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

Cirrhosis, Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04178096
• Other study ID #: PEX 19-003
• Secondary ID: 1I50HX002903-01A
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Fibrosis
• Liver Cirrhosis

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.

Locations

Country	Name	City	State
United States	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	VA Pittsburgh Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Screening for varices	Patients with diagnosis of cirrhosis, who do not have an active Veterans Affairs (VA) or NON-VA prescription for a preferred non-selective beta blocker (NSBB) documented in the Computerized Patient Record System (CPRS) (treatment), should have variceal screening completed within the last 3 years. This metric includes a 6-month grace period, so those completing esophagogastroduodenoscopy (EGD) within 3.5 years will meet the metric. Post-transplant patients are excluded. The investigators will compare those who have met the metric to those who have a diagnosis of cirrhosis, platelet count <150, and the investigators will look at data from 1999 to current.	Those who have had a variceal screening done in the past 3.5 years.