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

Conditions

• Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

50 Years - 75 Years

Healthy Volunteers

Accepted

Interventions

• Intervention Phase 1: Provider and Staff education — BEHAVIORAL
  In Phase 1, CRC control experts will identify critical messages on CRC, screening guidelines, and methods, and provide educational training to providers and staff in our partner FQHCs before implementing any intervention components. Additionally, the research team will provide refresher sessions and offer yearly training in CRC-relevant topics, including CRC and genetics.
• Intervention Phase 2: Provider and staff education + Patient reminder — BEHAVIORAL
  In Phase 2, we will add a patient reminder component using short message services (SMS) to engage and remind patients to complete the screening. For patients who use colonoscopy as a screening method, the SMS will also include instructions on bowel preparation and dietary restrictions for five days prior to the procedure.
• Intervention Phase 3: Provider and Staff education + Patient reminder + Patient navigation — BEHAVIORAL
  In Phase 3, we will add patient navigation services, which will address both organizational and individual barriers to obtaining screening.

Study Details

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 Dates

Start date

Sep 1, 2020

Status verified

Sep 2025

Primary completion

Dec 31, 2023

Completion

Dec 31, 2023

Study Design

Enrollment

4 participants (actual)

Arms

• Arm: Group 1
  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.
• Arm: Group 2
  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.

Primary Outcome Measure

CRC Screening Rate [ Time Frame: From date of randomization until the last subject completed the study. This could have been up to 36 months. ]

Locations (1)

Find similar trials in Oak Park, IL

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