Population-based Comparison of Evidence-based, Patient-centered Advance Care Planning Interventions on Advance Directive Completion, Goal Concordant Care and Caregiver Outcomes for Patients With Advanced Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8,707
- 试验地点
- 6
- 主要终点
- Research cohort: Goal concordant care, cross-sectional survey, 12 months
研究概览
简要总结
Using a cluster randomized design at the clinic level, this project will implement and test three real-world, scalable advance care planning interventions among primary care clinics across three University of California health systems. Seriously ill patients identified using data from the electronic health record will receive (1) an advance directive with targeted messaging, (2) intervention 1 plus prompting to engage with the Prepare For Your Care website, or (3) intervention 2 plus engagement from a clinic-based facilitator. A Research cohort of patients will provide complete surveys at baseline, 12 and 24 months. The main outcomes are advance directive completion among the population cohort and goal concordant care among the Research cohort at 12 months.
详细描述
The goal of the project is to test, implement, and disseminate real-world, scalable advance care planning (ACP) interventions among busy, primary care clinics across three UC Health systems. The study aims are as follows:
Aim 1: With the input of primary care stakeholders (i.e., adults with serious illness, caregivers and clinical staff) at each site, determine the barriers, facilitators and best workflow plans to implement the three ACP interventions.
Aim 2: Implement the three ACP interventions across primary care clinics using a cluster randomized design across three UC Health systems: distribution of an advance directive (AD) (arm 1), distribution of the AD plus prompting the patient to engage with the Prepare For Your Care website (arm 2), and the AD plus engagement with the Prepare For Your Care website plus a Care coordinator intervention to engage clinicians (arm 3).
Aim 3: Compare the effectiveness of the three interventions on documentation of ACP (represented by an AD, POLST or out-of-hospital DNR form available in the medical record) on a population-based primary care cohort of seriously ill patients across three UC Health systems, and assess ACP engagement, quality of communication and goal-concordant care among a Research cohort subset of these patients.
The investigators hypothesize that there will be a dose response of additive improvement from arm 1 to arm 2 to arm 3 on AD completion (primary outcome) at the population level and receipt of goal-concordant treatment at the Research cohort level.
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
Statistician blinded to study arm
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Research cohort: Derived from the population cohort plus:
- •Inclusion Criteria
- •Speak English or Spanish
- •Provide informed consent
- •Exclusion Criteria
- •Too cognitively impaired to provide informed consent
- •Primary care physician identifies that survey may be harmful
结局指标
主要结局
Research cohort: Goal concordant care, cross-sectional survey, 12 months
时间窗: 12 months or death
Goal concordant care measured by patient/caregiver reports of receipt of preference concordant care based on questions from SUPPORT (Teno JM, Fisher ES, Hamel MB, Coppola K, Dawson NV. Medical Care Inconsistent with Patients' Treatment Goals: Association with 1-Year Medicare Resource Use and Survival. J Am Geriatr Soc. 2002;50(3):496-500. doi:10.1046/j.1532-5415.2002.50116.)
Advance directive completion, 12 months
时间窗: 12 months or death
Proportion of patients that have advance care planning documentation (enduring advance directive, POLST or out-of-hospital DNR form in the electronic health record) at 12 months (or death) compared to baseline. Baseline date defined as the clinic intervention start date. Intention to treat analysis will use logistic regression models to account for patients clustered within clinics including covariates of patient age, gender, race/ethnicity, serious illness category, clinic baseline advance directive completion rate, study site, time, study arm, and study arm-time interaction.
次要结局
- Research cohort: Report of end of life care(24 months)
- Advance directive completion, 24 months(24 months or death)
- Research cohort: Goal concordant care, comparison of care to preferences(24 months or death)
- Research cohort: Goal concordant care, cross-sectional survey, 24 months(24 months or death)
- New advance directive completion, 24 months(24 months or death)
- Research cohort: Goal concordant care, post-mortem survey(24 months or death)
- New advance directive completion, 12 months(12 months or death)
研究者
Neil Wenger, MD, MPH
Professor
University of California, Los Angeles