CAREGIVER Randomized Trial of Two Mindfulness Methods to Improve the Burden and Distress of Caring for Persons with Cirrhosis.

BACKGROUND: Patient caregivers experience burden and distress that negatively impacts health-related quality of life (HRQOL). Mindfulness may alleviate caregiver burden but randomized trials of mindfulness activities on caregiver burden and distress are lacking. METHODS: Caregivers for patients with advanced liver disease were recruited from the Universities of Michigan and Pennsylvania (12/2019-12/2021) and followed for 8 weeks. Participants were randomized 1:1:1 to: written emotional disclosure for 4 weeks, resilience training for 4 weeks, or control (no active intervention). All completed assessments at baseline, week 4 and 8. The primary outcome was change in the Zarit Caregiver Burden Index-12 (ZBI) at week 8. Secondary outcomes included changes at week 4 and 8 in the ZBI, distress thermometer (DT), HRQOL visual analog scale (VAS), and caregiver captivity index (CCI). RESULTS: Eighty seven caregivers were enrolled, 59(72%) completed the study. In unadjusted analyses at week 4, the burden measured by ZBI was not significantly different between arms, increasing by 0.6 ± 5.7 and 2.5 ± 5.2 points, for the written emotional disclosure and resilience training study arms, respectively, and by 2.9 ± 6.1 points in the control arm. At week 8, the non-significant ZBI change was - 1.0 ± 8.9, 2.8 ± 6.1, and 1.5 ± 7.4 for written emotional disclosure, resilience training, at week 8, respectively. The DT and VAS worsened in all arms, however, it worsened the least in the written emotional disclosure arm. In analyses adjusted for differences in baseline characteristics, the ZBI declined by - 4.21 ± 2.03(p = 0.04) in the emotional disclosure arm at week 4. This decrease was attenuated week 8, - 1.13 ± 2.6(p = 0.67). There were no significant differences in secondary outcomes save for resilience training reducing the CCI at week 4 by 1.36 ± 0.67(p = 0.04). CONCLUSION: Written emotional disclosure may reduce caregiver burden in the short term among caregivers for patients with cirrhosis. REGISTRATION: NCT04205396.

A paradigm for fostering patient-centered research in liver disease: The liver transplant patient-engagement program.

BACKGROUND: Many federal funding and regulatory agencies require patient engagement to conduct patient-centered research and drug development. We developed a liver transplantation patient-engagement program, which can serve as a model for bringing the patient perspective to digestive diseases research. METHODS: Six liver transplantation patient-engagement program advisors completed training in patient engagement; participated in several virtual sessions; and completed postsession surveys. RESULTS: Qualitative and quantitative results elucidated patient-centered liver transplantation study outcomes and barriers/facilitators to conducting clinical research. Group satisfaction was very high. CONCLUSIONS: The liver transplantation patient-engagement program model provides a paradigm for how to engage patients in the formative steps of patient-centered clinical research.

Care quality and outcomes among US veterans with chronic hepatitis B in the hepatitis C direct-acting antiviral era.

Adherence to guideline-recommended hepatitis B virus (HBV) care is suboptimal. We hypothesized that national hepatitis C eradication efforts during the era from 2015 to 2017 would improve the quality of care for cHBV given increased recognition and specialty referrals for liver disease. The study described herein is a retrospective cohort study of veterans with at least one positive HBsAg (HBsAg+) result from 1 January 2003 to 31 December 2017 using the VA Corporate Data Warehouse (CDW) analysed by era (2003-2004, 2005-2009, 2010-2014, 2015-2017). Relevant covariates such as HCV co-infection, demographics, cirrhosis and baseline laboratory testing were obtained through previously validated approaches. We evaluated completion of process measures within 2 years of the index HBsAg + result: specialty care referral; testing of ALT, HBV-DNA, HBeAg and anti-HBe; testing for co-infection and/or vaccination for HAV, HCV, HDV and HIV; and hepatocellular carcinoma (HCC) surveillance among those meeting criteria. We also measured use of antiviral therapy in appropriate candidates (ALT ≥ 2 × ULN, HBV-DNA ≥ 2000 IU/mL). Of the 16 673 individuals with HBsAg + test results, 9,521 were confirmed as chronic HBV. Era-related (Era 3:2010-2014 vs Era 4:2015-2017) increases in guideline-recommended process measures included the following: outpatient visits with GI/ID specialists (78%-89%), HBV-DNA testing (73%-79%), HDV testing (27%-35%), appropriate HBV antiviral utilization (55%-70%) and HCC surveillance (40%-43%); all P < .0001. In the subset of HBV/HCV-co-infected patients, HCV DAA therapy was associated with a trend towards improved overall survival. In conclusion, the overall quality of care for HBV has significantly improved in the era of widespread HCV DAA therapy in an integrated health system possibly due to increased recognition and referral for liver disease.

Association of Provider Specialty and Multidisciplinary Care With Hepatocellular Carcinoma Treatment and Mortality.

BACKGROUND & AIMS: Little is known about provider and health system factors that affect receipt of active therapy and outcomes of patients with hepatocellular carcinoma (HCC). We investigated patient, provider, and health system factors associated with receipt of active HCC therapy and overall survival. METHODS: We performed a national, retrospective cohort study of all patients diagnosed with HCC from January 1, 2008 through December 31, 2010 (n = 3988) and followed through December 31 2014 who received care through the Veterans Administration (128 centers). Outcomes were receipt of active HCC therapy (liver transplantation, resection, local ablation, transarterial therapy, or sorafenib) and overall survival. RESULTS: In adjusted analyses, receiving care at an academically affiliated Veterans Administration hospital (odds ratio [OR], 1.97; 95% confidence interval [CI], 1.60-2.41) or a multi-specialist evaluation (OR, 1.60; 95% CI, 1.15-2.21), but not review by a multidisciplinary tumor board (OR, 1.19; 95% CI, 0.98-1.46), was associated with a higher likelihood of receiving active HCC therapy. In time-varying Cox proportional hazards models, liver transplantation (hazard ratio [HR], 0.22; 95% CI, 0.16-0.31), liver resection (HR, 0.38; 95% CI, 0.28-0.52), ablative therapy (HR, 0.63; 95% CI, 0.52-0.76), and transarterial therapy (HR, 0.83; 95% CI, 0.74-0.92) were associated with reduced mortality. Subspecialist care by hepatologists (HR, 0.70; 95% CI, 0.63-0.78), medical oncologists (HR, 0.82; 95% CI, 0.74-0.91), or surgeons (HR, 0.79; 95% CI, 0.71-0.89) within 30 days of HCC diagnosis, and review by a multidisciplinary tumor board (HR, 0.83; 95% CI, 0.77-0.90), were associated with reduced mortality. CONCLUSIONS: In a retrospective cohort study of almost 4000 patients with HCC cared for at VA centers, geographic, provider, and system differences in receipt of active HCC therapy are associated with patient survival. Multidisciplinary methods of care delivery for HCC should be prospectively evaluated and standardized to improve access to HCC therapy and optimize outcomes.