Comparing the effectiveness of implementation strategies to improve liver and colon cancer screening for Veterans: protocol for a large cluster-randomized implementation study.

Angela Park, Andrew J Gawron, Yiwen Yao, Heather M Patton, Jasmohan S Bajaj, Carolyn Lamorte, Sandra Gibson, Brittney Neely, Jennifer Anwar, Shari S Rogal, Rachel I Gonzalez, Chaeryon Kang, Nsikak R Ekanem, Anna Nobbe, Heather McCurdy, Jason A Dominitz, Timothy R Morgan, Vera Yakovchenko

Journal: Implementation science : IS 2025;20(1):38

PMID: 40783525

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Abstract

BACKGROUND

Screening for gastrointestinal (GI) cancers, specifically colorectal cancer (CRC) and hepatocellular carcinoma (HCC), is often inadequately and inequitably implemented, leading to preventable morbidity and mortality. This protocol paper describes a study designed to compare the effectiveness of external facilitation with patient navigation across hospitals in the Veterans Health Administration (VA).

METHODS

Two hybrid type 3, cluster-randomized trials will compare the effectiveness of patient navigation versus external facilitation for supporting HCC and CRC screening completion. Twenty-four sites will be included in the HCC trial and 32 in the CRC trial, cluster-randomizing Veterans by their site of primary care. The primary outcome of reach of cancer screening completion will be measured after intervention and during sustainment. Multi-level implementation determinants (i.e., barriers and facilitators), preconditions, and moderators will be evaluated pre- and post-intervention, using Consolidated Framework for Implementation Research (CFIR)-mapped surveys and interviews of Veteran participants and provider participants.

DISCUSSION

Comparing findings in the two trials will allow researchers to understand how implementation barriers and strategies operate differently for a one-time screening in a relatively healthy population (CRC) vs. repeated screening in a more medically complex population (HCC).

TRIAL REGISTRATION

This project was registered at ClinicalTrials.Gov (NCT06458998) on 6/13/24.

Address: Center for Healthcare Evaluation, Research, and Promotion, VA Pittsburgh Healthcare System, PA, Pittsburgh, USA. [email protected].; Division of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh, PA, Pittsburgh, USA. [email protected].; Department of Surgery, University of Pittsburgh, PA, Pittsburgh, USA. [email protected].; Center for Healthcare Evaluation, Research, and Promotion, VA Pittsburgh Healthcare System, PA, Pittsburgh, USA.; National Gastroenterology and Hepatology Program, Veterans Health Administration, DC, Washington, USA.; Gastroenterology Section, VA Long Beach Healthcare System, CA, Long Beach, USA.; Division of Gastroenterology, University of California, CA, Irvine, USA.; National Gastroenterology and Hepatology Program, Veterans Health Administration, DC, Washington, USA.; VA Puget Sound Health Care System, WA, Seattle, USA.; Division of Gastroenterology, University of Washington School of Medicine, WA, Seattle, USA.; Gastroenterology Section, VA, Ann Arbor Healthcare System, MI, Ann Arbor, USA.; Digestive Diseases Section, Cincinnati VA Medical Center, OH, Cincinnati, USA.; VA Northern Indiana Healthcare System, IN, Fort Wayne, USA.; Department of Psychiatry, School of Medicine, University of Pittsburgh, PA, Pittsburgh, USA.; Research Service, VA Long Beach Healthcare System, CA, Long Beach, USA.; Department of Veterans Affairs, Office of Healthcare Transformation, DC, Washington, USA.; National Gastroenterology and Hepatology Program, Veterans Health Administration, DC, Washington, USA.; Gastroenterology Section, VA Long Beach Healthcare System, CA, Long Beach, USA.; Center for Healthcare Evaluation, Research, and Promotion, VA Pittsburgh Healthcare System, PA, Pittsburgh, USA.; Division of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh, PA, Pittsburgh, USA.; Gastroenterology Section, Central Virginia VA Health Care System, VA, Richmond, USA.; Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, VA, Richmond, USA.; VA San Diego Healthcare System, CA, San Diego, USA.; University of California San Diego, CA, La Jolla, USA.; VA Salt Lake City Healthcare System, UT, Salt Lake City, USA.; University of Utah, UT, Salt Lake City, USA.; National Gastroenterology and Hepatology Program, Veterans Health Administration, DC, Washington, USA.; VA Salt Lake City Healthcare System, UT, Salt Lake City, USA.; University of Utah, UT, Salt Lake City, USA.

DOI: 10.1186/s13012-025-01448-1

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MeSH Terms: Humans, Carcinoma, Hepatocellular, Colonic Neoplasms, Colorectal Neoplasms, Early Detection of Cancer, Implementation Science, Liver Neoplasms, Mass Screening, Patient Navigation, Randomized Controlled Trials as Topic, United States, United States Department of Veterans Affairs, Veterans, Multicenter Studies as Topic