Improving Advance Care Planning for Frail, Elderly Residents in Canadian Nursing Homes: A Subproject of the BABEL Study (Better tArgetting, Better Outcomes for Frail ELderly Patients)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 713
- 试验地点
- 4
- 主要终点
- Advance Care Planning (ACP) Audit
研究概览
简要总结
1.0 SUMMARY Most Canadian nursing home (NH) residents are elderly and frail, have multiple chronic health conditions and impairments, and have dementia. In 2014, 244,000 Canadians lived in NHs, including 6% of those ≥65 y.o., at a cost of >$10 billion/yr. NH residents experience high rates of acute illness; approximately 33% have emergency department (ED) visits and 23% are hospitalized yearly. Many of these visits are avoidable, and expose residents to iatrogenic complications. In Manitoba >1.5% of NH residents are admitted to intensive care units yearly, where they receive highly aggressive care. Approximately 30-50% of NH residents die each year, experiencing a progressive burden of severe symptoms leading up to death. Thus, there are serious concerns about Advance Care Planning (ACP) and end-of-life (EOL) care in NHs.
Canadians in general have mediocre knowledge of, and engagement in ACP. Also, studies show that values such as quality of life and aversion to being dependent trump survival in determining care preferences. Among hospitalized octogenarians, 61% desired comfort care only, or just a brief trial of aggressive care. A U.S. study found that decisions for LTC residents to be sent to ED were frequently driven by families who felt unprepared for their loved ones' death, and insecure about the quality of NH care, where there had been little or no discussion about ACP.
Systematic approaches to ACP in NHs have demonstrated benefits, including: increases in ACP uptake, higher compliance with EOL wishes, higher satisfaction with care and emotional well-being, reduced family stress and anxiety, and lower rates of hospitalization. Generally, multimodal ACP interventions have shown the most benefits.
Thus, ACP can improve outcomes for NH residents, their families, and society. The goal of this proposal is to apply best practices in ACP, and demonstrate that it can be implemented it in a scalable, sustainable way across provinces. This will result from delivering the ACP intervention within the existing envelope of NH staffing, and by acquiring most of the data from the Resident Assessment Instrument (RAI), which is completed quarterly for NH residents in 9 provinces. As RAI contains information identifying NH residents at the highest risk for dying within 6-12 months, it will be used to target the ACP intervention to such individuals.
详细描述
2.0 SPECIFIC AIMS
2.1. Aim 1. Improve intervention acceptability, buy-in, and usability by engaging a diverse group of stakeholders to collaboratively design key details of the study.
- Aim 1A: The stakeholder group work to identify and agree upon key principles and practical aspects of ACP in the NH setting.
- Aim 1B: Using the key principles and practical aspects, and existing evidence about beneficial approaches to ACP in NHs, the investigator group will devise an evidence-based, integrated ACP intervention that can be applied by existing NH personnel.
- Aim 1C: Guided by the results of the stakeholder meeting, the investigator group will identify characteristics of NH residents -- available from RAI data routinely and repeatedly available in Canadian NHs -- to identify a cohort of residents who are at the highest risk of dying in the following 6-12 months.
- Aim 1D: Informed by the results of the stakeholder meeting, and existing data, the investigator group, will agree upon the outcomes to be assessed in this study.
2.2. Aim 2. Design and implement training of NH personnel in application of the systematic approach to ACP devised in Aim#1B.
2.3. Aim 3. For each participating NH, devise an approach for real-time access to, and use of, the RAI data for residents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Once the data is collected from all participating nursing homes, anonymized and and electronically encoded, the study arm will also be encoded and the person analyzing the data will be blinded to which group is which.
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
- •Residents of participating nursing homes
- •At high risk of death in the next 6-12 months, as indicated by data collected on the RAI (Resident Assessment Instrument) that completed quarterly in most Canadian nursing homes. Specifically the high-risk elements are any of: CHESS score ≥3; cancer; congestive heart failure; leave >25% of their food uneaten
- •Resident and resident's substitute decision-maker provide informed consent to participate.
排除标准
- •Resident and substitute decision-maker do not speak either English or French.
- •Residents who are deemed not be competent to make their own medical decisions AND their substitute decision-maker is a legally assigned public guardian, or they have no substitute decision-maker.
- •Residents who are transferred to a BABEL study home from another BABEL study home, with the date of transfer being after study initiation. Residents who transferred into a study home from a non-study home are eligible.
结局指标
主要结局
Advance Care Planning (ACP) Audit
时间窗: 6 weeks after study entry
7 item survey as described in: Heyland et al. Journal of Palliative Care Medicine 2(5), 2012. This will be obtained from the resident for those that have capacity, while for residents lacking capacity it will be completed by the Substitute Decision Maker. Each of the 7 items is scored as Yes (1) or No (0) -- thus the scale has a range of 0-7 representing the number of items answered 'Yes', with a higher score representing better processes of Advance Care Planning.
Comfort in Dying of Nursing Home Residents (CAD-EOLD)
时间窗: After death in nursing home, up to 18 months.
This is the 14 item version of this scale scale, as described in these 2 papers: Volicer et al., Alzheimer's Disease and Associated Disorders 15(4):194-200, 2001. Kiely et al., Alzheimer Dis Assoc Disord. 2006 Jul-Sep;20(3):176-81 As described in the Volicer paper, each item is scores 1-3, with total score then on a scale of 14-42, with lower values indicating greater comfort during the final week of life.
次要结局
- Rate of transfer from nursing home to emergency department or hospital.(Up to 18 months.)
- Discordance in care at the end of life(Up to 18 months.)
- Rate of admission to hospital(Up to 18 months.)
- Thematic analysis of experiences and feelings of nursing home staff about Advance Care Planning.(Performed 18 months after study initiation.)
- Rate in nursing home of transition to palliative (comfort) care(Up to 18 months.)
- Time from study entry to death(Up to 18 months.)
- Rate of use in nursing home of feeding tubes(Up to 18 months.)
- Rate of use in nursing home of systemic antibiotics(Up to 18 months.)
- Whether plan of care was followed.(Survey sent to family member 4 weeks after death of nursing home resident.)
- ACP Self-efficacy of Nursing Home Resident Subjects(6 weeks after study entry -- given along with the ACP Audit tool (outcome#1))
- Satisfaction with Care at End of Life (SWC-EOLD)(Survey sent to family member 4 weeks after death of nursing home resident.)
- Nursing Home staff self-efficacy in Advance Care Planning (ACP)(Completed by staff in all participating nursing homes both before nursing home resident recruitment begins, and again at study completion (18 months after study initiation).)
研究者
Dr. Allan Garland
Professor of Medicine and Community Health Sciences
University of Manitoba