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Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening

Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04683731
Enrollment
1111
Registered
2020-12-24
Start date
2021-01-19
Completion date
2023-07-31
Last updated
2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Screening Tests

Keywords

decision aid, cancer screening, risk assessment, risk communication, colorectal neoplasm, decision making

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.

Interventions

BEHAVIORALDecision aid without personalized message

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.

BEHAVIORALDecision aid with personalized message

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.

BEHAVIORALProvider notification without personalized message

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 electronic health record (EHR) within 24 hours of their visit with the enrolled patient.

BEHAVIORALProvider notification with personalized message

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 electronic health record (EHR) within 24 hours of their visit with the enrolled patient.

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Masking description

Provider-participants will know that their enrolled patient-participant is participating in the study but will not know what arm they were assigned.

Intervention model description

2x2, randomized, controlled trial

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Who Completed Colorectal Cancer Screening6 months after patient enrollmentPatients' 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 enrollmentDecision 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

MeasureTime frameDescription
Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior1 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 Visit1 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.
Average Decision Conflict of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit1 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 Who Completed Colorectal Cancer Screening by Type of Screening Test Completed6 months after participant enrollmentColorectal 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).
Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Decision Quality Instrumentapproximately 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.
Participant's Average Perception of Shared-Decision Making as Assessed by CollaboRATEapproximately 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) Test6 months after patient enrollmentA 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 Providers Who Open Their Provider Notification6 months after patient enrollmentOpening the provider notification sent for each patient was assessed by reviewing the electronic health record (EHR).
Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4approximately 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.
Average Intention to Get a Colorectal Cancer (CRC) Screening Test of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit1 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.

Countries

United States

Participant flow

Recruitment details

Patients were recruited from primary care practices between January 2021 and November 2022.

Participants by arm

ArmCount
Group 1
Patients view decision aid without personalized message and whose providers do not receive the personalized message. Decision aid without personalized message: 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. Provider notification without personalized message: 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.
290
Group 2
Patients view decision aid with personalized message and whose providers do not receive the personalized message. Decision aid with personalized message: 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. Provider notification without personalized message: 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.
262
Group 3
Patient view decision aid without the personalized message and whose providers receive the personalized message. Decision aid without personalized message: 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. Provider notification with personalized message: 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.
247
Group 4
Patients view decision aid with the personalized message and whose providers receive the personalized message. Decision aid with personalized message: 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. Provider notification with personalized message: 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.
285
Total1,084

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyDetermined patient was not eligible33123
Overall StudyWithdrawal by Subject1032

