Reducing Post-discharge Adverse Drug Events Amongst the Elderly: a Multi-centre Electronic Deprescribing Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6,582
- 试验地点
- 14
- 主要终点
- Adverse Drug Events within 30 days post-discharge (ascertained via telephone interviewer and adjudicated via clinician reviewers)
研究概览
简要总结
Reducing medications and associated side effects in older adults: an electronic hospital-based intervention
详细描述
Polypharmacy, or the concomitant use of 5 drugs or more, is a serious health concern and affects more than half of Canadians aged 65 years and older. It is the number one identifiable risk factor for adverse drug events (ADEs), which are responsible for 27,000 hospital admissions annually in Canada and up to 20% of return visits to the hospital within 30 days of discharge. Many ADEs are preventable or ameliorable through interventions to reduce inappropriate prescribing.
MedSafer, the intervention software, applies an electronic set of criteria, previously designed and piloted on one thousand (1000) hospitalized patients by a group of Quebec and Ontario internists, geriatricians, palliative care doctors and pharmacists, to identify potentially inappropriate medications (PIMs) in the hospitalized elderly and generate instructions for the patient and physician for safe discontinuation. The current study seeks to partially automate the deprescribing process and to demonstrate the efficacy of this type of intervention on adverse drug events at 30-days post hospital discharge.
At the time of hospitalization, the patient's medications, co-morbidities, and a measure of frailty will be entered into the MedSafer software which will output an individualized and prioritized deprescription plan for the most responsible physician's consideration. Any subsequent medication changes will be transmitted to relevant community physicians. The study will evaluate the impact of stopping PIMs on the occurrence of ADEs within 30 days of discharge, as compared to usual care.
This study will take place on the clinical teaching units (CTUs) at 11 hospitals from seven university hospital centres across Canada. Based on historical data, the investigators estimate a combined 5200 eligible patients per year with nearly 50% taking ten or more medications. Many will have multiple medical co-morbidities such as diabetes, heart disease, and renal insufficiency. A large portion will meet criteria for geriatric syndromes such as frailty and will be at high risk for the development of delirium, falls and functional decline. This population is ideal for a generalizable deprescribing study.
All patients aged 65 or older who meet inclusion/exclusion criteria will be enrolled. A trained research assistant will identify eligible patients and medications will be screened using MedSafer. A deprescribing plan will be generated for the CTU team containing the rationale for suggested medication changes and strategies for safe and successful deprescription. The CTU team will then decide, in conjunction with the patient/proxy and relevant consultants, whether to apply the suggested modifications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Medical chart abstracts compiled at discharge (including any subsequent visits within 30 days) will be combined with the patient telephone interview into a case summary report which will be reviewed independently by two trained and blinded clinician reviewers who will be made up of pharmacists and physicians from each study site (but who will not adjudicate any patients from their own site).
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
- •patients aged 65 years and older
- •patients who take five or more medications in the community
- •patients who are cognitively impaired or otherwise unable to provide consent will still be included as this subpopulation of patients may be at greatest risk of ADEs because of their communication problems.
排除标准
- •patients who take four or fewer medications in the community
- •patients expected to die within 30 days or be transferred to a palliative care unit/another hospital
- •patients without provincial health insurance or who normally live outside that province
- •patients previously enrolled
- •inability for patient or proxy to speak English or French
- •no means of contacting patient or proxy post-discharge
- •Patients discharged from non-study units will be excluded unless that unit is a transitional care, rehabilitation, or post-acute care unit which bridges the gap between acute medical hospitalization and community services.
结局指标
主要结局
Adverse Drug Events within 30 days post-discharge (ascertained via telephone interviewer and adjudicated via clinician reviewers)
时间窗: Interview performed 30-35 days post-discharge.
Post-discharge telephone interview performed by trained personnel using a modification of the Australian two-step adverse reaction and drug event report. Two trained and blinded clinician reviewers will independently use the Leape and Bates approach to assess whether an ADE was present (yes/no) and if so what was the nature of the injury resulting from it using a four-point Likert scale (definitely preventable, probably preventable, probably not preventable, and definitely not preventable), and assess the probability that an event was attributable to a specific drug that was newly started, changed or continued during hospitalization. In cases of disagreement, a third trained and blinded clinician will review and determine the final assessment.
次要结局
- Proportion of participants with one or more potentially inappropriate medications deprescribed(At hospital discharge)
- Number of potentially inappropriate medications(At hospital discharge and at 30-days post hospital discharge)
- Mortality within 30-days post discharge(30-days post hospital discharge)
- Quality of sleep(30 days post hospital discharge)
- Adverse events(30 days post hospital discharge)
- Falls post hospital discharge(30 days post hospital)
- Quality of life of participants(At 30-days post hospital discharge)
研究者
Emily McDonald
Dr. Emily McDonald, Assistant Professor of Medicine
McGill University Health Centre/Research Institute of the McGill University Health Centre