跳至主要内容
临床试验/NCT03323502
NCT03323502已完成不适用

A Nursing Home Pragmatic Trial of APPROACHES (Aligning Patient Preferences: a Role Offering Alzheimer's Patients, Caregivers, and Healthcare Providers Educ. and Support)

Indiana University4 个研究点 分布在 1 个国家目标入组 47,396 人开始时间: 2020年2月1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
47,396
试验地点
4
主要终点
Hospital Transfers

研究概览

简要总结

Nursing home (NH) patients with Alzheimer's disease and related dementias often receive unwanted, burdensome treatments such as hospitalization. Advance care planning (ACP) is a key strategy to support patients and family-caregivers in making informed decisions and ensuring treatment preferences are proactively known and honored. The ACP Specialist Program will improve care and reduce unwanted, burdensome hospitalizations through improved ACP procedures, standardized staff education on ACP, and systematic ACP facilitation delivered by existing NH staff.

详细描述

A significant number of patients with Alzheimer's disease or related dementia diagnoses will be cared for in nursing homes near the end of life. Unfortunately, many of these patients experience unwanted and burdensome medical treatments, such as potentially avoidable hospitalizations, that negatively impact quality of life. Advance care planning (ACP) discussions with patients and family caregivers are important to explore goals in advance of a crisis and support informed, values-based decision-making. The ACP process helps ensure that preferences about treatments such as hospitalization are known, documented, and honored. Research indicates that ACP can reduce burdensome treatments and increase the likelihood that care will match documented preferences. Nursing homes are currently required by regulations to offer ACP to patients and families. However, there are no training requirements for nursing home staff and approaches to fulfilling this regulatory and ethical responsibility vary widely, resulting in inconsistent ACP. The "Aligning Patient Preferences - a Role Offering Alzheimer's patients, Caregivers, and Healthcare providers Education and Support (APPROACHES)" trial will test the APPROACHES ACP Specialist Program. Existing nursing home staff members will be trained to enhance care and reduce unwanted, burdensome hospitalizations through improved ACP procedures, standardized staff education on ACP, and systematic ACP facilitation. The primary trial outcome is annual hospital transfers (admissions and emergency department visits). Consistent with the spirit of a pragmatic trial, study outcomes rely on data already collected for quality improvement, clinical or billing purposes. In the 18 month R21 pilot phase, the aims are to: 1) Establish the trial's organizational structure and processes; and 2) Pilot test the intervention in 4 nursing homes. In the R33 phase, a pragmatic cluster randomized clinical trial will be conducted in partnership with 2 nursing home corporations who operate a combined total of 142 diverse urban and rural facilities in 8 states. The aims of the 42 month R33 phase are to: 3) Evaluate the primary outcome of hospital transfers over 12 months among patients with dementia in intervention versus control nursing homes; and 4) Compare measures of quality of care at the end of life between the intervention versus control nursing homes. If successful, the APPROACHES ACP Specialist Program will be primed for rapid translation into nursing home practice to reduce unwanted, burdensome hospitalizations and improve quality of care for patients with dementia. Actual enrollment and outcomes will not be available until Centers for Medicare & Medicaid Services (CMS) claims and Minimum Data Set (MDS) data become available. Actual trial enrollment numbers will be updated at that time.

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
None (Investigator, Outcomes Assessor)

盲法说明

Cluster Randomized Pragmatic Trial: Randomization will occur at the facility level. In order to implement the intervention in the treatment arms facilities, study staff will be required to know the identity of participating facilities. Since this trial involves training staff at intervention facilities, the masking will be 'open label'.

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

  • Facilities are owned by NH corporate partners
  • Facilities are Medicare/Medicaid-certified
  • Facilities have an electronic medical records system
  • Minimum bedsize of 50 or more;
  • At least 50% long-stay as defined by a length of stay of 100 days or longer.

排除标准

  • Problematic or unstable facilities will be removed in consultation with NH corporate leaders prior to randomization

结局指标

主要结局

Hospital Transfers

时间窗: 12 months

Hospital transfers (admissions and emergency department visits) over 12 months between Alzheimer's Disease and Related Dementias (ADRD) patients in intervention vs. control NHs

Hospital Transfers

时间窗: 12 months

Hospital transfers (admissions and emergency department visits) over 12 months between Alzheimer's Disease and Related Dementias (ADRD) patients in intervention vs. control NHs

次要结局

  • Hospice Enrollment(12 months)
  • Death in Hospital(12 months)
  • Hospice Enrollment(12 months)
  • Death in Hospital(12 months)

研究者

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

Susan Elizabeth Hickman

Professor, Community Health Systems

Indiana University

研究点 (4)

Loading locations...

相似试验