Baseline characteristics

CharacteristicGroup 1Group 2Group 3Group 4Total
Age, Continuous56.2 years
STANDARD_DEVIATION 5.9
56.8 years
STANDARD_DEVIATION 6.5
56.5 years
STANDARD_DEVIATION 6.2
56.4 years
STANDARD_DEVIATION 6.2
56.5 years
STANDARD_DEVIATION 6.2
Education - highest level
Associates degree
28 Participants32 Participants24 Participants26 Participants110 Participants
Education - highest level
Bachelors degree
69 Participants42 Participants53 Participants68 Participants232 Participants
Education - highest level
High school graduate/GED
45 Participants54 Participants55 Participants55 Participants209 Participants
Education - highest level
Less than high school
9 Participants16 Participants10 Participants10 Participants45 Participants
Education - highest level
Prefer not to answer
9 Participants6 Participants6 Participants5 Participants26 Participants
Education - highest level
Professional or graduate degree
38 Participants33 Participants29 Participants45 Participants145 Participants
Education - highest level
Some college or technical school/trade school
79 Participants67 Participants59 Participants68 Participants273 Participants
Education - highest level
Unknown or Not Reported
13 Participants12 Participants11 Participants8 Participants44 Participants
Employed?
No
95 Participants85 Participants89 Participants105 Participants374 Participants
Employed?
Unknown or Not Reported
12 Participants12 Participants11 Participants8 Participants43 Participants
Employed?
Yes
183 Participants165 Participants147 Participants172 Participants667 Participants
Health Insurance?
No
10 Participants9 Participants9 Participants13 Participants41 Participants
Health Insurance?
Unknown or Not Reported
12 Participants12 Participants10 Participants8 Participants42 Participants
Health Insurance?
Yes
268 Participants241 Participants228 Participants264 Participants1001 Participants
Health Literacy2.1 units on a scale
STANDARD_DEVIATION 2.4
1.9 units on a scale
STANDARD_DEVIATION 2.2
2.1 units on a scale
STANDARD_DEVIATION 2.2
1.9 units on a scale
STANDARD_DEVIATION 2.2
2.0 units on a scale
STANDARD_DEVIATION 2.3
Insurance Lapse over 12 Months?
No
238 Participants227 Participants200 Participants239 Participants904 Participants
Insurance Lapse over 12 Months?
Unknown or Not Reported
25 Participants23 Participants23 Participants22 Participants93 Participants
Insurance Lapse over 12 Months?
Yes
27 Participants12 Participants24 Participants24 Participants87 Participants
Perceived Comparative Risk for Colorectal Cancer
About the same as other women/men your age
111 Participants101 Participants101 Participants110 Participants423 Participants
Perceived Comparative Risk for Colorectal Cancer
Don't know
88 Participants92 Participants72 Participants86 Participants338 Participants
Perceived Comparative Risk for Colorectal Cancer
Higher than other women/men your age
13 Participants7 Participants15 Participants9 Participants44 Participants
Perceived Comparative Risk for Colorectal Cancer
Lower than other women/men your age
68 Participants54 Participants53 Participants73 Participants248 Participants
Perceived Comparative Risk for Colorectal Cancer
Unknown or Not Reported
10 Participants8 Participants6 Participants7 Participants31 Participants
Race/Ethnicity, Customized
Consolidated Race
Black
76 Participants63 Participants74 Participants77 Participants290 Participants
Race/Ethnicity, Customized
Consolidated Race
Hispanic
13 Participants7 Participants8 Participants6 Participants34 Participants
Race/Ethnicity, Customized
Consolidated Race
Other
17 Participants15 Participants8 Participants13 Participants53 Participants
Race/Ethnicity, Customized
Consolidated Race
Unknown or Not Reported
13 Participants12 Participants9 Participants9 Participants43 Participants
Race/Ethnicity, Customized
Consolidated Race
White
171 Participants165 Participants148 Participants180 Participants664 Participants
Region of Enrollment
United States
290 participants262 participants247 participants285 participants1084 participants
Relationship
Divorced
69 Participants46 Participants54 Participants62 Participants231 Participants
Relationship
Married or living with a partner
140 Participants141 Participants128 Participants144 Participants553 Participants
Relationship
Never married
43 Participants43 Participants40 Participants43 Participants169 Participants
Relationship
Separated
14 Participants7 Participants9 Participants10 Participants40 Participants
Relationship
Unknown or Not Reported
12 Participants12 Participants9 Participants9 Participants42 Participants
Relationship
Widowed
12 Participants13 Participants7 Participants17 Participants49 Participants
Self-reported Health Status at Baseline
Excellent
10 Participants10 Participants10 Participants16 Participants46 Participants
Self-reported Health Status at Baseline
Fair
74 Participants62 Participants58 Participants64 Participants258 Participants
Self-reported Health Status at Baseline
Good
121 Participants117 Participants104 Participants114 Participants456 Participants
Self-reported Health Status at Baseline
Missing or Not Reported
14 Participants12 Participants10 Participants8 Participants44 Participants
Self-reported Health Status at Baseline
Poor
12 Participants9 Participants15 Participants13 Participants49 Participants
Self-reported Health Status at Baseline
Very Good
59 Participants52 Participants50 Participants70 Participants231 Participants
Sex: Female, Male
Female
173 Participants155 Participants140 Participants179 Participants647 Participants
Sex: Female, Male
Male
117 Participants107 Participants107 Participants106 Participants437 Participants
Subjective Income Level
Are comfortable
124 Participants134 Participants114 Participants126 Participants498 Participants
Subjective Income Level
Do NOT have enough to make ends meet
41 Participants23 Participants36 Participants42 Participants142 Participants
Subjective Income Level
Have just enough to make ends meet
109 Participants93 Participants86 Participants108 Participants396 Participants
Subjective Income Level
Missing or Not Reported
16 Participants12 Participants11 Participants9 Participants48 Participants
Subjective Numeracy4.2 units on a scale
STANDARD_DEVIATION 1.3
4.3 units on a scale
STANDARD_DEVIATION 1.2
4.2 units on a scale
STANDARD_DEVIATION 1.3
4.3 units on a scale
STANDARD_DEVIATION 1.2
4.3 units on a scale
STANDARD_DEVIATION 1.3

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 2900 / 2620 / 2470 / 285
other
Total, other adverse events
0 / 2900 / 2620 / 2470 / 285
serious
Total, serious adverse events
0 / 2900 / 2620 / 2470 / 285

Outcome results

Primary

Number of Participants Who Completed 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.

Time frame: 6 months after patient enrollment

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Group 1Number of Participants Who Completed Colorectal Cancer Screening110 Participants
Group 2Number of Participants Who Completed Colorectal Cancer Screening95 Participants
Group 3Number of Participants Who Completed Colorectal Cancer Screening113 Participants
Group 4Number of Participants Who Completed Colorectal Cancer Screening113 Participants
Primary

Number of Participants Who Made a High Quality Decision 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 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.

Time frame: 6 months after participant enrollment

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Group 1Number of Participants Who Made a High Quality Decision Using the Multi-dimensional Measure of Informed Consent (MMIC) Which Incorporates Knowledge, Intent, and Behavior.90 Participants
Group 2Number of Participants Who Made a High Quality Decision Using the Multi-dimensional Measure of Informed Consent (MMIC) Which Incorporates Knowledge, Intent, and Behavior.92 Participants
Group 3Number of Participants Who Made a High Quality Decision Using the Multi-dimensional Measure of Informed Consent (MMIC) Which Incorporates Knowledge, Intent, and Behavior.91 Participants
Group 4Number of Participants Who Made a High Quality Decision Using the Multi-dimensional Measure of Informed Consent (MMIC) Which Incorporates Knowledge, Intent, and Behavior.103 Participants
Secondary

Average Correct Responses of Participants to Knowledge Questions About Colorectal Cancer (CRC) and CRC Screening: Change Between Baseline, Post-intervention, and Post-provider Visit.

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.

Time frame: 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)

Population: Only participants who completed the item at each time point under comparison were used in the analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Group 1Average Correct Responses of Participants to Knowledge Questions About Colorectal Cancer (CRC) and CRC Screening: Change Between Baseline, Post-intervention, and Post-provider Visit.Change in correct responses from baseline (T0) to post-intervention (T1)3.65 units on a scale-number correctStandard Deviation 2.68
Group 1Average Correct Responses of Participants to Knowledge Questions About Colorectal Cancer (CRC) and CRC Screening: Change Between Baseline, Post-intervention, and Post-provider Visit.Change in correct responses from baseline (T0) to post-provider visit (T2)3.03 units on a scale-number correctStandard Deviation 2.71
Group 1Average Correct Responses of Participants to Knowledge Questions About Colorectal Cancer (CRC) and CRC Screening: Change Between Baseline, Post-intervention, and Post-provider Visit.Change in correct responses from post-intervention (T1) to post-provider visit (T2)-0.60 units on a scale-number correctStandard Deviation 1.4
Group 2Average Correct Responses of Participants to Knowledge Questions About Colorectal Cancer (CRC) and CRC Screening: Change Between Baseline, Post-intervention, and Post-provider Visit.Change in correct responses from baseline (T0) to post-intervention (T1)3.70 units on a scale-number correctStandard Deviation 2.74
Group 2Average Correct Responses of Participants to Knowledge Questions About Colorectal Cancer (CRC) and CRC Screening: Change Between Baseline, Post-intervention, and Post-provider Visit.Change in correct responses from baseline (T0) to post-provider visit (T2)3.10 units on a scale-number correctStandard Deviation 2.79
Group 2Average Correct Responses of Participants to Knowledge Questions About Colorectal Cancer (CRC) and CRC Screening: Change Between Baseline, Post-intervention, and Post-provider Visit.Change in correct responses from post-intervention (T1) to post-provider visit (T2)-0.58 units on a scale-number correctStandard Deviation 1.31
Group 3Average Correct Responses of Participants to Knowledge Questions About Colorectal Cancer (CRC) and CRC Screening: Change Between Baseline, Post-intervention, and Post-provider Visit.Change in correct responses from post-intervention (T1) to post-provider visit (T2)-0.60 units on a scale-number correctStandard Deviation 1.6
Group 3Average Correct Responses of Participants to Knowledge Questions About Colorectal Cancer (CRC) and CRC Screening: Change Between Baseline, Post-intervention, and Post-provider Visit.Change in correct responses from baseline (T0) to post-intervention (T1)3.75 units on a scale-number correctStandard Deviation 2.82
Group 3Average Correct Responses of Participants to Knowledge Questions About Colorectal Cancer (CRC) and CRC Screening: Change Between Baseline, Post-intervention, and Post-provider Visit.Change in correct responses from baseline (T0) to post-provider visit (T2)3.02 units on a scale-number correctStandard Deviation 3.02
Group 4Average Correct Responses of Participants to Knowledge Questions About Colorectal Cancer (CRC) and CRC Screening: Change Between Baseline, Post-intervention, and Post-provider Visit.Change in correct responses from baseline (T0) to post-intervention (T1)3.76 units on a scale-number correctStandard Deviation 2.9
Group 4Average Correct Responses of Participants to Knowledge Questions About Colorectal Cancer (CRC) and CRC Screening: Change Between Baseline, Post-intervention, and Post-provider Visit.Change in correct responses from baseline (T0) to post-provider visit (T2)3.31 units on a scale-number correctStandard Deviation 2.83
Group 4Average Correct Responses of Participants to Knowledge Questions About Colorectal Cancer (CRC) and CRC Screening: Change Between Baseline, Post-intervention, and Post-provider Visit.Change in correct responses from post-intervention (T1) to post-provider visit (T2)-0.43 units on a scale-number correctStandard Deviation 1.45
Secondary

Average Decision Conflict of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit

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.

