Using Data-Driven Implementation Strategies to Improve the Quality of Cirrhosis Care

Using Data-Driven Implementation Strategies to Improve the Quality of Cirrhosis Care (PEC 19-307)

This Veteran Affairs (VA) Quality Improvement project aims to understand which data-driven implementation strategies promote evidence based practices that improve high-quality care for Veterans with cirrhosis.

Study Overview

• Status: Completed
• Conditions: Cirrhosis, Liver
• Intervention / Treatment: Other: Quality Improvement Intervention

Detailed Description

Nearly 120,000 Veterans in care have cirrhosis, or advanced liver disease, from alcohol, hepatitis C, fatty liver disease, or other causes, and this number is rapidly increasing. There are life-saving measures that providers can take to prevent harm from cirrhosis. The three most impactful of these measures include providing access to post-discharge follow-up and screening for liver cancer and esophageal varices (veins that can cause catastrophic bleeding). However, only about one-third of Veterans receive care aligned with these three evidence-based practices (EBPs). Therefore, there is an urgent need to improve access to high-quality care for Veterans with this common condition.

By focusing on strategies that most successfully encourage implementation of evidence-based practices the investigators can address the urgent need to improve the quality and timeliness of care for Veterans with cirrhosis who receive care at VA hospitals. This quality improvement intervention seeks to understand which implementation strategies, or discrete activities that are conducted to promote EBP implementation, improve cirrhosis care. The aims of this evaluation are to: (1) empirically determine which combinations of implementation strategies ('data-driven strategies') are associated with the successful implementation of EBPs for Veterans with cirrhosis, (2) use Intervention Mapping to operationalize the 'data-driven' implementation strategies developed in the first aim, and (3) evaluate whether applying data-driven implementation strategies increases the use of EBPs for cirrhosis, using a hybrid type III stepped wedge cluster randomized trial. The investigators will measure cirrhosis care at all VA sites and use the data from aims 1 and 2 to provide feedback to all sites. The investigators anticipate that more intensive implementation interventions will directly impact 12 of the lowest-performing sites.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15240
      • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Veterans who have cirrhosis, or advanced liver disease, and receive care at VA.

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Quality Improvement Intervention; Low-performing sites will receive a package of strategies which have been empirically determined to be associated with successful implementation of evidence based practices that lead to improved health outcomes for Veterans with cirrhosis. This stepped wedge trial cluster randomized patients to the timing of site-level intervention.

Other: Quality Improvement Intervention; The investigators will assess the effectiveness of empirically determined implementation strategies that are associated with increasing cirrhosis evidence based practices and thus improving outcomes of Veterans with cirrhosis by introducing a bundle of these strategies to four new 'low-performing' hospitals every six months during and eighteen month period in this stepped wedge cluster randomized trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hepatocellular Carcinoma Screening	Active patients, or those with outpatient or prescription activity within the last eighteen months, with a diagnosis of cirrhosis should have abdominal imaging every 6 months. Hepatocellular carcinoma (HCC) and Post-transplant patients are not included. This measure is being assessed by comparing the patients that have had imaging for liver cancer screening in the last eight months to those that have not.	6 months after the previous screening.

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: VA Pittsburgh Healthcare System
• Investigators: Principal Investigator: Shari S Rogal, MD MPH, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Publications and helpful links

General Publications

• Rogal SS, Yakovchenko V, Morgan T, Bajaj JS, Gonzalez R, Park A, Beste L, Miech EJ, Lamorte C, Neely B, Gibson S, Malone PS, Chartier M, Taddei T, Garcia-Tsao G, Powell BJ, Dominitz JA, Ross D, Chinman MJ. Getting to implementation: a protocol for a Hybrid III stepped wedge cluster randomized evaluation of using data-driven implementation strategies to improve cirrhosis care for Veterans. Implement Sci. 2020 Oct 21;15(1):92. doi: 10.1186/s13012-020-01050-7.

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2020
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: November 6, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Evaluation; Virus Diseases; Hepatitis C; Hepatitis; Liver Diseases; Implementation Science; Cirrhosis, Liver; Liver Cirrhoses; Hepatic Cirrhoses; Strategies
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: PEX 19-003; 1I50HX002903-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No