Clinical trial NCT03457454: Reducing Rural Colon Cancer Disparities
Official title: Reducing Rural Colon Cancer Disparities Through Multi-level Interventions in Follow-up After Abnormal Screening Tests
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2018-03-07
Enrollment: 431
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Providers/Staff Participants, Patient Participants, and Colonoscopy Provider/Staff Participants from Southern Illinois Healthcare.

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.


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

Primary outcomes:
measure: Determine current practice and capacity regarding screening and follow-up of colorectal cancer screening at rural health clinics
timeFrame: Through completion of study (estimated to be 18 months)
measure: Assess factors that could influence implementation of multi-level EBIs
timeFrame: Through completion of study (estimated to be 18 months)
measure: Evaluate the capacity for colonoscopy and diagnostic follow-up by identifying those clinics/practitioners who deliver colonoscopy
timeFrame: Through completion of study (estimated to be 18 months)
measure: Assess the care coordination and communication with primary care providers by colonoscopy clinics/practitioners
timeFrame: Through completion of study (estimated to be 18 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Carbondale
country: United States
facility: Southern Illinois Healthcare
state: Illinois
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Aimee James, Ph.D., MPH
role: PRINCIPAL_INVESTIGATOR
References: