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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Data Completeness on Clinical Outcomes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Data Completeness on Clinical Outcomes
时间窗: 6 months
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.
Percentage of Screened Participants That Enroll
时间窗: This outcome is determined at the time of study enrollment.
The study will monitor how many older adults who satisfy the eligibility criteria are enrolled in the study.
Percentage of Participants Who Perceive a Benefit From the Intervention
时间窗: 6 months
Participants and study partners will be asked Likert-item response survey questions to assess the perceived benefit and burdensomeness of the intervention.
Percentage of Enrolled Participants That Are Retained
时间窗: 6 months
The study will monitor the percentage of participants that complete the study.
Percentage of Participants Screened as Eligible
时间窗: For each potential participant, this outcome is determined prior to possible study enrollment.
The study will monitor how many older adults are screened and satisfy the eligibility criteria.
Proportion of Critical Tasks Completed
时间窗: 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.
次要结局
- Home Time in Days (From the 3 to 6 Month Period)(Month 3 to Month 6 (3 months))
- Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)(6 months)
- Health Services Use, Percentage(Month 3 to Month 6 (3 months))
- Health Services Use, Mean(Month 3 to Month 6 (3 months))
- Home Time in Days (From the Baseline to 3 Month Period)(Baseline to Month 3 (3 months))
研究者
Adam Simning
Assistant Professor
University of Rochester