Life Expectancy-informed Colorectal Cancer Screening (CRC)

September 19, 2025 updated by: Kathryn Martinez

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:

  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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

15000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kathryn Martinez

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Kathryn Martinez, PhD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

August 19, 2025

First Submitted That Met QC Criteria

August 19, 2025

First Posted (Estimated)

August 26, 2025

Study Record Updates

Last Update Posted (Estimated)

September 24, 2025

Last Update Submitted That Met QC Criteria

September 19, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-1038
  • R01AG086247 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

De-identified data will be available to the research community after the later of:

The end of the grant award, The publication of resulting manuscripts, or Institutional approval to share data.

In accordance with Cleveland Clinic policy, the data will remain available for six years following study completion.

IPD Sharing Access Criteria

Researchers may request data directly from the Principal Investigator at Cleveland Clinic. Each request will be reviewed individually with input from the Principal Investigator, the Law Department, and the Institutional Review Board (IRB).

  • Data may only be used for academic research purposes.
  • Use for commercial purposes or by individuals affiliated with for-profit institutions is prohibited.
  • Only qualified users will be granted access.
  • Users must:

Accept a legal disclaimer. Refrain from attempting to identify participants. Obtain IRB approval or a determination that IRB approval is not required.

Additional requirements may apply to ensure compliance with NIH policy, IRB requirements, HIPAA, and other applicable laws and regulations.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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