Reducing Post-discharge Potentially Inappropriate Medications Among Older Adults: 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
- 924
- 试验地点
- 2
- 主要终点
- Proportion of Patients with cessation of Potentially Inappropriate Medications (PIMs)
研究概览
简要总结
Potentially inappropriate medications (PIMs) can lead to adverse drug events (ADEs) among older adults and especially those classified as frail. ADEs are responsible for nearly 27,000 hospital admissions in Canada annually. Within 30 days of discharge, medications contribute to two-thirds of adverse events, with nearly 60% being preventable or ameliorable. MedSafer is software product that guides patients and physicians in the community through the process of deprescribing. MedSafer electronically cross-references patient comorbidities with the most recent evidence-based PIMs, as of the study date, in order to generate a patient-tailored deprescribing care plan. This study will evaluate whether this application, when applied at hospitalization, leads to a reduction in the proprotion of patients with PIMs prescribed at discharge, by highlighting harmful medications for deprescription to treating physicians. This study will take place on the clinical teaching units (CTUs) at four hospitals. Based on historical records, the investigators estimate enrolling 480 patients aged 65 or older over three months. A trained research assistant will identify eligible patients, and will enter their medications, comorbidities, and an estimate of frailty into MedSafer. A deprescribing plan will be generated for the CTU team containing rationale for suggested medication changes and strategies for safe and successful deprescription. The CTU team will then decide in conjunction with the patient or proxy, and with relevant consultants, which medications can rationally be stopped or tapered at discharge.
详细描述
Deprescribing during hospitalization can be achieved through the concerted effort of expert clinicians. A single-centre randomized controlled trial (400 patients) demonstrated that by having a dedicated geriatrician apply the STOPP/START criteria [screening tool of older people's prescriptions (STOPP) and screening tool to alert to right treatment (START)] to screen for PIM use on admission could improve prescribing appropriateness by providing recommendations for medication management; these changes were shown to persist for at least six months post discharge. Recommendations were made in 58% of intervention patients, and these were accepted in greater than 90% of cases. At discharge the proportion of patients taking "unnecessary" therapy was 20% in the control group and 5.2% in the intervention arm. This study was underpowered to show meaningful differences in ADEs and was entirely dependent on a dedicated expert physician whose full time job was to provide this service; despite this, medications were discontinued in nearly 1 in 5 patients with a sustained post-discharge effect.
This catalyst program will build on the Canadian Frailty Network-funded Catalyst Research Program Grant (MEdication RAtionalization or MERA) by Co-Investigator James Downar. MERA identifies medication for deprescribing by combining STOPP/START, the Beers criteria, and Choosing Wisely Canada recommendations. A multidisciplinary case team then guides elderly patients and their caregivers through deprescription during their hospitalization. Both the Gallagher and MERA approaches are intensive in terms of human resources and are challenging to generalize, implement and sustain nationwide. Furthermore, the current lack of firm evidence on the risks and benefits of systemic deprescribing has limited the implementation of these concepts into routine medical practice. A technological solution that facilitates deprescribing and with proven effectiveness and safety would be a tremendous step forward for the deprescribing movement.
Research Objectives: The investigators will adapt and implement an electronic tool called MedSafer to identify PIMs within 72 hours of hospitalization and prioritize medications for deprescription. The tool will use three key criteria for deprescription: the potential for a drug to improve symptoms, the potential to reduce the risk of future illness, and the likelihood of causing harm. The recommendations from MedSafer will cue the treating team to consider deprescribing PIMs after taking into consideration their knowledge of the individual patient comorbidities, along with an understanding of patient values and goals of care.
The primary goal of this pilot study is to demonstrate that MedSafer can facilitate deprescription (beyond usual care) in a diverse population of elderly patients. This pilot will serve as the proof of concept for a larger multicenter RCT looking at the impact of this process on adverse drug events. This pilot will facilitate: 1) estimates of the frequency of PIMs; 2) adverse drug event rates; 3) rates of recruitment, refusal and loss to follow up; 4) refinement of MedSafer based on real world user feedback; and 6) refinement of the adverse drug event endpoint adjudication and health-related quality of life interview process. The study will be conducted at the Ottawa Hospital, the Toronto General Hospital and two hospitals at the McGill University Health Centre, in Montreal (Royal Victoria and Montreal General Hospitals).
