Clinical trial NCT06133439: Rural Indiana Screening for Colorectal Cancer
Official title: Implementing Evidence Based Colorectal Cancer Screening in Rural Clinics
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Indiana University Melvin and Bren Simon Cancer Center
name: National Cancer Institute (NCI)
First posted: 2023-11-15
Enrollment: 11
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Cluster-Randomized Stepped Wedge design. Clinics will be randomized to one of three clusters that include four defined phases each consisting of nine-month segments.
Primary purpose: SCREENING

Brief summary: The goal of this implementation study is to support an evidence-based intervention to the improve colorectal cancer (CRC) screening and diagnostic colonoscopy rates in rural Indiana. The main questions the study aims to answer are:

* How does the implementation of an evidence based intervention to increase CRC screening in rural Indiana improve CRC screening and diagnostic colonoscopy rates, defined as completed screening episode?
* Will dose and type of implementation strategies contribute to differences in contextual factors and readiness as well as different levels of implementation outcomes (reach and implementation) in rural clinic?
* Will Contextual factors (innovation, recipient, inner and outer context) and implementation outcomes (reach, and implementation) vary with the levels of CRC screening and diagnostic colonoscopy following active implementation (effectiveness) and throughout maintenance compared to baseline (usual care)?
* What is the cost and budget impact of the deployment of implementation strategies and processes for rural clinics and evaluate the cost-effectiveness of implementing and sustaining the CRC screening intervention?

Approach: Participating clinics tasks consist of mailing FIT kits, sending text messages, phone reminders, and the use of a Patient Navigator to initiate a screening episode with eligible patients who are 45-75 (and have no colonoscopy in the last 10 years or FIT in the last 12 months) as identified from medical records.

Detailed description: In Aim 1, the investigators will evaluate the ability of an implementation of an EBI to improve CRC screening and diagnostic colonoscopy rates, defined as completed screening episode (effectiveness) through implementation of an EBI for CRC screening in rural Indiana. The investigators hypothesize that a complete screening episode of CRC screening (FIT or screening colonoscopy), including diagnostic colonoscopy uptake following positive FIT, will be higher following implementation of an EBI and throughout maintenance compared to baseline (usual care). Resolution with diagnostic colonoscopy and repeat screening with FIT will be handled as exploratory outcomes.

In Aim 2, the investigators will evaluate the variation in contextual factors (innovation, recipient, inner and outer context), implementation strategies and implementation outcomes (reach and implementation) using mixed data (qualitative interviews and quantitative measures) to build implementation profiles of nine rural clinics.

In Aim 3, the investigators estimate the cost and budget impact of the deployment of implementation strategies and processes for rural clinics and evaluate the cost-effectiveness of implementing and sustaining the CRC screening intervention.

Study Overview: The investigators will partner with the IRHA, a not-for-profit organization, that was founded in 1997 to meet the healthcare needs of rural residents including Medicare and Medicaid recipients in underserved areas in Indiana. Nine IRHA with CRC screening rates below the state average of 68% were selected.

Approach and Design: The EBI for CRC screening consists of mailing an opportunity for patients not up to date with CRC screening to obtain a colonoscopy, Cologuard or FIT kit. Patients are provided with an opportunity to talk to a patient navigator and select screening options. Risk status for colorectal cancer is assessed. To initiate a screening episode, screening eligible patients who are 45-75 (no colonoscopy in the last 10 years or FIT in the last 12 months) will be identified from medical records

A centralized PN will serve all clinics during implementation, but this role will transition to clinic staff during maintenance. The PN will provide support to patients making decisions about the correct CRC screening test, scheduling a screening colonoscopy, and follow-up with a diagnostic colonoscopy when an FIT is positive.43,57-71 A standard operating procedure (SOP) will be developed during planning to support the navigation protocol and the transition of the PN role to clinic staff during maintenance. Navigation may include further assessment or confirmation of risk status, discussion about CRC screening or scheduling of a screening colonoscopy. With verbal consent, all calls will be recorded. Using the SOP, clinic staff who have basic medical assistant training will be able to support navigation when the PN role is transitioned to the clinic. A fidelity checklist will be used to assess 25% of all recorded calls for consistency in delivering the navigation protocol.

A positive stool-based test will prompt a stepped approach to counseling for diagnostic colonoscopy.

Implementation Strategy: The implementation strategy includes four components: 1) external facilitation, 2) CC identification and preparation, 3) establishment of a collaborative learning environment and 4) promotion of local adaptation.

Implementation Process: Startup activities occur in Year 1 and include ordering materials and supplies, hiring and training staff, establishing monthly research team meetings and EAB meetings, refining data collection measures and meeting with consultants. Using input from clinic staff, the investigators will hire and train interviewers and establish processes for all data collection including computer interfaces and database management. A PN will be available in each clinic to counsel patients. During Phase 1, investigators will assess CRC screening rates and promotion/education activities to identify a baseline as well as determine costs associated with any currently implemented strategies. Phase 2 begins as each cluster is stepped into the implementation design. A CC will be selected at each clinic and a learning collective will be developed to inform and engage all clinic staff. Before developing a clinic-specific plan, the investigators will assess contextual factors by collecting data from clinic staff and patients to inform the implementation plan. Assessment of contextual factors will provide information about the evidence surrounding the EBI, motivation or self-efficacy of staff/patients for implementing the EBI and factors in the inner or outer context that would facilitate or present challenges to implementation.

Following assessment, the clinics will begin development of a plan to support the steps necessary to implement the EBI, including the need for resources such as technical support for EMR programming and development of computerized logs for use in tracking activities. The clinic-specific plan will be developed in partnership with the CC and clinic staff. The learning collaborative will inform the implementation plan development, educate staff about the implementation process, and identify areas where adaptations to the plan are needed. After planning, the clinics will execute the implementation plan. Computerized clinic logs will track all steps of implementing the intervention including FIT and Cologuard distribution and retrieval, scheduling, completion of colonoscopy (screening and diagnostic) and PN calls. During active implementation, both the EIS and CC will use tracking sheets to record all actions, and fidelity will be monitored monthly. Adaptations to the initial implementation plan will be carefully documented.

Phase 3 (Maintenance) follows active implementation and is used to monitor continued adoption of the EBI and subsequent CRC screening, including annual repeat FIT screening for those who completed an initial negative FIT and diagnostic colonoscopy following a positive FIT. Cost effectiveness of implementation will be measured.

Eligibility criteria: Inclusion Criteria:

* All participants will be staff employed at the respective clinics. Patients will be age 45 to 75 and either male or female. Age limitations are necessary because colorectal cancer screening doesn't start until 45 and ends at 75.

Exclusion Criteria:

* Under surveillance (inherited familial syndromes),history of inflammatory bowel disease, and a previous adenomatous polyp, or previous colorectal cancer.

Primary outcomes:
measure: Effectiveness and Maintenance
timeFrame: Up to 12 months
measure: Contextual factors
timeFrame: Up to 12 months
measure: Implementation outcomes
timeFrame: Up to 36 months
Secondary outcomes:
Other outcomes:
measure: Maintenance
timeFrame: Up to 36 month
Locations:
city: Monroe
country: United States
facility: Monroe Family Medicine (Adams Medical Group Monroe)
state: Indiana
Study officials:
affiliation: Indiana University
name: Victoria Champion, PhD
role: PRINCIPAL_INVESTIGATOR
References: