Improving Person-Centered Outcomes for Older Adults With Cancer Discharged to Skilled Nursing Facilities and Their Family Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Intervention fidelity as assessed by fidelity checklist
研究概览
简要总结
The goal of this clinical trial is to learn if it is possible to deliver a palliative care intervention called ALIGN (Assessing and Listening to Individual Goals and Needs) to hospitalized older adults with advanced cancer who are discharged to a skilled nursing facility and their caregivers. The main questions it aims to answer are:
- Can the investigator successfully deliver the ALIGN intervention in different skilled community nursing facilities?
- Can the investigator successfully collect information from participants throughout the study?
- How can the investigator best prepare caregivers to make medical decisions for loved ones that become unable to do so themselves?
Researchers will compare ALIGN to care as it is usually delivered.
Participants will:
- Visit virtually with an ALIGN palliative care social worker every 1-2 weeks during their skilled nursing facility stay and up to 45 days after discharge from the facility or will see a palliative care clinician if recommended by their oncologist or other involved clinician.
- Participants will provide information about how they are doing 1 month, 3 months, and 6 months after enrolling in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 98 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between 18-98 years
- •Stage II-IV solid tumors
- •Discharging from an acute care hospital to a SNF in Colorado
- •English speaking
- •Receiving or establishing care at the University of Colorado Cancer Center
- •If a patient lacks capacity, a legal surrogate decision-maker will be approached to provide proxy consent.
- •Must have access to the technology needed to complete consenting visit and subsequent intervention visits. This includes internet access through a computer, tablet, or smartphone OR cellular service with adequate allowance of cellular minutes to allow virtual visits (by participant's assessment).
排除标准
- •Discharging with hospice care
- •Age less than 18
- •Lacking capacity without a legal surrogate decision maker or proxy. Patient with limited English
- •Inclusion Criteria:
- •Patient-selected
- •English speaking
- •Able to complete baseline measures.
- •Exclusion Criteria:
- •Discharging with hospice care
- •Age < 18
- •Caregivers with limited English proficiency will be excluded as ALIGN intervention content and documents have only been validated in an English-speaking population.
- •Inclusion Criteria:
- •One of 25 interdisciplinary clinicians from the 5 most common community SNFs
- •Staff must be employed by on of the 5 most common community SNFs named above. (care managers, social workers, nurses, physical therapists, occupational therapists, advanced practice providers, and physicians)
- •Exclusion Criteria:
- •Not employed by one of the top 5 community SNFs patients were discharged to during the pilot trial
- •Inclusion Criteria:
- •PCSWs who conducted the ALIGN intervention and consent to an interview
结局指标
主要结局
Intervention fidelity as assessed by fidelity checklist
时间窗: 2.5 years
Intervention fidelity will be assessed using a fidelity checklist. ALIGN will be considered feasible if at least one component of ≥ 80% of domains on the fidelity checklist are addressed, ≥ 50% of components of at least 1 intervention domain are delivered in follow up visits, and if a discharge note is entered for enrolled patients.
Assessment of treatment contamination in community skilled nursing facilities
时间窗: 2.5 years
The investigators will determine the proportion (% total) of caregivers in the control arm who reported that they received components of the ALIGN intervention during the skilled nursing facility stay. ALIGN will be considered feasible if contamination where ALIGN effects usual care is less than 10%.
The proportion (% total) of screened patients that are eligible for enrollment in the trial
时间窗: 2.5 years
The investigators will determine the proportion of screened patients (% total) who meet the inclusion criteria
The proportion (% total) of enrolled patients that are assessed for patient-centered outcomes
时间窗: 2.5 years
The investigators will determine the proportion of (% total) of enrolled patients that are succesfully assessed for patient-reported and patient-centered outcomes (please see secondary outcomes below)
The proportion (% total) of enrolled caregivers that are assessed for person-centered outcomes
时间窗: 2.5 years
The investigators will determine the proportion of (% total) of enrolled caregivers that are succesfully assessed for person-centered outcomes (please see secondary outcomes below)
The proportion (% total) of enrolled patients that are randomized
时间窗: 2.5 years
The investigators will determine the proportion of (% total) of enrolled patients that are succesfully randomized
The proportion (% total) of enrolled caregivers that are randomized
时间窗: 2.5 years
The investigators will determine the proportion of (% total) of enrolled caregivers that are succesfully randomized
Intervention fidelity as assessed by audio-recordings
时间窗: 2.5 years
Intervention visits will be recorded and reviewed to assess fidelity to the core intervention components of ALIGN.
次要结局
- Assessing changes in days at home(6 months after randomization)
- Assessing Changes in hospice length of stay(6 months after randomization)
- Health Care Utilization(6 months after randomization)
- Changes in caregiver coping as assessed by the Brief-Cope Questionaire(At enrollment and 1, 3, and 6 months after randomization)
- Changes in illness understanding and coping support as assessed by the Advanced Illness Coordinating Care Survey(At enrollment and then 1, 3, and 6 months after randomization)
- Change in quality of life as assessed by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-PAL-14)(At enrollment and then at 1, 3, and 6 months after randomization)
- Changes in agreement with health-related outcome statements as assessed by the Attitude Scale(From enrollment and then 1, 3 and 6 months after randomization)
- Change in frailty as assessed by the Practical Geriatric Assessment(From enrollment and then 1, 3, and 6 months after randomization)
- Change in Advance Care Planning Documentation(From enrollment and then at 6 months after randomization)
- Changes in the Perception of Patient Centeredness of Care Delivered as assessed by the Perception of Patient Centeredness of Care Measure(At enrollment and then 1, 3, and 6 months after randomization)
- Changes in the experience of feeling heard and understood as assessed by the Heard and Understood Survey(At enrollment and then 1, 3, and 6 months after randomization)
- Change in the burden or benefits of caregiving as assessed by the Caregiver Reaction Assessment(At enrollment and then at 1, 3 and 6 months after randomization)
- Changes in congruence between patient and oncologist understanding of the goals of treatment(At enrollment and then post-intervention protocol completion)
- Assessing Oncology Clinican Acceptability(After completion of the ALIGN protocol)
- Assessing the Bereaved Caregivers Satisfaction with Care During the Last Month of Life(1 month or later after patient death)