Implementing a Multilevel Intervention to Accelerate Colorectal Cancer Screening and Follow-up
Public ClinicalTrials.gov record NCT04514341. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Implementing a Multilevel Intervention to Accelerate Colorectal Cancer Screening and Follow-up in Federally Qualified Health Centers Using a Stepped Wedge Design
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04514341
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 4 participants
Conditions and interventions
Conditions
Interventions
- Intervention Phase 1: Provider and Staff education Behavioral
- Intervention Phase 2: Provider and staff education + Patient reminder Behavioral
- Intervention Phase 3: Provider and Staff education + Patient reminder + Patient navigation Behavioral
Behavioral
Eligibility (public fields only)
- Age range
- 50 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2020
- Primary completion
- Dec 30, 2023
- Completion
- Dec 30, 2023
- Last update posted
- Jan 13, 2026
2020 – 2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| PCC Community Wellness Centers | Oak Park | Illinois | 60302 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04514341, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 13, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04514341 live on ClinicalTrials.gov.