Getting To Implementation: Improving Cancer Screening for Veterans
NCT Number: NCT06458998
Acronym: GTI
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer of Liver|Cancer of Colon|Cirrhosis
Interventions: BEHAVIORAL: Patient Navigation|BEHAVIORAL: Implementation Facilitation
Sponsor: University of Pittsburgh
Collaborators: Patient-Centered Outcomes Research Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-07-15
Completion Date: 2030-02-28
Locations: VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, 15240, United States

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.

Primary Outcome Measures: Change in Reach of HCC screening from Baseline to 12 months, Reach of an intervention refers to the absolute number, proportion, and representativeness of individuals who are willing to participate in a given intervention. The reach outcome will be the percentage of eligible Veterans in the HCC screening subgroup receiving guideline-concordant abdominal imaging within the prior 6 months., Baseline, 12 months from Baseline|Change in Reach of CRC screening from Baseline to 12 months, Reach of an intervention refers to the absolute number, proportion, and representativeness of individuals who are willing to participate in a given intervention. The reach outcome will be the percentage of eligible Veterans in the CRC screening subgroup receiving a colonoscopy., Baseline, 12 months from Baseline
Secondary Outcome Measures: Effectiveness of screening - Change in the number of tumor/polyp/lesions detected from Baseline to 12 months, Effectiveness is the impact of an intervention on important individual outcomes, defined as detection of cancer., Baseline, 12 months from Baseline|Effectiveness of screening - Change in time to treatment from Baseline to 12 months, Effectiveness is the impact of an intervention on important individual outcomes, defined as time to treatment, which will be measured from the date of cancer diagnosis to the date of referral., Baseline, 12 months from Baseline|Change in Adoption of screening from Baseline to 12 months, Adoption is the absolute number, proportion, and representativeness of settings/people who are willing to initiate a program. Site-level adoption will be defined as meeting the national goal of 65% HCC screening and 80% linkage to colonoscopy within 6-months of positive stool-based screening., Baseline, 12 months from Baseline|Feasibility of intervention assessed by the Feasibility of Intervention measure (FIM), Feasibility refers to the extent to which an intervention can be successfully used within a given setting, as measured by the Feasibility of Intervention Measure (FIM) assessment. The FIM is a 4-item measure, with each item scored using a 5-point Likert scale. Scores range from a minimum of 4 points to a maximum of 20. Higher scores indicate greater feasibility., 12 months from Baseline|Acceptability assessed by the Acceptability of Intervention Measure (AIM), Acceptability refers to a given intervention being perceived as agreeable, palatable, or satisfactory by implementation stakeholders, as measured by the Acceptability of Intervention Measure (AIM). The AIM is a 4-item measure, with each item scored using a 5-point Likert scale. Scores range from a minimum of 4 points to a maximum of 20. Higher scores indicate greater acceptability., 12 months from Baseline|Appropriateness assessed by the Intervention Appropriateness Measure (IAM), Appropriateness is the perceived fit of an intervention to address a particular issue or problem, as measured by the Intervention Appropriateness Measure (IAM). The IAM is a 4-item measure, with each item scored using a 5-point Likert scale. Scores range from a minimum of 4 points to a maximum of 20. Higher scores indicate greater appropriateness., 12 months from Baseline|Fidelity - Proportion of Veterans receiving recommended screening, Fidelity is the degree to which an intervention/innovation is delivered as intended. Fidelity of cancer screenings will be assessed by the proportion of Veterans at a given site receiving HCC or CRC screening as recommended (correct timing and modality). Fidelity to core strategy elements will be evaluated using checklists., 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, Maintenance is the extent to which a program becomes part of routine organizational practices. Sustainment of HCC Screening will be measured by the percentage of eligible Veterans in the HCC screening subgroup receiving guideline-concordant abdominal imaging within the prior 6 months., 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, Maintenance is the extent to which a program becomes part of routine organizational practices. Sustainment of CRC Screening will be measured by the percentage of eligible Veterans in the CRC screening subgroup receiving a colonoscopy., 6 months post-intervention (18 months from Baseline), 12 months post-intervention (24 months from Baseline)