Clinical trial · Observational
Implementing a Multilevel Intervention to Accelerate Colorectal Cancer Screening and Follow-up
Implementing a Multilevel Intervention to Accelerate Colorectal Cancer Screening and Follow-up in Federally Qualified Health Centers Using a Stepped Wedge Design
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intervention Phase 1: Provider and Staff education | Behavioral | — | UNRESOLVED |
| Intervention Phase 2: Provider and staff education + Patient reminder | Behavioral | — | UNRESOLVED |
| Intervention Phase 3: Provider and Staff education + Patient reminder + Patient navigation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group 1
- description
- The study participants included two federally qualified health centers (FQHCs) in Illinois and two in Indiana. Together, these four FQHCs had 65 primary care clinics and served 131,233 individual patients in 2020. One FQHC in Illinois and one FQHC in Indiana were randomly assigned to group 1, and the other two FQHCs were assigned to group 2. The only difference between the two groups was a 3-month delay in implementing the study intervention components.
- interventionNames
- Behavioral: 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
- label
- Group 2
- description
- The study participants included two federally qualified health centers (FQHCs) in Illinois and two in Indiana. Together, these four FQHCs had 65 primary care clinics and served 131,233 individual patients in 2020. One FQHC in Illinois and one FQHC in Indiana were randomly assigned to group 1, and the other two FQHCs were assigned to group 2. The only difference between the two groups was a 3-month delay in implementing the study intervention components.
- interventionNames
- Behavioral: Intervention Phase 1: Provider and Staff education
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Eligibility for Federally Qualified Health Centers (FQHCs) Inclusion criteria: * 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 Exclusion criteria: * 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
References
Publications (1)
- DERIVEDKim K, Polite B, Hedeker D, Liebovitz D, Randal F, Jayaprakash M, Quinn M, Lee SM, Lam H. Implementing a multilevel intervention to accelerate colorectal cancer screening and follow-up in federally qualified health centers using a stepped wedge design: a study protocol. Implement Sci. 2020 Oct 29;15(1):96. doi: 10.1186/s13012-020-01045-4. PMID 33121536