CAPABLE Transitions: A Home Health-Based Intervention for the Hospital or Post-Acute Care Facility-to-Home Transition

Dementia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04460742
• Other study ID #: STUDY00004519
• Secondary ID: 5K23AG058757-023
• Status: Completed
• Phase: N/A
• Start date: March 18, 2021
• Est. completion date: May 19, 2023

Study information

• Verified date: July 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 19, 2023
• Est. primary completion date: May 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Care Transitions
• Dementia

Intervention

Behavioral:
• CAPABLE Transitions
The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (<6 visits), registered nurse (<5 visits), and handyman (<2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.
• Home Health Agency Care
Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency 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.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Screened as Eligible	The study will monitor how many older adults are screened and satisfy the eligibility criteria.	For each potential participant, this outcome is determined prior to possible study enrollment.
Primary	Percentage of Screened Participants That Enroll	The study will monitor how many older adults who satisfy the eligibility criteria are enrolled in the study.	This outcome is determined at the time of study enrollment.
Primary	Percentage of Enrolled Participants That Are Retained	The study will monitor the percentage of participants that complete the study.	6 months
Primary	Percentage of Participants Who Perceive a Benefit From the Intervention	Participants and study partners will be asked Likert-item response survey questions to assess the perceived benefit and burdensomeness of the intervention.	3 months
Primary	Percentage of Participants Who Perceive a Benefit From the Intervention	Participants and study partners will be asked Likert-item response survey questions to assess the perceived benefit and burdensomeness of the intervention.	6 months
Primary	Proportion of Critical Tasks Completed	The study will review audio recordings and study interventionists' documentation to examine fidelity to the intervention and score whether the interventionists completed the central tasks of CAPABLE Transitions. The study will score completion of the critical components as "yes" or "no" and this outcome will be reported as the proportion of critical components of the CAPABLE Transitions intervention that were completed by the occupational therapist and registered nurse.	Throughout Study Intervention, an average of 5 months
Primary	Data Completeness on Clinical Outcomes	The study will monitor the percentage of participants who have complete information on home time, quality of life, and health services utilization at 3 months.	3 months
Primary	Data Completeness on Clinical Outcomes	The study will monitor the percentage of participants who have complete information on home time, quality of life, and health services utilization at 6 months.	6 months
Secondary	Home Time in Days (From the Baseline to 3 Month Period)	Home time is the number of days participants spend alive in non-institutional settings (e.g., nursing homes and hospitals). The study will report the participants' home time from baseline to 3 months of follow-up.	Baseline to Month 3 (3 months)
Secondary	Home Time in Days (From the 3 to 6 Month Period)	Home time is the number of days participants spend alive in non-institutional settings (e.g., nursing homes and hospitals). The study will report the participants' home time from 3 to 6 months of follow-up.	Month 3 to Month 6 (3 months)
Secondary	Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)	The study will examine quality of life (EQ-5D-5L) among study participants at 3 months of follow-up (positive scores indicate improvement from baseline).; Rating: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each with 1 as lowest score and 5 as highest score: no problems, slight problems, moderate problems, severe problems and extreme problems, where higher scores indicate worse outcome.; The EQ VAS question records the patient's self-rated health on a vertical visual analogue scale from 0 to 100, where the endpoints are labelled 'The best health you can imagine' (score=100) and 'The worst health you can imagine' (score=0). Therefore higher scores may indicate better outcomes.	3 months
Secondary	Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)	The study will examine quality of life (EQ-5D-5L) among study participants at 6 months of follow-up (positive scores indicate improvement from baseline).; Rating: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each with 1 as lowest score and 5 as highest score: no problems, slight problems, moderate problems, severe problems and extreme problems, where higher scores indicate worse outcome.; The EQ VAS question records the patient's self-rated health on a vertical visual analogue scale from 0 to 100, where the endpoints are labelled 'The best health you can imagine' (score=100) and 'The worst health you can imagine' (score=0). Therefore higher scores may indicate better outcomes.	6 months
Secondary	Health Services Use, Percentage	The study will examine the percentage of participants who went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from baseline to 3 months of follow-up.	Baseline to Month 3 (3 months)
Secondary	Health Services Use, Percentage	The study will examine the percentage of participants who went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from 3 to 6 months of follow-up.	Month 3 to Month 6 (3 months)
Secondary	Health Services Use, Mean	The study will tabulate the mean number of times participants went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from baseline to 3 months of follow-up.	Baseline to Month 3 (3 months)
Secondary	Health Services Use, Mean	The study will tabulate the mean number of times participants went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from 3 to 6 months of follow-up.	Month 3 to Month 6 (3 months)