Falls are a major threat to the well-being of patients with cirrhosis, a chronic and irreversible scarring of the liver. Cirrhosis can cause poor nutrition, physical weakness, impaired balance, and mental fogginess or confusion. All of these complications may lead to falls and injury. People affected by cirrhosis are twice as likely to have brain bleeding and major fractures after a fall compared to those without cirrhosis. Preventing falls is extremely important. However, falls are often overlooked in cirrhosis and no falls prevention interventions have been developed in this group.
To address this problem, LIVE-SMART: Liver cirrhosis intervention for fall prevention: a Sequential, Multiple Assignment Randomized Trial was designed. This study compares a sequence of four treatments to prevent falls and improve quality of life and health outcomes in cirrhosis.
Who can use study results and how?
This study will help patients with cirrhosis at risk for falls, their caregivers, and their doctors understand the optimal treatment options to reduce the risk of falls.
In this trial,215 patients with cirrhosis at risk for falls and cirrhosis complications will be enrolled from three, large, expert liver disease centers in Michigan, Pennsylvania, and Texas.Patients will be approached by telephone or in liver clinics. The four treatment options include falls prevention and nutrition education, at-home Tai-Chi DVD, lactulose medication to improve alertness, and at-home live Tai-Chi sessions via zoom with an instructor (TeleTai-Chi). The treatment sequence will be switched halfway through the study after 3 months and participants will be followed for a total of 6 months. The treatment sequences will be evaluated to determine which was most effective and which groups of patients were helped the most. The intervention’s effect on the primary outcome of falls (without and without injury) and mental alertness (hepatic encephalopathy) will be measured at 6-months. Secondary outcomes are health-related quality of life, physical function, cognitive function, and days alive and out of the hospital at 3 and 6 months. This study will also help evaluate patient adherence to program recommendations and how to best deliver this intervention in home settings (fidelity). Outcomes will be collected using a combination of in-person visit surveys and assessments, online, telephone, and/or text message assessments, and from electronic medical records.
In previously conducted patient focus groups, 69% of those with cirrhosis felt that designing interventions to reduce falls risk is extremely important. As part of this study’s design, a 7-member patient engagement group of 4 patients with cirrhosis and 3 of their caregivers was consulted. The group helped to select the target population and study outcomes, how often those outcomes were measured, participant compensation, and recruitment procedures. The patient engagement group is excited to be part of this study and will continue to be involved monthly during the beginning of the study at least quarterly throughout the trial
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.