Promoting Veteran-Centered Colorectal Cancer Screening
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Systematic efforts to improve colorectal cancer screening use in the VA Healthcare System
      have resulted in an increase in not only appropriate, but also inappropriate use of
      screening. The purpose of this study is to test a new, more patient-centered approach to
      colon cancer screening. In older individuals (ages 70 to 75) who are "due" for screening, the
      investigators will provide education on the benefits and harms of colon cancer screening. But
      instead of simply providing these patients with "average" information about these benefits,
      the investigators will give them information that takes into account their personal
      characteristics (e.g., age, gender), overall health, and screening history and therefore
      applies to them more personally. The investigators will also work with the health system to
      create time and space for patient and doctor to discuss whether screening is the right choice
      for each individual. This way, patients can make an informed choice about what is right for
      them, with the help of their doctor. In the future, the results of this study will help
      patients make more informed screening decisions, especially when the benefits of screening
      may be uncertain for them personally.
    

Detailed description: 
      Colorectal cancer (CRC) screening is a widely recommended, evidence-based preventive service
      that has traditionally been underused. Over the last decade, organized efforts by the
      Veterans Health Administration (VHA) to increase population screening among Veterans have
      been successful. But these population-centered efforts have increased screening utilization
      in a way that is not always concordant with screening benefit, particularly among older
      Veterans, those with comorbid illness, and those who have previously been screened. As
      patients get older, acquire health problems, and undergo negative screening tests, the
      benefit of screening decreases and the potential harm of screening increases. Yet, existing
      population-centered efforts fail to adequately inform these patients about this changing
      balance in benefit and harm, often yielding screening utilization that is discordant with
      benefit. The purpose of this study is to test a more Veteran-centered approach to screening
      in these individuals, one that encourages informed, personalized screening decisions based on
      individual values, preferences, and health status.

      The 3-part intervention consists of: (1) a decision aid to help Veterans make informed
      screening decisions; (2) education for providers on how the benefits of screening vary
      between patients; and (3) modification of clinical reminder systems to allow Veterans to make
      informed decisions about screening. The intervention will be tested in a pragmatic
      cluster-randomized controlled trial (cluster = provider) at two sites in the VA Ann Arbor
      Healthcare System. The primary outcome will be whether screening was ordered at the clinic
      visit. The investigators will also assess the appropriateness of screening orders (i.e.,
      whether screening is ordered in concordance with screening benefit), conceptual understanding
      of screening, elements of informed decision-making addressed in the screening discussion, and
      screening utilization at 6 months.

      Note: In March 2023, during preparation of the final manuscript for submission for
      publication, the study team noted that one subject in the intervention arm had undergone
      colorectal cancer screening immediately prior to the study visit (but after assessment for
      study eligibility), making the subject ineligible (protocol violation). Study results were
      re-analyzed accordingly and updated on clinicaltrials.gov (analyzed N=431 rather than N=432).
      Additionally, a data entry error was noted on clinicaltrials.gov for the secondary outcome of
      screening utilization (control N=96 rather than control N=95).
    

Intervention name(s): Decision Aid; Provider Education; Performance Measure Modification; Simple Informational Booklet
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Printed booklet comprising educational information about benefits and harms of screening, individualized estimates of benefits and harms of screening, and values clarification exercise; Providers of patients in both arms of the study will be given an educational module about recent data on the benefits and harms of screening how these data fit in with existing population-centered guidelines.; The clinical reminder system will be modified so to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Additionally, providers who indicate a specific exception for not screening (using the modified clinical reminder) will be considered as satisfying the requirements and will not be penalized in terms of performance pay, and will be removed from feedback reports that encourage population screening.; A simple informational booklet explaining colorectal cancer screening and current screening recommendations.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A cluster-randomized (by provider) pragmatic trial of the patient-centered intervention versus pragmatic control.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: cancer screening; decision making