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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Patient-Centered Program
Other interventionEffective 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 interventionCaregiver strategies such as a family caregiver needs assessment, structured education, and skill building.
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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).
Number of Patient Readmissions
All-cause, acute care readmissions calculated as both a count and dichotomous using EHR and Medicare claims data.
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.
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.
Sponsors and contacts
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Wake Forest University Health Sciences
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator