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临床试验/NCT02545257
NCT02545257已完成不适用

Development of a Coordinated, Community-Based Medication Management Model for Home-Dwelling Aged in Primary Care

University of Helsinki2 个研究点 分布在 1 个国家目标入组 191 人开始时间: 2015年9月1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
191
试验地点
2
主要终点
GDS-15 (Geriatric Depression Scale)

研究概览

简要总结

The objective of this randomized controlled trial is to develop a coordinated, multiprofessional medication management model for home-dwelling aged in primary care and to study the effectiveness of this model. The main hypothesis is that the new model helps to identify aged people having potential risks with their medications and thus allows solving these risks.

详细描述

The demand for long-term home health care services is increasing due the demographic and societal developments. Aged people needing home care are increasingly older, have many chronic diseases and use multiple medicines and thus, are at high risk for drug-related problems (DRPs). In Finland, national and local healthcare and aged care strategies target to allowing aged people (over 65 years) living in their own homes as long as possible. This minimizes the costs of institutionalized care and also targets to add the quality of life of aged people. New approaches and service models are needed to meet these challenges.

The present study focuses on the development of a coordinated medication management model which aims to ensure the safe medication practises for home-dwelling aged in primary care. In the previous parts of this study project were developed a model for comprehensive medication review process (CMR) and a Drug-Related Problem Risk Assessment Tool. The present study uses a multistage intervention in which medications are reviewed (prescription review) in a community pharmacy using the SFINX-database to identify clinically significant drug-drug interactions and the Salko-database which identifies potentially inappropriate medications for aged people. In the next stage practical nurses use the Drug-Related Problem Risk Assessment Tool to identify potential risks. The following stages are based on the results from the risk assessment tool. Potential options are, e.g.,physician consultation, more frequent home care visits, counselling given by the community pharmacy or comprehensive medication review (CMR). The CMR process is only targeted to a limited group of study participants with clinically significant DRP who probably will benefit from more comprehensive CMR.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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
否

入选标准

  • •Home-dwelling over 65 year-old persons receiving regular home care from the City of Lohja

排除标准

  • •Home care is not given regularly

研究组 & 干预措施

Active comparator

Active Comparator

In addition to normal, standard care, participants allocated to intervention group will receive a coordinated medication management model containing prescription review, drug-related problems (DRP) risk assessment and required action based on the DRP risk assessment.

干预措施: Coordinated medication management model (Other)

Control group (standard care)

No Intervention

Normal, standard care (control group)

结局指标

主要结局

GDS-15 (Geriatric Depression Scale)

时间窗: Change from baseline at 12 and 24 months

Time to rise from a chair and return to the seated position 5 times (Lower extremity function).

时间窗: Change from baseline at 12 and 24 months

UDI-6 (Urinary Distress Inventory)

时间窗: Change from baseline at 12 and 24 months

Orthostatic hypotension (Short test, Freeman et al. 2011)

时间窗: Change from baseline at 12 and 24 months

AUDIT-C (Alcohol Use Disorder Identification Test, version C)

时间窗: Change from baseline at 12 and 24 months

Potentially inappropriate medicines (PIM) (Clinically significant drug-drug interactions, potentially inappropriate medicines for aged), identified from medication list review chart

时间窗: Change from baseline at 12 and 24 months

PIMs are identified with prescription review using SFINX database (clinically significant drug-drug interactions) and Salko database (e.g., for identifying potentially inappropriate medicines for the aged, anticholinergic and serotonergic load).

MMSE (Mini-Mental State Examination)

时间窗: Change from baseline at 12 and 24 months

Cognitive ability

MNA (Malnutrition Assessment)

时间窗: Change from baseline at 12 and 24 months

Rava (Functioning and disability, Finnish Consulting Group)

时间窗: Change from baseline at 12 and 24 months

次要结局

  • Use of health care services: visits to physician(at 12 and 24 months from baseline)
  • Use of health care services: hospital days(at 12 and 24 months from baseline)
  • Use of health care services: home care services(at 12 and 24 months from baseline)

研究者

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

Terhi Toivo

Project coordinator, MSc (Pharm), PhD student

University of Helsinki

研究点 (2)

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