Life Expectancy-informed Colorectal Cancer Screening
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age76+
SponsorKathryn Martinez
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
> 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
Disqualifiers
All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation.
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
Trial design
Design model
Parallel
Treatments tested in this trial
Decision Tool
BehavioralFor 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 groups
15,000 Participants
are divided into 2 treatment groupsGroup A: InterventionOther 1 intervention
Group B: Usual careNo intervention 0 interventions
Trial outcomes
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.
Time frame
7 daysSecondary 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
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.
Time frame
10 daysSponsors and contacts
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Kathryn Martinez
Lead sponsor
The Cleveland Clinic
Sponsor institution
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: