[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07661355":3,"trial-entities:NCT07661355":199,"trial-summary:NCT07661355":205},{"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":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":43,"secondary_outcomes":48,"sex":112,"minimum_age":113,"maximum_age":114,"healthy_volunteers":14,"eligibility_criteria":115,"std_ages":138,"locations":141,"central_contacts":184,"overall_officials":193,"references":197,"see_also_links":198},"NCT07661355","IRB00145199","Comparing Two Acute Care Transition Programs for Older Adults and Their Family Caregivers","RECRUITING","2031-11","2026-05","2026-07-31","2026-07-22","Wake Forest University Health Sciences","OTHER",true,"This study investigates better ways to help people after they leave the hospital and how to involve their families in this process. The main goal is to see if adding family support to a patient-centered hospital-to-home intervention helps patients stay safely at home, spend fewer days back in the emergency room or going back into the hospital. The study team also wants to see if the family-centered approach helps improve the patient's ability to do everyday activities without feeling overwhelmed. Two approaches are being compared: one focuses just on the patient, and the other includes special strategies to better support families involved too. Family will be involved in assessing what the patient and family needs. The family-focused approach not only emphasizes the experience, health, and safety of the patient but also the experience of the family member caring for the older adult. The study also involves families in education and provides families skills-building experiences that can help with caregiving stress, problem-solving, and communicating with the healthcare team. The approach will help the family member prepare for their loved one's transition home and provide coaching with the goal of reducing the mental, physical and financial burden of providing care at home. To spread the intervention across many states, the study team will be using telephone calls, video calls, and other technologies as families prefer.","For all patients, the transition from hospital to home is a vulnerable period, placing them at great risk for adverse events. In a landmark 2003 report on care transitions, investigators found that 19% of patients experience adverse events soon after discharge (many preventable or ameliorable) and 66% experience adverse drug events. Care transitions also impact those around the recently discharged patient - increasing the burden on family members who provide caregiving support. Without communication and engagement in care transitions, family members experience reduced preparedness for their post-discharge caregiving role, increased caregiver burden, social isolation, and reduced mental\u002Fphysical well-being.\n\nPatient-centered care transitions can be supported through evidence-based interventions. Recent knowledge generated through PCORI's Transitional Care Evidence to Action Network and other research programs has identified remaining evidence gaps. This Phased Large Award for Comparative Effectiveness Research entitled Comparing Two Acute Care Transition Programs for Older Adults and Their Family Caregivers will create new knowledge related to engaging and supporting family caregivers. After optimization in the feasibility phase, briefly, the Phase 2 comparative effectiveness trial will have the following characteristics:\n\nSetting: 20 Acute Care Hospitals across 5 states selected for rural\u002Furban diversity and patient characteristics Sample: Dyads: Older Adults (N = 1,200) discharged to home and their Family Caregivers (N = 1,200)\n\nComparators:\n\nComparator A is an active care transition program that includes effective strategies focused on the patient.\n\nComparator B includes all Comparator A active strategies, plus focused family caregiver engagement and support.\n\nRandomization:\n\n1:1 Dyad-level RCT stratified by rural\u002Furban home setting and presence of patient cognitive impairment\n\nPatient-Centered Outcomes Include: Patient remaining safely at home (60-day hospital free days), post-discharge adverse events, patient-reported outcomes (e.g.: role functioning). Also, this study extends beyond prior effectiveness research by assessing family-caregiver-reported outcomes (e.g.: caregiver burden).",[18],"Care Transition",[20,21,22,23,24],"hospitalization","older adults","aging","care transition","mild cognitive impairment","INTERVENTIONAL","SUPPORTIVE_CARE",[28],"NA",{"count":30,"type":31},2560,"ESTIMATED",[33,39],{"type":13,"name":34,"description":35,"armGroupLabels":36},"Patient-Centered Program","Effective strategies focused on the patient such as patient needs assessment, multi-disciplinary discharge planning, discharge instructions, follow-up education, and follow-up assessments.",[37,38],"Patient Focused Strategies","Patient and Family Focused Strategies",{"type":13,"name":40,"description":41,"armGroupLabels":42},"Family Caregiver