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Evaluating Intervention Allocation Policies for Reducing Hospital Readmissions at Michigan Medicine

2026年7月1日 更新者：Jenna Wiens、University of Michigan
The researchers are investigating if using a risk-based prediction score or benefit-based prediction score to allocate transition of care (TOC) interventions is more effective in reducing the rate of unplanned hospital readmissions or death within 30 days of hospital discharge.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

The intervention affects only how the TOC bundle is assigned and does not alter how the telephone calls are delivered. For example, both care navigators and pharmacists receive the same patient information and follow the same call procedures before and after the intervention.

Individuals with predicted benefits greater than the 40% quantile are assigned the phone call bundle while others were not assigned the bundle. During the trial the 40% quantile will be dynamically determined using discharge data from the previous week.

研究类型

介入性

注册 (估计的)

5000

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。

学习联系方式

学习地点

  • 美国
    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • The University of Michigan
        • 接触：
        • 首席研究员：
          • Jenna Wiens, PhD

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Patient meets the primary care established rule at Michigan Medicine (MM), AND
  • Patient's primary care physician (PCP) Department is one of our General Medicine or Family Medicine or Medical-Pediatrics departments, AND
  • Inpatient class is Inpatient or Observation or Obs Greater than 48 hours or Outpatient in a Bed or Extended Recovery or Hospital Care at Home Inpatient or Hospital Care at Home Observation, AND
  • Discharged from General Medicine or Family Medicine or Medicine Observation services, AND
  • Disposition of home or home with home care

Exclusion Criteria:

  • Physician Organization of Michigan Accountable Care Organization (POM ACO)
  • Sepsis patients (had a diagnosis of sepsis during admission, active or resolved on the hospital problem list)

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：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
有源比较器：Control Arm/Standard of care
The Control Arm, in which patients with a LACE Index score of 9 or greater on the day of hospital discharge will receive TOC interventions. This is the currently implemented allocation policy at Michigan Medicine. In this setting, approximately 60% of patients receive the TOC intervention. Thus, we will use a threshold of the 40th percentile for assigning the TOC telephone call bundle. Note that to maintain the 60% intervention rate throughout the study, the score threshold (LACE 9 or greater) will be monitored and dynamically adjusted. The LACE Index has four components: Length of Stay (L), Acuity of the Admission (A), Comorbidities (C), and Emergency Department Visits (E), and estimates the risk of a patient having an unplanned hospital readmission after being discharged from their current encounter.
其他：The LACE Index TOC assignment
The LACE Index has four components: Length of Stay (L), Acuity of the Admission (A), Comorbidities (C), and Emergency Department Visits (E), and estimates the risk of a patient having an unplanned hospital readmission after being discharged from their current encounter.
实验性的：Experimental Arm
The Experimental Arm, in which Causal-Hospital reAdmission Risk Prediction Model (C-HARP) scores will be used to allocate TOC interventions. C-HARP is a machine learning model that leverages routinely collected and stored patient data in the electronic health record (EHR) to estimate how much a patient will benefit from receiving MM's TOC telephone call bundle. The assignment threshold will be defined as the 40th percentile of C-HARP scores within the most recent 100 days of the target cohort, so that approximately 60% of patients are assigned the telephone call bundle. Based on current retrospective data, this threshold corresponds to a C-HARP score of 18.
设备：C-HARP TOC assignment
The Experimental Arm will allocate TOC interventions based on scores generated by the Causal-Hospital reAdmission Risk Prediction Model (C-HARP), C-HARP is a linear model that leverages routinely collected and stored patient data in the electronic health record (EHR) to estimate how much a patient will benefit from receiving Michigan Medicine's (MM's) TOC telephone call bundle.

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
The number of 30-day all-cause unplanned readmission or death
大体时间：30 calendar days following the index discharge
An unplanned readmission is defined as any not canceled inpatient, outpatient, or observation hospital admission with an admission type not recorded as "scheduled." Deaths are determined using the Michigan Death Index and matched to patient records using Social Security numbers.
30 calendar days following the index discharge

次要结果测量

结果测量
措施说明
大体时间
The number of 90-day all-cause unplanned readmission or death
大体时间：90 calendar days following the index discharge
An unplanned readmission is defined as any not canceled inpatient, outpatient, or observation hospital admission with an admission type not recorded as "scheduled." Deaths are determined using the Michigan Death Index and matched to patient records using Social Security numbers.
90 calendar days following the index discharge
Time to first 90-day all-cause unplanned readmission or death
大体时间：90 calendar days following the index discharge
An unplanned readmission is defined as any not canceled inpatient, outpatient, or observation hospital admission with an admission type not recorded as "scheduled." Deaths are determined using the Michigan Death Index and matched to patient records using Social Security numbers.
90 calendar days following the index discharge
TOC telephone call bundle completion (care navigator call)
大体时间：5 calendar days after discharge.

A care navigator call is considered complete if a completed call record is observed within 5 calendar days after discharge.

Calls are considered incomplete if the corresponding completed call record occurs after an all-cause unplanned readmission.
5 calendar days after discharge.
TOC telephone call bundle completion (clinical pharmacist call)
大体时间：14 calendar days after discharge

A clinical pharmacist call is considered complete if a completed call record is observed within 14 calendar days after discharge.

Calls are considered incomplete if the corresponding completed call record occurs after an all-cause unplanned readmission.
14 calendar days after discharge
TOC telephone call bundle completion (both calls)
大体时间：14 calendar days after discharge

Completed the care navigator call and completed the clinical pharmacist call.

Calls are considered incomplete if the corresponding completed call record occurs after an all-cause unplanned readmission.
14 calendar days after discharge

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。

赞助

University of Michigan

调查人员

  • 学习椅：Jenna Wiens, PhD、University of Michigan

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 (估计的)

2026年7月1日

初级完成 (估计的)

2027年8月1日

研究完成 (估计的)

2027年9月1日

研究注册日期

首次提交

2026年7月1日

首先提交符合 QC 标准的

2026年7月1日

首次发布 (实际的)

2026年7月8日

研究记录更新

最后更新发布 (实际的)

2026年7月8日

上次提交的符合 QC 标准的更新

2026年7月1日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HUM00282075

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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