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临床试验/NCT04857060
NCT04857060
已完成
不适用

Meeting the Challenges of COVID-19 by Expanding the Reach of Palliative Care: Proactive Advance Care Planning With Videos for the Elderly and All Patients With Dementia

Tufts Medical Center2 个研究点 分布在 1 个国家目标入组 11,174 人2021年7月1日

概览

阶段
不适用
干预措施
Usual Care
疾病 / 适应症
Advance Care Planning
发起方
Tufts Medical Center
入组人数
11174
试验地点
2
主要终点
Identification of a Goals of Care Conversation in the Electronic Health Record (EHR) During the Index Hospitalization
状态
已完成
最后更新
3个月前

概览

简要总结

The investigators propose to conduct a stepped wedge cluster randomized trial of an advance care planning (ACP) educator-led intervention among hospitalized patients aged 65 and over, or any patient with Alzheimer's Disease and Related Dementias (ADRD) and their proxy decision-makers in the ward and ICU settings of two major hospitals: Boston Medical Center and North Shore University Hospital in New York. Patient outcomes will be abstracted from electronic health records with Natural Language Processing. The effectiveness of the intervention will be evaluated by comparing the following outcomes among 9,000 hospitalized patients (Aim 1): ACP documentation; preferences for resuscitation; palliative care consults; and, hospice use. The investigators will characterize caregiver-centered outcomes of patients with ADRD, including (Aim 2): (1) knowledge, (2) confidence in future care, (3) communication satisfaction, and (4) decisional certainty in 600 caregivers of patients with ADRD admitted to the hospital. COVID-19 poses a unique dilemma for older Americans and patients with ADRD and their caregivers, who must balance their desire to live against the risk of a lonely and potentially traumatic hospital death. Video decision support is a practical, evidence-based, and innovative approach to assist patients facing such choices. If proven effective, this innovative care model can be immediately deployed across the country to improve the quality of care for millions of Americans.

详细描述

The majority of patients aged 65 or over, and patients with Alzheimer's Disease and Related Dementias (ADRD), have never communicated their preferences to clinicians or completed advance care planning (ACP) documents. Palliative care has the potential to improve ADRD care, improve patient-clinician communication and patient-centered outcomes, while decreasing unwanted burdensome treatments and improving care at the end of life. The novel Coronavirus Disease 2019 (COVID-19) has acutely escalated the importance of integrating ACP and palliative care services into medical care. The default response to critical illness for patients with ADRD (and all others) is intubation, mechanical ventilation, and aggressive care despite having no change in mortality outcome. ADRD patients and their caregivers may prefer to avoid these interventions. To address these gaps, the investigators have developed a COVID-19 ACP Educator-led, video-assisted palliative care intervention to improve patient-clinician communication, increase ACP documentation, and lead to more patient-centered care at the end of life. The investigators will identify all hospitalized patients aged 65 and older, and any patient with ADRD, and then an ACP Educator will proactively proceed with primary palliative care services of ACP, leveraging certified video decision aids developed by the research team. This will be considered the standard of care for all patients meeting eligibility criteria. The ACP Educator to be tested in this proposal represents a new role and proactive function for the palliative care team. The ACP Educator will work with older patients or patients with ADRD and proxy decision-makers to learn about and document patients' wishes.

注册库
clinicaltrials.gov
开始日期
2021年7月1日
结束日期
2022年10月31日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Inpatient at study sites
  • Age 65 and older
  • Inclusion Criteria: Aim 2 (Caregiver Survey)
  • Age 18 and older
  • Designated caregiver of inpatient identified in Aim 1 who are diagnosed with Alzheimer's Disease and Related Dementias or other cognitive impairments
  • English or Spanish speaking

排除标准

  • 未提供

研究组 & 干预措施

Usual Care

Subjects in this arm do not meet with ACP Educator during their index hospitalization.

ACP Educator led, video assisted discussion

For hospitalized patients identified by a defined EHR algorithm, an ACP Educator will meet with the patient in the hospital to provide primary palliative care services such as goals-of-care conversations and clinician communication by leveraging certified video decision aids.

干预措施: ACP Educator led, video assisted discussion

结局指标

主要结局

Identification of a Goals of Care Conversation in the Electronic Health Record (EHR) During the Index Hospitalization

时间窗: 12 months

Any documentation of a discussion pertaining to limitations of life sustaining treatment, palliative care, hospice, goals of care, time-limited trial, or surrogate decision makers.

次要结局

  • Change in Documentation of Medical Orders for Resuscitation Preferences in EHR(Baseline, 12 months)
  • Caregiver Confidence at 12 Months(Baseline, 12 months)
  • Caregiver Knowledge of ACP at 12 Months(Baseline, 12 months)
  • Caregiver Decisional Satisfaction at 12 Months(Baseline, 12 months)
  • Caregiver Communication Satisfaction at 12 Months(Baseline, 12 months)
  • Caregiver Decisional Certainty(Baseline, 12 months)

研究点 (2)

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