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临床试验/NCT04055896
NCT04055896终止不适用

Team Approach to Polypharmacy Evaluation and Reduction in a Long-Term Care Setting: A Feasibility Randomized Controlled Trial

McMaster University4 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
15
试验地点
4
主要终点
Successful Discontinuation (Difference in mean number of medications; reduction in dose)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

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

  • 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

排除标准

  • terminal illness or other circumstance precluding 6 month study period
  • recent (within 12 months) comprehensive medication review

结局指标

主要结局

Successful Discontinuation (Difference in mean number of medications; reduction in dose)

时间窗: 6 months

Difference in mean number of medications; number of medications reduced in dose

次要结局

  • Time to complete measures(Baseline, 6 months)
  • Difference in level of cognition(Baseline, 6 months)
  • Difference in level of quality of life(Baseline, 6 months)
  • Difference in number of falls(Baseline, 6 months)
  • Difference in level of sleep(Baseline, 6 months)
  • Changes in medication side effects and symptoms (adverse)(1-week, 3 months, 6 months)
  • Changes in medication side effects and symptoms (positive)(1-week, 3 months, 6 months)
  • Difference in number of serious adverse events(1-week, 3 months, 6 months)
  • Difference in level of physical functioning capacity and ability(Baseline, 6 months)
  • Difference in level of performance of activities of daily living(Baseline, 6 months)
  • Difference in level of frailty(Baseline, 6 months)
  • Difference in level of healthcare utilization use (hospitalizations)(Baseline, 6 months)
  • Difference in level of healthcare utilization use (emergency department visits)(Baseline, 6 months)
  • Difference in level of healthcare utilization use (physician visits)(Baseline, 6 months)
  • Enrollment rate(6 months)
  • Completion rate(6 months)
  • Difference in level of mood(Baseline, 6 months)
  • Difference in level of concern over falling(Baseline, 6 months)
  • Difference in level of pain(Baseline, 6 months)
  • Difference in level of incontinence(Baseline, 6 months)

研究者

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

Derelie Mangin

Professor; Associate Chair and Director, Research David Braley & Nancy Gordon Chair in Family Medicine

McMaster University

研究点 (4)

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