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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

65 and older

English and Spanish speaking

Preadmission location: community dwelling

Distance from Hospital: Local and Distant (rural) included

Disqualifiers

Admitted from skilled nursing facility

Discharged to skilled nursing facility

Left Against Medical Advice (AMA)

Planned readmission

Trial design

Design model

Parallel

Treatments tested in this trial

  • Patient-Centered Program

    Other 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.

  • Family Caregiver Enhanced Program

    Other intervention

    Caregiver strategies such as a family caregiver needs assessment, structured education, and skill building.

Treatment groups

2,560 Participants
are divided into 2 treatment groups
Group A: Patient Focused StrategiesActive comparator 1 intervention
Group B: Patient and Family Focused StrategiesExperimental treatment 2 interventions

Trial outcomes

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).

Time frame
Day 60

Secondary outcomes

1

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).

Time frame
Day 30, 90, and 180
2

Number of Patient Readmissions

All-cause, acute care readmissions calculated as both a count and dichotomous using EHR and Medicare claims data.

Time frame
Day 30, 60, and 90
3

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.

Time frame
Day 60
4

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.

Time frame
Day 30, 90, and 180

Other outcomes

Sponsors and contacts

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Wake Forest University Health Sciences

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator