The effectiveness of any colorectal cancer screening test depends on high rates of adherence and quality, but up to 50% of people who receive a recommendation for colonoscopy do not complete this test, especially in safety net hospitals. Although several test options are available for screening people at average risk for CRC, providers almost universally recommend colonoscopy; this practice is contributing to low screening rates. Colonoscopy is the most appropriate test for people at increased risk for CRC, but those at average risk – the majority of the population - can be screened with less invasive tests.
In one public safety net hospital, the colonoscopy completion rate in 2014 was only 41%, leaving 1150 people who were referred for colonoscopy unscreened in that year alone. The process of bowel cleansing is one of the most common barriers to colonoscopy, and approximately 25% of patients who do attend their scheduled colonoscopy have inadequately cleansed their bowel. Other reasons for colonoscopy non-completion include lack of awareness of the need for and benefits of screening, fear of pain, fear of finding cancer, unpleasantness of the bowel preparation, cost, transportation issues, and unwillingness to undergo invasive testing in the absence of symptoms
Interventions that improve patients’ knowledge about CRC screening, enhance access, improve skills needed to complete screening, and reduce barriers will lead to more people being screened. Both patient navigation and computer-tailored interventions have been shown to effectively increase CRC screening rates. Patient navigation in the context of cancer is a “barrier-focused intervention” that: 1) is provided to individual patients for a defined episode of cancer-related care; 2) has a definite endpoint when provision of services is complete; 3) targets a defined set of health services to complete an episode of cancer-related care; 4) focuses on individual patient-level barriers to accessing care; and 5) aims to reduce delays in accessing care with an emphasis on timeliness and a reduction in the number of patients lost to follow-up.” Though both computer-tailored and patient navigation interventions are effective for increasing CRC screening rates, there is no evidence of their comparative effectiveness or of the effects of combining them.
The purpose of this study is to compare two health system-based interventions, with each other and with usual care, to increase CRC screening rates among a diverse sample of low-income and minority patients. We are using a three-group randomized trial design to: 1) compare the effectiveness of the two interventions (a mailed tailored DVD alone vs. the mailed DVD plus a telephone-based patient navigator) to each other and to usual care; 2) examine age, sex, and race/ethnicity as potential moderators of intervention effects; and 3) examine changes in knowledge and health beliefs (perceived risk, perceived benefits, perceived barriers, and self-efficacy) as possible mediators of intervention effects.
We will enroll 750 patients aged 50-75 who were referred and scheduled for colonoscopy but cancelled, or did not attend, their scheduled appointment in a safety net hospital. Participants will be randomized to receive: 1) a mailed tailored DVD; 2) the mailed DVD plus a patient navigator; or 3) usual care. Data will be collected at baseline and at 6 months and 12 months post-baseline. This trial will compare the effectiveness of two health system-based interventions that have great potential for immediate dissemination into clinical settings to increase CRC screening rates and improve quality of bowel preparation for those who have a colonoscopy. If the interventions are found to be equally effective, or differentially effective for different subgroups of patients, health systems may consider implementing one or both of these interventions in their settings or replicating this study with their patient population. The processes used to engage patients and clinical stakeholders in the development and implementation of this comparative effectiveness trial will be described as exemplars of stakeholder engagement in patient-centered outcomes research.