Getting To Implementation: Improving Cancer Screening for Veterans

NCT ID: NCT06458998

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 30300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2030-02-28

Brief Summary

Gastrointestinal cancers such as colon cancer and liver cancer cause many deaths in the US. Testing could catch these cancers early, helping people live longer. The goal of this study is to compare two different ways of getting more people tested for these cancers: 1) by directly reaching out to the people who need testing or 2) by helping providers fix issues that hold up testing.

The main question it aims to answer is: how should healthcare systems go about choosing one or the other?

Researchers will look at cancer testing rates over time at sites that are trying these different approaches. They will also survey and interview participants from these sites.

Detailed Description

Researchers will conduct two hybrid type 3, cluster-randomized trials to compare the effectiveness of Patient Navigation (PN) and Implementation Facilitation (IF) on hepatocellular cancer (HCC) and colorectal cancer (CRC) screening completion. Trials will enroll 24 sites for the HCC arm and 32 sites for the CRC arm, passively enrolling and cluster-randomizing Veterans by their site of primary care. Multi-level implementation determinants (i.e., barriers and facilitators), preconditions, and moderators will also be evaluated pre- and post-intervention, using Consolidated Framework for Implementation Research (CFIR)-mapped surveys and interviews of Veteran participants and provider participants. Comparing findings in the two trials will allow researchers to understand how the 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).

Conditions

Cancer of Liver; Cancer of Colon; Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Patient Navigation (PN)

Half of the HCC sites and half of the CRC sites will be randomized to PN delivered by Clinical Resource Hub navigators.

Group Type: ACTIVE_COMPARATOR

Patient Navigation

Intervention Type: BEHAVIORAL

Clinical Resource Hub (CRH) providers include a small group of nurses, advance practice providers, and physicians who work to improve care across a range of measures using virtual PN. CRH providers will 1) use existing dashboards to identify at-risk Veterans, 2) conduct Veteran outreach (two calls, one letter) to provide education, problem solve, and offer screening, 3) order and schedule HCC or CRC screening tests, and 4) provide reminders and follow up on results.

Implementation Facilitation (IF)

Half of the HCC sites and half of the CRC sites will be randomized to IF delivered by 2 facilitators (one clinical and one evaluation expert) per site.

Group Type: ACTIVE_COMPARATOR

Implementation Facilitation

Intervention Type: BEHAVIORAL

Facilitators will provide 20 hours of virtual facilitation to site teams, through 1-hour meetings every other week and ad hoc meetings, over 12 months. They will guide site teams through a seven-step playbook called Getting To Implementation (GTI), which uses a series of tools to select context-specific strategies.

Interventions

Patient Navigation

Clinical Resource Hub (CRH) providers include a small group of nurses, advance practice providers, and physicians who work to improve care across a range of measures using virtual PN. CRH providers will 1) use existing dashboards to identify at-risk Veterans, 2) conduct Veteran outreach (two calls, one letter) to provide education, problem solve, and offer screening, 3) order and schedule HCC or CRC screening tests, and 4) provide reminders and follow up on results.

Intervention Type: BEHAVIORAL

Implementation Facilitation

Facilitators will provide 20 hours of virtual facilitation to site teams, through 1-hour meetings every other week and ad hoc meetings, over 12 months. They will guide site teams through a seven-step playbook called Getting To Implementation (GTI), which uses a series of tools to select context-specific strategies.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Veterans:

• ≥18 years of age
• Enrolled in Veterans Health Administration (VA)
• Have ≥1 VA encounter in the prior 18 months
• Hepatocellular cancer (HCC) screening subgroup: Diagnosis of cirrhosis in electronic medical record
• Colorectal cancer (CRC) screening subgroup: ≥45 years of age, positive fecal immunochemical test (FIT) (or other screening stool test) in the last 18 months

2. Providers:

• Healthcare provider or related staff at participating VA site or engaged in CRC or HCC screening pathways in an included VA site (e.g., scheduling)
• ≥18 years of age

Exclusion Criteria

1. Veterans:

• <18 years of age
• Not enrolled in VA
• No VA encounters in the prior 18 months
• Limited life expectancy (< 6 months), defined as having a code for hospice

2. Providers:

• Members of the study team will not participate, even if their sites are recruited

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Shari Rogal

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shari S Rogal, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Rogal SS, Yakovchenko V, Morgan TR, Dominitz JA, McCurdy H, Nobbe A, Ekanem NR, Kang C, Gonzalez RI, Park A, Anwar J, Neely B, Gibson S, Lamorte C, Bajaj JS, Patton HM, Yao Y, Gawron AJ. Comparing the effectiveness of implementation strategies to improve liver and colon cancer screening for Veterans: protocol for a large cluster-randomized implementation study. Implement Sci. 2025 Aug 9;20(1):38. doi: 10.1186/s13012-025-01448-1.

Reference Type: DERIVED

PMID: 40783525 (View on PubMed)

Other Identifiers

1792560

Identifier Type: OTHER

Identifier Source: secondary_id

BPS-2023C1-31034

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY24010054

Identifier Type: -

Identifier Source: org_study_id