The Effect of Medication Minimization on Mortality and Hospitalization in Long-Term Care Residents: The WiseMed RCT
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- Mortality Rate Compared Between Control and Intervention Group
研究概览
简要总结
The purpose of this experiment is to test the effect of medication minimization on mortality and hospitalization in long-term care residents.
详细描述
People living in residential care are typically elderly and often have complex co-morbid illnesses that are not expected to improve and which they are unable to manage on their own at home. Many of these patients have been prescribed multiple medications to:
- treat individual conditions
- theoretically prevent unwanted sequelae of chronic conditions and/or
- treat side effects of medications given for a) and b).
Advancing age has been found to be a significant factor in adverse drug events and polypharmacy has been found to be a stand alone risk factor for higher mortality and morbidity. However, in British Columbia, the average number of medications taken by patients in residential care is 9, with a range of 0-55 (hospital reporting data, specific reference pending).
Frail elders are often being treated for chronic diseases using published guidelines for both symptom modification and prevention despite the fact that very few of these guidelines are able to include convincing evidence about efficacy in the frail elder population.
Despite the available knowledge of the possible harm of adverse effects in the aged, polypharmacy and a lack of appropriate population-specific evidence, many residential care patients do not have medications stopped or tapered. The lack of change may be explained by the admitting physicians' belief that there is appropriate evidence or a reluctance to stop a medication that was started by a specialist. Other research has also suggested that there is little or no experience/education for many physicians about which medications to address and exactly how to stop/taper medications, and/or a concern/belief that patients or families will fear that the care provider is "giving up" on a patient or relegating her/him to a quicker death.
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
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Living in one of the 6 participating residential care facilities:
- •Youville Residence, PHC, 4950 Heather Street, Vancouver, BC, V5Z 3L9
- •Brock Fahrni Residence, 4650 Oak Street, Vancouver, BC, V6H 4J4
- •Mount St. Joseph's LTC, PHC, 3080 Prince Edward Street, Vancouver, BC, V5T 3N4
- •Holy Family Hospital, PHC, 7801 Argyle Street, Vancouver, BC, V5P 3L6
- •St. Vincent's Langara, PHC, 255 West 62nd Avenue, BC, V5X 4V4
- •Minoru Residence, VCH, 6111 Minoru Boulevard, Richmond, BC V6Y 1Y4
- •Attending GP has agreed to participate in study
- •Taking more that 5 medications
- •If unable to provide consent (due to cognitive impairment, aphasia or any other barrier), that there is a family member or designated decision maker able and willing to sign consent
- •Cognitive impairment will be identified by the attending GP. Any participant who is deemed unable to consent as a result of cognitive impairment will be offered a chance to participate by the research team contacting the alternate decision maker identified in the patient's chart. If appropriate, an assent form will be made available to those participants who agree to sign the consent form for their loved one
排除标准
- •On hemodialysis (due to multiple active prescribing MD's at anyone time)
- •If cognitively impaired, but family member, (or designated decision maker) cannot be contacted to discuss and sign consent
研究组 & 干预措施
Usual Care
This group will receive care as similar as possible to care that they received prior to the study beginning. Their attending MDs will be instructed and reminded to avoid making parallel changes in the prescribing for the control patients unless there is a specific medical indication to which they would normally respond with a medication reduction. No other reminders or prompts about the study will be provided for these patients.
Medication Minimization
- Initial Medication Review (IMR) Completed by Attending MD and identifies potential medications to be considered for minimization as well as those UNSUITABLE (as per usual MD opinion)
- Orders-Medication Update (OMU) (ref form) The attending MD will have identified one or more medications to be considered for minimization and in the IMR suggested a time when a reduced dose will be reviewed (recommended every 4 weeks). Each review will generate an OMU. This process will be repeated for every participant in the Medication Minimization arm until all medications are marked as having no further changes, ie no need for further OMU. At that time a participant's record will be marked as having completed medication minimization.
干预措施: Medication Minimization (Other)
结局指标
主要结局
Mortality Rate Compared Between Control and Intervention Group
时间窗: Up to 2 years
This information will be gathered from acute care and facility electronic health records and where needed validated using participant paper chart. A request will be made to facilities for this information every three months during the study.
次要结局
- Difference in Acute Care Transfers Between Control and Intervention Group(Up to 2 years)
- Comparison of Total Cost of Care Between Control and Intervention Group(Up to 2 years)
- Survival Analysis Compared Between Control and Intervention Group(Up to 2 years)
- Number of Attending MD emergency facility visits and nurse to physician phone calls billed by the attending physician (captures significant medical issues not requiring transfer to acute care problems)(Up to 2 years)
研究者
R McCracken
Dr. Rita McCracken
University of British Columbia