Trial Outcomes & Findings for Using Data-Driven Implementation Strategies to Improve the Quality of Cirrhosis Care (NCT NCT04178096)

NCT ID: NCT04178096

Last Updated: 2025-04-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 6 months after the previous screening.
• Results posted on: 2025-04-01

Participant Flow

Unit of analysis: sites

Participant milestones

Measure	Round 1 (Oct 2020-Mar 2021) 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. 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 an eighteen month period in this stepped wedge cluster randomized trial.	Round 2 (Apr 2021-Sep 2021) 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. 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 an eighteen month period in this stepped wedge cluster randomized trial.	Round 3 (Oct 2021-Mar 2022) 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. 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 an eighteen month period in this stepped wedge cluster randomized trial.
Oct 2020-Mar 2021 STARTED	0 4	0 0	0 0
Oct 2020-Mar 2021 COMPLETED	0 4	0 0	0 0
Oct 2020-Mar 2021 NOT COMPLETED	0 0	0 0	0 0
Apr 2021-Sep 2021 STARTED	0 0	0 4	0 0
Apr 2021-Sep 2021 COMPLETED	0 0	0 3	0 0
Apr 2021-Sep 2021 NOT COMPLETED	0 0	0 1	0 0
Oct 2021-Mar 2022 STARTED	0 0	0 0	0 4
Oct 2021-Mar 2022 COMPLETED	0 0	0 0	0 3
Oct 2021-Mar 2022 NOT COMPLETED	0 0	0 0	0 1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure

Quality Improvement Intervention n=8243 Participants 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. This stepped wedge trial cluster randomized patients to the timing of site-level intervention. 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.

Hepatocellular Carcinoma Screening

1.61 Odds ratio Interval 1.54 to 1.69

Adverse Events

Quality Improvement Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Shari Rogal

VA Pittsburgh Healthcare System

Phone: 412 360 6177

Email: shari.rogal@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place