ALIGN Intervention in Patients With Advanced Cancer Discharging to a SNF

Study Overview
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Brief Summary
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This is a single arm, pre-post, pilot study assessing the feasibility and acceptability of the ALIGN intervention in metastatic adult cancer patients discharging to local area SNFs.

Detailed Description
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A novel approach for delivering high quality palliative care for cancer patients discharging to a skilled nursing facility (SNF) is critically needed. This investigator plans to test a palliative care social work led intervention called ALIGN (Assessing and Listening to Individual Goals and Needs) that aims to define patient and caregiver goals, facilitate communication between patients and their care teams, and develop a patient-centered plan that accompanies the patient across all future health system transitions. The central hypothesis is that implementation of ALIGN is feasible and acceptable for cancer patients and their caregivers and SNF staff.

Official Title
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ALIGN - A Palliative Care Social Work Intervention for Cancer Patients Discharging to a Skilled Nursing Facility

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: ALIGN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage II - IV solid tumor malignancy Discharging from an acute care hospital to a SNF in the metro Denver area Decisional capacity to consent English speaking (During COVID requirements) Either 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 as their goal of care

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Discharged Cancer Patients<br>25 patients, adults ≥ 18, with stage II - IV solid tumor malignancy discharging from an acute care hospital to a SNF in the metro Denver area who have decisional capacity to consent and are English speaking. | Behavioral: ALIGN<br>* The ALIGN intervention was developed by the Holding Group, an independent partnership of palliative care-trained social workers. The intervention is theory driven, patient/caregiver centered, addresses palliative care and psychosocial issues, and integrates with health care teams. Working in collaboration with KPCO and Dr. Stacy Fischer (primary mentor), the Holding Group tested the ALIGN intervention in the LTAC and SNF setting (Preliminary Studies). The Holding Group will be the intervention personnel providing psychosocial care that targets communication, goal alignment, and caregiver support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject retention | This investigator anticipates the study to be feasible if enrollment and retention rates of patients and caregivers are within 60% of the goal and if, of those enrolled, 70% of patients and caregivers complete the intervention. | Two Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative interviews of ALIGN participants | Study staff will conduct individual semi-structured interviews with 15 patients and 15 caregivers who receive the ALIGN intervention. | 1.5 years | 
| Qualitative interviews of SNF staff | Exit interviews will be conducted with 10 SNF front line staff (social worker, medical director, care manager, director of nursing) from SNF's that had 2 or more patients that received the intervention. | 1.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative