ALIGN for Older Adults With Cancer in SNFs

Официальное название

Improving Person-Centered Outcomes for Older Adults With Cancer Discharged to Skilled Nursing Facilities and Their Family Caregivers

Обзор

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.

Вмешательства

• Другое Assessing and Listening to Individual Goals and Needs (ALIGN)
  Assessing and Listening to Individual Goals and Needs (ALIGN). ALIGN utilizes the skills of palliative care social workers (PCSWs) trained in family and systems-level theory to address changing preferences for care, family distress, and to facilitate communication across care transitions to improve care aligned with preferences. A patient navigator supports the patient/caregiver and social worker dynamic by helping patients access care and resources. The intervention is implemented virtually in

Первичные конечные точки

• Intervention fidelity as assessed by fidelity checklist [Срок оценки: 2.5 years]
• Intervention fidelity as assessed by audio-recordings [Срок оценки: 2.5 years]
• Assessment of treatment contamination in community skilled nursing facilities [Срок оценки: 2.5 years]
• The proportion (% total) of screened patients that are eligible for enrollment in the trial [Срок оценки: 2.5 years]
• The proportion (% total) of enrolled patients that are assessed for patient-centered outcomes [Срок оценки: 2.5 years]
• The proportion (% total) of enrolled caregivers that are assessed for person-centered outcomes [Срок оценки: 2.5 years]
• The proportion (% total) of enrolled patients that are randomized [Срок оценки: 2.5 years]
• The proportion (% total) of enrolled caregivers that are randomized [Срок оценки: 2.5 years]

Вторичные конечные точки (12)

• Assessing changes in days at home [Срок оценки: 6 months after randomization]
• Assessing Changes in hospice length of stay [Срок оценки: 6 months after randomization]
• Health Care Utilization [Срок оценки: 6 months after randomization]
• Change in quality of life as assessed by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-PAL-14) [Срок оценки: 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 [Срок оценки: From enrollment and then 1, 3 and 6 months after randomization]
• Change in frailty as assessed by the Practical Geriatric Assessment [Срок оценки: From enrollment and then 1, 3, and 6 months after randomization]
• Change in Advance Care Planning Documentation [Срок оценки: 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 [Срок оценки: At enrollment and then 1, 3, and 6 months after randomization]
• Changes in caregiver coping as assessed by the Brief-Cope Questionaire [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: At enrollment and then at 1, 3 and 6 months after randomization]

Критерии участия

Patients

Критерии включения

• Adults between 18-98 years
• Stage I-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.
• Must have an email address or caregiver with an email address to facilitate communication during the trial

Критерии исключения

• Discharging with hospice care
• Age less than 18
• Lacking capacity without a legal surrogate decision maker or proxy.
• Limited English proficiency
• Hospitalized for a planned admission or procedure
• Have any pschological or physical symptom, medication or other relevant finding prior to randomization, based on the clinical judgement of the PI or relevant clinical study staff that would make a participant unsuitable for the study

Caregivers

Критерии включения

• Patient-selected
• Age ≥ 18
• English speaking
• Able to complete baseline measures.

Критерии исключения

• 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.
• Have any pschological or physical symptom, medication or other relevant finding prior to randomization, based on the clinical judgement of the PI or relevant clinical study staff that would make a participant unsuitable for the study

SNF Staff

Критерии включения

1\. Working at a SNF that cared for a patient who received the ALIGN intervention

Критерии исключения

1\. Not employed by a community SNF where patients were discharged to during the pilot trial

PCSW

Критерии включения

1\. PCSWs who conducted the ALIGN intervention and consent to an interview

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Colorado Anschutz Medical Campus — Aurora

Идентификаторы

NCT: NCT06616298 · 24-0548.cc · K23AG076866

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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