Implementing a Multilevel Intervention to Accelerate Colorectal Cancer Screening and Follow-up

Completed

Conditions studied: Colorectal Cancer

In brief

Screening for colorectal cancer (CRC) not only detects disease early when treatment is more effective but also prevents cancer by finding and removing precancerous polyps. Because many of our nation's most disadvantaged and vulnerable individuals obtain health care at federally qualified health centers, these centers play a significant role in increasing CRC screenings among the most vulnerable populations. Furthermore, the full benefits of cancer screenings must include timely and appropriate follow-up of abnormal results. Thus, the purpose of this study is to implement a multilevel intervention to increase rates of CRC screenings, follow-ups, and referrals-to-care in federally qualified health centers (FQHCs). Also, we will examine the implementation strategies used to support the implementation process and their contribution to the adoption, implementation, and sustainment of the multilevel intervention. The multilevel intervention will target three different levels of influences: organization, provider, and individual. It will have multiple components, including provider and staff education, provider reminder, provider assessment and feedback, patient reminder, and patient navigation. This study is a multilevel, three-phase, stepped wedge cluster randomized trial with four clusters of clinics from four different FQHCs. Our FQHC partners together have 40 primary care clinics and 130 primary care providers. During Phase 1, there will be a 3-month waiting period during which no intervention components will be implemented. After the 3-month waiting period, we will randomize two clusters of clinics to cross from the control to the intervention and the remaining two clusters to follow three months later. All clusters of clinics will stay at the same phase for nine months, followed by a 3-month transition period, and then cross over to the next phase. In Phase 1, we will implement provider and staff education sessions. In Phase 2, we will add provider reminders, patient reminders, and provider assessment and feedback. We will add patient navigation during the last phase. Single level interventions are often insufficient at leading to sustainable changes. Multilevel interventions are needed to address multilevel contextual influences simultaneously. How to take advantage of multilevel interventions and how to implement such interventions and evaluate their effectiveness are the ultimate goals of this study.

Key facts

Study ID

NCT04514341

Run by

Milton S. Hershey Medical Center

People needed

4

Starts

2020-09-01

Expected to finish

2023-12-31

Last updated by the study team

2026-01-14

Who can join

Age: 50 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Located in Illinois or Indiana
• Provide adult primary care
• Serve patients between the ages of 50 and 75 years
• Able to provide patient-level data

You may not qualify if…

• Located outside Illinois or Indiana
• Do not provide adult primary care
• Unable to provide patient-level data
• Eligibility for patients whom our FQHC partners serve:
• Inclusion criteria:
• Between the ages of 50 and 75
• At general risk for colorectal cancer
• Exclusion criteria:
• Patients who are younger than 45 years old or older than 75 years old
• Patients who are at high risk for colorectal cancer screening and require early screening before the age of 45

Where it is running

• PCC Community Wellness Centers — Oak Park, Illinois, United States

Full record on ClinicalTrials.gov

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