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

Primary Purpose

Cirrhosis, Liver

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quality Improvement Intervention
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cirrhosis, Liver focused on measuring Hepatitis C, Liver Diseases, Hepatitis, Virus Diseases, Cirrhosis, Liver, Liver Cirrhoses, Hepatic Cirrhoses, Implementation Science, Strategies, Evaluation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Sites / Locations

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Quality Improvement Intervention

Control Arm

Arm Description

Twelve 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.

All sites besides the pre-selected twelve, a total of one hundred eighteen sites, will not receive the intervention and will provide care as usual.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 6, 2019
Last Updated
June 7, 2023
Sponsor
VA Office of Research and Development
Collaborators
VA Pittsburgh Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT04178096
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
VA Pittsburgh Healthcare System

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Liver
Keywords
Hepatitis C, Liver Diseases, Hepatitis, Virus Diseases, Cirrhosis, Liver, Liver Cirrhoses, Hepatic Cirrhoses, Implementation Science, Strategies, Evaluation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The investigators will select twelve '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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quality Improvement Intervention
Arm Type
Other
Arm Description
Twelve 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.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
All sites besides the pre-selected twelve, a total of one hundred eighteen sites, will not receive the intervention and will provide care as usual.
Intervention Type
Other
Intervention Name(s)
Quality Improvement Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hepatocellular carcinoma screening
Description
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.
Time Frame
6 months after the previous screening.
Title
Screening for varices
Description
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.
Time Frame
Those who have had a variceal screening done in the past 3.5 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veterans who have cirrhosis, or advanced liver disease, and receive care at VA. Exclusion Criteria: N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shari S. Rogal, MD MPH
Organizational Affiliation
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33087156
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.
Results Reference
derived

Learn more about this trial

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

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