Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening
Condition: Cancer Screening Tests
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Precision prevention holds great promise for colorectal cancer (CRC) screening but has not
      been adequately explored. A patient's chance of having an advanced colorectal neoplasm (ACN),
      i.e. a cancer or precancerous polyp in the colon, significantly affects the comparative
      effectiveness of approved tests. Giving patients a decision aid with information about their
      risk for ACN, and giving their providers similar information, could help patients and
      providers decide if colonoscopy or a non-invasive test (such as the fecal immunochemical
      test) is more appropriate. This could improve decision making and increase uptake of CRC
      screening, which are the investigative team's long-term goals.
    

Detailed description: 
      The research team has developed and pilot tested a decision aid and provider message that
      discloses the patient's current risk of ACN, based on a prediction rule developed and
      validated by Dr. Thomas Imperiale, a member of the study team. The Imperiale Prediction Rule
      uses five variables (gender, age, CRC family history, waist circumference, and smoking
      history) and identifies a wide range of risk for current ACN among average risk patients. For
      patients with "high-average" risk (22%), personalized messages in the decision aid and
      provider notification highlight the advantage of colonoscopy because of the likelihood of
      finding and removing an ACN. For patients at low risk for ACN (2% or 4%), personalized
      messages highlight the advantage of stool testing, due to the relatively low chance of
      failing to detect ACN.

      The investigators' long-term goal is to increase uptake of CRC screening by informing and
      improving patient and provider discussion and decisions. The main objective of this project
      is to test whether providing patients and their providers with personalized messages about
      ACN risk results in higher screening uptake and higher decision quality, compared to an
      approach that does not utilize ACN risk.
    

Intervention name(s): Decision aid without personalized message; Decision aid with personalized message; Provider notification without personalized message; Provider notification with personalized message
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.; The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.; Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.; Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2x2, randomized, controlled trial
Masking: Single (Participant)
Primary purpose: Screening
Keywords: decision aid; cancer screening; risk assessment; risk communication; colorectal neoplasm; decision making