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Not yet recruiting NCT07690657

Evaluating Intervention Allocation Policies for Reducing Hospital Readmissions at Michigan Medicine

No phase Interventional Transition of Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: C-HARP TOC assignment, The LACE Index TOC assignment.
Who it may be relevant to
Registry conditions: Transition of Care. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • 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.
  • 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.

Primary outcome measures

  • The number of 30-day all-cause unplanned readmission or death [Time frame: 30 calendar days following the index discharge]
Secondary outcome measures (5)
  • The number of 90-day all-cause unplanned readmission or death [Time frame: 90 calendar days following the index discharge]
  • Time to first 90-day all-cause unplanned readmission or death [Time frame: 90 calendar days following the index discharge]
  • TOC telephone call bundle completion (care navigator call) [Time frame: 5 calendar days after discharge.]
  • TOC telephone call bundle completion (clinical pharmacist call) [Time frame: 14 calendar days after discharge]
  • TOC telephone call bundle completion (both calls) [Time frame: 14 calendar days after discharge]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • The University of Michigan — Ann Arbor

Identifiers

NCT: NCT07690657 · HUM00282075

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