[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07690657":3,"trial-entities:NCT07690657":105,"trial-summary:NCT07690657":109},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":9,"sponsor_name":11,"lead_sponsor_class":12,"has_dmc":13,"brief_summary":14,"detailed_description":15,"conditions":16,"keywords":18,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":45,"sex":62,"minimum_age":63,"maximum_age":13,"healthy_volunteers":64,"eligibility_criteria":65,"std_ages":76,"locations":79,"central_contacts":98,"overall_officials":100,"references":103,"see_also_links":104},"NCT07690657","HUM00282075","Evaluating Intervention Allocation Policies for Reducing Hospital Readmissions at Michigan Medicine","NOT_YET_RECRUITING","2027-09","2026-07","2026-07-08","University of Michigan","OTHER",null,"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.\n\nIndividuals 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.",[17],"Transition of Care",[19,20],"Hospital readmission","death","INTERVENTIONAL","PREVENTION",[24],"NA",{"count":26,"type":27},5000,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"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.",[34],"Experimental Arm",{"type":12,"name":36,"description":37,"armGroupLabels":38},"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.",[39],"Control Arm\u002FStandard of care",[41],{"measure":42,"description":43,"timeFrame":44},"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.","30 calendar days following the index discharge",[46,49,51,55,59],{"measure":47,"description":43,"timeFrame":48},"The number of 90-day all-cause unplanned readmission or death","90 calendar days following the index discharge",{"measure":50,"description":43,"timeFrame":48},"Time to first 90-day all-cause unplanned readmission or death",{"measure":52,"description":53,"timeFrame":54},"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.\n\nCalls are considered incomplete if the corresponding completed call record occurs after an all-cause unplanned readmission.","5 calendar days after discharge.",{"measure":56,"description":57,"timeFrame":58},"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.\n\nCalls are considered incomplete if the corresponding completed call record occurs after an all-cause unplanned readmission.","14 calendar days after discharge",{"measure":60,"description":61,"timeFrame":58},"TOC telephone call bundle completion (both calls)","Completed the care navigator call and completed the clinical pharmacist call.\n\nCalls are considered incomplete if the corresponding completed call record occurs after an all-cause unplanned readmission.","ALL","18 Years",false,{"inclusion":66,"exclusion":72,"raw_text":75},[67,68,69,70,71],"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",[73,74],"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)","Inclusion Criteria:\n\n* Patient meets the primary care established rule at Michigan Medicine (MM), AND\n* Patient's primary care physician (PCP) Department is one of our General Medicine or Family Medicine or Medical-Pediatrics departments, AND\n* 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\n* Discharged from General Medicine or Family Medicine or Medicine Observation services, AND\n* Disposition of home or home with home care\n\nExclusion Criteria:\n\n* Physician Organization of Michigan Accountable Care Organization (POM ACO)\n* Sepsis patients (had a diagnosis of sepsis during admission, active or resolved on the hospital problem list)",[77,78],"ADULT","OLDER_ADULT",[80],{"facility":81,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":95},"The University of Michigan","Ann Arbor","Michigan","48109","United States",[87,92],{"name":88,"role":89,"phone":90,"email":91},"Stephanie Shepard, PhD","CONTACT","734-647-1098","sdokeefe@umich.edu",{"name":93,"role":94},"Jenna Wiens, PhD","PRINCIPAL_INVESTIGATOR",{"lat":96,"lon":97},42.27756,-83.74088,[99],{"name":88,"role":89,"phone":90,"email":91},[101],{"name":93,"affiliation":11,"role":102},"STUDY_CHAIR",[],[],{"nct_id":4,"conditions":106,"biomarkers":108},[107],"Hospital Readmission",[],{"nct_id":4,"found":110,"summary":111,"prompt_version":121},true,{"design":112,"status":113,"heading":114,"summary":115,"follow_up":116,"word_count":117,"commitments":118,"compensation":119,"drugs_mentioned":120},"This interventional study plans to enroll 5000 participants. It compares two different methods for assigning support services after hospital discharge.","completed","Evaluating Interventions to Reduce Hospital Readmissions","This study at Michigan Medicine is looking at different ways to assign support services (called Transition of Care or TOC interventions) to patients after they leave the hospital. Researchers want to see if using a risk prediction score, either C-HARP TOC assignment or The LACE Index TOC assignment, can help reduce the number of times patients are readmitted to the hospital or pass away within 30 days of discharge. You might be able to join if you are 18 or older, receive primary care at Michigan Medicine, and your primary care doctor is in one of their General Medicine, Family Medicine, or Medical-Pediatrics departments. The study is currently unclear on its recruitment status, but plans to enroll about 5000 people.","The study will track whether you are readmitted to the hospital or pass away for 30 days after you leave the hospital.",120,"Not specified in the trial record.","Not stated in the trial record.",[31,36],"v2"]