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.
Shari S Rogal, Vera Yakovchenko, Timothy Morgan, Jasmohan S Bajaj, Rachel Gonzalez, Angela Park, Lauren Beste, Edward J Miech, Carolyn Lamorte, Brittney Neely, Sandra Gibson, Patrick S Malone, Maggie Chartier, Tamar Taddei, Guadalupe Garcia-Tsao, Byron J Powell, Jason A Dominitz, David Ross, Matthew J Chinman
Author Information
Shari S Rogal: Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Research Office Building (151R), University Drive C, Pittsburgh, PA, 15240, USA. Shari.Rogal@va.gov. ORCID
Vera Yakovchenko: Center for Healthcare Organization and Implementation Research, Edith Nourse Rogers Memorial VA Hospital, Bedford, MA, USA.
Timothy Morgan: Gastroenterology Section, VA Long Beach Healthcare System, Long Beach, CA, USA.
Jasmohan S Bajaj: Division of Gastroenterology, Hepatology, and Nutrition, Virginia Commonwealth University, Richmond, VA, USA.
Rachel Gonzalez: Department of Veterans Affairs, Sierra Pacific Veterans Integrated Service Network, Pharmacy Benefits Management, Mather, CA, USA.
Angela Park: Office of Healthcare Transformation, Veterans Engineering Resource Center, Washington, DC, USA.
Lauren Beste: Division of General Internal Medicine, Department of Medicine, VA Puget Sound Healthcare System, Seattle, WA, USA.
Edward J Miech: Department of Veterans Affairs, Roudebush VA Medical Center, HSR&D Center for Health Information & Communication, VA PRIS-M QUERI, Indianapolis, IN, USA.
Carolyn Lamorte: Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Research Office Building (151R), University Drive C, Pittsburgh, PA, 15240, USA.
Brittney Neely: Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Research Office Building (151R), University Drive C, Pittsburgh, PA, 15240, USA.
Sandra Gibson: Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Research Office Building (151R), University Drive C, Pittsburgh, PA, 15240, USA.
Patrick S Malone: Duke University, Durham, NC, USA.
Maggie Chartier: HIV, Hepatitis and Related Conditions Programs, Office of Specialty Care Services, Veterans Health Administration, Washington, DC, USA.
Tamar Taddei: VA Connecticut Healthcare System, West Haven, CT, USA.
Guadalupe Garcia-Tsao: VA Connecticut Healthcare System, West Haven, CT, USA.
Byron J Powell: Brown School, Washington University in St. Louis, St. Louis, MO, USA.
Jason A Dominitz: Gastroenterology Section, VA Puget Sound Health Care System, Seattle, WA, USA.
David Ross: HIV, Hepatitis and Related Conditions Programs, Office of Specialty Care Services, Veterans Health Administration, Washington, DC, USA.
Matthew J Chinman: Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Research Office Building (151R), University Drive C, Pittsburgh, PA, 15240, USA.
BACKGROUND: Cirrhosis is a rapidly increasing cause of global mortality. To improve cirrhosis care, the Veterans Health Administration (VHA) developed the Hepatic Innovation Team (HIT) Collaborative to support VA Medical Centers (VAMCs) to deliver evidence-based cirrhosis care. This randomized HIT program evaluation aims to develop and assess a novel approach for choosing and applying implementation strategies to improve the quality of cirrhosis care. METHODS: Evaluation aims are to (1) empirically determine which combinations of implementation strategies are associated with successful implementation of evidence-based practices (EBPs) for Veterans with cirrhosis, (2) manualize these "data-driven" implementation strategies, and (3) assess the effectiveness of data-driven implementation strategies in increasing cirrhosis EBP uptake. Aim 1 will include an online survey of all VAMCs' use of 73 implementations strategies to improve cirrhosis care, as defined by the Expert Recommendations for Implementing Change taxonomy. Traditional statistical as well as configurational comparative methods will both be employed to determine which combinations of implementation strategies are associated with site-level adherence to EBPs for cirrhosis. In aim 2, semi-structured interviews with high-performing VAMCs will be conducted to operationalize successful implementation strategies for cirrhosis care. These data will be used to inform the creation of a step-by-step guide to tailoring and applying the implementation strategies identified in aim 1. In aim 3, this manualized implementation intervention will be assessed using a hybrid type III stepped-wedge cluster randomized design. This evaluation will be conducted in 12 VAMCs, with four VAMCs crossing from control to intervention every 6 months, in order to assess the effectiveness of using data-driven implementation strategies to improve guideline-concordant cirrhosis care. DISCUSSION: Successful completion of this innovative evaluation will establish the feasibility of using early evaluation data to inform a manualized, user-friendly implementation intervention for VAMCs with opportunities to improve care. This evaluation will provide implementation support tools that can be applied to enhance the implementation of other evidence-based practices. TRIAL REGISTRATION: This project was registered at ClinicalTrials.Gov ( NCT04178096 ) on 4/29/20.
