Clinical trial NCT04460742: CAPABLE Transitions: A Home Health-Based Intervention for the Hospital or Post-Acute Care Facility-to-Home Transition
Official title: CAPABLE Transitions: A Randomized, Unblinded, 60-Subject Clinical Trial of an Occupational Therapy-Led In-Home Intervention to Help Older Adults Transition to Their Homes Following Hospital or Post-Acute Care Facility Discharge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Care Transitions
Dementia
Keywords: Post-acute care
Home health agency
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-07-08
Enrollment: 31
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This clinical study is designed to test the feasibility of a new intervention, CAPABLE Transitions. CAPABLE Transitions is based on the Community Aging in Place, Advancing Better Living for Elders (CAPABLE) intervention designed by Dr. Sarah Szanton at Johns Hopkins University. Similar to CAPABLE, CAPABLE Transitions consists of an occupational therapy (OT)-led intervention in which the study OT, nurse, and handyman deliver an in-home intervention over 3-4 months. This intervention is designed to help with the transition of care from a hospital or post-acute care facility discharge as well as to optimize functioning and home safety. This clinical study plans to recruit a total of 60 older adults with and without dementia admitted to a home health agency following discharge from a hospital or post-acute care facility. Given that this is a feasibility study, it is not designed or powered to test hypotheses.

Detailed description: This pilot study is a randomized, care-as-usual (CAU)-comparator, unblinded clinical trial of an occupational therapy (OT)-led in-home intervention designed to help older adults successfully return to and remain in their homes following discharge from a hospital or post-acute care facility (e.g., skilled nursing or inpatient rehabilitation facilities). This intervention is called CAPABLE Transitions. In total, 60 adults (36 in the intervention arm, 24 in the CAU arm) aged 65 years and older recently discharged from a hospital or post-acute care facility and admitted to a Medicare-certified home health agency (CHHA) with and without dementia will be recruited. This pilot study's main outcomes relate to the feasibility of the study. These outcomes include study recruitment and retention, fidelity to and perceived benefit of the intervention, and data completeness with regard to clinical outcomes (e.g., home time, quality of life, and health care utilization).

This study will recruit English-speaking adults aged 65 years and older who live in the Rochester region and are admitted to a CHHA following a hospital or post-acute care facility stay. There are two treatment groups. The intervention group will receive CAPABLE Transitions as well as CHHA CAU services. The CAU group will receive CHHA CAU services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. CHHA clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.

Assessment interviews will be conducted at baseline as well as at three and six month follow-up. Interviews will assess sociodemographics, health and functioning, mental health and cognitive functioning, home environment, medical services use, and intervention feedback. Information also will be extracted on medical conditions, medications, communication with providers, and services utilization from participants' medical records.

Eligibility criteria: Inclusion Criteria:

* admitted to Medicare-certified home health agency following discharge from a hospital, inpatient rehabilitation facility, or skilled nursing facility
* live in Rochester, NY region
* aged 65 years or older
* English-speaking

Exclusion Criteria:

* plan to move within one year
* has a terminal diagnosis (e.g., \< 1-year life expectancy, in hospice)
* receiving active cancer treatment (active treatment includes surgery or a course of radiation or chemotherapy; it does not include long-term maintenance treatment such as daily hormonal treatment of prostate cancer)
* inability or unwillingness of individual or legal guardian/representative to give written informed consent or assent
* has been discharged from a hospital or post-acute care facility for more than 28 days
* are COVID-19 positive, have suspected COVID-19 infection, or resides with a person who is COVID-19 positive or has suspected COVID-19

Primary outcomes:
measure: Percentage of Participants Screened as Eligible
timeFrame: For each potential participant, this outcome is determined prior to possible study enrollment.
measure: Percentage of Screened Participants That Enroll
timeFrame: This outcome is determined at the time of study enrollment.
measure: Percentage of Enrolled Participants That Are Retained
timeFrame: 6 months
measure: Percentage of Participants Who Perceive a Benefit From the Intervention
timeFrame: 3 months
measure: Percentage of Participants Who Perceive a Benefit From the Intervention
timeFrame: 6 months
measure: Proportion of Critical Tasks Completed
timeFrame: Throughout Study Intervention, an average of 5 months
measure: Data Completeness on Clinical Outcomes
timeFrame: 3 months
measure: Data Completeness on Clinical Outcomes
timeFrame: 6 months
Secondary outcomes:
measure: Home Time in Days (From the Baseline to 3 Month Period)
timeFrame: Baseline to Month 3 (3 months)
measure: Home Time in Days (From the 3 to 6 Month Period)
timeFrame: Month 3 to Month 6 (3 months)
measure: Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)
timeFrame: 3 months
measure: Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)
timeFrame: 6 months
measure: Health Services Use, Percentage
timeFrame: Baseline to Month 3 (3 months)
measure: Health Services Use, Percentage
timeFrame: Month 3 to Month 6 (3 months)
measure: Health Services Use, Mean
timeFrame: Baseline to Month 3 (3 months)
measure: Health Services Use, Mean
timeFrame: Month 3 to Month 6 (3 months)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Adam Simning, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: