Coordinated care in cirrhosis; the need for further randomized controlled trials
Authors: Alan J. Wigg, Rosemary McCormick, Rachel Wundke, Richard J. Woodman
Journal: Journal of Hepatology (2013)

How to improve care in outpatients with cirrhosis and ascites: A new model of care coordination by consultant hepatologistsJournal of HepatologyVol. 59Issue 2PreviewThe development of ascites in patients with cirrhosis is associated with a high rate of health care utilization. New models of specialized caregiving support are necessary to optimize its management. The aim of the study was to evaluate the efficacy and financial sustainability of the "Care management check-up" as a new model of specialized caregiving support based on a series of diagnostic facilities performed in real time and on the integrated activity of consultant hepatologists at the hospital unit for outpatients, dedicated nurses, physicians in training and primary physicians, compared to standard care in outpatients with cirrhosis and ascites. Full-Text PDF Reply to: "Coordinated care models in cirrhosis; the need for further randomized controlled trials"Journal of HepatologyVol. 60Issue 2PreviewTo the Editor: Full-Text PDF Open Access To the Editor: We read with interest the recent study on care coordination for cirrhotic patients by Morando et al., with an accompanying editorial [1Morando F. Maresio G. Piano S. Fasolato S. Cavallin M. Romano A. et al.How to improve care in outpatients with cirrhosis and ascites: a new model of care coordination by consultant hepatologists.J Hepatol. 2013; 59: 257-264Abstract Full Text Full Text PDF PubMed Scopus (121) Google Scholar, 2Ge P.S. Runyon B.A. Care coordination for patients with cirrhosis: a "win-win" solution for patients, caregivers, providers and healthcare expenditures.J Hepatol. 2013; 59: 203-204Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar]. Firstly, we would like to congratulate the Padova group for focusing their research interest on this important topic and patient population. We must, however, correct the statement of the editorialists that this study represents the "first prospective trial in the cirrhosis population" [[2]Ge P.S. Runyon B.A. Care coordination for patients with cirrhosis: a "win-win" solution for patients, caregivers, providers and healthcare expenditures.J Hepatol. 2013; 59: 203-204Abstract Full Text Full Text PDF PubMed Scopus (3) Google Scholar]. We highlight the publication of our own randomized controlled trial of coordinated cirrhosis care, which preceded the publication of the Padova study in the literature [[3]Wigg A.J. McCormick R. Wundke R. Woodman R.J. Efficacy of a chronic disease management model for patients with chronic liver failure.Clin Gastroenterol Hepatol. 2013; 11: 850-858Abstract Full Text Full Text PDF PubMed Scopus (96) Google Scholar]. Referencing of our earlier study may have been helpful for the readership because, unlike the Padova study, it was a fully randomized controlled trial (RCT) with outcomes that were very different. We did not detect any improvement in either hospitalization measures or mortality in the 12 months following an intervention with a care co-ordination model. A major limitation of the Padova study is its lack of a blinded and completely randomized group allocation procedure, which was instead based on retrospective matching of known confounders. As a consequence, it remains possible that the beneficial effects seen were not related to the new care model, but instead to more competent physicians in the intervention team or to unknown confounders that were not balanced between the groups. Unfortunately details of the allocation procedures provided are insufficient to determine the levels of stratification used for each confounder and whether all patients commenced their treatment programs within a similar timeframe following discharge. There was also a lack of process measures performed during the trial, which would help support claims that the model was effective. For example, there were no data confirming that preventative medications prescribed were actually taken by patients, or that patient attendance at scheduled appointments was improved. Authors propose increased contacts with specialist physicians as explanation for improved outcomes in the coordinated care group. However, no analysis was performed to support the claims for associations between outcomes and greater specialist visit numbers being associated with reduced risk of mortality. In relation to mortality, the authors chose not to discuss the distribution of events throughout the study. A careful examination of the Kaplan Meier curves does however reveal some important details. Firstly, there was an increased risk of death for standard care patients during the first 3 months of the trial relative to expected deaths for patients at this level of MELD/Child Pugh score. There was also an increased risk of mortality in the intervention group compared to the standard care group in the second half of the trial. Additionally, the much lower risk for the coordinated care group in the first 3 months followed by a higher risk indicates that benefits of the program were mostly achieved early on and were therefore probably not strongly related to the total number of visits/time spent with clinicians. Likewise, the unexpectedly high death rate in the standard care group suggests either that the standard care program provided was below the average standard care program, that the patients in this group were sicker in respects to factors other than their MELD score, or perhaps that the group allocation procedure lead standard care patients to a more delayed treatment following discharge. With respect to the data on readmissions, knowledge of the unadjusted effects of the program, in addition to the adjusted effects, would have been useful to determine if confounding was present. The adjusted nature of the analysis, rather than a simple unadjusted comparison, perhaps reflects the observational nature of the study since an RCT automatically eliminates confounding from both known and unknown risk factors and does not therefore require statistical adjustment. We were also intrigued that although the analysis suggests an important effect of the intervention, a surprising additional result was that several known risk factors for readmission, including age and MELD, were not independent predictors beyond the group allocation. This suggests that the group allocation effect on readmission was strongly associated with these variables. We highlight the possibility that good coordinated care for sick patients may generate an increase in emergency readmissions in the short term, via improved access to care. This was an interesting finding in our study [[3]Wigg A.J. McCormick R. Wundke R. Woodman R.J. Efficacy of a chronic disease management model for patients with chronic liver failure.Clin Gastroenterol Hepatol. 2013; 11: 850-858Abstract Full Text Full Text PDF PubMed Scopus (96) Google Scholar] and has also been noted by other investigators [[4]Weinberger M. Oddone E.Z. Hendersen W.G. Does increased access to primary care reduce hospital readmissions?.N Engl J Med. 1996; 334: 1441-1447Crossref PubMed Scopus (628) Google Scholar]. For new care models to be adopted in cirrhosis the evidence base must be of the highest order, as it has been the case for other diseases such as heart failure [[5]Roccaforte R. Demers C. Baldassarre F. Teo K.K. Yusuf S. Effectiveness of comprehensive disease management programmes in improving outcomes in heart failure patients. A meta-analysis.Eur J Heart Fail. 2005; 7: 1133-1144Crossref PubMed Scopus (280) Google Scholar]. In the absence of high quality evidence, the significant upfront costs associated with re-organizing care along new models, are unlikely to be funded by current health care systems. Although we believe instinctively these models will work, these two important studies do not yet provide proof of principle for coordinated care models in cirrhosis. Further well-designed, randomized investigations in this field are still required. The authors declared that they do not have anything to disclose regarding funding or conflict of interest with respect to this manuscript.