Time frame: 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)

Population: Only participants who completed the item at each time point under comparison were used in the analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Group 1Average Decision Conflict of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from baseline (T0) to post-intervention (T1)-36.6 score on a scaleStandard Deviation 28.9
Group 1Average Decision Conflict of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from baseline (T0) to post-provider visit (T2)-39.0 score on a scaleStandard Deviation 29.2
Group 1Average Decision Conflict of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from post-intervention (T1) to post-provider visit (T2)-1.60 score on a scaleStandard Deviation 12.1
Group 2Average Decision Conflict of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from baseline (T0) to post-intervention (T1)-42.4 score on a scaleStandard Deviation 27.6
Group 2Average Decision Conflict of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from baseline (T0) to post-provider visit (T2)-41.6 score on a scaleStandard Deviation 28.8
Group 2Average Decision Conflict of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from post-intervention (T1) to post-provider visit (T2)-0.76 score on a scaleStandard Deviation 9.53
Group 3Average Decision Conflict of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from post-intervention (T1) to post-provider visit (T2)-2.32 score on a scaleStandard Deviation 11.6
Group 3Average Decision Conflict of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from baseline (T0) to post-intervention (T1)-37.1 score on a scaleStandard Deviation 27.7
Group 3Average Decision Conflict of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from baseline (T0) to post-provider visit (T2)-37.9 score on a scaleStandard Deviation 29.2
Group 4Average Decision Conflict of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from baseline (T0) to post-intervention (T1)-40.3 score on a scaleStandard Deviation 28.4
Group 4Average Decision Conflict of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from baseline (T0) to post-provider visit (T2)-39.3 score on a scaleStandard Deviation 29.2
Group 4Average Decision Conflict of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from post-intervention (T1) to post-provider visit (T2)-0.27 score on a scaleStandard Deviation 11.6
Secondary

Average Intention to Get a Colorectal Cancer (CRC) Screening Test of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit

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.

Time frame: 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)

Population: Only participants who completed the item at each time point under comparison were used in the analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Group 1Average Intention to Get a Colorectal Cancer (CRC) Screening Test of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from baseline (T0) to post-intervention (T1)0.59 score on a scaleStandard Deviation 0.79
Group 1Average Intention to Get a Colorectal Cancer (CRC) Screening Test of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from baseline (T0) to post-provider visit (T2)0.85 score on a scaleStandard Deviation 1.18
Group 1Average Intention to Get a Colorectal Cancer (CRC) Screening Test of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from post-intervention (T1) to post-provider visit (T2)0.23 score on a scaleStandard Deviation 0.93
Group 2Average Intention to Get a Colorectal Cancer (CRC) Screening Test of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from baseline (T0) to post-intervention (T1)0.68 score on a scaleStandard Deviation 0.86
Group 2Average Intention to Get a Colorectal Cancer (CRC) Screening Test of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from baseline (T0) to post-provider visit (T2)0.94 score on a scaleStandard Deviation 1.01
Group 2Average Intention to Get a Colorectal Cancer (CRC) Screening Test of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from post-intervention (T1) to post-provider visit (T2)0.24 score on a scaleStandard Deviation 0.74
Group 3Average Intention to Get a Colorectal Cancer (CRC) Screening Test of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from post-intervention (T1) to post-provider visit (T2)0.24 score on a scaleStandard Deviation 0.82
Group 3Average Intention to Get a Colorectal Cancer (CRC) Screening Test of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from baseline (T0) to post-intervention (T1)0.55 score on a scaleStandard Deviation 0.84
Group 3Average Intention to Get a Colorectal Cancer (CRC) Screening Test of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from baseline (T0) to post-provider visit (T2)0.80 score on a scaleStandard Deviation 1.15
Group 4Average Intention to Get a Colorectal Cancer (CRC) Screening Test of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from baseline (T0) to post-intervention (T1)0.63 score on a scaleStandard Deviation 0.83
Group 4Average Intention to Get a Colorectal Cancer (CRC) Screening Test of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from baseline (T0) to post-provider visit (T2)0.82 score on a scaleStandard Deviation 1.05
Group 4Average Intention to Get a Colorectal Cancer (CRC) Screening Test of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from post-intervention (T1) to post-provider visit (T2)0.20 score on a scaleStandard Deviation 0.79
Secondary

Average Perceived Personal Colorectal Cancer Risk of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit

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.

