Health Literacy Interventions to Overcome Disparities in CRC Screening
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      In the proposed project the investigators will evaluate two different follow-up approaches to
      improve low income patients' completion of initial and annual colorectal cancer (CRC)
      screening using the Fecal Immunochemical Test (FIT), the most sensitive FOBT. The purpose of
      this study is to compare the effectiveness of two distinct follow-up strategies to promote
      CRC screening: a prevention coordinator (PC) approach vs. an automated telephone reminder
      (ATR) system. The investigators will adapt a successful intervention tested in the Health
      Literacy and Cancer Screening Project by adding a follow-up strategy to the health literacy
      intervention. Specific Aims: The investigators Primary Aims are to: 1. Compare the
      effectiveness of the PC and ATR strategies to improve initial and repeat CRC screening. 2.
      Compare the cost effectiveness of the PC and ATR strategies for initial and repeat CRC
      screening. The investigators Secondary Aims are to: 3. Conduct a process evaluation of both
      follow-up strategies to investigate implementation and barriers 4. Determine if the effects
      of either strategy vary by patients' literacy skills. 5. Explore patient characteristics
      associated with CRC screening knowledge, beliefs, self-efficacy, and compliance over time
      between study arms.
    

Detailed description: 
      The investigators objective is to compare the effectiveness of two distinct follow-up
      strategies to promote colorectal cancer screening: a prevention coordinator (PC) approach vs.
      an automated telephone reminder (ATR) system. The investigators will adapt a successful
      intervention tested in the Health Literacy and Cancer Screening Project [R01CA115869] by
      adding a follow-up strategy to the health literacy intervention. In the proposed project the
      investigators will evaluate two different follow-up approaches to improve low income
      patients' completion of initial and annual CRC screening using Fecal Immunochemical Test
      (FIT).

      Substantial evidence shows that routine screening can prevent colorectal cancer (CRC) or
      detect it at an early stage, reducing related mortality. While overall CRC screening rates in
      the US are increasing, rates remain persistently low among uninsured and low-income
      individuals, those with fewer years of education, and racial/ethnic minorities. Low health
      literacy has been linked to cancer screening noncompliance, higher rates of advanced stage of
      presentation of disease and health disparities. In response, the Department of Health and
      Human Services has called for health information and services that are accurate, accessible,
      and actionable as well as culturally appropriate.

      This study will implement a two-arm, randomized controlled trial with low income,
      underinsured patients in federally qualified health centers (FQHCs) to evaluate and compare
      the effectiveness of PC and ATR follow-up strategies to increase CRC screening. All patients
      recruited to the study will receive evidence-based, literacy appropriate screening materials
      developed using health literacy 'best practices' and a simplified FIT kit. Use of these
      materials has been shown to significantly increase CRC screening rates in the investigators
      ongoing study. Patients will be randomized to receive either: 1) the PC follow-up strategy,
      in which a PC personally reminds patients to complete and mail FIT kits, and perceived
      barriers to screening are discussed and addressed; or 2) the ATR follow-up strategy, in which
      an automated system electronically encourages patients to complete and mail FIT kits using
      plain language messages. The effectiveness of these two approaches will be compared at 12 and
      24 months.
    

Intervention name(s): automated telephone reminder; prevention coordinator; Health literacy appropriate education and demonstration
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT. ATR will remind the patient of the importance of completing and returning the FIT results and encourage screening completion. There will also be an option where the patient can request another FIT kit be mailed to them, one to hear information on common problems with FIT completion or how to call the clinic if they have questions. Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly letter to remind them that it is time for their annual CRC screening and that a FIT kit will be mailed the following week. During the following week the patients will be mailed the FIT kit with addressed stamped envelope and the educational pamphlet they received at enrollment. For follow-up ATR calls, we will use the same protocol as described for the initial screening. Same procedure for year 3.; The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT by a prevention coordinator (PC). PC will call to encourage completion and ascertain any barriers to completion. The PCs will use Health Literacy and motivational interviewing techniques described in the training section to enhance understanding and confidence and reduce ambivalence to completing and returning the FIT. Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly letter to remind them that it is time for their annual CRC screening and that a FIT kit will be mailed the following week. During the following week the patients will be mailed the FIT kit with addressed stamped envelope and the educational pamphlet they received at enrollment. For follow-up PC calls, we will use the same protocol as described for the initial screening. Same procedure for year 3.; The Research Assistant (RA) will employ health literacy communication principles in providing a CRC recommendation and brief screening information using the CRC pamphlet and a FIT kit with simplified instructions and accompanying self-addressed, stamped envelope. A scripted message and illustrations will model what the patient needs to do to complete the FIT. The RA will appropriately demonstrate, using the kit, and will suggest patients show the pamphlet and FIT kit to their provider that day and talk to them about screening. Annual screening will be further emphasized at enrollment by giving patients an empowering message about the benefits of completing a FIT annually and telling them they will be mailed a reminder letter and FIT kit and receive outreach phone calls in 12 and 24 months for the next two years as well as a post survey and satisfaction interview over the phone at 6 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: colorectal cancer screening; low literacy; community clinics; Fecal Immunochemical Test