Reducing Rural Colon Cancer Disparities

Completed

• Conditions: Colon Cancer
• Interventions: Other: Colonoscopy Provider/Staff Participants Interviews; Other: Primary Care Provider/Staff Participants Interview; Other: Patient Participant Interview; Other: Patient Participant Anonymous Survey

• Registration Number: NCT03457454
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-08
• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-03-01
• Study First Posted: 2018-03-07
• Status Verified: 2021-03
• Primary Completion: 2021-03-18
• Study Completion: 2021-03-18
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 431

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Colonoscopy Provider/Staff Participants Interviews	Colonoscopy Provider/Staff Participants Interviews	* 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.
Primary Care Provider/Staff Participants Interviews	Primary Care Provider/Staff Participants Interview	* 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.
Patient Participants Interviews	Patient Participant Interview	* 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.
Patient Participants Anonymous Survey	Patient Participant Anonymous Survey	-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.

Primary Outcome Measures

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

Trial Locations

Locations (2)

Southern Illinois Healthcare; 🇺🇸 Carbondale, Illinois, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States