Primary objective: The primary outcome is the proportion of patients for whom 1 or more PIMs are stopped at discharge. We hypothesize that MedSafer will facilitate deprescription of PIMs compared to usual practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 120 Years(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will represent a consecutive series of persons.
- •Eligible participants include those who are:
- •aged 65 years or older;
- •taking 5 or more medications; and
- •admitted to the inpatient medical ward at any of the study sites.
- •Patients who are cognitively impaired or otherwise unable to provide consent will still be included as this sub-population of patients may be at greatest risk of ADEs because of their communication problems. Tri-council ethics guidelines (Canada) deem that this sub-population should not be excluded from interventions that potentially provide direct benefit to the participant due to the inability to provide informed consent (Article 4.5, Tri-Council Policy Statement 2008). For these patients, the family/proxy will authorize study participation pending the return of patient capacity to consent.
- •Patients who are ultimately discharged from non-study units during their hospitalization will be excluded unless that unit is a transitional care, rehabilitation, or post-acute care unit used to bridge the gap between acute medical hospitalization and community services.
排除标准
- •patients expected to be transferred to another acute care hospital, a non-medical unit, or a palliative care unit;
- •patients who normally live outside of the province of hospitalization;
- •patients not enrolled in (or eligible for) the provincial drug plans;
- •patients previously enrolled in the study;
- •patients or proxy not able to speak English or French;
- •no means of contacting patient or proxy post-discharge;
- •patients expected to die within 30 days and whose level of care has been declared to be palliative will be maintained in the study but will be excluded from select secondary outcomes.
研究组 & 干预措施
McGill University Health Centre
This arm is defined by the geographic cluster of all eligible participants presenting to the McGill University Health Centre (Montreal, Quebec, Canada) Montreal General Hospital or Royal Victoria Hospital during the study period. The arm will undergo a control and intervention (MedSafer) period. Participants will be enrolled in either the control or intervention period.
干预措施: MedSafer (Other)
University Health Network, Toronto
This arm is defined by the geographic cluster of all eligible participants presenting to the University Health Network (Toronto, Ontario, Canada) at the Toronto General Hospital or Toronto Western Hospital. The arm will undergo a control and intervention (MedSafer) period. Participants will be enrolled in either the control or intervention period.
干预措施: MedSafer (Other)
University of Ottawa, Ottawa
This arm is defined by the geographic cluster of all eligible participants presenting to the Ottawa Hospital (Ottawa, Ontario, Canada). The arm will undergo a control and intervention (MedSafer) period. Participants will be enrolled in either the control or intervention period.
干预措施: MedSafer (Other)
结局指标
主要结局
Proportion of Patients with cessation of Potentially Inappropriate Medications (PIMs)
时间窗: Proportion will be evaluated on the day of the patient's discharge from the hospital
The primary outcome is the proportion of patients with 1 or more PIM discontinued at discharge
次要结局
- The number of medications prescribed at discharge and 30 days post(Within 30 days after the patient was discharged from the hospital)
- Adverse event(Within 30 days after the patient was discharged from the hospital)
- Adverse drug event(Within 30 days after the patient was discharged from the hospital)
- Length of stay (days)(Duration of patient's hospital stay, from admission to discharge up to a maximum of 90 days)
- In-hospital mortality(Throughout the index admission from time patient admitted to time patient discharged up to a maximum of 90 days)
- Health related quality of life(At 30 days after the patient was discharged from the hospital)
- 30-day all cause mortality(At 30 days post hospital discharge)
- Return to the emergency department(At 30 days after the patient was discharged from the hospital)
- In hospital falls(During patient's index admission, evaluated from admission to discharge, up to a maximum of 90 days)
- Proportion of potentially inappropriate medications at 30-days post discharge(At 30 days post discharge)
研究者
Todd Lee
Associate Professor of Medicine, General Internal Medicine
McGill University Health Centre/Research Institute of the McGill University Health Centre
