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

Overview

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.

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 program 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).

Interventions

• Other 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.
• Other Family Caregiver Enhanced Program
  Caregiver strategies such as a family caregiver needs assessment, structured education, and skill building.

Primary outcome measures

• Hospital-Free Days [Time frame: Day 60]

Secondary outcome measures (12)

• Number of Hospital-Free Days [Time frame: Day 30, 90, and 180]
• Number of Patient Readmissions [Time frame: Day 30, 60, and 90]
• Zarit Burden Interview Score [Time frame: Day 60]
• Zarit Burden Interview Score [Time frame: Day 30, 90, and 180]
• PROMIS Ability to Participate in Social Roles and Activities 8-item short form (APS-SF8) Score [Time frame: Day 60]
• PROMIS Ability to Participate in Social Roles and Activities 8-item short form (APS-SF8) Score [Time frame: Day 30, 90 and 180]
• Partners at Care Transitions Measure (PACT-M) - Patient Satisfaction Score [Time frame: Day 7]
• Partners at Care Transitions Measure (PACT-M) - Patient Self-Efficacy Score [Time frame: Day 30]
• Patient Activation Measures Score [Time frame: Day 60]
• Preparedness for Caregiving Scale Score [Time frame: Day 7]
• Caregiver Self-Efficacy Scale Score [Time frame: Day 30]
• Caregiver Activation Measures Score [Time frame: Day 60]

Eligibility criteria

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 (< 12 on MCA)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

United States · 4 centers

• Davie Medical Center — Bermuda Run
• High Point Medical Center — High Point
• Atrium Health Wake Forest Baptist Wilkes Medical Center — North Wilkesboro
• Atrium Health Wake Forest Baptist Medical Center — Winston-Salem

Identifiers

NCT: NCT07661355 · IRB00145199 · PLACER-2025C1-43844

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