Using Data-Driven Implementation Strategies to Improve the Quality of Cirrhosis Care (PEC 19-307)
Phase: NA
Conditions: Cirrhosis, Liver
Sponsor: VA Office of Research and Development

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Study Protocol  
 
 
 
 
 
 
Official Title: Using Data-Driven Implementation Strategies to 
Improve the Quality of Cirrhosis Care 
  
 
 
ClinicalTrials.gov ID (NCT number): NCT04178096 
 
 
 
Protocol Date:  September 9, 2021 
 
 
 
 

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Scientific Background 
Cirrhosis, or advanced liver disease, affects approximately four million people in the US. 
Approximately 100,000 Veterans under the care of the Veterans Health Administration (VA) 
have cirrhosis due to alcohol, hepatitis C (HCV), fatty liver disease, or other causes, and this 
number is rapidly increasing. There are lifesaving measures that providers can take to prevent 
harm from cirrhosis, including providing access to screening for liver cancer. However, less than 
30% of Veterans receive guideline-concordant cirrhosis care. 
 
In 2015, the VA’s HIV, Hepatitis and Related Conditions Program Office (HHRC) established 
the national Hepatic Innovation Team (HIT) Learning Collaborative as part of its efforts to 
improve Veterans’ access to new, highly effective HCV treatments. The PI’s previous work 
evaluating the HIT Collaborative program identified specific implementation strategies that were 
associated with higher rates of HCV treatment using an annual 73-item survey based on the 
Expert Recommendations for Implementing Change (ERIC) implementation strategy taxonomy.  
 
In 2018, the HIT Collaborative’s focus pivoted from HCV elimination towards cirrhosis care. 
The PI’s evaluation team and other investigators aimed to develop a manualized cirrhosis care 
intervention that would help VA facilities develop and roll-out implementation strategies unique 
to their needs. The framework for this manualized intervention was based on an implementation 
strategy bundle called Getting To Outcomes (GTO), a 10-step approach that guides organizations 
through the process of choosing, implementing, evaluating, and improving an evidence-based 
practice (EBP) or intervention. While GTO had been applied to many content domains and 
settings, it had yet to be tested in healthcare settings. In addition, GTO was designed for 
selection of effective interventions, not for the selection of implementation strategies to 
implement a pre-specified intervention. 
 
Thus, “Getting to Implementation” (GTI) was created to support the selection, tailoring, and use 
of implementation strategies in health care settings. An adaptation of GTO, GTI was developed 
using the evaluation team’s surveys to identify effective strategies associated with improved 
cirrhosis care, as well as interviews with providers at VA facilities that were performing well on 
guideline-concordant cirrhosis care metrics.  
 
This study aims to test the effectiveness of GTI to increase cirrhosis EBP uptake in VA facilities 
that are performing low on cirrhosis care metrics. 
 
  
Study Objectives 
The goal of this study is to assess the effectiveness of GTI’s set of prescribed data-driven 
implementation strategies in increasing liver cancer screening for Veterans with cirrhosis at 
participating VA facilities. GTI is an 8-step program supported by a facilitation team with 
clinical and evaluation expertise that provides participating facilities’ implementation teams with 
guidance and training to select and implement effective strategies to best fit their needs in order 
to improve care.  
 

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Study Design & Methods 
This interventional study is a hybrid type III, stepped-wedge, cluster-randomized trial. 
Participating facilities will be randomized to the time that they receive the intervention. All 
intervention activities will be completed virtually. 
 
Study Procedures 
Intervention 
Getting to Implementation (GTI) is an 8-step intervention involving biweekly meetings with a 2-
person facilitation team. In addition to the participating facility’s preliminary step of forming a 
local implementation team, GTI steps include:  
• Step 1 – Identify Gaps and Goals   
• Step 2 – Assess Facilitators and Barriers 
• Step 3 – Choose Implementation Strategies 
• Step 4 – Adapt Strategies and Address Readiness 
• Step 5 – Plan Implementation  
• Step 6 – Implement and Evaluate 
• Step 7 – Improve Implementation 
• Step 8 – Sustain Implementation   
The intervention is delivered to the participating facility’s implementation team over a 6-month 
active implementation period, followed by a 6-month sustainment period. 
 
Manual  
The GTI manual will guide the intervention. It includes step-by-step instructions through the GTI 
steps, worksheets, and resources. The GTI manual specifies eight “core” strategies found to be 
empirically associated with better cirrhosis care outcomes. Each of the core implementation 
strategies includes an accompanying appendix to aid in operationalizing it, and a tracking form 
to document use and fidelity. 
 
Meetings 
GTI facilitators will hold biweekly, 1-hour virtual meetings for a 6-month period to guide the 
participating facility’s implementation team through GTI. This will be followed by 3 additional  
meetings over the 6-month sustainment period. 
 
Toolkit 
The GTI Toolkit includes editable versions of worksheets from the GTI manual. Participating 
facilities will complete these tools collaboratively with facilitators during meetings.  
 
Data Collection 
Facilitators will track GTI implementation and fidelity from several sources. A tracking 
spreadsheet will be used to record the time spent on each step, how and by whom GTI tools were 
completed, challenges encountered, and other relevant field notes. Additional sources include 
contemporaneous notes from biweekly meetings; completed GTI tools; and summative 
interviews with local implementation teams asking about their experiences with GTI and 
facilitation, the core strategies, and barriers and facilitators experienced. 
 

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Clinical outcomes at the facility- and patient-level will be obtained from the national Advanced 
Liver Disease Dashboard, which uses data from the VA’s Corporate Data Warehouse (CDW) to 
identify Veterans with cirrhosis and to track interventions such as abdominal imaging (i.e., liver 
cancer screening). 
 
 
Study Population  
 
VA Facilities 
We will enroll up to 12 VA facilities in the lowest quartile of guideline-concordant cirrhosis 
care. Implementation will be conducted in three steps over a 2-year period, with four facilities 
crossing from control to intervention every 6 months until all sites are exposed to the 
intervention. 
 
Veterans 
Veterans with cirrhosis engaged in care at a participating VA facility will be included in analysis. 
Engagement in care will be defined as having at least one encounter for clinical care in the prior 
18 months. Veterans will be assigned to the facility in which they receive their primary care at 
the time of randomization.