Clinical trial NCT04178096: Using Data-Driven Implementation Strategies to Improve the Quality of Cirrhosis Care
Official title: Using Data-Driven Implementation Strategies to Improve the Quality of Cirrhosis Care (PEC 19-307)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis, Liver
Keywords: Hepatitis C
Liver Diseases
Hepatitis
Virus Diseases
Cirrhosis, Liver
Liver Cirrhoses
Hepatic Cirrhoses
Implementation Science
Strategies
Evaluation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Pittsburgh Healthcare System
First posted: 2019-11-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Hepatocellular Carcinoma Screening
timeFrame: 6 months after the previous screening.
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
name: Shari S Rogal, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.