ALIGN for Older Adults With Cancer in SNFs

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Advanced Cancer

Treatments: Other: Assessing and Listening to Individual Goals and Needs (ALIGN)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06616298

K23AG076866 (U.S. NIH Grant/Contract)

24-0548.cc

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 98 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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'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 < 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Older patients with advanced cancer

Experimental group

Description:

Older adults with advanced cancer from the University of Colorado Hospital being discharged to skilled nursing facilities (SNF).

Treatment:

Other: Assessing and Listening to Individual Goals and Needs (ALIGN)

Caregivers of older patients with advanced cancer

Experimental group

Description:

Caregivers of older adults with advanced cancer from the University of Colorado Hospital being discharged to skilled nursing facilities.

Treatment:

Other: Assessing and Listening to Individual Goals and Needs (ALIGN)

Control Arm

No Intervention group

Description:

Control arm participants will receive enhanced usual care. Patients will be provided resources for advance care planning and interact with SNF staff and involved providers who may refer them to palliative care or hospice like previous rigorous palliative care trials.