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临床试验/NCT03955133
NCT03955133已完成不适用

Polypharmacy and Adverse Drug Reactions: Nurse-led Intervention to Minimise Adverse Drug Reactions for Older Adults in Care Homes: a Quality Improvement Process Intervention

Swansea University1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2018年12月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
主要终点
Number of Participants With Changes in Signs and Symptoms Related to Adverse Effects of Prescribed Medicines. Clinical Gains and Benefits to Residents

研究概览

简要总结

Polypharmacy, the use of multiple or inappropriate medications, has the potential to harm older adults by causing cognitive impairment, falls, and hospitalisations. The nurse-led intervention (The ADRe Profile) to review mental health medicines has demonstrated improved care quality by: identifying serious adverse drug reactions (ADRs); reducing prescription of mental health medicines; reducing the prevalence of pain and nausea; and, increasing non-urgent national health service (NHS) contacts. The investigators will develop ADRe to encompass medicines commonly prescribed in primary care and evaluate intervention implementation in care homes in Aneurin Bevan University Health Board.

详细描述

The investigators will introduce medicines' monitoring using the PADRe Profile into up to 7 care homes, each with up to 26 residents prescribed >4 medicines (estimated ~90% residents).

Each home will identify a nurse lead and a deputy. Nurses will be asked to administer the PADRe Profile with all patients prescribed >4 medicines.

Barriers, facilitators, and feasibility of the Profile will be explored. This will identify how, in which contexts medicines' monitoring can be integrated into routine care, relate the Profile to improved processes and outcomes of care, and inform implementation strategies (see logic model in cited papers).

Data collection:

  • Record review before and after each of 3 administrations of the intervention to identify clinical and prescription changes. Narrative accounts of problems causing moderate or severe harm will be prepared.
  • Serial interviews and debriefs with nurses: three per nurse.
  • Stakeholder interviews with patients, participating pharmacists and prescribers for an overview of implementation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

盲法说明

Use of the intervention could not be blinded.

入排标准

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

入选标准

  • •• Resident at the care home and expected to continue to live there for 1 year
  • •Currently taking >3 prescribed medicines daily
  • •Willing and able to give informed, signed consent themselves, or where capacity is lacking, a consultee is willing to give advice and assent to the resident participating.

排除标准

  • •Prescribed <4 medicines daily;
  • •Receiving active palliative care
  • •Not well enough to participate, as screened by their nurses

研究组 & 干预措施

intervention

Experimental

This is a single arm before and after study with data collection at 4 time points.

干预措施: Adverse Drug Reaction ADRe Profile for Polypharmacy (Other)

结局指标

主要结局

Number of Participants With Changes in Signs and Symptoms Related to Adverse Effects of Prescribed Medicines. Clinical Gains and Benefits to Residents

时间窗: 3 months from start of intervention

Number of participant with a change in signs and symptoms related to adverse effects of prescribed medicines. Care quality/ clinical gain/ benefit to patients as recorded in notes and on the Profile by the number and nature of all health problems addressed, particularly serious adverse events.

次要结局

  • Number of Clinical Gains Per Resident Between Baseline and 3 Months(Baseline, then 3 months from start of intervention)
  • Number of Medicines Prescribed: Change Between Baseline and 3 Months(Baseline, then 3 months from start of intervention)
  • Number of Problems Listed on Profile(Baseline, then 3 months from start of intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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