跳至主要内容
临床试验/NCT04070183
NCT04070183已完成不适用

POST Facilitation for Community Dwelling Older Adults With and Without Dementia

Indiana University6 个研究点 分布在 1 个国家目标入组 389 人开始时间: 2020年5月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
389
试验地点
6
主要终点
Discordance between treatment preferences and treatment received 12 months after POST Facilitation

研究概览

简要总结

We propose to study the effects of Physician Orders for Scope of Treatment (POST) Facilitation in a randomized controlled trial in a population of community dwelling older adults who qualify for POLST facilitation, including those with normal cognition and those with Alzheimer's Disease and Related Disorders.

详细描述

The POLST paradigm, which stands for Physician Orders for Life Sustaining Treatment, was developed to address inconsistencies between care received and patient and family wishes for treatment, with an aim to increase concordant care. The POLST paradigm is nationally recognized and implemented in a number of states under different names. In Indiana, for example, it is called "Physician Orders for Scope of Treatment" (POST). Because of this, all patient facing materials will refer to POST, however, we use the terms POST and POLST interchangeably in this proposal.

POLST affects delivery of medical interventions and improved concordance between patient preferences and care received.

Our specific aims are:

  1. To test the effect of high quality POLST Facilitation delivered in the home compared to attention control on:

a.discordance between preferences for treatment and treatments received in the subsequent 12 months (primary outcome). 2. To test the effect of POLST Facilitation on intermediate outcomes including:

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)

入排标准

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

入选标准

  • 65 or older
  • have decision making capacity OR a qualified surrogate decision maker
  • must meet one of the following index scores:
  • Gagne Mortality Index score of 7 or greater (30% mortality risk)
  • Medicare Criteria for Hospice Admission: Functional Assessment Staging Tool (FAST) Index (Advanced Alzheimer's disease and related dementia) 7c or higher plus one or more comorbid conditions.
  • Seattle Heart Failure Model (congestive heart failure): score conferring a one-year mortality risk of 30% or greater
  • Eastern Cooperative Oncology Group (ECOG) performance status (metastatic cancer): Patients with an impaired performance score (greater than zero)
  • Liu Comorbidity Index (End Stage Renal Disease): Patients with a score of 10 or greater
  • blood results (B), age (A), respiratory variables (airflow obstruction, exacerbations, smoking) (R) and comorbidities (C) (BARC) Index for chronic obstructive pulmonary disease (COPD): high risk group
  • Model for End Stage Liver Disease (MELD) Index
  • must be able to pass consent verification
  • must not be enrolled in hospice
  • must not have an acute illness
  • must give patient's provider opportunity to review the "surprise question" (e.g. would you be surprised if the patient died in the next year) to confirm anticipated mortality within the next year (14 days to respond)
  • must not have a POST form on file.
  • Exclusion criteria:
  • lack of a patient or surrogate decision maker who can participate in POLST facilitation (for non-decisional patients a health care representative (HCR) or designated power of attorney for health care (DPOA-HC) must enroll with them)
  • patients who are already enrolled in hospice
  • patients or surrogates who cannot pass consent verification
  • patients or surrogates who do not speak English
  • patients with a POST form on file
  • patients who are not community-dwelling

排除标准

  • 未提供

结局指标

主要结局

Discordance between treatment preferences and treatment received 12 months after POST Facilitation

时间窗: Assessed 12 months from the date that the patient receives POST facilitation or home safety evaluation

Chart review and comparative statistics will be used to determine discordance between patient/family preferences and care received at the end of life.

次要结局

  • Decision quality- POLST Knowledge(Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation)
  • Effect of the intervention on psychological well-being (post traumatic stress)(Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation)
  • Proportion of patients who have a completed POST form 3 months after receiving POST Facilitation(Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation)
  • Decision quality- ACP engagement(Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation)
  • Effect of the intervention on psychological well-being (anxiety)(Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation)
  • Effect of the intervention on psychological well-being (depression)(Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation)
  • Decision conflict(Assessed 3 months from the date that the participant receives POST facilitation or a home safety evaluation)
  • Effect of the intervention on cost and end of life care (EOL) for patients who die within 12 months of the intervention(Assessed by chart review 12 months from the date that the participant receives POST facilitation or a home safety evaluation)

研究者

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

Alexia M. Torke

Associate Professor of Medicine

Indiana University

研究点 (6)

Loading locations...

相似试验

POST Facilitation for Community Dwelling Older... | 临床试验