Time frame: 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)

Population: Only participants who completed the item at each time point under comparison were used in the analysis.

ArmMeasureGroupValue (MEAN)Dispersion
Group 1Average Perceived Personal Colorectal Cancer Risk of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from baseline (T0) to post-provider visit (T2)0.14 score on a scaleStandard Deviation 0.79
Group 1Average Perceived Personal Colorectal Cancer Risk of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from post-intervention (T1) to post-provider visit (T2)-0.10 score on a scaleStandard Deviation 0.86
Group 1Average Perceived Personal Colorectal Cancer Risk of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from baseline (T0) to post-intervention (T1)0.21 score on a scaleStandard Deviation 0.74
Group 2Average Perceived Personal Colorectal Cancer Risk of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from baseline (T0) to post-provider visit (T2)0.28 score on a scaleStandard Deviation 0.87
Group 2Average Perceived Personal Colorectal Cancer Risk of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from baseline (T0) to post-intervention (T1)0.15 score on a scaleStandard Deviation 0.78
Group 2Average Perceived Personal Colorectal Cancer Risk of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from post-intervention (T1) to post-provider visit (T2)0.12 score on a scaleStandard Deviation 0.82
Group 3Average Perceived Personal Colorectal Cancer Risk of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from baseline (T0) to post-intervention (T1)0.14 score on a scaleStandard Deviation 0.81
Group 3Average Perceived Personal Colorectal Cancer Risk of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from post-intervention (T1) to post-provider visit (T2)0.10 score on a scaleStandard Deviation 0.87
Group 3Average Perceived Personal Colorectal Cancer Risk of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from baseline (T0) to post-provider visit (T2)0.21 score on a scaleStandard Deviation 0.98
Group 4Average Perceived Personal Colorectal Cancer Risk of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from baseline (T0) to post-provider visit (T2)0.14 score on a scaleStandard Deviation 0.84
Group 4Average Perceived Personal Colorectal Cancer Risk of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from post-intervention (T1) to post-provider visit (T2)0.05 score on a scaleStandard Deviation 0.83
Group 4Average Perceived Personal Colorectal Cancer Risk of Participants: Change Between Baseline, Post-intervention, and Post-provider VisitChange from baseline (T0) to post-intervention (T1)0.08 score on a scaleStandard Deviation 0.77
Secondary

Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior

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.

Time frame: 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)

