Evaluating Intervention Allocation Policies for Reducing Hospital Readmissions at Michigan Medicine
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- The number of 30-day all-cause unplanned readmission or death
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Population Health Coordinators, Care Navigators, and Clinical Pharmacists will see a flag indicating whether or not a patient is assigned to receive MM's TOC interventions. To maintain appropriate masking, they will not have knowledge of whether or not this flag is determined by the Control Arm policy or Experimental Arm policy, in some cases they may access the LACE score but will not have access to the C-HARP scores. Patients will only be aware of TOC interventions if they are deemed to be at high risk for an unplanned hospital readmission and are assigned to receive them, which is the current standard of care and operational process at MM. Given the setting of this trial, there are no circumstances in which unblinding will occur.
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
- •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
排除标准
- •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)
结局指标
主要结局
The number of 30-day all-cause unplanned readmission or death
时间窗: 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.
次要结局
- The number of 90-day all-cause unplanned readmission or death(90 calendar days following the index discharge)
- Time to first 90-day all-cause unplanned readmission or death(90 calendar days following the index discharge)
- TOC telephone call bundle completion (care navigator call)(5 calendar days after discharge.)
- TOC telephone call bundle completion (clinical pharmacist call)(14 calendar days after discharge)
- TOC telephone call bundle completion (both calls)(14 calendar days after discharge)
研究者
Jenna Wiens
Associate Professor of Electrical Engineering and Computer Science
University of Michigan