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NCT07141901

Life Expectancy-informed Colorectal Cancer Screening

Sponsor: Kathryn Martinez

View on ClinicalTrials.gov

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. 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. 2. 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. 3. 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.

Official title: Improving Colorectal Cancer Screening Decisions Through Consideration of Life Expectancy

Key Details

Gender

All

Age Range

76 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15000

Start Date

2026-08-01

Completion Date

2029-03-01

Last Updated

2025-09-24

Healthy Volunteers

Yes

Conditions

Colorectal Cancer Control and Prevention

Interventions

BEHAVIORAL

Decision Tool

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.

Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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: * 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)

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States