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

NCT04178096 | Completed Results

• 2 other identifiers: PEX 19-0031I50HX002903-01A1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cirrhosis, Liver

Keywords

Hepatitis C; Liver Diseases; Hepatitis; Virus Diseases; Cirrhosis, Liver; Liver Cirrhoses; Hepatic Cirrhoses; Implementation Science; Strategies; Evaluation

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Quality Improvement Intervention

OTHER

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

Interventions

Quality Improvement Intervention OTHER

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.

Quality Improvement Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• VA Office of Research and Development: lead
• VA Pittsburgh Healthcare System: collaborator

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Publications (4)

• Yakovchenko V, Kang C, Neely B, Lamorte C, McCurdy H, Scott D, Nobbe A, Robins G, Ekanem NR, Merante M, Gibson S, Spoutz P, Chia L, Gonzalez RI, Chinman MJ, Ross D, Chartier M, Beste LA, Bajaj JS, Taddei T, Morgan TR, Rogal SS. Getting to Implementation: applying data-driven implementation strategies to improve guideline concordant surveillance for hepatocellular carcinoma. Implement Sci. 2025 Dec 12;20(1):53. doi: 10.1186/s13012-025-01469-w.

  PMID: 41388318 DERIVED

• Yakovchenko V, Merante M, Chinman MJ, Neely B, Lamorte C, Gibson S, Kirchner J, Morgan TR, Rogal SS. The "good enough" facilitator: elucidating the role of working alliance in the mechanism of facilitation. Implement Sci Commun. 2025 Feb 25;6(1):22. doi: 10.1186/s43058-025-00705-0.

  PMID: 40001234 DERIVED

• Yakovchenko V, Rogal SS, Goodrich DE, Lamorte C, Neely B, Merante M, Gibson S, Scott D, McCurdy H, Nobbe A, Morgan TR, Chinman MJ. Getting to implementation: Adaptation of an implementation playbook. Front Public Health. 2023 Jan 6;10:980958. doi: 10.3389/fpubh.2022.980958. eCollection 2022.

  PMID: 36684876 DERIVED

• 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.

  PMID: 33087156 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Hepatitis C; Liver Diseases; Hepatitis; Virus Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Flaviviridae Infections; RNA Virus Infections

Results Point of Contact

• Title: Dr. Shari Rogal
• Organization: VA Pittsburgh Healthcare System

shari.rogal@va.gov

412 360 6177

Study Officials

• Shari S Rogal, MD MPH

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The investigators will select 'low-performing' sites to receive a bundle of strategies that have been empirically determined to be associated with evidence based practices for Veterans with cirrhosis. Using a hybrid type III stepped wedge cluster design, in which the investigators provide the bundle of strategies to four sites every six month period, then will evaluate whether applying these data-driven implementation strategies increases the use of evidence based practices and outcomes for cirrhosis compared to VA sites operating as usual.

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 26, 2019
• Study Start: September 18, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 1, 2025
• Results First Posted: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)