Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer Screening Tests
- Sponsor
- Indiana University
- Enrollment
- 1111
- Locations
- 1
- Primary Endpoint
- Number of Participants Who Completed Colorectal Cancer Screening
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Peter Schwartz
Principal Investigator
Indiana University
Eligibility 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.
Outcomes
Primary Outcomes
Number of Participants Who Completed 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.
Number of Participants Who Made a High Quality Decision Using the Multi-dimensional Measure of Informed Consent (MMIC) Which Incorporates Knowledge, Intent, and Behavior.
Time Frame: 6 months after participant enrollment
Decision quality will be assessed using the multi-dimensional measure of informed consent (MMIC), where a high-quality decision is one where the individual has adequate knowledge regarding the available options and undergoes the screening test that he or she has chosen or that fits his or her values ("values concordance"). Patient knowledge of colorectal cancer and screening will be assessed by a 12-item test made up of 6 multiple choice questions and 6 true-false questions. Adequate knowledge = 9 correct. Concordance will be measured between the patient's test choice at the post-provider survey and the screening test underwent, if any, within 6 months after patient enrollment.
Secondary Outcomes
- Number of Participants Who Completed Colorectal Cancer Screening by Type of Screening Test Completed(6 months after participant enrollment)
- Average Intention to Get a Colorectal Cancer (CRC) Screening Test of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit(1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2))
- Average Decision Conflict of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit(1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2))
- Number of Participants Intended Colorectal Cancer (CRC) Screening Behavior(1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2))
- 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))
- Average Perceived Personal Colorectal Cancer Risk of Participants: Change Between Baseline, Post-intervention, and Post-provider Visit(1 day (immediately before viewing intervention [baseline/T1] and after viewing intervention [post-intervention/T1]); and approximately 4-30 days after viewing intervention and 4-14 days after provider visit (post-provider visit/T2))
- Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Shared Decision Making Process Survey-4(approximately 4-30 days after viewing intervention and 4-14 days after provider visit [post-provider visit/T2])
- Number of Participants Who Perceive Being Involved in Shared-Decision Making as Assessed by the Decision Quality Instrument(approximately 4-30 days after viewing intervention and 4-14 days after provider visit [post-provider visit/T2])
- Participant's Average Perception of Shared-Decision Making as Assessed by CollaboRATE(approximately 4-30 days after viewing intervention and 4-14 days after provider visit [post-provider visit/T2])
- Number of Participants With Orders for a Colorectal Cancer Screening (CRC) Test(6 months after patient enrollment)
- Number of Providers Who Open Their Provider Notification(6 months after patient enrollment)