Liver cirrhosis places a significant burden on individuals and society, causing diminished quality of life, increased disability, morbidity, and mortality; and high costs and utilization of health care resources. These outcomes could be improved with existing resources, but the current fragmented nature of the health care system does not allow for the necessary coordination to best care for this population. To address the general lack of care coordination in the health care system, collaborative care models have been developed for a wide range of clinical settings, and have successfully improved care for patients with numerous chronic diseases. Researchers at the Indiana University School of Medicine have over 20 years of experience in developing, testing, and implementing collaborative care for patients with dementia, depression, and other conditions. Building on these successes, investigators have customized the collaborative care model to best meet the unique needs of patients with decompensated cirrhosis: The Cirrhosis Medical Home (CMH). This proposal aims to establish the feasibility of performing a randomized controlled trial comparing the CMH to usual care for patients discharged from the hospital with decompensated cirrhosis.
The specific aims are: (1) to test the screening and enrollment processes for a randomized trial of the CMH compared to usual care for patients discharged from the hospital with decompensated cirrhosis; (2) to assess the data collection process, outcome assessment, and the acceptability of the CMH randomized trial; and (3) to estimate the effect size of the CMH intervention on quality of life after six months. Upon completion of the proposed study, the investigators will have demonstrated the feasibility of enrolling and retaining subjects in a randomized trial of the CMH, and they will have established an estimated effect size that will ensure adequate power for a future randomized trial that will evaluate the efficacy of the CMH.

Public Health Relevance

Patients with liver cirrhosis have severe symptoms that lead to poor quality of life, reduced physical and social function, frequent disability, and repeated hospitalizations. These burdens to individuals and society could be improved through the use of innovative collaborative care models that seek to coordinate patient-centered, interdisciplinary care. This proposal aims to establish the feasibility of studying a novel collaborative care model, The Cirrhosis Medical Home, in a future randomized clinical trial.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Research Grants (R03)
Project #
1R03DK122230-01A1
Application #
9978477
Study Section
Kidney, Urologic and Hematologic Diseases D Subcommittee (DDK)
Program Officer
Saslowsky, David E
Project Start
2020-07-01
Project End
2022-04-30
Budget Start
2020-07-01
Budget End
2021-04-30
Support Year
1
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Indiana University-Purdue University at Indianapolis
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
603007902
City
Indianapolis
State
IN
Country
United States
Zip Code
46202