PROVEN: Pragmatic Trial of Video Education in Nursing Homes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 197,692
- 试验地点
- 4
- 主要终点
- Hospital Transfer Rate in Target Cohort
研究概览
简要总结
This is a pragmatic cluster-randomized control trial (RCT) of an Advance Care Planning (ACP) Video Program for nursing home (NH) patients ≥ 65 years old who are cared for in 360 NH facilities (intervention arm n=119; control arm n=241) within two NH health care systems: Genesis HealthCare and PruittHealth. The intervention NH facilities will implement the ACP Video Program, while the control NH facilities will follow their usual ACP procedures. The trial will evaluate the effectiveness of the ACP Video Program by comparing hospitalizations, advance directives, and hospice use in the intervention vs. control NHs.
详细描述
Nursing homes are complex health care systems that serve increasingly sick patients who have advanced comorbid conditions. NHs are often charged with guiding patients through decisions about the direction of their treatment. Patients at NHs commonly get aggressive care that may be inconsistent with their preferences and of little clinical benefit. Identifying effective approaches that NHs can use to better promote goal-directed care and optimize resources is a research, public health, and clinical priority.
Advance care planning is the most consistent modifiable factor associated with better palliative care outcomes. Traditional ACP relies on verbal descriptions of hypothetical health states and treatments. This approach is limited because complex scenarios are difficult to envision, counseling is inconsistent, and verbal explanations are hindered by literacy and language barriers.
To address these shortcomings, the PROVEN project has developed video-assisted ACP decision-support tools that have shown efficacy in small randomized controlled trials. While several large health care systems have begun to adopt the videos, efforts have not rigorously evaluated outcomes-a critical step prior to widespread implementation.
The goal of PROVEN is to conduct a pragmatic cluster-randomized trial to evaluate the effectiveness of the ACP Video Program in the NH setting by partnering with 2 large health care systems that operate 456 nursing homes nationwide. This work has the potential to improve the care provided to millions of older Americans in nursing homes and enable future pragmatic trials in this setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Facilities are within Genesis HealthCare or PruittHealth health care systems
- •Facilities have facility identifiers that indicate that they are Medicare/Medicaid-certified nursing facilities in the U.S.
- •Facilities serve both short and long-stay patients
- •Facilities have >50 beds
- •Facilities have an electronic medical records system
- •Facilities had at least 20 admissions and 20 annual Minimum Data Set (MDS) assessments (regardless of whether they were discharged alive) in 2013
排除标准
- •Facilities excluded per corporate leaders in health care system because of recent turnover in NH administrator or Director of Nursing
- •Facilities excluded per corporate leaders in health care system because of recent bad state or federal quality assurance survey (e.g. restriction on admissions, levied large civil monetary penalty, etc.)
- •Facilities excluded per corporate leaders in health care system because of current new initiatives/competing demands
结局指标
主要结局
Hospital Transfer Rate in Target Cohort
时间窗: 12-month observation period
Number of hospital transfers (number of transfers/person-days alive) over a 12-month observation period among Medicare fee-for-service long-stay residents (in a NH \>=90 days) who are \>=65 years old and who have EITHER advanced dementia or advanced congestive heart failure/chronic obstructive lung disease
次要结局
- Hospital Transfer Rate Among Long-stay Residents Without Advanced Illness(12-month observation period)
- Proportion of Long-stay Residents Without Advanced Illness With Last Observed Advance Directive Status(12-month observation period)
- Proportion of Short-stay Residents Without Advanced Illness Receiving Any Burdensome Treatment(100-day observation period)
- Proportion of Long-stay Residents Without Advanced Illness With Any Hospice Enrollment(12-month observation period)
- Proportion of Short-stay Residents Without Advanced Illness With Any Hospice Enrollment(100-day observation period)
- Proportion of Short-stay Residents With Advanced Illness That Has Medicare ACP Billing Codes(100-day observation period)
- Proportion of Short-stay Residents Without Advanced Illness That Has Medicare ACP Billing Codes(100-day observation period)
- Hospital Transfer Rate Among Short-stay Residents With Advanced Illness(100-day observation period)
- Proportion of Short-stay Residents With Advanced Illness With Last Observed Advance Directive Status(100-day observation period)
- Proportion of Long-stay Residents Without Advanced Illness Receiving Any Burdensome Treatment(12-month observation period)
- Proportion of Short-stay Residents Without Advanced Illness With Last Observed Advance Directive Status(100-day observation period)
- Proportion of Short-stay Residents With Advanced Illness With Any Hospice Enrollment(100-day observation period)
- Hospital Transfer Rate Among Short-stay Residents Without Advanced Illness(100-day observation period)
- Proportion of Target Cohort With Last Observed Advance Directive Status(12-month observation period)
- Proportion of Target Cohort Receiving Any Burdensome Treatment(12-month observation period)
- Proportion of Short-stay Residents With Advanced Illness Receiving Any Burdensome Treatment(100-day observation period)
- Proportion of Target Cohort With Any Hospice Enrollment(12-month observation period)
- Proportion of Target Cohort That Has Medicare ACP Billing Codes(12-month observation period)
- Proportion of Long-stay Residents Without Advanced Illness That Has Medicare ACP Billing Codes(12-month observation period)
研究者
Vincent Mor
Professor of Medical Science, Florence Pirce Grant University Professor, Health Services, Policy & Practice
Brown University