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The Interprofessional Medication Assessment for Older Patients

2016年6月10日 更新者:East Savo Hospital District

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

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

514

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Forssa、芬兰、FI 30100
        • Welfare district of Forssa
      • Haapajärvi、芬兰、FI 85800
        • Selänne Basic Health Care District
      • Juva、芬兰、FI-51900
        • Juva Health Care
      • Lahti、芬兰、FI-15100
        • City of Lahti, home care
      • Savonlinna、芬兰、FI-57100
        • Eastern Savo Hospital District

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年 及以上 (年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

Home dwelling ≥65 years-old persons registered to public home care services and who

  1. have had dizziness, orthostatic hypotension or have fallen or
  2. use at least six medicines

Exclusion Criteria:

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).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Active comparator
In addition to usual care, participants allocated to intervention group will receive medication assessment and treatment plan based on it

Intervention

  • Phase I: A medication assessment conducted by an interprofessional team including nurse, pharmacist and physician. The assessment is based on current medication list and basic information cathered by nurse.
  • Phase II: This phase is needed if the assessment cannot be conducted safely without physical examination conducted by physician. The comprehensive interprofessional assessment takes place after the clinical examination conducted by home care physician.
无干预:Usual care
Usual care (reference group).

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Functional capacity IADL (Instrumental Activities of Daily Living)
大体时间:at 6 months from baseline
at 6 months from baseline
Functional capacity ADL (Activities of daily living;KATZ)
大体时间:at 6 months from baseline
at 6 months from baseline
Functional capacity TUG (Timed up and go)
大体时间:at 6 months from baseline
at 6 months from baseline
Functional capacity MMSE ( Mini-mental state examination)
大体时间:at 6 months from baseline
at 6 months from baseline
Functional capacity GDS (Geriatric Depression Scale)-15
大体时间:at 6 months from baseline
at 6 months from baseline

次要结果测量

结果测量
措施说明
大体时间
Use of health care services
大体时间:at 6 and 12 months from baseline
visits to physician, hospital days and nursing care at home
at 6 and 12 months from baseline
Need of services delivered to home
大体时间:at 6 and 12 months from baseline
at 6 and 12 months from baseline
Number of medicines
大体时间:at 6 and 12 months from baseline
at 6 and 12 months from baseline
Quality of medicines
大体时间:at 6 and 12 months from baseline
at 6 and 12 months from baseline
Cost of medicines
大体时间:at 6 and 12 months from baseline
at 6 and 12 months from baseline
Health related quality of life assessed with EQ-5D
大体时间:at 6 and 12 months from baseline
at 6 and 12 months from baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Pekka Mäntyselkä, MD、professor

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年2月1日

初级完成 (实际的)

2016年6月1日

研究完成 (预期的)

2018年12月1日

研究注册日期

首次提交

2015年3月13日

首先提交符合 QC 标准的

2015年3月20日

首次发布 (估计)

2015年3月26日

研究记录更新

最后更新发布 (估计)

2016年6月13日

上次提交的符合 QC 标准的更新

2016年6月10日

最后验证

2016年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • ILMA

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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