Getting To Implementation: Improving Cancer Screening for Veterans

Cirrhosis Clinical Trial

— GTI  

Official title:

Getting To Implementation: Comparing the Effectiveness of Implementation Strategies to Improve Cancer Screening for Veterans

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06458998
• Other study ID #: STUDY24010054
• Secondary ID: 1792560BPS-2023C
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 2024
• Est. completion date: February 28, 2030

Study information

• Verified date: June 2024
• Source: University of Pittsburgh
• Contact: Shari S Rogal, MD, MPH
• Phone: 412-360-6177
• Email: shari.rogal[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30300
• Est. completion date: February 28, 2030
• Est. primary completion date: February 28, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Colon
• Cancer of Liver
• Cirrhosis
• Colonic Neoplasms
• Liver Neoplasms

Intervention

Behavioral:
• Patient Navigation
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.
• Implementation 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.

Locations

Country	Name	City	State
United States	VA Pittsburgh Healthcare System	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)