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| ID | Type | Description | Link |
|---|---|---|---|
| 1I50HX002903-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| VA Pittsburgh Healthcare System | FED |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quality Improvement Intervention | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality Improvement Intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shari S Rogal, MD MPH | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania | 15240 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41388318 | Derived | Yakovchenko V, Kang C, Neely B, Lamorte C, McCurdy H, Scott D, Nobbe A, Robins G, Ekanem NR, Merante M, Gibson S, Spoutz P, Chia L, Gonzalez RI, Chinman MJ, Ross D, Chartier M, Beste LA, Bajaj JS, Taddei T, Morgan TR, Rogal SS. Getting to Implementation: applying data-driven implementation strategies to improve guideline concordant surveillance for hepatocellular carcinoma. Implement Sci. 2025 Dec 12;20(1):53. doi: 10.1186/s13012-025-01469-w. | |
| 40001234 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Oct 2020-Mar 2021 |
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| Apr 2021-Sep 2021 |
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| Oct 2021-Mar 2022 |
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Individual participants were not enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | Quality Improvement Intervention | 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 and eighteen month period in this stepped wedge cluster randomized trial. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | 95% Confidence Interval | Odds ratio | 6 months after the previous screening. |
|
1 year
Individual participants were not enrolled. "Participants" here refers to sites.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Quality Improvement Intervention | 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 and eighteen month period in this stepped wedge cluster randomized trial. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shari Rogal | VA Pittsburgh Healthcare System | 412 360 6177 | shari.rogal@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 9, 2021 | Dec 31, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 30, 2024 | Dec 31, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D006526 | Hepatitis C |
| D008107 | Liver Diseases |
| D006505 | Hepatitis |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The investigators will select '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.
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| Yakovchenko V, Merante M, Chinman MJ, Neely B, Lamorte C, Gibson S, Kirchner J, Morgan TR, Rogal SS. The "good enough" facilitator: elucidating the role of working alliance in the mechanism of facilitation. Implement Sci Commun. 2025 Feb 25;6(1):22. doi: 10.1186/s43058-025-00705-0. |
| 36684876 | Derived | Yakovchenko V, Rogal SS, Goodrich DE, Lamorte C, Neely B, Merante M, Gibson S, Scott D, McCurdy H, Nobbe A, Morgan TR, Chinman MJ. Getting to implementation: Adaptation of an implementation playbook. Front Public Health. 2023 Jan 6;10:980958. doi: 10.3389/fpubh.2022.980958. eCollection 2022. |
| 33087156 | Derived | 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. |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| Age, Continuous |
| Sex: Female, Male |
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| Race (NIH/OMB) |
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| Region of Enrollment | participants |
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |