Clinical trial NCT02027545: Promoting Veteran-Centered Colorectal Cancer Screening
Official title: Promoting Veteran-Centered Colorectal Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: cancer screening
decision making
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Colorado, Denver
name: Memorial Sloan Kettering Cancer Center
name: Erasmus Medical Center
First posted: 2014-01-06
Enrollment: 436
Sex: ALL
Minimum age (years): 70
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A cluster-randomized (by provider) pragmatic trial of the patient-centered intervention versus pragmatic control.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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).

Eligibility criteria: Inclusion Criteria:

* Aged 70-75 years
* Due for screening according to the 2008 USPSTF colorectal cancer screening guideline
* Scheduled for a non-urgent primary care visit at the Ann Arbor VA Medical Center or Toledo VA Community-Based Outpatient Clinic

Exclusion Criteria:

* Increased risk for colorectal cancer (and therefore not candidates for average-risk screening)
* Limited life expectancy (e.g., enrolled in hospice or diagnosed with metastatic cancer), or for whom the provider previously documented an intention not to pursue screening.
* Scheduled for an appointment where stimulating a discussion about screening is likely to be inappropriate: urgent appointment (for acute complaints), follow-up visit after hospitalization
* Have a condition that would impair his/her ability to participate in the study: dementia or other cognitive impairment, visual impairment, non-English speaking
* Assigned to an ineligible primary care provider (i.e., the provider did not consent to the study)
* Have Medical Guardian who makes decisions for the patient about his/her care

Primary outcomes:
measure: Number of Participants With CRC Screening Ordered
timeFrame: 2 weeks
Secondary outcomes:
measure: Concordance Between Screening Orders and Screening Benefit
timeFrame: 2 weeks
measure: Number of Participants With CRC Screening Utilized
timeFrame: 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Sameer D. Saini, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saini SD, van Hees F, Vijan S. Smarter screening for cancer: possibilities and challenges of personalization. JAMA. 2014 Dec 3;312(21):2211-2. doi: 10.1001/jama.2014.13933. No abstract available.
citation: van Hees F, Saini SD, Lansdorp-Vogelaar I, Vijan S, Meester RG, de Koning HJ, Zauber AG, van Ballegooijen M. Personalizing colonoscopy screening for elderly individuals based on screening history, cancer risk, and comorbidity status could increase cost effectiveness. Gastroenterology. 2015 Nov;149(6):1425-37. doi: 10.1053/j.gastro.2015.07.042. Epub 2015 Aug 4.
citation: Caverly TJ, Kerr EA, Saini SD. Delivering Patient-Centered Cancer Screening: Easier Said Than Done. Am J Prev Med. 2016 Jan;50(1):118-121. doi: 10.1016/j.amepre.2015.08.003. Epub 2015 Oct 9. No abstract available.
citation: Veenstra CM, Abrahamse P, Wagner TH, Hawley ST, Banerjee M, Morris AM. Employment benefits and job retention: evidence among patients with colorectal cancer. Cancer Med. 2018 Mar;7(3):736-745. doi: 10.1002/cam4.1371. Epub 2018 Feb 23.