Increasing Engagement With Messages Regarding CRC Screening Among Adults Aged 45-49
Condition: Colorectal Cancer; Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      In May of 2021, the United States Preventive Service Task Force (USPSTF) updated their
      colorectal cancer (CRC) screening guidelines by recommending screening at an earlier age for
      average-risk adults starting at the age of 45 years old (Grade B recommendation). This is in
      addition to their Grade A recommendations of continuing to screen average-risk adults ages
      50-75 years old. As the investigators health system aims to screen the newly eligible
      population of average-risk patients between the ages of 45-49, the investigators proposed
      randomized controlled trial is aimed to determine the most effective patient outreach
      approach to increase patients' engagement with messages regarding CRC screening and screening
      uptake within this specific age-group.
    

Detailed description: 
      Colorectal cancer (CRC) is the second leading cause of cancer-related death for both men and
      women in the United States. One in 17 Americans will suffer from CRC during their lifetime
      and early detection of cancers and polyps by screening is shown to reduce CRC mortality. In
      2021, the USPSTF updated its CRC screening guidelines to start screening average-risk
      individuals at the age of 45 years due in part to a rising incidence of CRC and premalignant
      polyps in younger patients.

      This current study will be a nested study within a larger investigation to determine the most
      effective patient outreach approach to increase patients' engagement with messages regarding
      CRC screening and CRC screening utilization in average-risk individuals ages 45-49 years.
      Here the investigators are testing which type of SMS messaging is most effective in prompting
      people to review MyChart message regarding CRC screening and thus increasing CRC screening
      uptake among individuals 45-49 years old.

      There will be three different text messages that have been formulated utilizing behavioral
      science principles, and then randomize them equally among the eligible population. There will
      be stratified patient randomization based on arm assignment in our 'CRC45+ Choice' evaluation
      to prevent cross-study contamination. The arms for this investigation will be 1) Control, 2)
      Risk Information and 3) Risk Information + Action. In the control (standard care) arm,
      patients will receive the standard SMS text message. In the Risk Information arm, patients
      will receive a message indicating their risk for colorectal cancer, on top of the content in
      the Control arm. Finally, in the Risk Information + Action arm patients will receive risk
      information and importance of taking quick action, on top of the content in the Control arm.
      The investigators will also randomly assign patients into receiving our text message on one
      of ten workdays, stratifying by arm assignment in both the CRC45+ Choice Evaluation and
      CRC45+ Text Evaluation.

      We will send text reminders to patients two weeks after they receive the initial text
      message. Reminder content will be very similar to the content of initial text message, and
      differ by arm.

      For this investigation the investigators hypothesize:

        1. Hyp 1: Patients assigned to the Risk Information + Action Arm (Arm 2) will have a higher
           click rate than patients assigned to the Control Arm (Arm 0)

        2. Hyp 2: Patients assigned to the Risk Information + Action Arm (Arm 2) will have a higher
           click rate than patients assigned to the Risk Information Arm (Arm 1)

      Analysis: The investigators will utilize patient-level ordinary least squares (OLS)
      estimation, with statistical inferences based on model-robust standard errors. The primary
      model term will be indicator variables for arm assignment.

      The analysis will adjust for sex, race/ethnicity, social vulnerability index (at the ZIP code
      level), and MyChart logins decile.

      Treatment effects will be summarized using rate differences and 95% CI's. Exploratory
      analyses will investigate heterogenous treatment effects by demographic subgroups by
      splitting the sample into each demographic subgroup as well as by testing demographics and
      text message arm interactions. Sensitivity analyses will be performed without covariates, and
      using logistic regression models in place of linear regression models. Missing covariate
      values will be handled by including 'unknown' indicators, along with mean imputation for
      quantitative covariates.

      The investigators will additionally explore how click rates within the SMS message vary with
      the day of the week.

      Primary analyses will use intention-to-treat protocol.
    

Intervention name(s): Risk Information; Risk Information + Action
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This group will receive an SMS text message highlighting their risk for CRC on top of the content in the Control arm.; This group will receive an SMS text message highlighting their risk for CRC and the importance of taking quick action, on top of the content in the Control arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Parallel-arm randomized controlled trial,
Three arms
Arm 0: Standard of care control (standard text messaging)
Arm 1: Experimental, "Risk Information" group
Arm 2: Experimental, "Risk Information + Action" group
Patient-level randomization stratified by arm assignment in CRC45+ Choice Evaluation. The investigators will also randomly assign patients into receiving the text message on one of ten workdays, stratifying by arm assignment in both the CRC45+ Choice Evaluation and CRC45+ Text Evaluation
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Colorectal Cancer Screening; Behavioral Economics; Colorectal Cancer