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Group 1Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-provider (T2)Unknown or not reported61 Participants
Group 1Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-intervention (T1)Intends to be screened and don't know which test25 Participants
Group 1Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at baseline (T0)Intends to be screened with another test2 Participants
Group 1Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-provider (T2)Intends to be screened with a stool test (FIT or Cologuard)92 Participants
Group 1Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-intervention (T1)Does not intend to be screened52 Participants
Group 1Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-intervention (T1)Unknown or not reported22 Participants
Group 1Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at baseline (T0)Intends to be screened with colonoscopy70 Participants
Group 1Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-provider (T2)Intends to be screened with colonoscopy104 Participants
Group 1Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at baseline (T0)Intends to be screened and don't know which test37 Participants
Group 1Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-provider (T2)Does not intend to be screened26 Participants
Group 1Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at baseline (T0)Does not intend to be screened111 Participants
Group 1Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at baseline (T0)Intends to be screened with a stool test (FIT or Cologuard)62 Participants
Group 1Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at baseline (T0)Unknown or not reported8 Participants
Group 1Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-provider (T2)Intends to be screened and don't know which test6 Participants
Group 1Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-intervention (T1)Intends to be screened with colonoscopy106 Participants
Group 1Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-intervention (T1)Intends to be screened with a stool test (FIT or Cologuard)85 Participants
Group 1Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-provider (T2)Intends to be screened with another test1 Participants
Group 1Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-intervention (T1)Intends to be screened with another test0 Participants
Group 2Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-intervention (T1)Intends to be screened with colonoscopy82 Participants
Group 2Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-provider (T2)Intends to be screened with a stool test (FIT or Cologuard)84 Participants
Group 2Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at baseline (T0)Intends to be screened with a stool test (FIT or Cologuard)53 Participants
Group 2Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-intervention (T1)Intends to be screened and don't know which test18 Participants
Group 2Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at baseline (T0)Does not intend to be screened105 Participants
Group 2Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-provider (T2)Intends to be screened with another test1 Participants
Group 2Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-provider (T2)Intends to be screened and don't know which test5 Participants
Group 2Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-intervention (T1)Does not intend to be screened40 Participants
Group 2Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at baseline (T0)Intends to be screened with another test3 Participants
Group 2Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-provider (T2)Intends to be screened with colonoscopy90 Participants
Group 2Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-intervention (T1)Intends to be screened with another test0 Participants
Group 2Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-intervention (T1)Unknown or not reported16 Participants
Group 2Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at baseline (T0)Unknown or not reported6 Participants
Group 2Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-intervention (T1)Intends to be screened with a stool test (FIT or Cologuard)106 Participants
Group 2Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-provider (T2)Does not intend to be screened25 Participants
Group 2Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at baseline (T0)Intends to be screened with colonoscopy58 Participants
Group 2Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at baseline (T0)Intends to be screened and don't know which test37 Participants
Group 2Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-provider (T2)Unknown or not reported57 Participants
Group 3Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-provider (T2)Intends to be screened and don't know which test2 Participants
Group 3Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-provider (T2)Intends to be screened with another test0 Participants
Group 3Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at baseline (T0)Unknown or not reported4 Participants
Group 3Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at baseline (T0)Intends to be screened with colonoscopy56 Participants
Group 3Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at baseline (T0)Intends to be screened with a stool test (FIT or Cologuard)55 Participants
Group 3Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at baseline (T0)Intends to be screened with another test2 Participants
Group 3Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at baseline (T0)Intends to be screened and don't know which test35 Participants
Group 3Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at baseline (T0)Does not intend to be screened95 Participants
Group 3Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-intervention (T1)Intends to be screened with colonoscopy93 Participants
Group 3Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-intervention (T1)Intends to be screened with a stool test (FIT or Cologuard)74 Participants
Group 3Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-intervention (T1)Intends to be screened with another test1 Participants
Group 3Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-intervention (T1)Intends to be screened and don't know which test19 Participants
Group 3Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-intervention (T1)Does not intend to be screened39 Participants
Group 3Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-intervention (T1)Unknown or not reported21 Participants
Group 3Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-provider (T2)Intends to be screened with colonoscopy83 Participants
Group 3Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-provider (T2)Intends to be screened with a stool test (FIT or Cologuard)89 Participants
Group 3Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-provider (T2)Does not intend to be screened25 Participants
Group 3Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-provider (T2)Unknown or not reported48 Participants
Group 4Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-intervention (T1)Intends to be screened with another test0 Participants
Group 4Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at baseline (T0)Intends to be screened with colonoscopy79 Participants
Group 4Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-provider (T2)Intends to be screened with a stool test (FIT or Cologuard)117 Participants
Group 4Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-intervention (T1)Intends to be screened with a stool test (FIT or Cologuard)133 Participants
Group 4Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-intervention (T1)Intends to be screened with colonoscopy86 Participants
Group 4Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-provider (T2)Intends to be screened with another test1 Participants
Group 4Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at baseline (T0)Unknown or not reported3 Participants
Group 4Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at baseline (T0)Does not intend to be screened99 Participants
Group 4Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-provider (T2)Intends to be screened with colonoscopy89 Participants
Group 4Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-provider (T2)Intends to be screened and don't know which test3 Participants
Group 4Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at baseline (T0)Intends to be screened and don't know which test32 Participants
Group 4Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at baseline (T0)Intends to be screened with another test2 Participants
Group 4Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-provider (T2)Unknown or not reported48 Participants
Group 4Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-provider (T2)Does not intend to be screened27 Participants
Group 4Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-intervention (T1)Unknown or not reported16 Participants
Group 4Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-intervention (T1)Does not intend to be screened31 Participants
Group 4Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at baseline (T0)Intends to be screened with a stool test (FIT or Cologuard)70 Participants
Group 4Number of Participants Intended Colorectal Cancer (CRC) Screening BehaviorIntended screening behavior at post-intervention (T1)Intends to be screened and don't know which test19 Participants
Secondary

Number of Participants Who Completed Colorectal Cancer Screening by Type of Screening Test Completed

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).

