Improving colorectal cancer screening in primary care clinics

PB-iCRC: Multi-site Practice-Based Implementation of a ColoRectal Cancer Screening Intervention

This study is testing two different ways to improve colorectal cancer screening rates in primary care clinics to see which one helps more people get screened.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 2200 (estimated)
• Ages: 45 Years to 75 Years
• Sex: All
• Sponsor: University of Kansas Medical Center (other)
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT06682650 on ClinicalTrials.gov

What this trial studies

This study aims to enhance colorectal cancer screening uptake in primary care settings by comparing two implementation strategies: a Normalization Process Theory-informed Participatory Learning in Action (NPT-PLA) approach and a usual quality improvement method. Conducted in 20 US primary care clinics, the trial will assess the effectiveness of the NPT-PLA intervention in increasing screening orders and completions over a six-month period. Additionally, the study will evaluate the facilitators and barriers encountered in each implementation arm using an expanded Normalization Process Theory framework. Patients aged 45 to 75 who are due for screening will be enrolled and monitored for their screening outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 45 to 75 who are due for colorectal cancer screening and prefer Spanish as their primary language.

Not a fit: Patients with a personal or close family history of colorectal cancer who are ineligible for routine screening may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly increase colorectal cancer screening rates, leading to earlier detection and improved patient outcomes.

How similar studies have performed: Previous studies have shown success with implementation intentions-based tools for increasing colorectal cancer screening, making this approach promising yet still innovative in its application.

Eligibility criteria

Inclusion Criteria:

Clinics participating in the DARTNet Institute /AAFP-affiliated NRN clinic serving communities in which at least 25% of the population prefers Spanish-language.

Clinic implementation teams Patients participating in implementation teams for whom Spanish is their preferred language, who are bilingual in English and Spanish, Clinics Staff will be included who have any contact regarding CRC screening with patients eligible for screening.

Patients whose CRC screening outcomes will be monitored:

adults 45 to 75 years of age who are due for CRC screening, i.e. who have not received a high-sensitivity fecal occult blood test or a fecal immunochemical test within the past year, fecal DNA testing within 3 years, sigmoidoscopy or barium enema within 5 years, or colonoscopy within 10 years; and who receive primary care at least annually from the site.

Exclusion Criteria:

* patients ineligible for routine screening based on a personal or close family history of colorectal cancer or who have increased genetic risk of colon cancer.
* cognitive or decisional incapacity will be excluded from the implementation teams, after completion of a brief, validate screening tool, the Mini-Cog Exam.

Where this trial is running

Aurora, Colorado

• DARTNet Institute — Aurora, Colorado, United States (RECRUITING)

Study contacts

• Principal investigator: Joseph W LeMaster, MD MPH — University of Kansas
• Study coordinator: Joseph W LeMaster, MD MPH

Conditions: Colorectal Carcinoma, colorectal carcinoma, implementation science, cancer prevention, cancer screening, normalization process theory, participatory health research, cluster randomized trial