Evaluating Intervention Allocation Policies for Reducing Hospital Readmissions at Michigan Medicine

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Transition of Care
• Intervention / Treatment: Other: The LACE Index TOC assignment; Device: C-HARP TOC assignment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 5000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie Shepard, PhD; Phone Number: 734-647-1098; Email: sdokeefe@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • The University of Michigan
      • Contact: Stephanie Shepard, PhD; Phone Number: 734-647-1098; Email: sdokeefe@umich.edu
      • Principal Investigator: Jenna Wiens, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: 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.
Experimental: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of 30-day all-cause unplanned readmission or death	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of 90-day all-cause unplanned readmission or death	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	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)	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)	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)	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

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Study Chair: Jenna Wiens, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: July 1, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: death; Hospital readmission
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Death
• Other Study ID Numbers: HUM00282075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No