Colorectal Cancer Control and PreventionCRCNCT07141901
Life Expectancy-informed Colorectal Cancer Screening
A study testing Decision Tool in people with Colorectal Cancer Control and Prevention, run by Kathryn Martinez at 1 site in United States.
Trial summary
The purpose of this study is to improve life-expectancy concordant colorectal cancer screening for adults over 75 years through design and testing of a life expectancy notification to clinicians delivered via the electronic health record. This study has three components: 1. Read more about this study
- Who is it for?
- Ages 76 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Control and Prevention
- What is being tested?
- Decision Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2027to 10 Sep 2029
- Phase
- Interventional
- 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 76 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aim 1a: Patients must meet all the inclusion criteria listed below to be included:
- > 75 years of age
- Resident of Ohio
- Had at least one Internal Medicine or Family Medicine visit at Cleveland Clinic Health System between January 1, 2007, and September 1, 2022.
- Aim 1b: Clinicians must meet all the inclusion criteria listed below to be included:
- Internal Medicine or Family Medicine clinician (MD, DO, or APP) practicing at Cleveland Clinic Health System in Northeast Ohio
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- Saw ≥10 study-eligible patients, defined as patients aged >75 years who were due or overdue for colorectal cancer screening, between 2024-2025
- With a colonoscopy ordering rate for patients >75 years in either the top quarter of the distribution of all eligible clinicians or bottom quarter of all eligible clinicians
- Aim 2: Clinics must meet all the inclusion criteria listed below to be included:
- Internal Medicine or Family Medicine clinical site included in the Cleveland Clinic Health System in Northeast Ohio or Florida
- Clinicians must meet all the inclusion criteria listed below to be included:
- Currently practicing in Internal or Family Medicine as an attending clinician
- Saw ≥10 study-eligible patients, defined as patients aged >75 years who were due or overdue for colorectal cancer screening, between 2024-2025
- Patients must meet all the inclusion criteria listed below to be included:
- >75 years of age
- Have not received a colonoscopy in the prior 10 years
- Have not received a FOBT/FIT in prior year
- Had a visit in Internal Medicine or Family Medicine between January 1, 2026 and January 1, 2028
Who cannot join
- All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation.
- Aim 1a:
- Patients aged ≤75 years
- Patients who did not have at least one subsequent Internal or Family Medicine visit in Ohio within two years from the date of their baseline visit
- Patients being actively treated for non-skin cancer
- Aim 1b:
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- Clinicians who are not in the top or bottom quarter of the distribution of colonoscopy orderers for patients aged >75 years
- Trainees/residents
- Saw <10 study-eligible patients between 2024-2025
- Aim 2:
- Patients aged <75 years
- Patients up to date with colorectal cancer screening (colonoscopy within 10 years or FOBT/FIT/Cologuard within the past year)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cleveland Clinic
Cleveland, Ohio, 44195
Kathryn Martinez, PhD, 216 636-0673, MARTINK12@ccf.org
About this study
Official title: Improving Colorectal Cancer Screening Decisions Through Consideration of Life Expectancy
The purpose of this study is to improve life-expectancy concordant colorectal cancer screening for adults over 75 years through design and testing of a life expectancy notification to clinicians delivered via the electronic health record.
This study has three components:
- The investigators will develop a life expectancy prediction model using patient data from the Cleveland Clinic electronic health record (EHR) and test it against two existing life expectancy prediction models to determine which should be used in clinical care. This is an observational cohort study.
- Concurrently with the development and testing of the life expectancy prediction model, the investigators will conduct interviews with clinicians to generate knowledge regarding the optimal way to integrate life expectancy information into decision making about colorectal cancer screening in patients over 75 years. This is a qualitative study.
- The investigators will then conduct a cluster randomized trial of a clinical decision support-delivered life expectancy notification on life expectancy-congruent colorectal cancer screening orders by primary care clinicians.
Read the detailed description
The purpose of this study is to improve life-expectancy concordant colorectal cancer screening for adults over 75 years through design and testing of a life expectancy notification to clinicians delivered via the electronic health record.
The investigators will pull patient data from the Cleveland Clinic Electronic Health Record (EHR) and use this to build and test a prediction model. The investigators will compare this model against two other existing life expectancy prediction models using these data. Once the investigators have identified the model with the best predictive ability, the investigators will test the model in the Metro Health System study population.
