Decision Tool for Colorectal Cancer Screening

(CRC Trial)

Overseen By Carson Campola, BS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Kathryn Martinez

Disqualifiers: Non-skin cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve colorectal cancer screening for people over 75 by using a tool that predicts life expectancy. The researchers seek to determine if showing doctors a patient's life expectancy can assist in deciding whether screening is advisable. The study will test how this information, delivered through electronic health records, influences doctors' screening recommendations. People over 75 who haven't had a colonoscopy in 10 years and live in Ohio might be suitable candidates for this trial. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that may enhance decision-making in healthcare.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this decision tool is safe for colorectal cancer screening in adults over 75 years?

Research shows that using life expectancy to guide colorectal cancer screening decisions leads to better outcomes. For example, studies have found that individuals with a longer life expectancy are more likely to undergo screening. This approach helps provide the most beneficial care for patients.

In this trial, researchers use life expectancy information to determine who should be screened. This method involves no new drugs or invasive procedures. Instead, it relies on existing information to make decisions, eliminating physical risks such as side effects or other negative reactions often associated with medical treatments.

Overall, using life expectancy data for screening decisions is considered safe, as it builds on current screening practices. The goal is to make screening more personalized and effective. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to personalize colorectal cancer screening by considering a patient's life expectancy. Unlike the typical one-size-fits-all screening approach, this protocol uses a decision tool that provides tailored recommendations: an active alert for those with less than a 10-year life expectancy to avoid unnecessary tests, and a passive alert suggesting screening for those with a life expectancy of 10 years or more. This method could optimize screening practices, ensuring that patients receive care that aligns with their individual health outlooks, potentially improving outcomes and reducing unnecessary interventions.

What evidence suggests that this decision tool is effective for colorectal cancer screening?

Research has shown that life expectancy significantly influences decisions about colorectal cancer screening. One study found that 76% of individuals expecting to live another 10–15 years were more likely to undergo screening, compared to only 52% of those with a shorter life expectancy. This trial will compare two approaches: one where clinicians receive alerts based on patients' life expectancy to guide screening decisions, and another where usual care is provided without such alerts. The goal is to align screening with actual life expectancy, avoiding unnecessary tests for those with a shorter expected lifespan. This approach ensures screenings are both helpful and timely. ^{1 2 6 7 8}

Who Is on the Research Team?

Kathryn Martinez, PhD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 75 years old. It aims to help doctors decide if a patient should be screened for colorectal cancer based on their life expectancy. Participants will have their data used to develop and test a life expectancy prediction model.

Inclusion Criteria

I am a clinician who saw 10 or more patients over 75 due for colorectal screening.

I am over 75, live in Ohio, and visited a Cleveland Clinic doctor between 2007 and 2022.

Clinics that are Internal Medicine or Family Medicine clinical sites included in the Cleveland Clinic Health System in Northeast Ohio or Florida

Exclusion Criteria

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

I am not among the highest or lowest prescribers of colonoscopies for patients over 75.

Trainees/residents

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Model Development and Testing

Development and testing of a life expectancy prediction model using patient data from the Cleveland Clinic EHR and comparison with existing models

3 months

Ongoing data analysis and model testing

Clinician Interviews

Conduct interviews with clinicians to integrate life expectancy information into decision making about colorectal cancer screening

2 months

Interviews conducted via Microsoft Teams

Pilot Testing

Pilot testing of the life expectancy algorithm and Best Practice Alerts (BPA) in the EHR with clinicians

1-2 months

Pilot monitoring and feedback collection

Cluster Randomized Trial

Conduct a cluster randomized trial of clinical decision support-delivered life expectancy notification on colorectal cancer screening orders

12 months

Data collection and analysis at intervention and control sites

Follow-up

Participants are monitored for outcomes such as colonoscopy orders and hospitalizations

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Life Expectancy-informed Colorectal Cancer Screening

Trial Overview The study is testing a decision tool that notifies clinicians about patients' life expectancies through the electronic health record (EHR). The goal is to see if this tool influences decisions on whether or not to screen for colorectal cancer.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

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.

Group II: Usual care Active Control 1 Intervention

Usual care

Who Is Running the Clinical Trial?

Kathryn Martinez

Lead Sponsor

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07141901

Life Expectancy-informed Colorectal Cancer Screening The purpose of this study is to improve life-expectancy concordant colorectal cancer screening for adults over 75 years through design and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5440484/

Perceived Life Expectancy Is Associated with Colorectal ... Screening uptake was 76% (1272/1683) among those who estimated their 10–15-year life expectancy as 75–100%, compared with 52% (126/243) among ...

3. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2809542

Frequency of Screening for Colorectal Cancer by Predicted ... This study assessed whether CRC screening varied by predicted life expectancy in a national sample of Veterans Affairs (VA) patients.

4. ctv.veeva.com ctv.veeva.com/study/life-expectancy-informed-colorectal-cancer-screening

Life Expectancy-informed Colorectal Cancer Screening The purpose of this study is to improve life-expectancy concordant colorectal cancer screening for adults over 75 years through design and ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2211335519301731

Perceived life expectancy and colorectal cancer screening ... This study investigates the relationships between PLE and each of: the intention to complete faecal occult blood test (FOBt) screening, 'ever' uptake of FOBt ...

6. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2808648

Estimated Lifetime Gained With Cancer Screening Tests The findings of this meta-analysis suggest that colorectal cancer screening with sigmoidoscopy may extend life by approximately 3 months.

7. evidence.nejm.org evidence.nejm.org/doi/full/10.1056/EVIDra2100035

Colorectal Cancer Screening — Approach, Evidence, and ... Screening for colorectal cancer is widespread and successful, but screening programs across the globe differ in their recommendations.

8. elifesciences.org elifesciences.org/articles/85264

Projected long-term effects of colorectal cancer screening ... Seventy-year-olds who were up-to-date with their screening and experienced short-term delays of up to 18 months can expect minimal loss of LY ...