Transition of CareNCT07690657
Evaluating Intervention Allocation Policies for Reducing Hospital Readmissions at Michigan Medicine
A study testing C-HARP TOC assignment and The LACE Index TOC assignment in people with Transition of Care, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transition of Care
- What is being tested?
- C-HARP TOC assignment and The LACE Index TOC assignment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Michigan
Ann Arbor, Michigan, 48109
Stephanie Shepard, PhD, 734-647-1098, sdokeefe@umich.edu
Jenna Wiens, PhD
About this study
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.
Read the 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.
- Conditions
- Transition of Care
- Being tested
- C-HARP TOC assignment, The LACE Index TOC assignment
- Keywords
- Hospital readmission, death
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-HARP TOC assignmentDevice
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 assignmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm/Standard of care | Active comparator | 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. Receives: Other: The LACE Index TOC assignment |
| Experimental Arm | Experimental | 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. Receives: Device: C-HARP TOC assignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 calendar days following the index discharge
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 calendar days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transition of CareStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenna Wiens, University of Michigan
- Investigators
- Jenna Wiens, PhD, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690657
- Sponsor's protocol ID
- HUM00282075
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Intervention Allocation Policies for Reducing Hospital Readmissions at Michigan Medicine
- ClinicalTrials.gov ID
- NCT07690657
- Acronym / sponsor ID
- HUM00282075
- Conditions
- Transition of Care
- Keywords
- Hospital readmission, death
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm/Standard of care | Active comparator | Other: The LACE Index TOC assignmentThe 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 Arm | Experimental | Device: C-HARP TOC assignmentThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-HARP TOC assignmentThe 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. | Device | Experimental Arm |
| The LACE Index TOC assignmentThe 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 | Control Arm/Standard of care |
Primary outcome
The number of 30-day all-cause unplanned readmission or death
Time frame: 30 calendar days following the index discharge
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jenna Wiens, PhD study chair
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-HARP TOC assignment and The LACE Index TOC assignment in people with Transition of Care, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Shepard, PhD (734-647-1098, sdokeefe@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of 30-day all-cause unplanned readmission or death (time frame: 30 calendar days following the index discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.