Background and design of the symptom burden in end-stage liver disease patient-caregiver dyad study

Abstract

Over half a million Americans are affected by cirrhosis, the cause of end-stage liver disease (ESLD). Little is known about how symptom burden changes over time in adults with ESLD and their informal caregivers, which limits our ability to develop palliative care interventions that can optimize symptom management and quality of life in different patient-caregiver dyads. The purpose of this article is to describe the background and design of a prospective, longitudinal descriptive study, "Symptom Burden in End-Stage Liver Disease Patient-Caregiver Dyads," which is currently in progress. The study is designed to (i) identify trajectories of change in physical and psychological symptom burden in adults with ESLD; (ii) identify trajectories of change in physical and psychological symptom burden in caregivers of adults with ESLD; and (iii) determine predictors of types of patient-caregiver dyads that would benefit from tailored palliative care interventions. We aim for a final sample of 200 patients and 200 caregivers who will be followed over 12 months. Integrated multilevel and latent growth mixture modeling will be used to identify trajectories of change in symptom burden, linking those changes to clinical events, and quality of life outcomes and characterizing types of patient-caregiver dyads based on patient-, caregiver-, and dyad-level factors. Challenges we have encountered include unexpected attrition of study participants, participants not returning their baseline questionnaires, and hiring and training of research staff. The study will lay the foundation for future research and innovation in ESLD, end-of-life and palliative care, and caregiving.

Keywords: caregivers; liver cirrhosis; palliative care; quality of life; research protocol.

Figure 1. Research Framework

To effectively capture interactions among symptoms, we will quantify patterns of association among multiple patient (C₁) and caregiver (C₂) symptoms over time. These observed trajectories may have different intercepts (i), slopes (s), and non-linear patterns of change over time (q). Many approaches to understanding symptoms fail to demonstrate sufficient clinical relevance of the findings. Our approach is to link patterns with significant and clinically meaningful differences and QOL and clinical events (H1.1; H2.1). We will also help establish the clinical relevance of patient symptoms by quantifying the degree of agreement in change (a.k.a. concordance) between symptoms and indices of disease severity and function (H1.2). Because our long-term goal is to design and test early, specifically tailored palliative care interventions, we are interested in the socio-demographic and clinical characteristics that help determine which type of patient and caregiver is more likely to have worsening of symptoms over time (H1.3; H2.2). Finally, identifying a typology of ESLD dyads is integral to our research approach. We will be able to identify distinct patterns of patients with ESLD and their caregivers and differentiate them based on patient- (e.g., optimism), caregiver- (e.g., pessimism), and dyadic-level (i.e., relationship quality) factors (H3.1).