Time frame: 6 months after participant enrollment

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Group 1Number of Participants Who Completed Colorectal Cancer Screening by Type of Screening Test CompletedCompleted a colonoscopy59 Participants
Group 1Number of Participants Who Completed Colorectal Cancer Screening by Type of Screening Test CompletedDid not complete a CRC screening test180 Participants
Group 1Number of Participants Who Completed Colorectal Cancer Screening by Type of Screening Test CompletedCompleted a stool test (FIT or Cologuard)51 Participants
Group 2Number of Participants Who Completed Colorectal Cancer Screening by Type of Screening Test CompletedCompleted a colonoscopy39 Participants
Group 2Number of Participants Who Completed Colorectal Cancer Screening by Type of Screening Test CompletedDid not complete a CRC screening test167 Participants
Group 2Number of Participants Who Completed Colorectal Cancer Screening by Type of Screening Test CompletedCompleted a stool test (FIT or Cologuard)56 Participants
Group 3Number of Participants Who Completed Colorectal Cancer Screening by Type of Screening Test CompletedCompleted a stool test (FIT or Cologuard)61 Participants
Group 3Number of Participants Who Completed Colorectal Cancer Screening by Type of Screening Test CompletedCompleted a colonoscopy52 Participants
Group 3Number of Participants Who Completed Colorectal Cancer Screening by Type of Screening Test CompletedDid not complete a CRC screening test134 Participants
Group 4Number of Participants Who Completed Colorectal Cancer Screening by Type of Screening Test CompletedCompleted a colonoscopy51 Participants
Group 4Number of Participants Who Completed Colorectal Cancer Screening by Type of Screening Test CompletedDid not complete a CRC screening test172 Participants
Group 4Number of Participants Who Completed Colorectal Cancer Screening by Type of Screening Test CompletedCompleted a stool test (FIT or Cologuard)62 Participants
Secondary

Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Decision Quality Instrument

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.

Time frame: approximately 4-30 days after viewing intervention and 4-14 days after provider visit [post-provider visit/T2]

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Group 1Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Decision Quality InstrumentYes152 Participants
Group 1Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Decision Quality InstrumentUnknown or not reported62 Participants
Group 1Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Decision Quality InstrumentNo76 Participants
Group 2Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Decision Quality InstrumentYes134 Participants
Group 2Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Decision Quality InstrumentUnknown or not reported56 Participants
Group 2Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Decision Quality InstrumentNo72 Participants
Group 3Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Decision Quality InstrumentNo69 Participants
Group 3Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Decision Quality InstrumentYes130 Participants
Group 3Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Decision Quality InstrumentUnknown or not reported48 Participants
Group 4Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Decision Quality InstrumentYes159 Participants
Group 4Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Decision Quality InstrumentUnknown or not reported49 Participants
Group 4Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Decision Quality InstrumentNo77 Participants
Secondary

Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4

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.

Time frame: approximately 4-30 days after viewing intervention and 4-14 days after provider visit [post-provider visit/T2]

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Group 1Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might not want to do a stool test?Enough108 Participants
Group 1Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might not want to do a stool test?Unknown or not reported61 Participants
Group 1Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might want to do a stool test?Not enough69 Participants
Group 1Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might want to have a colonoscopy?Enough203 Participants
Group 1Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might want to do a stool test?Unknown or not reported61 Participants
Group 1Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might want to have a colonoscopy?Unknown or not reported61 Participants
Group 1Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might not want to have a colonoscopy?Enough106 Participants
Group 1Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might want to have a colonoscopy?Not enough26 Participants
Group 1Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might not want to do a stool test?Not enough121 Participants
Group 1Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might not want to have a colonoscopy?Not enough123 Participants
Group 1Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might not want to have a colonoscopy?Unknown or not reported61 Participants
Group 1Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might want to do a stool test?Enough160 Participants
Group 2Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might want to have a colonoscopy?Not enough28 Participants
Group 2Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might want to do a stool test?Enough146 Participants
Group 2Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might not want to have a colonoscopy?Enough89 Participants
Group 2Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might want to do a stool test?Unknown or not reported56 Participants
Group 2Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might not want to do a stool test?Enough92 Participants
Group 2Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might want to do a stool test?Not enough60 Participants
Group 2Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might want to have a colonoscopy?Enough178 Participants
Group 2Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might not want to have a colonoscopy?Unknown or not reported56 Participants
Group 2Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might not want to have a colonoscopy?Not enough117 Participants
Group 2Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might want to have a colonoscopy?Unknown or not reported56 Participants
Group 2Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might not want to do a stool test?Unknown or not reported56 Participants
Group 2Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might not want to do a stool test?Not enough114 Participants
Group 3Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might want to do a stool test?Not enough52 Participants
Group 3Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might want to have a colonoscopy?Enough164 Participants
Group 3Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might want to have a colonoscopy?Not enough35 Participants
Group 3Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might want to have a colonoscopy?Unknown or not reported48 Participants
Group 3Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might not want to have a colonoscopy?Enough91 Participants
Group 3Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might not want to have a colonoscopy?Not enough108 Participants
Group 3Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might not want to have a colonoscopy?Unknown or not reported48 Participants
Group 3Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might want to do a stool test?Enough146 Participants
Group 3Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might want to do a stool test?Unknown or not reported49 Participants
Group 3Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might not want to do a stool test?Enough93 Participants
Group 3Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might not want to do a stool test?Not enough106 Participants
Group 3Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might not want to do a stool test?Unknown or not reported48 Participants
Group 4Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might not want to have a colonoscopy?Unknown or not reported49 Participants
Group 4Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might not want to have a colonoscopy?Not enough117 Participants
Group 4Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might want to have a colonoscopy?Enough201 Participants
Group 4Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might not want to do a stool test?Enough111 Participants
Group 4Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might not want to have a colonoscopy?Enough119 Participants
Group 4Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might want to have a colonoscopy?Unknown or not reported49 Participants
Group 4Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might not want to do a stool test?Unknown or not reported50 Participants
Group 4Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might not want to do a stool test?Not enough124 Participants
Group 4Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might want to do a stool test?Not enough63 Participants
Group 4Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might want to do a stool test?Enough173 Participants
Group 4Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might want to have a colonoscopy?Not enough35 Participants
Group 4Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4How much did you and your provider talk about the reasons you might want to do a stool test?Unknown or not reported49 Participants
Secondary

