Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening

• ClinicalTrials.gov Identifier: NCT04683731
• Recruitment Status: Recruiting
• First Posted: December 24, 2020
• Last Update Posted: April 8, 2021
• Sponsor: Indiana University
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Peter Schwartz, Indiana University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cancer Screening Tests	Behavioral: Decision aid without personalized message; Behavioral: Decision aid with personalized message; Behavioral: Provider notification without personalized message; Behavioral: Provider notification with personalized message	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 2x2, randomized, controlled trial
• Masking: Single (Participant)
• 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.
• Primary Purpose: Screening
• Official Title: Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening
• Actual Study Start Date: January 19, 2021
• Estimated Primary Completion Date: April 30, 2023
• Estimated Study Completion Date: April 30, 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Group 1; Patients view decision aid without personalized message and whose providers do not receive the personalized message.	Behavioral: 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.; Behavioral: 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.
Experimental: Group 2; Patients view decision aid with personalized message and whose providers do not receive the personalized message.	Behavioral: 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.; Behavioral: 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.
Experimental: Group 3; Patient view decision aid without the personalized message and whose providers receive the personalized message.	Behavioral: 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.; Behavioral: 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.
Experimental: Group 4; Patients view decision aid with the personalized message and whose providers receive the personalized message.	Behavioral: 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.; Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

1. Number of patients who complete colorectal cancer screening [ Time Frame: 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.
2. Decision Quality assessed using the multi-dimensional measure of informed consent (MMIC) which incorporates knowledge, intent, and behavior. [ Time Frame: 6 months after patient 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 intervention that he or she has chosen or that fits his or her values ("values concordance"). Patient knowledge of colorectal cancer and screening will be assessed by a 12-item test made up of 6 multiple choice questions and 6 true-false questions. Adequate knowledge = 10 correct. Concordance will be measured between the patient's test choice at the post-provider survey and the screening test underwent, if any, within 6 months after patient enrollment.

Secondary Outcome Measures :

1. Colorectal Cancer (CRC) Screening Intention [ Time Frame: 1 day ]
   Patients' intention to be screened for CRC with any CRC screening test will be measured with 1 item: "Do you plan to get any type of colon cancer test within the next 6 months?".
2. Colorectal Cancer (CRC) Screening Test Choice [ Time Frame: 1 day ]
   For those patients who answer the screening intent with "definitely not," "probably not," or "may or may not", test choice will be categorized as "no screening". Those who answer Screening Intent with "Probably" or "Definitely" have Test Choice categorized based on their answer to a single item: "If you have a colon test, which one would you choose?" Response options are: Stool test (FIT or Cologuard), Colonoscopy, Another test, or Don't know.
3. Perceived Risk of Colorectal Cancer (CRC) [ Time Frame: 1 day ]
   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.
4. Decision Conflict Scale [ Time Frame: 1 day ]
   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].
5. Perceived Shared Decision Making [ Time Frame: 1 day ]
   Patients will answer five items assessing the extent to which they were involved in the decision-making process and three items to assess how much effort was made by their provider to: explain colon cancer screening, ask for screening preferences, and incorporate those preferences into the decision.
6. Number of orders for a Colorectal Cancer Screening (CRC) Test [ Time Frame: 6 months after patient enrollment ]
   A provider order for FIT, colonoscopy, or other CRC screening test for each of their enrolled patients will be assessed by reviewing the electronic health record (EHR).
7. Number of providers who open their provider notification [ Time Frame: 1 day ]
   Opening the provider notification will be assessed by reviewing the electronic health record (EHR).

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Indiana

Indiana University; Recruiting

Indianapolis, Indiana, United States, 462020

Contact: Karen K Schmidt, MSN 317-278-4049 schmidtk@iu.edu

Indiana University; Recruiting

Indianapolis, Indiana, United States, 46202

Contact: Karen K Schmidt, MSN 317-278-4049 schmidtk@iu.edu

Contact: Peter H Schwartz, MD, PhD 317-278-4037 phschwar@iu.edu

Sponsors and Collaborators

Indiana University

Patient-Centered Outcomes Research Institute

More Information

• Responsible Party: Peter Schwartz, Principal Investigator, Indiana University
• ClinicalTrials.gov Identifier: NCT04683731
• Other Study ID Numbers: 2004109966; CDR-2018C3-14715 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute )
• First Posted: December 24, 2020
• Last Update Posted: April 8, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peter Schwartz, Indiana University:

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

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases