Randomized Evaluation of Default Access to Palliative Services (REDAPS)
2020年9月10日 更新者:University of Pennsylvania
Default Palliative Care Consultation for Seriously Ill Hospitalized Patients
This is a large pragmatic, randomized controlled trial to test the real-world effectiveness of inpatient palliative care consultative services in improving a number of patient- and family-centered processes and outcomes of care among seriously ill hospitalized patients.
The investigators hypothesize that improved patient-centered outcomes can be achieved without higher costs by simply changing the default option for inpatient palliative care consultation for eligible patients from an opt-in to an opt-out system.
To test this hypothesis the investigators will conduct a clinical trial at 11 hospitals using the same electronic health record within Ascension Health, the largest non-profit health system in the U.S.
研究概览
详细说明
The REDAPS trial aims to generate large-scale, experimental evidence regarding the real-world effectiveness of inpatient palliative consultative services (IPCS) and to test the incremental effectiveness and costs of a simple, scalable method to increase IPCS utilization among properly selected patients.
The REDAPS trial will also compare the effectiveness of different palliative care team structures and services and identify patient subgroups most likely to benefit from IPCS.
To achieve these goals, the investigators will conduct a clinical trial at 11 Ascension Health hospitals using the same electronic health record.
Participating hospitals first contribute a minimum of 4 months of data under the control paradigm (opt-in model), where physicians must identify patients who may benefit from palliative care consultation and actively order such services.
Then, using a stepped-wedge design, the hospitals are randomly assigned to begin the intervention in intervals spaced approximately 2.7 months apart.
During the intervention, patients meeting consensus criteria for eligibility for palliative care consultation are identified by the electronic health record, a consultation is ordered by default, physicians may cancel the order after being alerted to it, and patients or family members may decline such services.
By the end of the trial, all hospitals will have utilized the intervention paradigm of palliative care consultation for at least 4 months.
The REDAPS trial will compare outcomes (clinical, economic, and process measures) before and after implementation within hospitals, as well as comparisons among hospitals at given time points.
研究类型
介入性
注册 (实际的)
34239
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Connecticut
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Bridgeport、Connecticut、美国、06606
- St. Vincent's Medical Center
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Florida
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Jacksonville、Florida、美国、32204
- St. Vincent's Medical Center, Riverside
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Jacksonville、Florida、美国、32216
- St. Vincent's Medical Center, Southside
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Kansas
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Wichita、Kansas、美国、67214
- Via Christi Hospital, St. Francis
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Wichita、Kansas、美国、67218
- Via Christi Hospital, St. Joseph
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Michigan
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Kalamazoo、Michigan、美国、49048
- Borgess Medical Center
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New York
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Binghamton、New York、美国、13905
- Our Lady of Lourdes Memorial Hospital
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Tennessee
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Nashville、Tennessee、美国、37205
- St. Thomas West Hospital
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Texas
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Austin、Texas、美国、78701
- University Medical Center Brackenridge
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Wisconsin
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Mequon、Wisconsin、美国、53097
- Columbia St. Mary's, Ozaukee
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Milwaukee、Wisconsin、美国、53211
- Columbia St. Mary's, North Lake
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
65年 及以上 (年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age 65 years or older
- Current hospitalization of at least 3 calendar days (modified ITT)
Diagnosis of one or more of the following:
- End-stage renal disease (ESRD) on dialysis
- Chronic obstructive pulmonary disease (COPD) with home oxygen dependence or 2 or more hospitalizations in the past 12 months
- Dementia admitted from a long-term care facility or prior placement of a surgical feeding tube or 2 or more additional hospitalizations in the past 12 months
Exclusion criteria:
1. Patients younger than 65 years old will not receive the intervention
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:Default ordering of palliative consult
Hospitals randomized to the intervention arm will adopt a system whereby eligible patients are identified by the electronic health record, a consultation is ordered by default, and physicians may cancel the order after being alerted to it, and patients or family members may decline such services.
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无干预:Usual care
There will be no trial-driven approach to care.
Inpatient palliative care consultative services will be actively requested by physicians as in usual care.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Composite Measure: Length of Stay and In-Hospital Mortality
大体时间:Duration of hospital stay, an expected average of 8 days
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The primary outcome is a composite measure of in-hospital mortality and hospital length-of-stay that ranks deaths along the length-of-stay distribution.
Data is extracted from the electronic health record.
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Duration of hospital stay, an expected average of 8 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Goals of care assessment
大体时间:Duration of hospital stay, an expected average of 8 days
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Documented assessments of patients' goals of care within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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Pain assessment
大体时间:Duration of hospital stay, an expected average of 8 days
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Documented assessments of patients' pain scores within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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Dyspnea assessment
大体时间:Duration of hospital stay, an expected average of 8 days
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Documented assessments of patients' dyspnea within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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Code status
大体时间:Duration of hospital stay, an expected average of 8 days
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Code status documented within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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Mechanical ventilation
大体时间:Duration of hospital stay, an expected average of 8 days
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Documented orders for mechanical ventilation within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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Cardiopulmonary resuscitation
大体时间:Duration of hospital stay, an expected average of 8 days
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Documented orders for cardiopulmonary resuscitation within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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Inpatient dialysis
大体时间:Duration of hospital stay, an expected average of 8 days
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Documented orders for dialysis during inpatient stay within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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ICU admission
大体时间:Duration of hospital stay, an expected average of 8 days
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Transferal to an intensive care unit documented within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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Hospital discharge status
大体时间:Duration of hospital stay, an expected average of 8 days
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Hospital discharge disposition code documented within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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Discharge planning orders
大体时间:Duration of hospital stay, an expected average of 8 days
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Discharge orders for home care services documented within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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Hospital readmission
大体时间:30 days
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30-day hospital re-admissions documented within the Premier database
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30 days
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Direct cost per day
大体时间:Duration of hospital stay, an expected average of 8 days
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Direct cost per day documented within the Premier database
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Duration of hospital stay, an expected average of 8 days
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Direct cost per hospitalization
大体时间:Duration of hospital stay, an expected average of 8 days
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Direct cost per hospitalization documented within the Premier database
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Duration of hospital stay, an expected average of 8 days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Scott D Halpern, PhD,MD、University of Pennsylvania
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年3月1日
初级完成 (实际的)
2018年11月1日
研究完成 (实际的)
2020年9月1日
研究注册日期
首次提交
2015年7月16日
首先提交符合 QC 标准的
2015年7月20日
首次发布 (估计)
2015年7月22日
研究记录更新
最后更新发布 (实际的)
2020年9月11日
上次提交的符合 QC 标准的更新
2020年9月10日
最后验证
2020年9月1日
更多信息
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