ALIGN Intervention in Patients With Advanced Cancer Discharging to a SNF (ALIGN)

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: ALIGN

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Stage II - IV solid tumor malignancy
2. Discharging from an acute care hospital to a SNF in the metro Denver area
3. Decisional capacity to consent
4. English speaking
5. (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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Discharged Cancer Patients; 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Advanced Illness Coordinating Care Survey	A survey of satisfaction with care for patients and caregivers	Baseline and 60 days
Goal alignment measurement	Patients and providers will be asked a focus of treatment question ("Please select one of the options below that best describes your current focus of treatment") and asked to select from the following options: curative, life prolonging/rehabilitative, or comfort focused. Patients and providers will be asked this question at the beginning and end of the study. We are measuring whether there is increased congruence in the response between patient and providers at the end of the study. If there is increased congruence this suggests that the ALIGN intervention is helping facilitate illness and prognostic understanding.	Baseline and 60 days
FACIT-Pal	This 39 item questionnaire measures four primary quality of life domains: physical well-being, social/family well-being, emotional well-being, functional well-being, and spiritual well-being. Lower scores indicate lower quality of life.	Baseline and 60 days
Advance Care Planning documentation	Study staff will collect patient and caregiver reported outcomes (virtually by phone or Zoom) to help guide future estimations of sample size. MDPOA, CPR directive, MOST are documents that communicate end of life wishes for patients and also who they would designate to make medical decisions on their behalf if they are unable to do so themselves. We are measuring completion rates of these documents in patients who participate in the ALIGN intervention. The more patients that have an MDPOA/CPR directives/MOST form completed after the intervention suggests that the ALIGN intervention helps people with advance care planning.	Baseline and 60 days
Decision Regret Scale	This 5 item scale measures distress or remorse after a health care decision. The minimum score is 0 and the maximum score is 100. A higher score indicates greater regret.	Baseline and 60 days
Caregiver Reaction Assessment	This is a 24 item instrument designed to measure the reactions of family members to caring for adults with a variety of illness. The instrument focuses on five dimensions: caregiver's esteem, lack of family support, impact on finances, impact on schedule, and impact on health. The minimum score is 0 and the maximum score is 24. A higher score indicates greater caregiver burden.	Baseline and 60 days

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Cancer Institute (NCI); Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2020
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 10, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Palliative
• Other Study ID Numbers: 20-1656.cc; P30CA046934 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No