Getting To Implementation: Improving Cancer Screening for Veterans

Official title

Getting To Implementation: Comparing the Effectiveness of Implementation Strategies to Improve Cancer Screening for Veterans

Overview

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).

Interventions

• Behavioral Patient Navigation
  Patient Navigation providers include nurses, advance practice providers, and physicians who work to improve care across a range of measures using virtual PN. Providers will 1) use existing dashboards to identify at-risk Veterans, 2) conduct Veteran outreach (e.g., 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.
• 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.

Primary outcome measures

• Change in Reach of HCC screening from Baseline to 12 months [Time frame: Baseline, 12 months from Baseline]
• Change in Reach of CRC screening from Baseline to 12 months [Time frame: Baseline, 12 months from Baseline]

Secondary outcome measures (9)

• Effectiveness of screening - Change in the number of tumor/polyp/lesions detected from Baseline to 12 months [Time frame: Baseline, 12 months from Baseline]
• Effectiveness of screening - Change in time to treatment from Baseline to 12 months [Time frame: Baseline, 12 months from Baseline]
• Change in Adoption of screening from Baseline to 12 months [Time frame: Baseline, 12 months from Baseline]
• Feasibility of intervention assessed by the Feasibility of Intervention measure (FIM) [Time frame: 12 months from Baseline]
• Acceptability assessed by the Acceptability of Intervention Measure (AIM) [Time frame: 12 months from Baseline]
• Appropriateness assessed by the Intervention Appropriateness Measure (IAM) [Time frame: 12 months from Baseline]
• Fidelity - Proportion of Veterans receiving recommended screening [Time frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12]
• Maintenance of HCC Screening at 18 and 24 months from Baseline [Time frame: 6 months post-intervention (18 months from Baseline), 12 months post-intervention (24 months from Baseline)]
• Maintenance of CRC Screening at 18 and 24 months from Baseline [Time frame: 6 months post-intervention (18 months from Baseline), 12 months post-intervention (24 months from Baseline)]

Eligibility criteria

Inclusion criteria

• 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
• 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

• 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
• Providers:

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 1 center

• VA Pittsburgh Healthcare System — Pittsburgh

Publications

• 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. PMID 40783525

Identifiers

NCT: NCT06458998 · STUDY24010054 · 1792560 · BPS-2023C1-31034

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