Life Expectancy-informed Colorectal Cancer Screening (CRC)

Kathryn Martinez

Status: Begins enrollment in 7 months

Conditions: Colorectal Cancer Control and Prevention

Treatments: Behavioral: Decision Tool

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07141901

24-1038

R01AG086247 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15,000 estimated patients

Sex: All

Ages: 76+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15,000 participants in 2 patient groups

Intervention

Other group

Description:

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.

Treatment:

Behavioral: Decision Tool

Usual care

No Intervention group

Description:

Usual care