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临床试验/NCT02398812
NCT02398812Unknown不适用

The Interprofessional Medication Assessment for Older Patients - a Multicenter Randomized Trial in Primary Care Setting

East Savo Hospital District10 个研究点 分布在 1 个国家目标入组 514 人开始时间: 2015年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
514
试验地点
10
主要终点
Functional capacity IADL (Instrumental Activities of Daily Living)

研究概览

简要总结

The objective of this pragmatic multi-center randomized controlled trial is to test the effectiveness of interprofessional medication assessment in older patients needing home care due to their diseases or decreased functional capacity in primary care. The main hypothesis is that intervention has a positive impact on functional capacity and for rational and safe use of medicines.

详细描述

Aging increases the risk of adverse effects and interactions caused by medication. Medication reconciliation and medication review are well-known practices to optimize medicines use. Both interventions usually require a team-based approach to be effective. Medication reconciliation is the process of obtaining and documenting a complete and accurate list of current patient medications and comparing this list with medication orders at each point of care transition to identify and rectify any discrepancies before patient harm occurs. Medication review is the process of evaluating current medication treatment to manage the risk and optimize the outcomes of medication treatment by detecting, solving, and preventing medication-related problems. The present study focuses on medication assessment including both medication reconciliation and review combined to clinical assessment of an individual patient.

According to a systematic review there is a need for research focusing on medication management in community settings and especially to assess the impact of medication assessment on clinical outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Home dwelling ≥65 years-old persons registered to public home care services and who
  • have had dizziness, orthostatic hypotension or have fallen or
  • use at least six medicines

排除标准

  • Home care is not responsible for patient's medication, for example due to severe chronic illness (for example severe renal insufficiency or cancer with active treatment in secondary or tertiary care).

结局指标

主要结局

Functional capacity IADL (Instrumental Activities of Daily Living)

时间窗: at 6 months from baseline

Functional capacity ADL (Activities of daily living;KATZ)

时间窗: at 6 months from baseline

Functional capacity MMSE ( Mini-mental state examination)

时间窗: at 6 months from baseline

Functional capacity TUG (Timed up and go)

时间窗: at 6 months from baseline

Functional capacity GDS (Geriatric Depression Scale)-15

时间窗: at 6 months from baseline

次要结局

  • Number of medicines(at 6 and 12 months from baseline)
  • Use of health care services(at 6 and 12 months from baseline)
  • Quality of medicines(at 6 and 12 months from baseline)
  • Health related quality of life assessed with EQ-5D(at 6 and 12 months from baseline)
  • Cost of medicines(at 6 and 12 months from baseline)
  • Need of services delivered to home(at 6 and 12 months from baseline)

研究者

发起方
East Savo Hospital District
申办方类型
Other
责任方
Sponsor

研究点 (10)

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