Promoting Veteran-Centered Colorectal Cancer Screening (PROM-IS)

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Decision Aid; Behavioral: Provider Education; Behavioral: Performance Measure Modification; Behavioral: Simple Informational Booklet

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).

• Study Type: Interventional
• Enrollment (Actual): 436
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • VA Ann Arbor Healthcare System, Ann Arbor, MI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 75 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Decision Aid; Patients of primary care providers randomly assigned to the Decision Aid intervention (DA) that includes an individualized decision aid, provider education, and modified performance measure/reminder.	Behavioral: Decision Aid; Printed booklet comprising educational information about benefits and harms of screening, individualized estimates of benefits and harms of screening, and values clarification exercise; Behavioral: Provider Education; 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.; Behavioral: Performance Measure Modification; 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.
Other: No Decision Aid; Patients of primary care providers will be randomly assigned to the pragmatic control (PC) that includes provider education and modified performance measure/reminder, but no decision aid.	Behavioral: Provider Education; 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.; Behavioral: Performance Measure Modification; 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.; Behavioral: Simple Informational Booklet; A simple informational booklet explaining colorectal cancer screening and current screening recommendations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With CRC Screening Ordered	The primary dependent variable in the analysis was whether screening was ordered within two weeks after the clinic visit (dichotomous). Screening orders were determined by manual record review of electronic health records.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance Between Screening Orders and Screening Benefit	Defined as the degree to which screening orders align with expected screening benefit, such that individuals with low screening benefit receive screening orders at a lower rate than those with high screening benefit. We hypothesized that Veterans randomized to the intervention (decision aid) would receive screening orders that were more concordant with screening benefit than those randomized to the control. The expected benefit of screening (reduction in CRC incidence) was calculated using the MISCAN-Colon model. For a given patient, this value was a function of age, gender, health status, and prior screening history. The regression analysis included screening orders as the dependent variable, and, study arm, expected benefit, and an interaction term between study arm and expected benefit as the independent variables. The p-value reported is for the interaction term.	2 weeks
Number of Participants With CRC Screening Utilized	Screening test completion was collected through manual review of electronic medical records.	6 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: University of Colorado, Denver; Memorial Sloan Kettering Cancer Center; Erasmus Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Click here for more information about this study: Promoting Veteran-Centered Colorectal Cancer Screening

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2015
• Primary Completion (Actual): August 8, 2018
• Study Completion (Actual): August 22, 2018

Study Registration Dates

• First Submitted: December 18, 2013
• First Submitted That Met QC Criteria: January 2, 2014
• First Posted (Estimate): January 6, 2014

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: decision making; cancer screening
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: IIR 12-411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No