Clinical trial NCT06458998: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cancer of Liver
Cancer of Colon
Cirrhosis
Keywords: implementation strategies
patient navigation
implementation facilitation
Consolidated Framework for Implementation Research
Early detection of cancer
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2024-06-14
Enrollment: 30300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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

Primary outcomes:
measure: Change in Reach of HCC screening from Baseline to 12 months
timeFrame: Baseline, 12 months from Baseline
measure: Change in Reach of CRC screening from Baseline to 12 months
timeFrame: Baseline, 12 months from Baseline
Secondary outcomes:
measure: Effectiveness of screening - Change in the number of tumor/polyp/lesions detected from Baseline to 12 months
timeFrame: Baseline, 12 months from Baseline
measure: Effectiveness of screening - Change in time to treatment from Baseline to 12 months
timeFrame: Baseline, 12 months from Baseline
measure: Change in Adoption of screening from Baseline to 12 months
timeFrame: Baseline, 12 months from Baseline
measure: Feasibility of intervention assessed by the Feasibility of Intervention measure (FIM)
timeFrame: 12 months from Baseline
measure: Acceptability assessed by the Acceptability of Intervention Measure (AIM)
timeFrame: 12 months from Baseline
measure: Appropriateness assessed by the Intervention Appropriateness Measure (IAM)
timeFrame: 12 months from Baseline
measure: Fidelity - Proportion of Veterans receiving recommended screening
timeFrame: 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
measure: Maintenance of HCC Screening at 18 and 24 months from Baseline
timeFrame: 6 months post-intervention (18 months from Baseline), 12 months post-intervention (24 months from Baseline)
measure: Maintenance of CRC Screening at 18 and 24 months from Baseline
timeFrame: 6 months post-intervention (18 months from Baseline), 12 months post-intervention (24 months from Baseline)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Shari S Rogal, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: