users in care homes
  • Unwilling to consent to participation

结局指标

主要结局

Number of Participants With Adverse Drug Reactions (ADRs) Treated

时间窗: 6 months

ADRs (adverse drug reactions) (as listed in the British National Formulary and manufacturers' datasheets) where actions are taken to correct the problem.

次要结局

  • Number of Changes to Care by Nurses Identified Per Resident(up to 4 weeks)
  • Time for ADRe Administration (Including Interruptions) in Minutes(up to 1 hour)
  • Number of Problems Identified Per Resident(up to 1 hour)
  • Number of Pharmacist Recommendations for Prescription Review Per Resident(up to 4 weeks)
  • Number of Drug Interactions Per Resident(up to 4 weeks)

研究者

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

Professor Sue Jordon

Prof Susan Jordan

Swansea University

研究点 (10)

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