Promoting Veteran-Centered Colorectal Cancer Screening — PROM-IS  

Colorectal Cancer Clinical Trial

Official title: Promoting Veteran-Centered Colorectal Cancer Screening

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT02027545
• Study type: Interventional
• Source: VA Office of Research and Development
• Status: Completed
• Phase: N/A
• Start date: November 20, 2015
• Completion date: August 22, 2018