An interventional study of C-HARP TOC assignment and The LACE Index TOC assignment in Transition of Care, sponsored by University of Michigan. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by University of Michigan · Not applicable, Interventional, and Prevention
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.
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.
456 studies on the registry are indexed under Death; 86 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 163 across 210 interventional studies indexed under Death.
Browse Death studies →University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 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.
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.
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.
Time frame: 30 calendar days following the index discharge
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 14 calendar days after discharge
Plan to share: No
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Start is estimated for Jul 2026; primary completion for Aug 2027, 13 months later.
Of 105 non-industry interventional studies with no phase under Death, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 13 months is below that.
Counting every sponsor, half of 109 studies reached it within 24 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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