Comparing Two Acute Care Transition Programs for Older Adults and Their Family Caregivers

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Care Transition
• Intervention / Treatment: Other: Patient-Centered Intervention; Other: Family Caregiver Enhanced Intervention

Detailed Description

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/physical well-being.

Patient-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:

Setting: 20 Acute Care Hospitals across 5 states selected for rural/urban diversity and patient characteristics Sample: Dyads: Older Adults (N = 1,200) discharged to home and their Family Caregivers (N = 1,200)

Comparators:

Comparator A is an active care transition intervention that includes effective strategies focused on the patient.

Comparator B includes all Comparator A active strategies, plus focused family caregiver engagement and support.

Randomization:

1:1 Dyad-level RCT stratified by rural/urban home setting and presence of patient cognitive impairment

Patient-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).

• Study Type: Interventional
• Enrollment (Estimated): 2560
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michiyah Kimber; Phone Number: 336-716-2236; Email: michiyah.kimber@advocatehealth.org
• Study Contact Backup: Name: Erica Hale; Phone Number: 3367162236; Email: erica.hale@advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Bermuda Run, North Carolina, United States, 27006
      • Davie Medical Center
      • Contact: Houston; Phone Number: 508-688-4341; Email: Thomas.Houston@advocatehealth.org
    • High Point, North Carolina, United States, 27262
      • High Point Medical Center
      • Contact: Houston; Phone Number: 508-688-4341; Email: Thomas.Houston@advocatehealth.org
    • North Wilkesboro, North Carolina, United States, 28659
      • Atrium Health Wake Forest Baptist Wilkes Medical Center
      • Contact: Houston; Phone Number: 508-688-4341; Email: Thomas.Houston@advocatehealth.org
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist Medical Center
      • Contact: Houston; Phone Number: 508-688-4341; Email: Thomas.Houston@advocatehealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Patient Inclusion Criteria:

• 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

Patient Exclusion Criteria:

• 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

Caregiver Inclusion Criteria:

• 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

Caregiver Exclusion Criteria:

• Has a greater than a mild cognitive impairment (≤ 22 on MCA)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patient Focused Strategies; An active care transition intervention that includes effective strategies focused on the patient.	Other: Patient-Centered Intervention; Effective strategies focused on the patient such as patient needs assessment, multi-disciplinary discharge planning, discharge instructions, follow-up education, and follow-up assessments.
Experimental: Patient and Family Focused Strategies; An active care transition intervention that includes effective strategies focused on the patient plus focused family caregiver engagement and support.	Other: Patient-Centered Intervention; Effective strategies focused on the patient such as patient needs assessment, multi-disciplinary discharge planning, discharge instructions, follow-up education, and follow-up assessments.; Other: Family Caregiver Enhanced Intervention; Caregiver strategies such as a family caregiver needs assessment, structured education, and skill building.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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.	Day 60
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.	Day 30, 90, and 180
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.	Day 60
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.	Day 30, 90 and 180
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
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
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.	Day 60
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.	Day 7
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.	Day 30
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.	Day 60
Visit Completion Rate	Number of patients that completed follow-up visit	Day 14 and 30
Time to First Outpatient Follow-up	Number of days between discharge and first outpatient follow-up visit	Day 14 and 30
Rate of Access to Community Services - Patient	Number of patients that had screening and intervention assessment for unmet social needs.	Day 30 and 60
Rate of Access to Community Services - Caregiver	Number of caregivers that had screening and intervention assessment for unmet social needs	Day 30 and 60
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
Mortality Rate	Count of days to date of patient death	Day 60 and 180
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Thomas Houston, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): November 1, 2031
• Study Completion (Estimated): November 1, 2031

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: older adults; aging; mild cognitive impairment; care transition; hospitalization
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: IRB00145199; PLACER-2025C1-43844 (Other Grant/Funding Number: Patient Centered Outcomes Research Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No