Default Palliative Care Consultation for Seriously Ill Hospitalized Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34,239
- 试验地点
- 22
- 主要终点
- Composite Measure: Length of Stay and In-Hospital Mortality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, 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
- 否
入选标准
- •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:
- •Patients younger than 65 years old will not receive the intervention
排除标准
- 未提供
结局指标
主要结局
Composite Measure: Length of Stay and In-Hospital Mortality
时间窗: Duration of hospital stay, an expected average of 8 days
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.
次要结局
- Code status(Duration of hospital stay, an expected average of 8 days)
- Mechanical ventilation(Duration of hospital stay, an expected average of 8 days)
- Cardiopulmonary resuscitation(Duration of hospital stay, an expected average of 8 days)
- Inpatient dialysis(Duration of hospital stay, an expected average of 8 days)
- ICU admission(Duration of hospital stay, an expected average of 8 days)
- Hospital discharge status(Duration of hospital stay, an expected average of 8 days)
- Discharge planning orders(Duration of hospital stay, an expected average of 8 days)
- Goals of care assessment(Duration of hospital stay, an expected average of 8 days)
- Pain assessment(Duration of hospital stay, an expected average of 8 days)
- Dyspnea assessment(Duration of hospital stay, an expected average of 8 days)
- Hospital readmission(30 days)
- Direct cost per day(Duration of hospital stay, an expected average of 8 days)
- Direct cost per hospitalization(Duration of hospital stay, an expected average of 8 days)