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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04178096
Recruitment Status : Enrolling by invitation
First Posted : November 26, 2019
Last Update Posted : October 1, 2020
Sponsor:
Collaborator:
VA Pittsburgh Healthcare System
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Cirrhosis, Liver Other: Quality Improvement Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Health Services Research
Official Title: Using Data-Driven Implementation Strategies to Improve the Quality of Cirrhosis Care (PEC 19-307)
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
Quality Improvement Intervention
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.
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.

No Intervention: Control Arm
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.



Primary Outcome Measures :
  1. Hepatocellular carcinoma screening [ Time Frame: 6 months after the previous 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.

  2. Screening for varices [ Time Frame: Those who have had a variceal screening done in the past 3.5 years. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04178096


Locations
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United States, Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240
Sponsors and Collaborators
VA Office of Research and Development
VA Pittsburgh Healthcare System
Investigators
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Principal Investigator: Shari S. Rogal, MD MPH VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04178096    
Other Study ID Numbers: PEX 19-003
1I50HX002903-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
Hepatitis C
Liver Diseases
Hepatitis
Virus Diseases
Cirrhosis, Liver
Liver Cirrhoses
Hepatic Cirrhoses
Implementation Science
Strategies
Evaluation
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases