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OpenTrials
Enrolling by Invitation

NCT Number: NCT06597955

Large-Scale Implementation of a Decision Aid About Colorectal Cancer Screening

The goal of the project is to improve shared decision making and increase uptake of colorectal cancer (CRC) screening by facilitating the implementation of a decision aid about CRC and screening options in two healthcare systems in Indiana.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University

Indianapolis, Indiana, 46202, United States

About this study

This implementation project is putting a shared decision making approach into routine practice to help patients make informed decisions about colorectal cancer(CRC) screening. Regular screening is recommended for adults ages 45 - 75 years old, and there are multiple approved tests for individuals at average risk for colorectal cancer. A video-based decision aid about CRC screening was developed and tested in a previous study by the project team. The study showed that viewing the decision aid had positive effects on measures directly related to shared decision making (knowledge, decision conflict) as well as intent to undergo CRC screening. The project team is working with two healthcare systems to provide patients who are eligible for CRC screening access to the decision aid, training staff and clinicians how to use the decision aid to support shared decision making for CRC screening, working with healthcare system leaders to support the staff and clinicians, and providing support for the ongoing use of the decision aid.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthcare system participants will be eligible if they are employed by one of the project team's partner healthcare systems
  • Patient participants will be eligible if they are considered due for colorectal cancer screening by the healthcare systems' criteria.

Exclusion criteria

Patient participants will be excluded if they:

  • are not between ages of 45 - 75 years old
  • self-report that they no longer receive primary care at either of the project team's partner healthcare systems
  • self-report that they are not due for colorectal cancer screening (had colonoscopy within the past 10 years, sigmoidoscopy in the last 5 years, FIT in the past year, or Cologuard in the past 3 years)
  • are unable to speak or read English or Spanish

Treatment and study plan

Primary outcomes

  1. Shared decision making

    Time frame: 18 months

    Shared decision making will be assessed using the CollaboRATE scale. CollaboRATE is a three-item measure that assesses three key areas of shared decision making; 1) explaining the health issue; 2) asking for patient preferences; and 3) incorporating patient preferences into the decision. Each item uses 0 - 9 likert response options ranging from 0 = "no effort was made" to 9 = "every effort was made". The higher the score the better the shared decision making.

  2. Implementation of decision aid

    Time frame: 18 months

    Interviews with healthcare system leadership, clinicians, staff and patients

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Eskenazi Health
  • Indiana University Health

Registry information

Acronym: IDecide

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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