Enhanced Program","Caregiver strategies such as a family caregiver needs assessment, structured education, and skill building.",[38],[44],{"measure":45,"description":46,"timeFrame":47},"Hospital-Free Days","The count of days alive and outside acute care hospitals from discharge to day 60. It will be calculated using EHR and Medicare claims data to objectively capture hospital free days elements (i.e.: mortality days, inpatient days, observation stays, and ED visits).","Day 60",[49,53,57,60,61,64,66,70,74,77,80,83,86,90,93,97,100,104,108],{"measure":50,"description":51,"timeFrame":52},"Number of Hospital-Free Days","The count of days alive and outside acute care hospitals from discharge to a specified day. It will be calculated using EHR and Medicare claims data to objectively capture hospital free days elements (i.e.: mortality days, inpatient days, observation stays, and ED visits).","Day 30, 90, and 180",{"measure":54,"description":55,"timeFrame":56},"Number of Patient Readmissions","All-cause, acute care readmissions calculated as both a count and dichotomous using EHR and Medicare claims data.","Day 30, 60, and 90",{"measure":58,"description":59,"timeFrame":47},"Zarit Burden Interview Score","Caregiver burden will be measured using the 12-item Zarit Burden Interview. Scores will range from 0 to 48. Higher scores indicate greater burden.",{"measure":58,"description":59,"timeFrame":52},{"measure":62,"description":63,"timeFrame":47},"PROMIS Ability to Participate in Social Roles and Activities 8-item short form (APS-SF8) Score","Social role function is one's ability to perform usual social roles and activities (e.g.: leisure, family). It will be measured by using the APS-SF8. Each item is scored using a 5-point Likert scale (1=Never, 5=Always). Scores are typically converted to a standardized T-score, with a mean of 50 and a standard deviation of 10.",{"measure":62,"description":63,"timeFrame":65},"Day 30, 90 and 180",{"measure":67,"description":68,"timeFrame":69},"Partners at Care Transitions Measure (PACT-M) - Patient Satisfaction Score","Patient satisfaction will be measured using the 9-item PACT-M-1. Scores will range from 9 to 45. Higher scores indicate better perception of the quality of discharge arrangements.","Day 7",{"measure":71,"description":72,"timeFrame":73},"Partners at Care Transitions Measure (PACT-M) - Patient Self-Efficacy Score","Patient self-efficacy will be measured using the 8-item PACT-M-2. Scores will range from 8 to 40. Higher scores indicate a better experience with managing care at home.","Day 30",{"measure":75,"description":76,"timeFrame":47},"Patient Activation Measures Score","Patient activation will be measured using the 13-item Patient Activation Measures. Scores will range from 0 to 100. Higher scores indicate greater knowledge, skills, and confidence for managing their health and health care.",{"measure":78,"description":79,"timeFrame":69},"Preparedness for Caregiving Scale Score","Family caregiver preparedness will be measured using the 8-item Preparedness for Caregiving Scale. Scores will range from 0 to 32. Higher scores indicate better preparedness for the caregiving role.",{"measure":81,"description":82,"timeFrame":73},"Caregiver Self-Efficacy Scale Score","Family caregiver self-efficacy will be measured using the 8-item Caregiver Self-Efficacy Scale. Scores will range from 8 to 80. Higher scores indicate higher self-efficacy.",{"measure":84,"description":85,"timeFrame":47},"Caregiver Activation Measures Score","Patient activation will be measured using the 13-item Caregiver Activation Measures. Scores will range from 0 to 100. Higher scores indicate greater knowledge, skills, and confidence for managing their health and health care.",{"measure":87,"description":88,"timeFrame":89},"Visit Completion Rate","Number of patients that completed follow-up visit","Day 14 and 30",{"measure":91,"description":92,"timeFrame":89},"Time to First Outpatient Follow-up","Number of days between discharge and first outpatient follow-up visit",{"measure":94,"description":95,"timeFrame":96},"Rate of Access to Community Services - Patient","Number of patients that had screening and intervention assessment for unmet social needs.","Day 30 and 60",{"measure":98,"description":99,"timeFrame":96},"Rate of Access to Community Services - Caregiver","Number of caregivers that had screening and intervention assessment for unmet social needs",{"measure":101,"description":102,"timeFrame":103},"Partners at Care Transitions Measures - Adverse Events Score","Adverse events will be measured using the 7-item Partners at Care Transitions Measures. Scores will range from 7 to 30. Higher scores indicate greater care problems and more adverse events post discharge.","Day 7 and 30",{"measure":105,"description":106,"timeFrame":107},"Mortality Rate","Count of days to date of patient death","Day 60 and 180",{"measure":109,"description":110,"timeFrame":111},"Montreal Cognitive Assessment 5-minute Protocol Score","Cognitive function (attention, orientation, language, memory, and