Clinical trial NCT06616298: ALIGN for Older Adults With Cancer in SNFs
Official title: Improving Person-Centered Outcomes for Older Adults With Cancer Discharged to Skilled Nursing Facilities and Their Family Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advanced Cancer
Keywords: Skilled Nursing Facility
Caregiver
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-09-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 98
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Patients

Inclusion Criteria:

1. Adults between 18-98 years
2. Stage II-IV solid tumors
3. Discharging from an acute care hospital to a SNF in Colorado
4. English speaking
5. Receiving or establishing care at the University of Colorado Cancer Center
6. If a patient lacks capacity, a legal surrogate decision-maker will be approached to provide proxy consent.
7. 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\&#39;s assessment).

Exclusion Criteria:

1. Discharging with hospice care
2. Age less than 18
3. Lacking capacity without a legal surrogate decision maker or proxy. Patient with limited English

Caregivers

Inclusion Criteria:

1. Patient-selected
2. Age ≥ 18
3. English speaking
4. Able to complete baseline measures.

Exclusion Criteria:

1. Discharging with hospice care
2. Age \&lt; 18
3. Caregivers with limited English proficiency will be excluded as ALIGN intervention content and documents have only been validated in an English-speaking population.

SNF Staff

Inclusion Criteria:

1. One of 25 interdisciplinary clinicians from the 5 most common community SNFs
2. 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:

1. Not employed by one of the top 5 community SNFs patients were discharged to during the pilot trial

PCSW

Inclusion Criteria:

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

Primary outcomes:
measure: Intervention fidelity as assessed by fidelity checklist
timeFrame: 2.5 years
measure: Intervention fidelity as assessed by audio-recordings
timeFrame: 2.5 years
measure: Assessment of treatment contamination in community skilled nursing facilities
timeFrame: 2.5 years
measure: The proportion (% total) of screened patients that are eligible for enrollment in the trial
timeFrame: 2.5 years
measure: The proportion (% total) of enrolled patients that are assessed for patient-centered outcomes
timeFrame: 2.5 years
measure: The proportion (% total) of enrolled caregivers that are assessed for person-centered outcomes
timeFrame: 2.5 years
measure: The proportion (% total) of enrolled patients that are randomized
timeFrame: 2.5 years
measure: The proportion (% total) of enrolled caregivers that are randomized
timeFrame: 2.5 years
Secondary outcomes:
measure: Assessing changes in days at home
timeFrame: 6 months after randomization
measure: Assessing Changes in hospice length of stay
timeFrame: 6 months after randomization
measure: Health Care Utilization
timeFrame: 6 months after randomization
measure: Change in quality of life as assessed by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-PAL-14)
timeFrame: At enrollment and then at 1, 3, and 6 months after randomization
measure: Changes in agreement with health-related outcome statements as assessed by the Attitude Scale
timeFrame: From enrollment and then 1, 3 and 6 months after randomization
measure: Change in frailty as assessed by the Practical Geriatric Assessment
timeFrame: From enrollment and then 1, 3, and 6 months after randomization
measure: Change in Advance Care Planning Documentation
timeFrame: From enrollment and then at 6 months after randomization
measure: Changes in the Perception of Patient Centeredness of Care Delivered as assessed by the Perception of Patient Centeredness of Care Measure
timeFrame: At enrollment and then 1, 3, and 6 months after randomization
measure: Changes in caregiver coping as assessed by the Brief-Cope Questionaire
timeFrame: At enrollment and 1, 3, and 6 months after randomization
measure: Changes in illness understanding and coping support as assessed by the Advanced Illness Coordinating Care Survey
timeFrame: At enrollment and then 1, 3, and 6 months after randomization
measure: Changes in the experience of feeling heard and understood as assessed by the Heard and Understood Survey
timeFrame: At enrollment and then 1, 3, and 6 months after randomization
measure: Change in the burden or benefits of caregiving as assessed by the Caregiver Reaction Assessment
timeFrame: At enrollment and then at 1, 3 and 6 months after randomization
measure: Changes in congruence between patient and oncologist understanding of the goals of treatment
timeFrame: At enrollment and then post-intervention protocol completion
measure: Assessing Oncology Clinican Acceptability
timeFrame: After completion of the ALIGN protocol
measure: Assessing the Bereaved Caregivers Satisfaction with Care During the Last Month of Life
timeFrame: 1 month or later after patient death
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Sarguni Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: