Assessing and Listening to Individual Goals and Needs (ALIGN) versus enhanced usual care for hospitalized older patients with cancer discharged to skilled nursing facilities: Protocol for a pilot randomized controlled trial

Abstract

Introduction: Hospitalized older adults with malignant solid tumor cancer discharged to skilled nursing facilities (SNFs) are at high risk of being "rehabbed to death." These patients have high 6-month mortality, experience burdensome care transitions near the end of life, and have limited access to palliative care. The Assessing and Listening to Individual Goals and Needs (ALIGN) intervention aims to address unmet palliative care needs and leverages the skills of palliative care social workers (PCSWs) to support serious illness communication, decision-making, and caregiver needs. We report the protocol of a pilot randomized controlled trial (RCT) of ALIGN that tests the (a) feasibility of delivering the intervention with fidelity across multiple SNFs, (b) collection of patient-centered outcomes, (c) preliminary efficacy, and (d) risk of contamination.

Materials and methods: This single site, single-blinded, pilot RCT of ALIGN versus enhanced usual care will recruit 60 patients with cancer and up to 60 caregivers from an academic medical center discharged to a SNF. Patients will be randomized 1:1 to ALIGN or enhanced usual care. ALIGN consists of virtual PCSW visits every 1-2 weeks during a SNF stay and for up to 45 days after SNF discharge. ALIGN visits are manualized, theory-driven, and evidence-based, focusing on illness understanding, discussing evolving care preferences, caregiver needs, and care transition needs. The enhanced usual care arm will receive usual care and additional information about advance care planning (ACP). Participants will complete assessments at baseline, 1, 3, and 6-months after enrollment. The primary goal of the pilot RCT is to measure feasibility, defined by enrollment within 20% of the target sample of 60 patients, ≥ 70% intervention completion, <5% missing data for patient-centered outcomes collected in the electronic health record, and < 10% contamination in the control arm based on caregiver report of exposure to ALIGN content from SNF staff. Fidelity will be assessed through checklists, review of visit notes, and auditing of audio-recorded visits.

Discussion: This trial will test whether ALIGN can be delivered feasibly and with high fidelity across multiple SNFs, a high-risk transition point for older adults with cancer. Findings will inform a fully powered efficacy trial of ALIGN.

Keywords: Decision-making; Feasibility study; Oncology; Palliative care; Serious illness communication; Skilled nursing facility; Social worker.