Number of Participants With Orders for a Colorectal Cancer Screening (CRC) Test

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).

Time frame: 6 months after patient enrollment

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Group 1Number of Participants With Orders for a Colorectal Cancer Screening (CRC) TestNO order for CRC screening test89 Participants
Group 1Number of Participants With Orders for a Colorectal Cancer Screening (CRC) TestYES order for CRC screening test201 Participants
Group 2Number of Participants With Orders for a Colorectal Cancer Screening (CRC) TestYES order for CRC screening test178 Participants
Group 2Number of Participants With Orders for a Colorectal Cancer Screening (CRC) TestNO order for CRC screening test84 Participants
Group 3Number of Participants With Orders for a Colorectal Cancer Screening (CRC) TestNO order for CRC screening test79 Participants
Group 3Number of Participants With Orders for a Colorectal Cancer Screening (CRC) TestYES order for CRC screening test168 Participants
Group 4Number of Participants With Orders for a Colorectal Cancer Screening (CRC) TestNO order for CRC screening test84 Participants
Group 4Number of Participants With Orders for a Colorectal Cancer Screening (CRC) TestYES order for CRC screening test201 Participants
Secondary

Number of Providers Who Open Their Provider Notification

Opening the provider notification sent for each patient was assessed by reviewing the electronic health record (EHR).

Time frame: 6 months after patient enrollment

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Group 1Number of Providers Who Open Their Provider NotificationProvider notification was opened181 Participants
Group 1Number of Providers Who Open Their Provider NotificationProvider notification was not opened34 Participants
Group 1Number of Providers Who Open Their Provider NotificationProvider notification was not sent7 Participants
Group 1Number of Providers Who Open Their Provider NotificationUnable to determine if provider notification was opened68 Participants
Group 2Number of Providers Who Open Their Provider NotificationProvider notification was not opened33 Participants
Group 2Number of Providers Who Open Their Provider NotificationProvider notification was not sent4 Participants
Group 2Number of Providers Who Open Their Provider NotificationUnable to determine if provider notification was opened64 Participants
Group 2Number of Providers Who Open Their Provider NotificationProvider notification was opened161 Participants
Group 3Number of Providers Who Open Their Provider NotificationProvider notification was not sent7 Participants
Group 3Number of Providers Who Open Their Provider NotificationProvider notification was not opened29 Participants
Group 3Number of Providers Who Open Their Provider NotificationUnable to determine if provider notification was opened58 Participants
Group 3Number of Providers Who Open Their Provider NotificationProvider notification was opened153 Participants
Group 4Number of Providers Who Open Their Provider NotificationUnable to determine if provider notification was opened80 Participants
Group 4Number of Providers Who Open Their Provider NotificationProvider notification was not opened28 Participants
Group 4Number of Providers Who Open Their Provider NotificationProvider notification was opened175 Participants
Group 4Number of Providers Who Open Their Provider NotificationProvider notification was not sent2 Participants
Secondary

Participant's Average Perception of Shared-Decision Making as Assessed by CollaboRATE

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.

Time frame: approximately 4-30 days after viewing intervention and 4-14 days after provider visit [post-provider visit/T2]

ArmMeasureValue (MEAN)Dispersion
Group 1Participant's Average Perception of Shared-Decision Making as Assessed by CollaboRATE6.4 score on a scaleStandard Deviation 3.1
Group 2Participant's Average Perception of Shared-Decision Making as Assessed by CollaboRATE6.3 score on a scaleStandard Deviation 3.2
Group 3Participant's Average Perception of Shared-Decision Making as Assessed by CollaboRATE6.3 score on a scaleStandard Deviation 3.2
Group 4Participant's Average Perception of Shared-Decision Making as Assessed by CollaboRATE6.5 score on a scaleStandard Deviation 3

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026