Life Expectancy-informed Colorectal Cancer Screening

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Kathryn Martinez
Study ID
NCT07141901
Status
Not Yet Recruiting

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Conditions

  • Colorectal Cancer Control and Prevention

Eligibility Criteria

Sex
ALL
Age
76 Years - N/A
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Aug 1, 2026
Status verified
Sep 2025
Primary completion
Jan 1, 2029
Completion
Mar 1, 2029

Study Design

Enrollment
15,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • 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.
  • No Intervention: Usual care
    Usual care

Primary Outcome Measure

Life-expectancy congruent colonoscopy ordering at the clinic level [ Time Frame: 7 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Kathryn Martinez, PhD
216 636-0673

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