A Pragmatic Randomized Trial Assessing Efficacy of the Rothman Index
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Mortality and/or discharge to hospice care
研究概览
简要总结
This study is designed to assess the efficacy of the Rothman Index in combination with a set of recommended-use protocols to improve rates of mortality and/or rates of discharge to hospice care in hospitalized patients.
详细描述
The Rothman Index (RI), created by PeraHealth, Inc., is a clinical support system used to recognize the early stages of clinical deterioration. It uses time-updated physiological data (vital signs, lab values, nursing assessments) to calculate a single score that objectively quantifies a patient's condition in real-time. The score is used to detect a patient's declining health and predict risk of decompensation and death. Various risk thresholds exist to describe a patient's status. "Medium" risk is defined by a 30% reduction in a patient's RI score over 24 hours, "high" risk is defined by a 40% drop in the RI score over 12 hours, and "very high" risk" is having a score less than or equal to 20 on the RI. Some institutions have created protocols to be followed by providers when an RI risk threshold is reached (such as triggering rapid response team mobilization), however, there are no standardized protocols shared between hospitals, and none which have been rigorously tested to determine whether they effectively reduce mortality and adverse outcomes.
This is a randomized controlled trial to determine the efficacy of the Rothman Index and an associated set of RI-triggered recommended-use protocol sin improving rates of mortality and/or discharge to hospice care among inpatients of two hospitals within the Yale New Haven Health System. All inpatients admitted to any unit within the study sites who generate at least 2 RI index scores will be automatically enrolled and randomized to either usual care, in which the patient's RI score is calculated but remains unavailable to providers (and available only to the study team), or to the intervention group in which the RI is calculated and visible to providers who will be encouraged to follow recommended protocols appropriate to the RI risk threshold achieved.
The primary outcome is the rates of mortality and/or discharge to hospice care. Secondary outcomes include rates of inpatient mortality, ICU transfer, length of hospital stay, incurred costs, 30 day readmission and mortality rates, and rates of transfer to home.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults inpatients greater than or equal to 18 years of age
- •Admitted to any inpatient unit at two study sites within the Yale New Haven Health System
- •Has generated at least 2 Rothman Index scores during the present hospital admission
排除标准
- •Prior admission in which patient was randomized
- •Patient has opted out of electronic health record consent
- •Patient in observation status
- •Patient admitted to hospice service
结局指标
主要结局
Mortality and/or discharge to hospice care
时间窗: Assessed from the date of randomization to the date of the first documented death or discharge to hospice during patient's current hospitalization, up to 365 days
A composite outcome of mortality and discharge to hospice care as determined by medical record review. Either will be adequate to meet this endpoint.
次要结局
- ICU transfer(Assessed from the date of randomization to the date of first documented ICU transfer during patient's current hospitalization, up to 365 days)
- Incurred hospital costs(Assessed as costs accrued from the date of randomization to the patient's first documented discharge, up to 365 days)
- Length of stay(Assessed as the number of days from the date of randomization to the first documented discharge, up to 365 days)
- 30 day mortality(30 days post-randomization)
- Readmission(30 days post-randomization)
- Discharge to home(Assessed from the date of randomization to the date of the first document discharge to home, up to 365 days)