Abstract

Background: Advanced liver disease (AdvLD) is a serious illness that disproportionately affects Veterans. As many as half of AdvLD patients die within 2 years of developing liver complications, and nearly all suffer increasing symptoms and hospitalizations. Although many patients hope for curative liver transplantation, few receive it while experiencing an increasingly severe illness. We found Veterans with AdvLD report many unmet curative and supportive care needs. They also prefer to align care with their outcome goals earlier in the AdvLD course than is now common. A Whole Health program in AdvLD focused on what matters most to Veterans, shared goals, and goal-aligned treatments could improve both curative and supportive care. Objectives: Our overall goal is to develop and test a sustainable Whole Health, Integrated-Veteran-centered Care in Advanced Liver Disease (I-VCALD). We propose a hybrid type 1 effectiveness-implementation study utilizing formative implementation assessment prior to an effectiveness trial and assessment of implementation outcomes following the trial. Our specific aims are: 1) conduct a formative assessment of I-VCALD implementation for Veterans with AdvLD; 2) evaluate the effectiveness of I-VCALD in a randomized controlled study at 4 VA centers; and 3) conduct a summative assessment of implementation outcomes of I-VCALD. Methods: For Aim 1, we will conduct a formative evaluation of implementation using stakeholder interviews with patients, leadership, clinicians, and staff partners at the four study sites structured by i-PARiHS framework. The assessment will identify barriers and promoters of I-VCALD implementation within VA, strategies to overcome barriers and build on strengths, and modify existing tools to embed them into clinical structures and workflows. Expected outcomes include recruitment of clinical champions and refinements to study procedures to facilitate implementation in routine care; care counselor training program; informational materials; EHR note templates; and menu of communication processes. For Aim 2, we will conduct a randomized clinical trial to determine if I-VCALD improves timely decisions about transplantation and goals of care planning. Secondary outcomes include goal concordant care, health related quality of life, shared decision making, satisfaction with treatment experience, and quality of supportive AdvLD care. Participants will be identified by population screening at participating sites for AdvLD and new onset complications and confirmed by manual chart review. Consented patients will be randomized to usual care or referral to I-VCALD nurse care manager who will conduct 4-5 visits over six months. The care counselor will facilitate serious illness conversations to assess and cultivate patients’ understanding of their illness, identify patient priorities, and work with patients’ clinicians to help tailor curative and supportive care such that it aligns with patients’ understanding of their prognosis and priorities. For Aim 3, we will conduct a summative evaluation of implementation using the Proctor framework domains of acceptability, adoption, appropriateness, feasibility, fidelity, penetration, and cost to guide interpretation of study findings. Assessments include chart review, qualitative interviews with patients, clinicians, and interventional staff, and structured implementation surveys. Findings will inform adaptations and further efforts to implement and disseminate the I-VCALD approach. Significance: Our proposed project has the potential to significantly improve care for AdvLD and could be a model for redesigning care for other seriously ill Veteran populations. Together, these aims will provide evidence for the clinical effectiveness of the I-VCALD approach and barriers and promotors of its implementation across other VA sites. We have assembled an advisory panel including leadership from the national VA whole health, gastroenterology and hepatology, and palliative care programs who will inform adaptations and subsequent dissemination of integrated, whole health for AdvLD care.

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DRA: Aging, Older Veterans' Health and Care, Digestive Diseases

DRE: TRL - Applied/Translational, Treatment - Efficacy/Effectiveness Clinical Trial

Keywords: Care Coordination, End-of-Life, Patient Preferences, Quality of Care

MeSH Terms: None at this time.