Recruiting

Transition of Care

Sponsor:

University of Michigan

Code:

NCT07690657

Conditions

Transition of Care

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

C-HARP TOC assignment

The LACE Index TOC assignment

Study Details

Brief summary:

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.

Conditions

Transition of Care

Study ID

NCT07690657

Start date

Jul 13, 2026

Status verified date

Nov, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

5000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • The number of 30-day all-cause unplanned readmission or death [ Time Frame: 30 calendar days following the index discharge ]

Central Contacts and Locations

Central contacts

Stephanie Shepard, PhD

734-647-1098sdokeefe@umich.edu

Locations

The University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Stephanie Shepard, PhD

734-647-1098sdokeefe@umich.edu

Principal Investigator:

Jenna Wiens, PhD

More Information

Sponsor

University of Michigan

Last update posted

Nov 13, 2026

Last verified

Nov, 2026

Keywords

  • Hospital readmission
  • death

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-14. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-11-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.