跳至主要内容
临床试验/NCT03577002
NCT03577002Unknown不适用

A Cluster-randomized Trial Comparing Team-based Versus Primary Care Clinician-led Advance Care Planning in the Meta-LARC Practice-based Research Networks

Oregon Health and Science University12 个研究点 分布在 2 个国家目标入组 1,120 人开始时间: 2019年2月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,120
试验地点
12
主要终点
Global rating of goal-concordant care, patient-reported

研究概览

简要总结

This project compares two models of the Serious Illness Care Program (SICP) in primary care: clinician-focused SICP and team-based SICP. Discussion and planning for serious illness care can help patients identify what is most important to them and assure they receive care that best matches their goals and values, such as spending more time at home or not being in pain.

详细描述

Background and Significance:

Many people die after living with chronic conditions that have a broadly predictable course. This should give patients and families the opportunity to consider what is most important to them and plan for the care they wish to receive in their final months and at the end of life. However, in many cases health care defaults to more testing and treatments, creating a potential mismatch between healthcare services and what patients and families want.

Serious illness care planning occurs once a patient with advanced illness reaches a life expectancy of one to two years. Patients face a wide range of choices that can profoundly affect their quality of life. Planning for the last months and days may improve quality of life, by assuring health care supports patient goals and that preferences for life-sustaining interventions honored. For many patients, this planning should occur in the primary care setting, but primary care practices are over-extended, clinicians and staff are often uncomfortable discussing prognosis, and patients and families often do not ask.

The Serious Illness Care Program (SICP) provides a comprehensive implementation strategy, training modules, and a structured conversation guide to promote realistic and compassionate discussions with seriously ill patients in any health care setting. SICP is widely used, having trained hundreds of clinicians and used with thousands of patients. It contributes to the quadruple aims of optimizing healthcare performance through improving patient experience and appropriate utilization of resources, increasing population health, and improving the work life of clinicians. The challenge is that it is unclear whether whether targeting clinicians or entire teams is more efficient and effective when implementing SICP in primary care.

Study Aims:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Can provide verbal consent
  • Be an adult 18 years of age or older
  • Has a serious illness(es) or condition(s) that is likely to limit the patient's life expectancy to less than 2 years as defined by using clinical intuition or a patient identification algorithm when possible
  • Is community-dwelling or is planned to be discharged to a community-based setting
  • Can speak, read and write in English, French or Spanish
  • Has had an initial advance care planning (ACP) conversation at a primary care practice participating in this project.

排除标准

  • Patients may not already be enrolled in hospice
  • Patients may not currently be in an intensive care unit or hospital with no expectation of discharge
  • Patient may not be in an institution (e.g., nursing home) or awaiting nursing home placement in the near future

结局指标

主要结局

Global rating of goal-concordant care, patient-reported

时间窗: 12 months after enrollment

Comparison between arms of whether care received corresponds to patient goals. This will be assessed at 12 months.

次要结局

  • Cumulative time spent at home, patient-reported questionnaires(12 months after enrollment)
  • Generalized Anxiety Disorder (GAD-7)(Baseline, 6 months and 12 months after enrollment)
  • Patient Health Questionnaire (PHQ-9) - Depression(Baseline, 6 months and 12 months after enrollment)
  • Patient-reported outcomes for individuals living with chronic conditions(Baseline, 6 months and 12 months after enrollment)
  • SICP acceptability(Baseline, 6 months and 12 months after enrollment)
  • SICP experience(Baseline, 6 months and 12 months after enrollment)
  • Quality of communication(Baseline, 6 months and 12 months after enrollment)
  • Shared decision making for healthcare decisions(Baseline, 6 months and 12 months after enrollment)
  • Hospice use(Baseline, 6 months and 12 months after enrollment)
  • Detailed items on goal-concordant care(6 months and 12 months after enrollment)
  • Global rating of goal-concordant care, patient-reported(6 months after enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Annette Totten

Associate Professor

Oregon Health and Science University

研究点 (12)

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