TABLE 3.
Recent Prospective Nonhospice PC Intervention Studies for ESLD Population
| Author/Study (Year) | Study Design/Location | Sample Size | Population | PC Intervention (Comparators) | Primary Outcome | Secondary Outcomes | Results |
|---|---|---|---|---|---|---|---|
| Verma et al. PAL-LIVER study (2019)(16) | Cluster RCT, multisite/U.S. | Projected n = 1,260 patient-caregiver dyads | ESLD (with complications within 6 months) Including HCC | Comparative-effectiveness research of 2 PC models: trained hepatologist—led PC vs. consultative PC | QOL (Fact-HEP) | Symptom burden, distress, caregiver burden, and QOL; health care use, goal-concordant care, end-of-life care | Ongoing |
| Shinall et al. COMPASS trial (2019)(17) | RCT/U.S. | N = 63 | Inpatients with ESLD | Inpatient specialist PC consultations + outpatient follow-up by a PC nurse vs. standard care | Time until first readmission | Days alive outside hospital, referral to hospice, death, readmissions, QOL, depression, anxiety, and quality of end of life | Stopped before enrollment intervention group had lower hazard of readmission and greater odds of having more days alive outside the hospital |
| Chung, ACP decision support tool (2018)(18) | RCT/U.S. | Projected n = 50 | ESLD (ineligible for LT), H/O hospitalization | ACP videos vs. narrative description by a research assistant | Feasibility | Patient knowledge, end-of-life care, ACP discussions | Ongoing |
| Wray, Early PC for HCC (2019)(19) | RCT/U.S. | Projected n = 72 | Advanced HCC | Early PC consultation (at time of HCC diagnosis) vs. standard care/no PC | QOL | Survival, resource use, cost use | Ongoing |
| Kimbell et al. (2018)(20) | Single-arm feasibility trial/Scotland/UK | 47 patients, 23 caregivers, 13 case-linked professionals | Decompensated cirrhosis with unplanned hospitalization, not transplantation eligible | Liver nurse specialist trained In primary PC delivered the Intervention after hospital discharge, for 6 months | Mixed-methods feasibility assessment | PC outcomes and QOL | High patient and provider acceptability; Improved QOL |
| Hansen et al. (2017)(21) | Single-arm longitudinal study/U.S. | Projected n = 200 patlent-careglver dyads | ESLD | Tailored PC intervention | Change in symptoms and QOL in patients and caregivers | Predictors of types of patient-caregiver dyads that would benefit from tailored PC interventions | Ongoing |
| Hudson et al. (2017)(22) | Single-arm quality improvement study/UK (development and implementation of a prognostic tool) | n = 73 | Inpatients with decompensated cirrhosis | Prognostic screening coupled with supportive care Intervention | Feasibility In routine care | Validation of prognostic tool | A model of integrated PC coupled with a prognostic toolkit for inpatient cirrhosis care |
| Bauman et al. (2015)(51) | Single-arm quality Improvement study/U.S. | n = 50 | Patients with ESLD awaiting LT | Early PC by a PC provider and research nurse | Symptom control | Depression and mood | 50% of moderate-to-severe symptoms improved; 43% of patients had improvement In depression |
Abbreviations: ACP, advance care planning; COMPASS, Cardiovascular Outcomes for People Using Anticoagulation Strategies; ESLD, end-stage liver disease; Fact-HEP, Functional Assessment of Cancer Therapy-Hepatobiliary Cancer; H/O, history of; HCC, hepatocellular carcinoma; LT, liver transplantation; PAL LIVER, Palliative Care for Liver Diseases; PC, palliative care; QOL, quality of life; RCT, randomized controlled trial; U.S., United States.