Care Transition
Conditions
Keywords
hospitalization, older adults, aging, care transition, mild cognitive impairment
Brief summary
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
OTHERPatient-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.
OTHERFamily Caregiver Enhanced Program
Caregiver strategies such as a family caregiver needs assessment, structured education, and skill building.
Sponsors
Wake Forest University Health Sciences
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital-Free Days | Day 60 | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Hospital-Free Days | Day 30, 90, and 180 | 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 | Day 30, 60, and 90 | All-cause, acute care readmissions calculated as both a count and dichotomous using EHR and Medicare claims data. |
| Zarit Burden Interview Score | Day 60 | Caregiver burden will be measured using the 12-item Zarit Burden Interview. Scores will range from 0 to 48. Higher scores indicate greater burden. |
| PROMIS Ability to Participate in Social Roles and Activities 8-item short form (APS-SF8) Score | Day 60 | 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. |
| Partners at Care Transitions Measure (PACT-M) - Patient Satisfaction Score | Day 7 | 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. |
| Partners at Care Transitions Measure (PACT-M) - Patient Self-Efficacy Score | Day 30 | 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. |
| Patient Activation Measures Score | Day 60 | 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. |
| Preparedness for Caregiving Scale Score | Day 7 | 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. |
| Caregiver Self-Efficacy Scale Score | Day 30 | 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. |
| Caregiver Activation Measures Score | Day 60 | 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. |
| Visit Completion Rate | Day 14 and 30 | Number of patients that completed follow-up visit |
| Time to First Outpatient Follow-up | Day 14 and 30 | Number of days between discharge and first outpatient follow-up visit |
| Rate of Access to Community Services - Patient | Day 30 and 60 | Number of patients that had screening and intervention assessment for unmet social needs. |
| Rate of Access to Community Services - Caregiver | Day 30 and 60 | Number of caregivers that had screening and intervention assessment for unmet social needs |
| Partners at Care Transitions Measures - Adverse Events Score | Day 7 and 30 | 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. |
| Mortality Rate | Day 60 and 180 | Count of days to date of patient death |
| Montreal Cognitive Assessment 5-minute Protocol Score | Day 0, 60, and 180 | 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. |
Countries
United States
Contacts
CONTACTMichiyah Kimber
CONTACTErica Hale
PRINCIPAL_INVESTIGATORThomas Houston, MD
Wake Forest University Health Sciences
Outcome results
None listed