Team Approach to Polypharmacy Evaluation and Reduction in a Long-Term Care Setting (TAPER-LTC)
2021年6月2日 更新者：Derelie Mangin、McMaster University
Team Approach to Polypharmacy Evaluation and Reduction in a Long-Term Care Setting: A Feasibility Randomized Controlled Trial
Medication side effects and interactions between medications are very common in older adults and are related to negative health outcomes.
In this study, the investigators will test a new process aimed at reducing unnecessary medication use and drug side effects in seniors using the best medical evidence and patient preferences for treatment.
This study will assess how feasible the implementation of this intervention is within a long-term care facility as well as if it is possible.
Participants in two long-term care facilities will participate in this study.
Measures will include feasibility outcomes regarding the logistics of the intervention as well as patients outcomes (falls, hospitalizations, and medications) collected before and after implementation.
This trial will be a randomized control trial with an adaptive trial design.
研究概览
详细说明
There are substantial associations between polypharmacy and reduced function from older adults and this is likely to be important in frail older adults both in long term care and in the community.
The reversibility of drug-induced mobility impairment is unclear therefore the investigators plan to investigate signals of any impact of reducing polypharmacy on mobility.
The investigators chose the long-term care setting given the presence of complete medication administration records and this patient population's high prevalence of polypharmacy and risk of adverse drug events.
TaperMD is an electronic tool for systematic medication reduction that incorporates patient priorities, electronic screening for potentially harmful medicines,supporting evidence tools and a monitoring pathway to support medication reduction.
This study will examine the feasibility of this tool in a long-term care setting as well as examine.
Participants in two long-term care facilities will participate in this study.
Measures will include feasibility outcomes regarding the logistics of the intervention as well as patients outcomes (falls, hospitalizations, and medications) collected before and after implementation.
The study will be an adaptive trial design with two phases.
Phase 1 will be an internal pilot.
This will allow the investigators to re-evaluate and modify outcome measures and processes as necessary.
Phase 2 of this trial will allow for continuation after adjustments to the process or design has been made in a larger randomized controlled trial.
研究类型
介入性
注册 (实际的)
15
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
-
-
Ontario
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Brampton、Ontario、加拿大、L6Y 5P2
- Holland Christian Homes - Faith Manor
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Brampton、Ontario、加拿大、L6Y 5P2
- Holland Christian Homes - Grace Manor
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-
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
70年 及以上 (年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- residing in 2 long-term care facilities in Brampton, ON
- on 5 or more long-term medications
- 70 years of age or older
- adequate English language
Exclusion Criteria:
- terminal illness or other circumstance precluding 6 month study period
- recent (within 12 months) comprehensive medication review
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：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Control Group
Standard of Care as wait list control.
Control group will be offered intervention as part of usual clinical care at 6 months.
|
|
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实验性的：TAPER
The intervention is medication reduction. This arm is comprised of:
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Systematic approach to reduction in polypharmacy
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Successful Discontinuation (Difference in mean number of medications; reduction in dose)
大体时间：6 months
|
Difference in mean number of medications; number of medications reduced in dose
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6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Difference in level of cognition
大体时间：Baseline, 6 months
|
The Mini Mental Status Examination
|
Baseline, 6 months
|
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Difference in level of quality of life
大体时间：Baseline, 6 months
|
EuroQol five dimensions questionnaire (EQ5D-5L) will measure quality of life.
Scores range from 0 (low quality of life) to 1 (high quality of life).
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Baseline, 6 months
|
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Difference in number of falls
大体时间：Baseline, 6 months
|
Total number of falls resulting in medication consultation or treatment recorded in hospital admission and primary care records, and by patient
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Baseline, 6 months
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Difference in level of sleep
大体时间：Baseline, 6 months
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The sleep question on the 15-Dimensional (15-D) scale will be used.
Scores range from 1 (no sleep problems) to 5 (severe sleep problems).
