Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening

Study Overview
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Brief Summary
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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
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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.

Official Title
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Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening

Conditions
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Cancer Screening Tests

Intervention / Treatment
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* Behavioral: Decision aid without personalized message
* Behavioral: Decision aid with personalized message
* Behavioral: Provider notification without personalized message
* Behavioral: Provider notification with personalized message


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PATIENTS will be eligible if they are: age 50 - 75 years have not had a colonoscopy performed in the last 10 years, sigmoidoscopy in the last 5 years, fecal occult blood testing (FOBT or FIT) in the last year, or Cologuard in the last 3 years have not had a colonoscopy since turning 50 years old have a scheduled appointment with a provider who agreed to participate in the study PROVIDERS will be eligible if they are: a physician (MD or DO), nurse practitioner (NP), or physicians assistant (PA) practicing at a partner research site Exclusion Criteria: PATIENTS will be excluded if they are: undergoing workup for symptoms consistent with CRC, such as unexplained weight loss, change in bowel habit, or rectal bleeding have a diagnosis or medical history conferring elevated risk for CRC including a previous adenomatous polyp or CRC, inflammatory bowel disease, high-risk syndromes, or a significant family history of CRC (two or more first degree relatives (FDR) with CRC or one FDR with a CRC diagnosis prior to age 60) are unable to speak and read English previously participated in any research projects regarding colorectal cancer screening or colonoscopy including, but not limited to the investigators' previous studies members of the study team will not be participating in the study; therefore, patients who have a scheduled appointment with any member of the study team will not be eligible. PROVIDERS will be excluded if they: do not have patients between 50 - 75 years old.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2x2, randomized, controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Patients view decision aid without personalized message and whose providers do not receive the personalized message. | Behavioral: Decision aid without personalized message<br>* 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.<br>Behavioral: Provider notification without personalized message<br>* 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.<br>|
| Experimental: Group 2<br>Patients view decision aid with personalized message and whose providers do not receive the personalized message. | Behavioral: Decision aid with personalized message<br>* 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.<br>Behavioral: Provider notification without personalized message<br>* 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.<br>|
| Experimental: Group 3<br>Patient view decision aid without the personalized message and whose providers receive the personalized message. | Behavioral: Decision aid without personalized message<br>* 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.<br>Behavioral: Provider notification with personalized message<br>* 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.<br>|
| Experimental: Group 4<br>Patients view decision aid with the personalized message and whose providers receive the personalized message. | Behavioral: Decision aid with personalized message<br>* 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.<br>Behavioral: Provider notification with personalized message<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who complete colorectal cancer screening | Patients' completion of colonoscopy, fecal immunochemical testing (FIT), or other CRC screening within 6 months, based on documentation in the participants' electronic health record. | 6 months after patient enrollment | 
| Decision Quality assessed using the multi-dimensional measure of informed consent (MMIC) which incorporates knowledge, intent, and behavior. | Decision quality will be assessed using the multi-dimensional measure of informed consent (MMIC), where a high-quality decision is one where the individual has adequate knowledge regarding the available options and undergoes the intervention that he or she has chosen or that fits his or her values (values concordance). Patient knowledge of colorectal cancer and screening will be assessed by a 12-item test made up of 6 multiple choice questions and 6 true-false questions. Adequate knowledge = 10 correct. Concordance will be measured between the patient's test choice at the post-provider survey and the screening test underwent, if any, within 6 months after patient enrollment. | 6 months after patient enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colorectal Cancer (CRC) Screening Intention | Patients' intention to be screened for CRC with any CRC screening test will be measured with 1 item: Do you plan to get any type of colon cancer test within the next 6 months?. | 1 day | 
| Colorectal Cancer (CRC) Screening Test Choice | For those patients who answer the screening intent with definitely not, probably not, or may or may not, test choice will be categorized as no screening. Those who answer Screening Intent with Probably or Definitely have Test Choice categorized based on their answer to a single item: If you have a colon test, which one would you choose? Response options are: Stool test (FIT or Cologuard), Colonoscopy, Another test, or Don't know. | 1 day | 
| Perceived Risk of Colorectal Cancer (CRC) | Multiple choice questions assessing the patients' perception of how likely they are to get colon cancer in the next 5 years, in the next 10 years, and sometime during their lifetime. Each has response options: 4=very likely, 3=somewhat likely, 2=somewhat unlikely, and 1=very unlikely. | 1 day | 
| Decision Conflict Scale | Patients' decision conflict is assessed using the low literacy version of the Decision Conflict Scale, a ten-item instrument that assesses patients' subjective feeling regarding the decision process over five areas. Each item has three response categories (yes, no, unsure). Scores are summed; divided by 10; and multiplied by 25. Scores range from 0 [no decisional conflict] to 100 [extremely high decisional conflict]. | 1 day | 
| Perceived Shared Decision Making | Patients will answer five items assessing the extent to which they were involved in the decision-making process and three items to assess how much effort was made by their provider to: explain colon cancer screening, ask for screening preferences, and incorporate those preferences into the decision. | 1 day | 
| Number of orders for a Colorectal Cancer Screening (CRC) Test | A provider order for FIT, colonoscopy, or other CRC screening test for each of their enrolled patients will be assessed by reviewing the electronic health record (EHR). | 6 months after patient enrollment | 
| Number of providers who open their provider notification | Opening the provider notification will be assessed by reviewing the electronic health record (EHR). | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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decision aid, cancer screening, risk assessment, risk communication, colorectal neoplasm, decision making