Cancer of Colon, Cancer of Liver, Cirrhosis
Conditions
Keywords
implementation strategies, patient navigation, implementation facilitation, Consolidated Framework for Implementation Research, Early detection of cancer
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).
Interventions
BEHAVIORALPatient 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.
BEHAVIORALImplementation 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.
Sponsors
University of Pittsburgh
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Reach of HCC screening from Baseline to 12 months | Baseline, 12 months from Baseline | 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. |
| Change in Reach of CRC screening from Baseline to 12 months | Baseline, 12 months from Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of screening - Change in the number of tumor/polyp/lesions detected from Baseline to 12 months | Baseline, 12 months from Baseline | Effectiveness is the impact of an intervention on important individual outcomes, defined as detection of cancer. |
| Effectiveness of screening - Change in time to treatment from Baseline to 12 months | Baseline, 12 months from Baseline | 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. |
| Change in Adoption of screening from Baseline to 12 months | Baseline, 12 months from Baseline | 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. |
| Feasibility of intervention assessed by the Feasibility of Intervention measure (FIM) | 12 months from Baseline | 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. |
| Acceptability assessed by the Acceptability of Intervention Measure (AIM) | 12 months from Baseline | 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. |
| Appropriateness assessed by the Intervention Appropriateness Measure (IAM) | 12 months from Baseline | 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. |
| Fidelity - Proportion of Veterans receiving recommended screening | 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 | 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. |
| Maintenance of HCC Screening at 18 and 24 months from Baseline | 6 months post-intervention (18 months from Baseline), 12 months post-intervention (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. |
| Maintenance of CRC Screening at 18 and 24 months from Baseline | 6 months post-intervention (18 months from Baseline), 12 months post-intervention (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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORShari S Rogal, MD, MPH
University of Pittsburgh
Outcome results
None listed