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临床试验/NCT03698487
NCT03698487进行中(未招募)不适用

Pharmacist Led Intervention to Improve Medication Use in Older In-patients Living With Frailty: the Drug Burden Index

Emily2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年2月6日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
200
试验地点
2
主要终点
Number of participants with changed or unchanged DBI score at discharge compared to admission

研究概览

简要总结

Older people in Canada commonly take multiple medicines for their health conditions. Certain medicines, especially when taken together can lead to serious harms, such as falls. As people age and their health changes, medicines that were once helpful may become harmful. Healthcare professionals recognise that better tools and procedures are needed to make sure that people are taking the right medicines at the right time.

A tool has been recently created, called the Drug Burden Index (DBI) Calculator©, to be used by hospital pharmacists. It helps them identify which medicines (and combinations of medicines) are harmful to older people. This tool also produces reports for the doctor and for the older person and their family.

In this study, hospital pharmacists will use the DBI calculator© during their normal activities. The investigators will measure what effect this has on the medicines used and health outcomes in older adults. The investigators are also interested in what influences use and impact of the calculator. For example, there may be differences in use in older males compared to females or in the benefits seen in people living with frailty compared to those who are not frail. Use of the DBI calculator© may lead to improvements in how medicines are managed in hospital. This would mean less drug costs and drug side effects. Overall, the project may lead to improving the quality of life for older Canadians.

Hypothesis: Implementation of a ward-based, pharmacist-led intervention utilizing the DBI Calculator© will lead to optimization of medications, reduced DBI and improved health outcomes in frail and non-frail older adults.

详细描述

Polypharmacy and inappropriate medication use in older adults is common and associated with a number of harms including adverse drug reactions, falls, hospitalization, reduced quality of life and mortality. There is particular concern about medications with anticholinergic and sedative effects.Older adults may be sensitive to adverse effects of these agents due to changes in pharmacokinetics (increased exposure to the drug) and pharmacodynamics (increased sensitivity to the effects).

Frailty is a condition of cumulative reduction in function of multiple body systems. Frail individuals are vulnerable to external stressors and less able to recover; as such they are at greater risk of medication related harms.

Anticholinergic medications are used for a variety of conditions such as allergic rhinitis, urinary incontinence, and nausea/vomiting. Other medications, including some common anti-depressants also have anticholinergic activity, even when not central to their efficacy. Sedatives may be used short term to treat insomnia and anxiety, however, many medications produce sedation as an unintended side effect. While these medications have therapeutic effects, their use in older adults has been linked to multiple adverse effects manifesting as limitations in physical and cognitive function.Furthermore, there may be reduced or limited benefits of these agents. Taken altogether, in older adults with multi-morbidity and polypharmacy there is a picture of reduced benefit and increased risk associated with use of anticholinergic and sedative medications which may be amplified among frail individuals.

The Drug Burden Index (DBI) is an evidence-based risk assessment tool developed to measure exposure to anticholinergic and sedative medications to determine the effect on physical and cognitive function. DBI score has been associated in several cross-sectional studies with poorer physical function, reduced quality of life, frailty, falls and hospital readmission. Cognition and mortality have been found to be effected by DBI score in some cross-sectional studies, but not others. Longitudinal studies have found increased DBI is independently associated with lower physical function over 5 years, poorer delayed memory performance, increased physician visits and mortality. These results represent 20 different studies, span multiple countries (Australia, Canada, Finland, the Netherlands, New Zealand, UK and US) and provide a substantial argument to reduce DBI score in individuals where possible.

Despite the knowledge of the risks associated with anticholinergic and sedative medications, their use is relatively common with studies showing use of one or more of these agents in approximately 20-80% of older adults. Concerningly, their use may also be more common in frail older adults who are at further risk of harm from medication use. A provincial based point prevalence study conducted within the Nova Scotia Health Authority (NSHA) found an overall prevalence of 35% of benzodiazepine use among patients admitted to acute care.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Age ≥70 years old
  • DBI score >0 (taking ≥1 regular medication with a sedative or anticholinergic effect prior to admission)
  • Informed consent able to be obtained from patient or substitute decision maker as per hospital policy
  • Able to communicate in English (as DBI report only available in English)

排除标准

  • Expected discharge within 24 hours of recruitment or 48 hours of admission
  • Terminal phase of illness (expected to die during current admission) OR noted to be 'palliative care'
  • Usual residence outside Nova Scotia

结局指标

主要结局

Number of participants with changed or unchanged DBI score at discharge compared to admission

时间窗: Up to 12 weeks

• Proportion of inpatients in whom DBI is decreased, unchanged or increased at discharge, compared to on admission to hospital

次要结局

  • Number of participants with changed (or unchanged) DBI score(90 days)
  • Pharmacist time(Up to 12 weeks)
  • Total number of medications(90 days)
  • Clinical outcomes during hospitalization(Up to 12 weeks)
  • Clinical outcomes after hospitalization(90 days)

研究者

发起方
Emily
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Emily

Affiliate Scientist

Nova Scotia Health Authority

研究点 (2)

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