Thursday, March 21, 2019

Power Struggle: The Quest to Increase the Impact of Significant Preliminary Findings


Sam Miller, MD
Resident in Internal Medicine at MGH
PGY-2

March 20, 2019 

Project Summary
Our project addresses an issue near and dear to the hearts of hospitalists, gastroenterologists, hepatologists, administrators, case managers and nurses at MGH; we are attempting to identify predictors of readmission in cirrhotic patients admitted with hepatic encephalopathy. Our study enrolls cirrhotic patients admitted with hepatic encephalopathy at MGH as they approach discharge. We examine patient demographics (age, education level, gender, etiology of cirrhosis, discharge destination), hospital complications (GI bleed, infection, drug use, kidney injury), treatments prescribed (dose of lactulose, stool frequency, rifaxamin prescription) and scores on a battery of cognitive tests (MOCA, Pscyhometric Hepatic Encephalopathy Score) at the time of discharge, to see if any of these parameters predict readmission within 30 days for hepatic encephalopathy, other liver-related complications, or alternatively, death/hospice/liver transplant.

Project Obstacles
Patient recruitment is a difficult process. This requires bi-weekly chart review of the entire hospitalist service at MGH, and communication with patients’ primary teams to determine discharge timing and confirm a diagnosis of hepatic encephalopathy. Then patients need to be approached for consent, enrolled (an hour-long process), and called for follow-up at 30 days post-discharge. Patients are often “busy” during their time in the hospital, working with PT, nutrition, case management, and consulting services, and this can often delay enrollment. Discharge timing is a constantly moving target, and staying up to date on a patient’s discharge plan requires a great deal of attention. And calling patients for follow-up is no guarantee that they will answer the phone on the first, second, or third try!

What are the next steps?
Our project has enrolled 44 patients to date, and we have found that scores on one specific cognitive test (Number Connection Test A, a component of the Psychometric Hepatic Encephalopathy Score) does predict readmission for hepatic encephalopathy, and death/hospice/transplant in a statistically significant fashion. However, the absolute number of readmissions for hepatic encephalopathy is not as high as we would like, so our next steps are to increase our enrollment in order to increase the power of our study. Fortunately, our significant findings have been collated in an abstract that has been accepted for presentation at a national conference (Digestive Disease Week in May 2019) and we are currently preparing a poster for presentation.

What have you learned about engaging in research?
First and foremost, I have learned the immense difference that a highly-functional team can make in a research project. Our prospective study design and significant administrative burden have made this immediately apparent. Without the work of our highly-motivated and flexible team members, we would not be able to enroll the number of patients we have enrolled to date. Each team member has also made significant intellectual contributions to the project; one team member has utilized their facility with statistics to ensure that our significant findings are adequately reported, while another team member independently had the idea to use a composite endpoint of death/hospice/transplant to make our findings more generalizable and clinically useful.

I have also learned the importance of flexibility when conducting a research project. For example, we had one method of collecting data on stool frequency at discharge for our patient cohort that was simply not feasible. We changed this method and have been able to report results consistently and accurately. We also had to adjust our inclusion criteria in order to capture enough patients for our cohort, and this markedly increased our yield. These small tweaks are not particularly profound, but have had significant implications for our project and have allowed us to discover clinically meaningful data that will hopefully make an impact on future patient care!
Number Connection Test A (connect the numbers in order from 1-25)

Number Connection Test B (connect alternating numbers/letters from 1-13 and A-L)

Digital Symbol Test (copy the symbols associated with each number) 

Serial Dotting Test (make a dot in the center of each circle, moving R to L) 
Line Tracing Test (complete the maze without touching the black outline.) 

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