Reducing Rural Colon Cancer Disparities

Study Overview
=================
Brief Summary
-----------------
The investigators will conduct pre-implementations assessments of primary care clinics within a rural health system to determine current practices and capacities regarding colorectal cancer (CRC) screening and follow-up, preferred evidence-based interventions (EBIs) to improve follow-up, and factors that could influence successful implementation and eventual impact of a multi-level intervention to increase timely and complete follow-up after positive fecal occult blood test (FOBT) in rural patients.

Official Title
-----------------
Reducing Rural Colon Cancer Disparities Through Multi-level Interventions in Follow-up After Abnormal Screening Tests

Conditions
-----------------
Colon Cancer

Intervention / Treatment
-----------------
* Other: Primary Care Provider/Staff Participants Interview
* Other: Patient Participant Interview
* Other: Patient Participant Anonymous Survey
* Other: Colonoscopy Provider/Staff Participants Interviews


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for Primary Care Provider/Staff Participants -Eligible providers and staff include physicians, nurse practitioners, nurses, case managers, medical assistants, administrative staff, or other employees of the clinic involved in the cancer screening and follow-up process. Inclusion Criteria for Patient Participants (Interview) -Positive FOBT or colonoscopy Inclusion Criteria for Patient Participants (Survey) 50 years of age or older Had a colonoscopy at one of Southern Illinois Healthcare's facilities within the last 24 months Inclusion Criteria for Colonoscopy Provider/Staff Participants -Provider and a staff or mid-level provider in each office (5 colonoscopy providers in the Southern Illinois Healthcare region) Exclusion Criteria for Primary Care Provider/Staff Participants -None Exclusion Criteria for Patient Participants (Interview) Negative FOBT or colonoscopy Exclusion Criteria for Patient Participants (Survey) Younger than 50 years of age Exclusion Criteria for Colonoscopy Provider/Staff Participants None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Care Provider/Staff Participants Interviews<br>Up to two primary care providers and at least one staff person at each of the 16 clinics, with approximately 5 interviewees per clinic. Eligible providers and staff include physicians, nurse practitioners, nurses, case managers, medical assistants, administrative staff, or other employees of the clinic involved in the cancer screening and follow-up process. If the participant verbally consents, the research team member will conduct an interview with the provider to learn about the current processes used to support and monitor colorectal cancer screening (CRC) from screening initiation through follow-up; assess capacity and interest in implementing Evidence Based Practices for supporting and monitoring CRC screening, including any ideas interviewees have or find appealing; and engage the organizations as partners to build interest, capacity, and infrastructure for future intervention trial and other future studies. | Other: Primary Care Provider/Staff Participants Interview<br>* -Approximately a 30 minute interview<br>|
| Patient Participants Interviews<br>10 patients across 5 clinics will be recruited for interviews, which will address the patient experience with screening and follow-up. If the participant verbally consents, the research team member will conduct an interview with the patient participant to gain a deeper understanding of the CRC screening process from the patient's perspective; the gaps, challenges, or road blocks/speed bumps to completing CRC screening steps; and what organizations can do better or differently to help people complete the CRC screening process. | Other: Patient Participant Interview<br>* -Approximately 45-60 minute interview<br>|
| Patient Participants Anonymous Survey<br>-Patient participants will be recruited to take an anonymous mailed survey, which will address patient level barriers to screening and follow-up focusing on out of pocket costs. | Other: Patient Participant Anonymous Survey<br>* -Survey completion will take approximately 15 minutes<br>|
| Colonoscopy Provider/Staff Participants Interviews<br>Colonoscopy providers and a staff or mid-level provider in each office will be recruited for interviews. If the participant consents, the research team member will conduct an interview to learn about current processes used to support and monitor colorectal cancer screening from the perspective of gastroenterology/colonoscopy sites and to learn about how gastroenterology/colonoscopy sites communicate and coordinate care with other healthcare organizations and patients to support and monitor colorectal cancer screening. | Other: Colonoscopy Provider/Staff Participants Interviews<br>* -Approximately a 30 minute interview<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine current practice and capacity regarding screening and follow-up of colorectal cancer screening at rural health clinics | -This will be measured by interviews | Through completion of study (estimated to be 18 months) | 
| Assess factors that could influence implementation of multi-level EBIs | -This will be measured by interviews | Through completion of study (estimated to be 18 months) | 
| Evaluate the capacity for colonoscopy and diagnostic follow-up by identifying those clinics/practitioners who deliver colonoscopy | -This will be measured by interviews | Through completion of study (estimated to be 18 months) | 
| Assess the care coordination and communication with primary care providers by colonoscopy clinics/practitioners | -This will be measured by interviews | Through completion of study (estimated to be 18 months) |