Comparing Two Acute Care Transition Programs for Older Adults and Their Family Caregivers
2 other identifiers
interventional
2,560
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2026
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2026
CompletedFirst Posted
Study publicly available on registry
June 22, 2026
CompletedStudy Start
First participant enrolled
July 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2031
July 31, 2026
May 1, 2026
5.3 years
June 16, 2026
July 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (19)
Number of Hospital-Free Days
Day 30, 90, and 180
Number of Patient Readmissions
Day 30, 60, and 90
Zarit Burden Interview Score
Day 60
Zarit Burden Interview Score
Day 30, 90, and 180
PROMIS Ability to Participate in Social Roles and Activities 8-item short form (APS-SF8) Score
Day 60
- +14 more secondary outcomes
Study Arms (2)
Patient Focused Strategies
ACTIVE COMPARATORAn active care transition program that includes effective strategies focused on the patient.
Patient and Family Focused Strategies
EXPERIMENTALAn active care transition program that includes effective strategies focused on the patient plus focused family caregiver engagement and support.
Interventions
Effective strategies focused on the patient such as patient needs assessment, multi-disciplinary discharge planning, discharge instructions, follow-up education, and follow-up assessments.
Caregiver strategies such as a family caregiver needs assessment, structured education, and skill building.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Adults 18 and older
- English and Spanish speaking
- Providing tangible support to patient
- Distance from Hospital: Local and Distant (rural) included
- Only Mild Cognitive Impairment allowed
- Able to be trained in Video Visit Technology
- Available to support post-discharge
- Has a greater than a mild cognitive impairment (\< 12 on MCA)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Davie Medical Center
Bermuda Run, North Carolina, 27006, United States
High Point Medical Center
High Point, North Carolina, 27262, United States
Atrium Health Wake Forest Baptist Wilkes Medical Center
North Wilkesboro, North Carolina, 28659, United States
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Houston, MD
Wake Forest University Health Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2026
First Posted
June 22, 2026
Study Start
July 22, 2026
Primary Completion (Estimated)
November 1, 2031
Study Completion (Estimated)
November 1, 2031
Last Updated
July 31, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share