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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
2,560
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.
Davie Medical Center
Bermuda Run, North Carolina, United States
RECRUITINGHigh Point Medical Center
High Point, North Carolina, United States
RECRUITINGAtrium Health Wake Forest Baptist Wilkes Medical Center
North Wilkesboro, North Carolina, United States
RECRUITINGAtrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
RECRUITINGHospital-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
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
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
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 60
Visit Completion Rate
Number of patients that completed follow-up visit
Time frame: Day 14 and 30
Time to First Outpatient Follow-up
Number of days between discharge and first outpatient follow-up visit
Time frame: Day 14 and 30
Rate of Access to Community Services - Patient
Number of patients that had screening and intervention assessment for unmet social needs.
Time frame: Day 30 and 60
Rate of Access to Community Services - Caregiver
Number of caregivers that had screening and intervention assessment for unmet social needs
Time frame: 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.
Time frame: Day 7 and 30
Mortality Rate
Count of days to date of patient death
Time frame: 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.
Time frame: Day 0, 60, and 180
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