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Evaluating Intervention Allocation Policies for Reducing Hospital Readmissions at Michigan Medicine

Evaluating Intervention Allocation Policies for Reducing Hospital Readmissions at Michigan Medicine

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07690657
Enrollment
5000
Registered
2026-07-08
Start date
2026-07-01
Completion date
2027-09-01
Last updated
2026-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transition of Care

Keywords

Hospital readmission, death

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.

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.

Interventions

DEVICEC-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.

OTHERThe 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.

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
The number of 30-day all-cause unplanned readmission or death30 calendar days following the index dischargeAn 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.

Secondary

MeasureTime frameDescription
The number of 90-day all-cause unplanned readmission or death90 calendar days following the index dischargeAn 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.
Time to first 90-day all-cause unplanned readmission or death90 calendar days following the index dischargeAn 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.
TOC telephone call bundle completion (care navigator call)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.
TOC telephone call bundle completion (clinical pharmacist call)14 calendar days after dischargeA 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.
TOC telephone call bundle completion (both calls)14 calendar days after dischargeCompleted 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.

Countries

United States

Contacts

CONTACTStephanie Shepard, PhD
sdokeefe@umich.edu734-647-1098
STUDY_CHAIRJenna Wiens, PhD

University of Michigan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 9, 2026