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Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening

Primary Purpose

Cancer Screening Tests

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision aid without personalized message
Decision aid with personalized message
Provider notification without personalized message
Provider notification with personalized message
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cancer Screening Tests focused on measuring decision aid, cancer screening, risk assessment, risk communication, colorectal neoplasm, decision making

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Indiana University
  • Indiana University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Patients view decision aid without personalized message and whose providers do not receive the personalized message.

Patients view decision aid with personalized message and whose providers do not receive the personalized message.

Patient view decision aid without the personalized message and whose providers receive the personalized message.

Patients view decision aid with the personalized message and whose providers receive the personalized message.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 20, 2020
Last Updated
August 22, 2023
Sponsor
Indiana University
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04683731
Brief Title
Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening
Official Title
Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 19, 2021 (Actual)
Primary Completion Date
May 17, 2023 (Actual)
Study Completion Date
July 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Screening Tests
Keywords
decision aid, cancer screening, risk assessment, risk communication, colorectal neoplasm, decision making

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2x2, randomized, controlled trial
Masking
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.
Allocation
Randomized
Enrollment
1439 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Patients view decision aid without personalized message and whose providers do not receive the personalized message.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Patients view decision aid with personalized message and whose providers do not receive the personalized message.
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Patient view decision aid without the personalized message and whose providers receive the personalized message.
Arm Title
Group 4
Arm Type
Experimental
Arm Description
Patients view decision aid with the personalized message and whose providers receive the personalized message.
Intervention Type
Behavioral
Intervention Name(s)
Decision aid without personalized message
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Decision aid with personalized message
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Provider notification without personalized message
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Provider notification with personalized message
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients who complete colorectal cancer screening
Description
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
Title
Decision Quality assessed using the multi-dimensional measure of informed consent (MMIC) which incorporates knowledge, intent, and behavior.
Description
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.
Time Frame
6 months after patient enrollment
Secondary Outcome Measure Information:
Title
Colorectal Cancer (CRC) Screening Intention
Description
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?".
Time Frame
1 day
Title
Colorectal Cancer (CRC) Screening Test Choice
Description
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.
Time Frame
1 day
Title
Perceived Risk of Colorectal Cancer (CRC)
Description
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.
Time Frame
1 day
Title
Decision Conflict Scale
Description
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].
Time Frame
1 day
Title
Perceived Shared Decision Making
Description
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.
Time Frame
1 day
Title
Number of orders for a Colorectal Cancer Screening (CRC) Test
Description
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).
Time Frame
6 months after patient enrollment
Title
Number of providers who open their provider notification
Description
Opening the provider notification will be assessed by reviewing the electronic health record (EHR).
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
462020
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening

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