跳至主要内容
临床试验/NCT05585268
NCT05585268已完成不适用

Electronic Decision Support for Deprescribing in Patients on Hemodialysis: a Prospective, Controlled, Quality Improvement Study

McGill University Health Centre/Research Institute of the McGill University Health Centre1 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2022年10月3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
发起方
入组人数
195
试验地点
1
主要终点
Proportion of patients with one or more PIMs deprescribed

研究概览

简要总结

Dialysis patients are prescribed an average of 10-12 medications per day, from up to 4-5 different clinicians and have the heaviest pill burden of all chronic conditions given their degree of comorbidity. One strategy for addressing the problem of "medication overload" is through scalable deprescribing interventions. MedSafer is an electronic deprescribing tool that cross-references patient health data with existing deprescribing guidelines and provides a deprescribing report to clinicians to facilitate deprescribing and reducing the burden of polypharmacy. In this study the investigators will test MedSafer on dialysis patients paired with medication reconciliation on an intervention unit compared to a control unit.

详细描述

Patients on dialysis are prescribed an average of 10-12 medications per day from up to 4-5 different clinicians and amounting to up to 19 pills per day. This patient population has one of the the heaviest pill burdens of all chronic conditions because of therapy to treat comorbidities like disease, hypertension, or diabetes as well as therapy directed at symptoms and drug side effects.

Over 90% of hemodialysis patients take 5 or more medications (polypharmacy), contributing to medication overload. Further, up to 50% of patients on dialysis are prescribed a potentially inappropriate medication (PIM), defined as a medication carrying an increased risk of contributing to an adverse drug event (ADE). Polypharmacy and associated ADEs increase emergency room visits, hospital admissions and the risk of premature death. Furthermore, some medications have little therapeutic benefit and simply add to pill burden.

Studies continue to document the pressing need for deprescribing, medication reconciliation, and medication management programs in dialysis patient populations for the above reasons. While deprescribing guidelines are available to clinicians, they can be difficult to implement as few tools consolidate the recommendations, guidelines are often long lists which require memorization, and they may not explain how to deprescribe and what rebound symptoms to watch out for. The investigators have previously demonstrated that the electronic tool MedSafer, which identifies deprescribing opportunities based on comparing medication lists and comorbidities to a curated ruleset which incorporates publicly available deprescribing guidance and emerging literature, can be a valuable aid in supporting deprescription of PIMs during acute care episodes. MedSafer has also been shown to be of benefit in Long Term Care settings. Dialysis patients, with a large burden of polypharmacy and complex medical histories, coupled with a high risk for adverse drug events leading to hospitalization and death, represent a unique population in which to study a systematic deprescribing intervention as a means of improving quality of care.

Objectives The primary aim is to provide deprescribing reports containing MedSafer recommendations to the clinical team of a hemodialysis unit during the process of Medication reconciliation, to determine if the identification of deprescribing opportunities can improve medication appropriateness as defined by the receipt of potentially inappropriate medications (PIMs) at the patient level. This intervention will be compared to the efficacy of the intervention with a control dialysis unit that will undergo the standard of care medication reconciliation process with a MedSafer report.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • •Age 18 years and older
  • •On outpatient maintenance hemodialysis
  • •On one of the study units

排除标准

  • •Patient is hospitalized during the period of the intervention
  • •Patient is newly initiated on hemodialysis during the intervention

研究组 & 干预措施

MedSafer-supplemented medication reconciliation

Active Comparator

This unit will act as an intervention unit for the MedRec where MedSafer deprescribing reports will be handed to the treating team and deprescribing brochures from the Canadian Deprescribing Network will be given to patients.

干预措施: Medication reconciliation supplemented with MedSafer and deprescribing brochures (Other)

Standard of care medication reconciliation

No Intervention

This unit will serve as the control unit where standard of care will be provided and no deprescribing reports nor brochures will be delivered. MedSafer reports will be generated but withheld from the clinical team. This will serve as a comparator to determine if the intervention unit was more successful in deprescribing compared to this control unit.

结局指标

主要结局

Proportion of patients with one or more PIMs deprescribed

时间窗: 1 month

The proportion of participants with one or more PIMs deprescribed following a medication reconciliation, compared between intervention and control units.This will be conditioned on patients with 1 or more PIMs at baseline.

次要结局

  • Mean number of total medications(1 month)

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emily McDonald

Associate Professor of Medicine

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (1)

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