executive function) will be measured using the Montreal Cognitive Assessment 5-min protocol. Scores will range from 0 to 30. Higher scores indicate better cognitive function.","Day 0, 60, and 180","ALL","18 Years",null,{"inclusion":116,"exclusion":130,"raw_text":137},[117,118,119,120,121,122,123,124,125,118,126,120,127,128,129],"65 and older","English and Spanish speaking","Preadmission location: community dwelling","Distance from Hospital: Local and Distant (rural) included","Cognitive impairment, dementia allowed","Technology Literacy: Flexible from high to low","EPIC readmission risk score over 12","Discharged home","Adults 18 and older","Providing tangible support to patient","Only Mild Cognitive Impairment allowed","Able to be trained in Video Visit Technology","Available to support post-discharge",[131,132,133,134,135,136],"Admitted from skilled nursing facility","Discharged to skilled nursing facility","Left Against Medical Advice (AMA)","Planned readmission","Died during index admission","Caregiver unwilling to participate","Patient Inclusion Criteria:\n\n* 65 and older\n* English and Spanish speaking\n* Preadmission location: community dwelling\n* Distance from Hospital: Local and Distant (rural) included\n* Cognitive impairment, dementia allowed\n* Technology Literacy: Flexible from high to low\n* EPIC readmission risk score over 12\n* Discharged home\n\nPatient Exclusion Criteria:\n\n* Admitted from skilled nursing facility\n* Discharged to skilled nursing facility\n* Left Against Medical Advice (AMA)\n* Planned readmission\n* Died during index admission\n* Caregiver unwilling to participate\n\nCaregiver Inclusion Criteria:\n\n* Adults 18 and older\n* English and Spanish speaking\n* Providing tangible support to patient\n* Distance from Hospital: Local and Distant (rural) included\n* Only Mild Cognitive Impairment allowed\n* Able to be trained in Video Visit Technology\n* Available to support post-discharge\n\nCaregiver Exclusion Criteria:\n\n• Has a greater than a mild cognitive impairment (\\\u003C 12 on MCA)",[139,140],"ADULT","OLDER_ADULT",[142,157,166,175],{"facility":143,"status":7,"city":144,"state":145,"zip":146,"country":147,"contacts":148,"geoPoint":154},"Davie Medical Center","Bermuda Run","North Carolina","27006","United States",[149],{"name":150,"role":151,"phone":152,"email":153},"Houston","CONTACT","508-688-4341","Thomas.Houston@advocatehealth.org",{"lat":155,"lon":156},36.00375,-80.422,{"facility":158,"status":7,"city":159,"state":145,"zip":160,"country":147,"contacts":161,"geoPoint":163},"High Point Medical Center","High Point","27262",[162],{"name":150,"role":151,"phone":152,"email":153},{"lat":164,"lon":165},35.95569,-80.00532,{"facility":167,"status":7,"city":168,"state":145,"zip":169,"country":147,"contacts":170,"geoPoint":172},"Atrium Health Wake Forest Baptist Wilkes Medical Center","North Wilkesboro","28659",[171],{"name":150,"role":151,"phone":152,"email":153},{"lat":173,"lon":174},36.15847,-81.14758,{"facility":176,"status":7,"city":177,"state":145,"zip":178,"country":147,"contacts":179,"geoPoint":181},"Atrium Health Wake Forest Baptist Medical Center","Winston-Salem","27157",[180],{"name":150,"role":151,"phone":152,"email":153},{"lat":182,"lon":183},36.09986,-80.24422,[185,189],{"name":186,"role":151,"phone":187,"email":188},"Michiyah Kimber","336-716-2236","michiyah.kimber@advocatehealth.org",{"name":190,"role":151,"phone":191,"email":192},"Erica Hale","3367162236","erica.hale@advocatehealth.org",[194],{"name":195,"affiliation":12,"role":196},"Thomas Houston, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":200,"biomarkers":204},[201,202,203],"Dementia","Mild cognitive disorder","Transition of care",[],{"nct_id":4,"found":14,"summary":206,"prompt_version":217},{"design":207,"status":208,"heading":6,"summary":209,"follow_up":210,"word_count":211,"commitments":212,"compensation":213,"drugs_mentioned":214},"This interventional study plans to enroll 2560 participants. It compares two different care transition programs.","completed","This study is looking for better ways to help older adults go home from the hospital and stay healthy, especially with support from their families. It compares two approaches: one that focuses on the patient's needs (Patient-Centered Intervention) and another that also includes special support for family caregivers (Family Caregiver Enhanced Intervention). The goal is to see if adding family support helps patients avoid returning to the hospital or emergency room, and if it helps them with daily activities without feeling overwhelmed. You might be able to join if you are 65 or older, speak English or Spanish, live at home, and are being discharged from the hospital. The study is currently unclear on its recruitment status and plans to enroll 2560 people.","The main goal is measured at Day 60, looking at how many days you are not in the hospital.",123,"Not specified in the trial record.","Not stated in the trial record.",[215,216],"Patient-Centered Intervention","Family Caregiver Enhanced Intervention","v2"]