Concurrently with the development and testing of the life expectancy prediction model, the study team will develop the interview guide, which will be semi-structured; the investigators will use pre-defined questions based on study interest but will also allow for new topics to emerge. The investigators will invite clinicians for interviews based on their prior two-year colonoscopy ordering for patients >75 years, identifying clinicians in the top quarter and bottom quarter of colonoscopy orders compared to their peers. Akin to a "positive deviance" sampling approach, this method will capture clinician perspectives at both ends of the distribution and will provide richer information about how varied clinicians consider life expectancy in colonoscopy decision making. As the investigators want to collect diverse clinician perspectives, unique clinicians will be recruited for each phase of interviews. Interviews will last between 45 minutes and an hour take place via Microsoft Teams. Interviews will be audio recorded and transcribed verbatim. For each phase, following coding of 10 interviews, investigators will share findings with the study team and develop a preliminary coding dictionary. Subsequent interviews will be coded using this dictionary, adding additional codes as they emerge. Interviews will continue until thematic saturation is reached. Based on prior similar studies the investigators anticipate this will require 20 clinician interviews per phase.
The investigators will work with the Cleveland Clinic EHR team to implement the life expectancy algorithm and the Best practice alerts (BPA) into EHR. The BPAs will be piloted over a one-month period by 10 clinicians. During the pilot, the investigators will monitor use to ensure the BPAs are working correctly, in keeping with the 5 Rights framework. (e.g. displaying for the right patients in the right location). The investigators will conduct clinician interviews to elicit feedback on the notification, including making changes to the suggested language to support screening discontinuation for patients with <10 years life expectancy. The investigators will then modify the placement and/or the wording of the notifications and conduct another pilot. Based on experience, 1-2 pilots will be sufficient, but the investigators can conduct a third round, if needed.
The investigators will randomize the clinics 3:2, with 30 sites in the intervention arm and 20 sites in the control arm. The investigators will then turn on the Clinical Decision Support at the intervention sites, where it will fire automatically for any eligible patient. By pulling data from the EHR, the investigators will assess colonoscopy orders, and other outcomes between 1 and 365 days following the index visit.
- Conditions
- Colorectal Cancer Control and Prevention
- Being tested
- Decision Tool
- Keywords
- life expectancy, colorectal cancer, screening, preventative, decision support tool
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision ToolBehavioural
For patients with life expectancy <10 years: Active (i.e. interruptive) BPA that will fire when the clinician orders colorectal cancer screening. The BPA will advise that screening is not recommended due to <10 year life expectancy. An active alert is required to prevent the clinician from ordering a potentially inappropriate test. The BPA will contain a box with suggested language with which to express this to the patient.
For patients with life expectancy ≥10 years: Passive alert on the Storyboard indicating that patient could benefit from screening as their predicted life expectancy is ≥10 years. A passive alert does not interfere with workflow and is available whenever it is convenient for the clinician to address it.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | For patients with life expectancy <10 years: Active (i.e. interruptive) BPA that will fire when the clinician orders colorectal cancer screening. The BPA will advise that screening is not recommended due to <10 year life expectancy. An active alert is required to prevent the clinician from ordering a potentially inappropriate test. The BPA will contain a box with suggested language with which to express this to the patient.
For patients with life expectancy ≥10 years: Passive alert on the Storyboard indicating that patient could benefit from screening as their predicted life expectancy is ≥10 years. A passive alert does not interfere with workflow and is available whenever it is convenient for the clinician to address it. Receives: Behavioral: Decision Tool |
| Usual care | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life-expectancy congruent colonoscopy ordering at the clinic level
The investigators will define this separately for patients with <10 years life expectancy and those with ≥10 years life expectancy. For both groups, the investigators will assess the proportion who received an order for colonoscopy versus not. The investigators hypothesize the intervention will result in more life expectancy-appropriate ordering: for those in the <10-year life expectancy group, the intervention will be associated with a lower ordering rate, while in the ≥10-year life expectancy group, the intervention will be associated with a higher ordering rate. The investigators will measure colonoscopy orders within 7 days of their index visit.
