Life Expectancy-informed Colorectal Cancer Screening

NCT07141901 | Not Yet Recruiting DMC

• 2 other identifiers: 24-1038R01AG086247
• Study Type: interventional
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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.

Conditions

Colorectal Cancer Control and Prevention

Keywords

life expectancy; colorectal cancer; screening; preventative; decision support tool

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  10 days

Study Arms (2)

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.

Behavioral: Decision Tool

Usual care

NO INTERVENTION

Usual care

Interventions

Decision Tool BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 76 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• \> 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.
• 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
• 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
• \>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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kathryn Martinez: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Kathryn Martinez, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn Martinez, PhD

CONTACT

216 636-0673; MARTINK12@ccf.org

Carson Campola, BS

CONTACT

2164450719; campolc2@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Staff

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)