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Baseline, 6 months
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Changes in medication side effects and symptoms (adverse)
大体时间：1-week, 3 months, 6 months
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Patient self-report of appearance (new or worsening) of side effects associated with medications
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1-week, 3 months, 6 months
|
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Changes in medication side effects and symptoms (positive)
大体时间：1-week, 3 months, 6 months
|
Patient self-report of disappearance (improvement or disappearance) of side effects associated with medications
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1-week, 3 months, 6 months
|
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Difference in number of serious adverse events
大体时间：1-week, 3 months, 6 months
|
Any event that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death (Health Canada (2011) Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products)
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1-week, 3 months, 6 months
|
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Difference in level of physical functioning capacity and ability
大体时间：Baseline, 6 months
|
Time on the timed-up-and-go test
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Baseline, 6 months
|
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Difference in level of performance of activities of daily living
大体时间：Baseline, 6 months
|
Barthel Index will be used to measure performance of activities of daily living.
Ten activities are scored in terms of level of independence or assistance, with higher scores reflecting higher level of independent performance.
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Baseline, 6 months
|
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Difference in level of frailty
大体时间：Baseline, 6 months
|
The total score on the Edmonton Frail Scale will be used to measure frailty.
The scale included 11 items, with scores ranging from 0 (not frail) to 17 (severe frailty).
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Baseline, 6 months
|
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Difference in level of healthcare utilization use (hospitalizations)
大体时间：Baseline, 6 months
|
Number of hospitalizations
|
Baseline, 6 months
|
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Difference in level of healthcare utilization use (emergency department visits)
大体时间：Baseline, 6 months
|
Number of emergency department visits
|
Baseline, 6 months
|
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Difference in level of healthcare utilization use (physician visits)
大体时间：Baseline, 6 months
|
Number of physician visits
|
Baseline, 6 months
|
|
Enrollment rate
大体时间：6 months
|
Number of participants that enroll in study relative to number of participant invited to participant
|
6 months
|
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Completion rate
大体时间：6 months
|
Number of participants that complete 6-month collection relative to number of participants enrolled
|
6 months
|
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Time to complete measures
大体时间：Baseline, 6 months
|
Average duration of data collection appointments
|
Baseline, 6 months
|
|
Difference in level of mood
大体时间：Baseline, 6 months
|
The total score on the Geriatric Depression Scale (Short Form) will be used to measure mood.
The scale includes 15 yes/no items and score range from 0 to 15, with high scores indicating depression.
|
Baseline, 6 months
|
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Difference in level of concern over falling
大体时间：Baseline, 6 months
|
The score on the Falls Efficacy Scale-International (Short Version) will be used to measure falling-related concerns.
The scale includes 7 items, with scores ranging from 7 (no concern) to 28 (severe concern of falling)
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Baseline, 6 months
|
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Difference in level of pain
大体时间：Baseline, 6 months
|
The Brief Pain Inventory (short form) will be used to measure pain severity (mean of 4 items, rated 0-10) and pain interference (mean of 7 items, rated 0-10).
Higher scores represent higher pain severity and interference.
|
Baseline, 6 months
|
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Difference in level of incontinence
大体时间：Baseline, 6 months
|
Frequency of incontinence as recorded in patient electronic medical record
|
Baseline, 6 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Loved one's perspective of deprescribing
大体时间：6 months
|
Perspectives from focus groups
|
6 months
|
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
- 首席研究员：Dee Mangin, MBChB, DPH, FRNZC, MD、McMaster University
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 (实际的)
2019年10月15日
初级完成 (实际的)
2021年3月30日
研究完成 (实际的)
2021年3月30日
研究注册日期
首次提交
2019年8月12日
首先提交符合 QC 标准的
2019年8月12日
首次发布 (实际的)
2019年8月14日
研究记录更新
最后更新发布 (实际的)
2021年6月7日
上次提交的符合 QC 标准的更新
2021年6月2日
最后验证
2021年6月1日
更多信息
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.