Getting To Implementation: Improving Cancer Screening for Veterans (GTI)

University of Pittsburgh

Status: Invitation-only

Conditions: Cancer of Colon; Cirrhosis; Cancer of Liver

Treatments: Behavioral: Implementation Facilitation; Behavioral: Patient Navigation

Study type: Interventional

Funder types: Other

Identifiers

NCT06458998

1792560 (Other Identifier)

STUDY24010054

BPS-2023C1-31034 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30,300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30,300 participants in 2 patient groups

Patient Navigation (PN)

Active Comparator group

Description:

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

Treatment:

Behavioral: Patient Navigation

Implementation Facilitation (IF)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Implementation Facilitation