Participatory Research to Advance Colon Cancer Prevention
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The overall goal of this study is to test strategies to raise rates of colorectal cancer
      screening among the Latino population in a federally qualified health center that operates
      multiple clinics. This intervention study will test automated and live prompts to a
      direct-mail fecal testing program in two phases.

      In Phase I (Years 01 - 02), the investigators will tailor and define intervention components
      using a community-based participatory research approach called boot camp translation (BCT).
      The ultimate design of the intervention will be defined by patient and provider feedback from
      BCT. The investigators will then conduct a three-arm patient-randomized comparative
      effectiveness trial in two pilot clinics to compare 1) automated prompts (i.e., automated
      phone calls, text messages) to alert and remind patients to complete screening, 2) live
      prompts (i.e., live phone calls), and 3) a combination approach of automated plus live
      prompts.

      In Phase II (Years 03 - 05), the investigators will spread and test the spread of the adapted
      intervention to additional clinics within the partnering health center using a two-arm main
      trial.

      Both phases will be guided by an advisory group of clinicians, researchers, policy makers,
      and patients.
    

Detailed description: 
      The study will fulfill the following aims:

      Aim 1: Develop personalized messages (e.g., phone scripts, text messages, patient portal
      prompts) and define an intervention using boot camp translation to increase colon cancer
      screening among Latino populations.

      Aim 2: Assess the reach, effectiveness, and differences by subgroup (e.g., preferred
      language) of a three-arm colorectal cancer screening program among Latino FQHC patients, in 2
      clinics, through a patient randomized-controlled trial.

      In addition to Usual Care, the arms are:

        -  Automated Prompts-an automated data-driven program for delivering FIT kit prompts (using
           automated phone calls, text messages, and/or emails) to patients due for colorectal
           cancer screening.

        -  Automated Plus Live Prompts-a higher-intensity program using automated, data-driven
           strategies for delivering FIT kit prompts plus linguistically and culturally tailored
           live prompts.

      Aim 3: Test the spread of the program across additional clinics using a two-arm randomized
      approach and develop an implementation guide that includes outreach materials, strategies for
      incorporating patient input, and resources.
    

Intervention name(s): Automated Prompts; Automated Plus Live Prompts
Intervention type(s): Other; Other
Intervention description(s): This intervention is an automated data-driven program, using automated phone calls, text messages, and/or emails, for delivering FIT kit prompts to patients due for colorectal cancer screening. The specific components of the intervention are forthcoming and will be determined using a community-based participatory research approach known as boot camp translation which seeks input from patients and providers.; This intervention is a higher-intensity program, using automated data-driven prompts plus linguistically and culturally tailored live prompts, for delivering FIT kit messages to patients due for colorectal cancer screening. The specific components of the intervention are forthcoming and will be determined using a community-based participatory research approach known as boot camp translation which seeks input from patients and providers.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Phase I: The investigators will conduct a three-arm patient-randomized trial to compare 1) usual care, 2) automated prompts, and 3) automated plus live prompts. (Number of Arms: 3)
Phase II: This spread trial will use a stepped-wedge design, which is a variant of a crossover randomized trial, where clinics cross over from usual practice to the best practices program. In the stepped-wedge design, a baseline period controls for the level and rate of change of the outcomes prior to program implementation and the staggered implementation minimizes confounding due to changes in the secular trend. By randomizing practices to when they receive an intervention instead of whether they receive it, the stepped wedge design ensures that all practices eventually receive the intervention, an important consideration for clinic leadership. Furthermore, the wedge-defined clusters act as their own controls as they each receive both intervention conditions. (Number of Arms: 2)
Masking: None (Open Label)
Primary purpose: Screening
Keywords: colorectal cancer screening; cancer screening; pragmatic trial; boot camp translation