Measured: 7 days
Secondary outcomes (1)
ordering of fecal occult blood tests (FOBT) or fecal immunochemical testing (FIT), colonoscopies performed, colorectal cancers/advanced adenomas detected, polyps removed, cancers treated, and perforations
For patients who underwent colonoscopy, the investigators will assess the rate of hospitalization within 10 days, compared to hospitalizations within 10 days of the half-birthdays of patients who did not undergo colonoscopy. The investigators will assess the proportion of patients in each study arm for whom a colonoscopy was either recommended/not recommended by their clinicians who chose the opposite course of action.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Mar 2027 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion10 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Control and PreventionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kathryn Martinez
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Kathryn Martinez, The Cleveland Clinic
- Investigators
- Kathryn Martinez, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141901
- Sponsor's protocol ID
- 24-1038
- Other IDs
- R01AG086247
- Acronym
- CRC
- Status last verified
- Oct 2026
- First submitted
- 19 Aug 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be shared in compliance with institutional policies, IRB approval, and applicable laws and regulations (including the HIPAA Privacy Rule). Certain variables may be excluded based on organizational policies or legal requirements, such as data for which participant consent was not obtained or data that could potentially identify participants.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Colorectal Cancer Screening Decisions Through Consideration of Life Expectancy
- ClinicalTrials.gov ID
- NCT07141901
- Acronym / sponsor ID
- CRC / 24-1038
- Conditions
- Colorectal Cancer Control and Prevention
- Keywords
- life expectancy, colorectal cancer, screening, preventative, decision support tool
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Kathryn MartinezUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 10 Sep 2029 (estimated)
- First posted
- 26 Aug 2025 (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 purpose of this study is to improve life-expectancy concordant colorectal cancer screening for adults over 75 years through design and testing of a life expectancy notification to clinicians delivered via the electronic health record.
This study has three components:
- The investigators will develop a life expectancy prediction model using patient data from the Cleveland Clinic electronic health record (EHR) and test it against two existing life expectancy prediction models to determine which should be used in clinical care. This is an observational cohort study.
- Concurrently with the development and testing of the life expectancy prediction model, the investigators will conduct interviews with clinicians to generate knowledge regarding the optimal way to integrate life expectancy information into decision making about colorectal cancer screening in patients over 75 years. This is a qualitative study.
- The investigators will then conduct a cluster randomized trial of a clinical decision support-delivered life expectancy notification on life expectancy-congruent colorectal cancer screening orders by primary care clinicians.
Detailed description
The purpose of this study is to improve life-expectancy concordant colorectal cancer screening for adults over 75 years through design and testing of a life expectancy notification to clinicians delivered via the electronic health record.
The investigators will pull patient data from the Cleveland Clinic Electronic Health Record (EHR) and use this to build and test a prediction model. The investigators will compare this model against two other existing life expectancy prediction models using these data. Once the investigators have identified the model with the best predictive ability, the investigators will test the model in the Metro Health System study population.
Concurrently with the development and testing of the life expectancy prediction model, the study team will develop the interview guide, which will be semi-structured; the investigators will use pre-defined questions based on study interest but will also allow for new topics to emerge. The investigators will invite clinicians for interviews based on their prior two-year colonoscopy ordering for patients >75 years, identifying clinicians in the top quarter and bottom quarter of colonoscopy orders compared to their peers. Akin to a "positive deviance" sampling approach, this method will capture clinician perspectives at both ends of the distribution and will provide richer information about how varied clinicians consider life expectancy in colonoscopy decision making. As the investigators want to collect diverse clinician perspectives, unique clinicians will be recruited for each phase of interviews. Interviews will last between 45 minutes and an hour take place via Microsoft Teams. Interviews will be audio recorded and transcribed verbatim. For each phase, following coding of 10 interviews, investigators will share findings with the study team and develop a preliminary coding dictionary. Subsequent interviews will be coded using this dictionary, adding additional codes as they emerge. Interviews will continue until thematic saturation is reached. Based on prior similar studies the investigators anticipate this will require 20 clinician interviews per phase.
The investigators will work with the Cleveland Clinic EHR team to implement the life expectancy algorithm and the Best practice alerts (BPA) into EHR. The BPAs will be piloted over a one-month period by 10 clinicians. During the pilot, the investigators will monitor use to ensure the BPAs are working correctly, in keeping with the 5 Rights framework. (e.g. displaying for the right patients in the right location). The investigators will conduct clinician interviews to elicit feedback on the notification, including making changes to the suggested language to support screening discontinuation for patients with <10 years life expectancy. The investigators will then modify the placement and/or the wording of the notifications and conduct another pilot. Based on experience, 1-2 pilots will be sufficient, but the investigators can conduct a third round, if needed.
