Colorectal Cancer ScreeningIDecideNCT06597955
Large-Scale Implementation of a Decision Aid About Colorectal Cancer Screening
An observational study of Colorectal Cancer Screening, run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The participants will be healthcare system primary care patients, and health system leadership, clinicians, and staff involved in primary care.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Conditions
- Colorectal Cancer Screening
- Keywords
- decision aid, implementation, colorectal cancer, shared decision making, electronic health record
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthcare system leadership, providers, and staff | Leadership, providers, and staff at the project team's affiliated healthcare system | |
| Patients due for colorectal cancer screening | Patients who are considered due for colorectal cancer screening prior to a scheduled appointment with a primary care provider at the project team's affiliated healthcare system and completed the appointment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shared decision making
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.
Measured: 18 months
Implementation of decision aid
Interviews with healthcare system leadership, clinicians, staff and patients
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start28 Aug 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University Health, Eskenazi Health
- Responsible party
- Principal investigator, Peter Schwartz, Indiana University
- Investigators
- Peter H. Schwartz, MD, PhD, Principal investigator, Indiana UniversityTeresa M. Damush, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597955
- Sponsor's protocol ID
- 22517
- Other IDs
- SDM-2022C2-28397
- Acronym
- IDecide
- Status last verified
- Jun 2026
- First submitted
- 4 Sep 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Large-Scale Implementation of a Decision Aid About Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT06597955
- Acronym / sponsor ID
- IDecide / 22517
- Conditions
- Colorectal Cancer Screening
- Keywords
- decision aid, implementation, colorectal cancer, shared decision making, electronic health record
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Indiana University Health, Eskenazi Health
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthcare system leadership, providers, and staff | – | –Leadership, providers, and staff at the project team's affiliated healthcare system |
| Patients due for colorectal cancer screening | – | –Patients who are considered due for colorectal cancer screening prior to a scheduled appointment with a primary care provider at the project team's affiliated healthcare system and completed the appointment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The participants will be healthcare system primary care patients, and health system leadership, clinicians, and staff involved in primary care.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Implementation of decision aid
Time frame: 18 months
Interviews with healthcare system leadership, clinicians, staff and patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter H. Schwartz, MD, PhD principal investigator
Indiana University
Teresa M. Damush, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Screening, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shared decision making (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.