Getting To Implementation: Improving Cancer Screening for Veterans

Trial Title: Getting To Implementation: Improving Cancer Screening for Veterans

NCT ID: NCT06458998

Condition: Cancer of Liver
Cancer of Colon
Cirrhosis

Conditions: Official terms:
Colonic Neoplasms
Liver Neoplasms

Conditions: Keywords:
implementation strategies
patient navigation
implementation facilitation
Consolidated Framework for Implementation Research
Early detection of cancer

Study type: Interventional

Study phase: N/A

Overall status: Enrolling by invitation

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Health Services Research

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Patient Navigation
Description: 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.
Arm group label: Patient Navigation (PN)

Intervention type: Behavioral
Intervention name: Implementation Facilitation
Description: 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.
Arm group label: Implementation Facilitation (IF)

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).

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: VA Pittsburgh Healthcare System

Address:
City: Pittsburgh
Zip: 15240
Country: United States

Start date: July 15, 2024

Completion date: February 28, 2030

Lead sponsor:
Agency: University of Pittsburgh
Agency class: Other

Collaborator:
Agency: Patient-Centered Outcomes Research Institute
Agency class: Other

Source: University of Pittsburgh

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06458998