The investigators will randomize the clinics 3:2, with 30 sites in the intervention arm and 20 sites in the control arm. The investigators will then turn on the Clinical Decision Support at the intervention sites, where it will fire automatically for any eligible patient. By pulling data from the EHR, the investigators will assess colonoscopy orders, and other outcomes between 1 and 365 days following the index visit.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: Decision ToolFor patients with life expectancy <10 years: Active (i.e. interruptive) BPA that will fire when the clinician orders colorectal cancer screening. The BPA will advise that screening is not recommended due to <10 year life expectancy. An active alert is required to prevent the clinician from ordering a potentially inappropriate test. The BPA will contain a box with suggested language with which to express this to the patient. For patients with life expectancy ≥10 years: Passive alert on the Storyboard indicating that patient could benefit from screening as their predicted life expectancy is ≥10 years. A passive alert does not interfere with workflow and is available whenever it is convenient for the clinician to address it. |
| Usual care | No intervention | –Usual care |
Who may qualify
- Ages
- 76 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (18 listed)
- Aim 1a: Patients must meet all the inclusion criteria listed below to be included:
- Internal Medicine or Family Medicine clinician (MD, DO, or APP) practicing at Cleveland Clinic Health System in Northeast Ohio
- Saw ≥10 study-eligible patients, defined as patients aged >75 years who were due or overdue for colorectal cancer screening, between 2024-2025
- With a colonoscopy ordering rate for patients >75 years in either the top quarter of the distribution of all eligible clinicians or bottom quarter of all eligible clinicians
- Internal Medicine or Family Medicine clinical site included in the Cleveland Clinic Health System in Northeast Ohio or Florida
Key exclusion criteria (12 listed)
- All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation.
- Patients aged ≤75 years
- Patients who did not have at least one subsequent Internal or Family Medicine visit in Ohio within two years from the date of their baseline visit
- Patients being actively treated for non-skin cancer
- Clinicians who are not in the top or bottom quarter of the distribution of colonoscopy orderers for patients aged >75 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision ToolFor patients with life expectancy <10 years: Active (i.e. interruptive) BPA that will fire when the clinician orders colorectal cancer screening. The BPA will advise that screening is not recommended due to <10 year life expectancy. An active alert is required to prevent the clinician from ordering a potentially inappropriate test. The BPA will contain a box with suggested language with which to express this to the patient. For patients with life expectancy ≥10 years: Passive alert on the Storyboard indicating that patient could benefit from screening as their predicted life expectancy is ≥10 years. A passive alert does not interfere with workflow and is available whenever it is convenient for the clinician to address it. | Behavioural | Intervention |
Primary outcome
Life-expectancy congruent colonoscopy ordering at the clinic level
Time frame: 7 days
The investigators will define this separately for patients with <10 years life expectancy and those with ≥10 years life expectancy. For both groups, the investigators will assess the proportion who received an order for colonoscopy versus not. The investigators hypothesize the intervention will result in more life expectancy-appropriate ordering: for those in the <10-year life expectancy group, the intervention will be associated with a lower ordering rate, while in the ≥10-year life expectancy group, the intervention will be associated with a higher ordering rate. The investigators will measure colonoscopy orders within 7 days of their index visit.
1 secondary outcome
ordering of fecal occult blood tests (FOBT) or fecal immunochemical testing (FIT), colonoscopies performed, colorectal cancers/advanced adenomas detected, polyps removed, cancers treated, and perforations
Time frame: 10 days
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 20 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared in compliance with institutional policies, IRB approval, and applicable laws and regulations (including the HIPAA Privacy Rule). Certain variables may be excluded based on organizational policies or legal requirements, such as data for which participant consent was not obtained or data that could potentially identify participants.
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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.
Kathryn Martinez, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Tool in people with Colorectal Cancer Control and Prevention, run by Kathryn Martinez 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 18 inclusion and 12 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: opening soon, as of the sponsor's last update on 20 Oct 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?
Contact Kathryn Martinez, PhD (216 636-0673, MARTINK12@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life-expectancy congruent colonoscopy ordering at the clinic level (time frame: 7 days). 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 20 Oct 2026.