MedSafer E-care: an Automated Deprescribing Solution for Community-dwelling Older Adults Living With Polypharmacy (E-CARE Study)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Proportion of patients with one or more PIM (potentially inappropriate medication) reduced or stopped
研究概览
简要总结
The investigators will link MedSafer (a Canadian-made electronic tool) with a large multi-national electronic medical record (EMR), MED e-care, through an existing application programming interface (API) that provides clinicians with electronic, patient-specific deprescribing reports. They will implement a highly scalable deprescribing intervention in a staged and controlled fashion across five Canadian Aged Care Facilities. The investigators aim to test the feasibility of the API for the purposes of generating real time automated deprescribing reports, displayed to the user in the EMR.
详细描述
MedSafer is a Canadian-made electronic tool that automates deprescribing and generates individualized, prioritized deprescribing opportunities for older adults based on existing evidence from algorithms such as the Beer's criteria and STOPP/START in order to stop potentially inappropriate medications. Its clinical content has been in place for over a year in a Canadian Institutes for Health Research funded study and has been tested on over 5000 hospitalized patients. Software output has been analyzed and validated by Canadian experts in internal medicine, geriatrics, palliative care, nursing, and pharmacy.
In the previous study funded by the Canadian Institutes for Health Research (expected total recruitment: 6000), while deprescribing reports were generated automatically, data still had to be entered manually, by trained research assistants. For this study, the next stage of development involved creating an API that could accept medical conditions in the format of ICD10 codes and medications as DINs.
"MedSafer e-Care" addresses the needs of patients and caretakers by facilitating safe deprescribing. Deprescribing is time consuming, complex, and not all caretakers (clinicians) are trained with the expert knowledge required to cross reference multiple medical conditions with often 10 or more medications. "MED e-care" is an EMR (electronic medical record) that contains patient medical conditions and medications stored as international disease classification codes (ICD10) and drug identification numbers (DIN). The MedSafer team has designed an API that cross-references ICD10 codes and DINs against existing evidence-based algorithms for safe deprescribing. The API has been tested on a variety of medical conditions and medications contained within the MedSafer rule set. This process can overcome barriers to stopping medications including caretaker time constraints and knowledge gaps.
Data packets are processed by the MedSafer API and deprescribing reports are returned to MED e-care and displayed to the user on the EMR interface. Reports will be available to caretakers (nurses, physicians and pharmacists) who can choose to stop or taper medications within the EMR. Opportunities are prioritized based on potential for harm and ease of discontinuation, and factor in a measure of patient frailty and life expectancy. When necessary, instructions for tapering medications are provided. Links to patient educational brochures are included and can be printed for the patient and family detailing harmful medications and deprescribing rationale. MED e-care has already entered negotiations with the nursing home group OMNI Health Care to recruit at least five and up to 18 of the 18 care sites from within the OMNI group of homes across Ontario.
The estimated duration of the study is 12 months. Deployment will approximate a Stepped Wedge Cluster Randomized Trial Design (calculations performed with steppedwedge function in Stata v. 15). To accomplish this, at least 10 unique patients would need to be enrolles per ACF every 2 months following a 3-month baseline period (minimum total 300 patients).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The investigator will receive anonymous data and when performing the analysis will not know if the participant received the intervention or not. The same is true for the outcome assessor (blinded to study intervention). All patient and time identifiers stripped from the outcome adjudication.
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
- •All residents of the participating Ontario long term care facilities (OMNI) who are 65 years of age or older and are taking a potentially inappropriate medication (as identified by MedSafer) are eligible for the deprescribing component of this study.
排除标准
- •If a patient is unable to complete the survey due to a language barrier or cognitive impairment, the research assistant will seek consent from an appropriate proxy. In the event where both the patient and proxy are unable to complete the survey or there was no proxy identified or proxy could not be reached, the patient will be excluded from the survey component of the study. The health care professionals will still have access to their MedSafer file for the purposes of patient care.
结局指标
主要结局
Proportion of patients with one or more PIM (potentially inappropriate medication) reduced or stopped
时间窗: 30-days after the prescriber receives a deprescribing report.
Proportion of patients with one or more PIM (potentially inappropriate medication) reduced or stopped 30-days after the treating physician receives a deprescribing report.
次要结局
- Sustainability; quality of life; sleep quality; falls; transfer to acute hospital; hip fractures; and delirium(Examined at 30-days following each intervention cycle (3 cycles))
研究者
Emily McDonald
Assistant Professor of Medicine, Director of General Internal Medicine Consult Service (Royal Victoria Hospital)
McGill University Health Centre/Research Institute of the McGill University Health Centre
