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

NCT ID: NCT04178096

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-18
• Study Completion Date: 2023-12-31

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.

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.

Conditions

Cirrhosis, Liver

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Quality Improvement Intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• N/A

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Pittsburgh Healthcare System

FED

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shari S Rogal, MD MPH

Role: PRINCIPAL_INVESTIGATOR

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Locations

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40001234 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36684876 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33087156 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1I50HX002903-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PEX 19-003

Identifier Type: -

Identifier Source: org_study_id