Using Data-Driven Implementation Strategies to Improve the Quality of Cirrhosis Care
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|ClinicalTrials.gov Identifier: NCT04178096|
Recruitment Status : Enrolling by invitation
First Posted : November 26, 2019
Last Update Posted : October 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cirrhosis, Liver||Other: Quality Improvement Intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|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|
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.
- 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.
- 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.
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
|United States, Pennsylvania|
|VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA|
|Pittsburgh, Pennsylvania, United States, 15240|
|Principal Investigator:||Shari S. Rogal, MD MPH||VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA|