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

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ClinicalTrials.gov Identifier: NCT04460742
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : January 5, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Adam Simning, University of Rochester

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.

Condition or disease Intervention/treatment Phase
Care Transitions Dementia Behavioral: CAPABLE Transitions Behavioral: Home Health Agency Care Not Applicable

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. Study recruitment will occur over three waves, which will enable enhancement and optimization of the study protocol and procedures in-between recruitment waves. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Actual Study Start Date : November 30, 2020
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CAPABLE Transitions
Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months.
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.

Behavioral: Home Health Agency Care
The care as usual group 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.

Active Comparator: Care As Usual
Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.
Behavioral: Home Health Agency Care
The care as usual group 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.




Primary Outcome Measures :
  1. Proportion of participants screened as eligible [ Time Frame: Through study completion, an average of 3 years ]
    The study will monitor how many older adults are screened and satisfy the eligibility criteria.

  2. Proportion of screened participants that enroll [ Time Frame: Through study completion, an average of 3 years ]
    The study will monitor how many older adults who satisfy the eligibility criteria are enrolled in the study.

  3. Proportion of enrolled participants that are retained [ Time Frame: 6 months ]
    The study will monitor the proportion of participants that complete the study.

  4. Proportion of participants who perceive a benefit from the intervention [ Time Frame: 3 months ]
    Participants and study partners will be asked Likert-item response survey questions to assess the perceived benefit and burdensomeness of the intervention.

  5. Proportion of participants who perceive a benefit from the intervention [ Time Frame: 6 months ]
    Participants and study partners will be asked Likert-item response survey questions to assess the perceived benefit and burdensomeness of the intervention.

  6. Proportion of Critical Tasks Completed [ Time Frame: Throughout Study Intervention, an average of 5 months ]
    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.

  7. Data Completeness on Clinical Outcomes [ Time Frame: 3 months ]
    The study will monitor the proportion of participants who have complete information on home time, quality of life, and health services utilization at 3 months.

  8. Data Completeness on Clinical Outcomes [ Time Frame: 6 months ]
    The study will monitor the proportion of participants who have complete information on home time, quality of life, and health services utilization at 6 months.


Secondary Outcome Measures :
  1. Home Time in Days [ Time Frame: 3 months ]
    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 at 3 months of follow-up.

  2. Home Time in Days [ Time Frame: 6 months ]
    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 at 6 months of follow-up.

  3. Mean change in quality of life using EQ-5D-5L (unabbreviated title) [ Time Frame: 3 months ]

    The study will examine quality of life (EQ-5D-5L) among study participants at 3 months of follow-up.

    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, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine' out of 100. Therefore higher scores may indicate better outcomes.


  4. Mean change in quality of life using EQ-5D-5L (unabbreviated title) [ Time Frame: 6 months ]

    The study will examine quality of life (EQ-5D-5L) among study participants at 6 months of follow-up.

    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, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine' out of 100. Therefore higher scores may indicate better outcomes.


  5. Health Services Use [ Time Frame: 3 Months ]
    The study will examine the proportion of participants who went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility within 3 months of follow-up. The study also will tabulate the mean number of times they used these services within 3 months of follow-up.

  6. Health Services Use [ Time Frame: 6 Months ]
    The study will examine the proportion of participants who went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility within 6 months of follow-up. The study also will tabulate the mean number of times they used these services within 6 months of follow-up.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • primary care provider is a University of Rochester Medicine physician (allows study to access electronic medical records)
  • as those with cognitive impairment may be unable to understand and comply with study procedures, if moderate or severe cognitive impairment is present (determined by a Mini-Mental Status Exam score of 20 or less), participants must have a live-in caregiver who will serve as a Study Partner.

Exclusion Criteria:

  • plan to move within one year
  • has a terminal diagnosis (e.g., < 1-year life expectancy, in hospice)
  • receiving active cancer treatment
  • inability or unwillingness of individual or legal guardian/representative to give written informed consent, if the prospective participant is determined to have moderate to severe cognitive impairment based on Mini-Mental Status Exam score of 20 or less.
  • has been discharged from a hospital or post-acute care facility for more than 10 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04460742


Contacts
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Contact: Rachel Missell, MS 585-273-1668 rachel_missell@urmc.rochester.edu

Locations
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United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Rachel Missell, MS    585-273-1668    rachel_missell@urmc.rochester.edu   
Sponsors and Collaborators
University of Rochester
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Adam Simning, PhD University of Rochester
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Responsible Party: Adam Simning, Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT04460742    
Other Study ID Numbers: STUDY00004519
5K23AG058757-02 ( U.S. NIH Grant/Contract )
3 K 23 AG058757-02S1 ( Other Grant/Funding Number: National Institute of Aging )
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be shared upon request as part of a academic collaboration

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adam Simning, University of Rochester:
Post-acute care
Home health agency
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders