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ALIGN for Older Adults With Cancer in SNFs

ConditionAdvanced Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-98
SponsorUniversity of Colorado, Denver

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Adults between 18-98 years

Stage I-IV solid tumors

Discharging from an acute care hospital to a SNF in Colorado

English speaking

Disqualifiers

Discharging with hospice care

Age less than 18

Lacking capacity without a legal surrogate decision maker or proxy.

Limited English proficiency

Trial design

Design model

Parallel

Treatments tested in this trial

  • Assessing and Listening to Individual Goals and Needs (ALIGN)

    Other intervention

    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 community SNFs and follows patients for 45 days after SNF discharge to reflect real-world patient flow.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Older patients with advanced cancerExperimental treatment 1 intervention
Group B: Caregivers of older patients with advanced cancerExperimental treatment 1 intervention
Group C: Control ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Intervention fidelity as assessed by fidelity checklist

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.

Time frame
2.5 years
2

Intervention fidelity as assessed by audio-recordings

Intervention visits will be recorded and reviewed to assess fidelity to the core intervention components of ALIGN.

Time frame
2.5 years
3

Assessment of treatment contamination in community skilled nursing facilities

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%.

Time frame
2.5 years
4

The proportion (% total) of screened patients that are eligible for enrollment in the trial

The investigators will determine the proportion of screened patients (% total) who meet the inclusion criteria

Time frame
2.5 years

Secondary outcomes

1

Assessing changes in days at home

In this exploratory outcome measure, days at home will be calculated as 180 days minus the number of inpatient days in an acute care facility, an inpatient rehabilitation facility, a skilled nursing facility, or an inpatient hospice unit.

Time frame
6 months after randomization
2

Assessing Changes in hospice length of stay

In this exploratory outcome measures, changes in the length of a hospice stay in both arms of the clinical trial will be measured

Time frame
6 months after randomization
3

Health Care Utilization

Rehospitalization and emergency department visits for any cause and receipt of chemotherapy within 14 days of death will be collected

Time frame
6 months after randomization
4

Change in quality of life as assessed by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-PAL-14)

In this exploratory outcome measure, patients will be asked to complete this 14 item Likert-type scale that measures four primary quality of life domains: physical well-being, social/family well-being, emotional well-being, functional well-being, and spiritual well-being. Scores range from 0-56. Lower scores indicate lower quality of life.

Time frame
At enrollment and then at 1, 3, and 6 months after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov
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