Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening

Not Applicable

Completed

Conditions: Cancer Screening Tests

Interventions: Behavioral: Decision aid without personalized message
Behavioral: Decision aid with personalized message
Behavioral: Provider notification without personalized message
Behavioral: Provider notification with personalized message

Registration Number: NCT04683731

Lead Sponsor: Indiana University

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1111

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Decision aid without personalized message	Patients view decision aid without personalized message and whose providers do not receive the personalized message.
Group 4	Decision aid with personalized message	Patients view decision aid with the personalized message and whose providers receive the personalized message.
Group 1	Provider notification without personalized message	Patients view decision aid without personalized message and whose providers do not receive the personalized message.
Group 4	Provider notification with personalized message	Patients view decision aid with the personalized message and whose providers receive the personalized message.
Group 2	Decision aid with personalized message	Patients view decision aid with personalized message and whose providers do not receive the personalized message.
Group 2	Provider notification without personalized message	Patients view decision aid with personalized message and whose providers do not receive the personalized message.
Group 3	Decision aid without personalized message	Patient view decision aid without the personalized message and whose providers receive the personalized message.
Group 3	Provider notification with personalized message	Patient view decision aid without the personalized message and whose providers receive the personalized message.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Completed Colorectal Cancer Screening	6 months after patient enrollment	Patients' completion of colonoscopy, fecal immunochemical testing (FIT), or other CRC screening within 6 months, based on documentation in the participants' electronic health record.
Number of Participants Who Made a High Quality Decision Using the Multi-dimensional Measure of Informed Consent (MMIC) Which Incorporates Knowledge, Intent, and Behavior.	6 months after participant enrollment	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 screening test 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 = 9 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.

Secondary Outcome Measures

Name	Time	Method
Participant's Average Perception of Shared-Decision Making as Assessed by CollaboRATE	approximately 4-30 days after viewing intervention and 4-14 days after provider visit [post-provider visit/T2]	A 3-item measure assessing how much effort was made by their provider to: explain colon cancer screening, ask for screening preferences, and incorporate those preferences into the decision. Response options ranged from 0="No effort was made" to 9="Every effort was made". The three items were summed and a mean was calculated. Scores can range from 0-9. A higher score indicates more perceived shared decision making. Higher perceived shared decision making is a better outcome.
Number of Participants With Orders for a Colorectal Cancer Screening (CRC) Test	6 months after patient enrollment	A FIT, colonoscopy, or other CRC screening test ordered within 6 months of each participants' enrollment based on documentation in the electronic health record (EHR).
Number of Participants Who Completed Colorectal Cancer Screening by Type of Screening Test Completed	6 months after participant enrollment	Colorectal cancer (CRC) screening uptake and type of screening test completed within 6 months of enrolled was assessed, as documented in the electronic health record (EHR).
Average Intention to Get a Colorectal Cancer (CRC) Screening Test of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit	1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2)	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 screening test within the next 6 months?". The response options were: 5=Definitely; 4=Probably; 3=May or may not; 2=Probably not; and 1=Definitely not. Higher positive change means CRC screening intention increased. Increased intention to be screened is a better outcome.
Number of Providers Who Open Their Provider Notification	6 months after patient enrollment	Opening the provider notification sent for each patient was assessed by reviewing the electronic health record (EHR).
Average Decision Conflict of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit	1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2)	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 \[extremely high decisional conflict\]. Negative change means decision conflict decreased. A decrease in decision conflict is a better outcome.
Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior	1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2)	For those patients who answer the screening intent item 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.
Average Correct Responses of Participants to Knowledge Questions About Colorectal Cancer (CRC) and CRC Screening: Change Between Baseline, Post-intervention, and Post-provider Visit.	1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2)	Knowledge was assessed with six multiple choice and six true/false questions regarding general information (including risk factors, screening test options, and test frequency) of CRC and CRC screening. Knowledge scores were derived by summing correct responses to the 12 individual knowledge questions (range, 0-12), and change was calculated from baseline (T0) to post-intervention (T1), post-intervention (T1) to post-provider visit (T2), and from baseline (T0) to post-provider (T2) by using the knowledge score at the later time point minus the knowledge score of the former time point. The range for change could be -12 to 12 with higher values meaning an increase in knowledge which is a better outcome.
Average Perceived Personal Colorectal Cancer Risk of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit	1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2)	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. The mean of the 3 questions was calculated (each combined score has a range of 1 to 4) at each time point. We calculated the change from baseline (T0) to post-intervention (T1), post-intervention (T1) to post-provider visit (T2), and from baseline (T0) to post-provider (T2) by using the mean of the later time point minus the mean of the former time point. The range for change could be from -3 to 3 with higher values meaning an increase in perceived risk.
Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4	approximately 4-30 days after viewing intervention and 4-14 days after provider visit [post-provider visit/T2]	Patients answered four items assessing the extent to which they were involved in the decision-making process. Each item had response options: 1= A lot; 2=Some; 3=A little; 4=Not at all. Each item was analyzed separately and responses "A lot", "Some" and "A little" were considered "enough" and received 1 point. The response "Not at all" was considered "not enough" and received 0 points.
Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Decision Quality Instrument	approximately 4-30 days after viewing intervention and 4-14 days after provider visit [post-provider visit/T2]	A single-item measure taken from the Colon Cancer Testing Decision Quality Worksheet v.2.0 assessing if the patients' primary care provider asked them which type of colon cancer screening test they wanted.