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A Randomized Controlled Trial of a Tailored Navigation and a Standard Intervention in Colorectal Cancer Screening

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A Randomized Controlled Trial of a Tailored Navigation and a Standard Intervention in Colorectal Cancer Screening Published OnlineFirst November 1, 2012; DOI: 10.1158/1055-9965.EPI-12-0701 Cancer Epidemiology, Research Article Biomarkers & Prevention A Randomized Controlled Trial of a Tailored Navigation and a Standard Intervention in Colorectal Cancer Screening Ronald E. Myers1, Heather Bittner-Fagan4, Constantine Daskalakis2, Randa Sifri3, Sally W. Vernon5, James Cocroft1, Melissa DiCarlo1, Nora Katurakes4, and Jocelyn Andrel2 Abstract Background: This randomized, controlled trial assessed the impact of a tailored navigation intervention versus a standard mailed intervention on colorectal cancer screening adherence and screening decision stage (SDS). Methods: Primary care patients (n ¼ 945) were surveyed and randomized to a Tailored Navigation Intervention (TNI) Group (n ¼ 312), Standard Intervention (SI) Group (n ¼ 316), or usual care Control Group (n ¼ 317). TNI Group participants were sent colonoscopy instructions and/or stool blood tests according to reported test preference, and received a navigation call. The SI Group was sent both colonoscopy instructions and stool blood tests. Multivariable analyses assessed intervention impact on adherence and change in SDS at 6 months. Results: The primary outcome, screening adherence (TNI Group: 38%, SI Group: 33%, Control Group: 12%), was higher for intervention recipients than controls (P ¼ 0.001 and P ¼ 0.001, respectively), but the two intervention groups did not differ significantly (P ¼ 0.201). Positive SDS change (TNI Group: þ45%, SI Group: þ37%, and Control Group: þ23%) was significantly greater among intervention recipients than controls (P ¼ 0.001 and P ¼ 0.001, respectively), and the intervention group difference approached significance (P ¼ 0.053). Secondary analyses indicate that tailored navigation boosted preferred test use, and suggest that intervention impact on adherence and SDS was attenuated by limited access to screening options. Conclusions: Both interventions had significant, positive effects on outcomes compared with usual care. TNI versus SI impact had a modest positive impact on adherence and a pronounced effect on SDS. Impact: Mailed screening tests can boost adherence. Research is needed to determine how preference, access, and navigation affect screening outcomes. Cancer Epidemiol Biomarkers Prev; 22(1); 109–17. Ó2012 AACR. Introduction adults who are 50 or more years of age, asymptomatic, There will be an estimated 143,640 new cases of and and are at average risk for CRC (2). Colonoscopy every 10 51,690 deaths from colorectal cancer (CRC) in 2012 (1). years and annual stool blood test (SBT) use are the most Late diagnosis will account for many of CRC-related frequently conducted CRC screening tests in primary deaths. CRC screening can detect colorectal adenomas care, the setting in which most screening takes place (3). before they progress to cancer; and can find early cancer, While CRC screening is increasing in the United States, when the disease can be more readily cured. The Amer- rates lag behind those for breast and cervical cancer ican Cancer Society (ACS) and the United States Preven- screening (4). Healthy People 2020 has called for CRC tive Services Task Force encourage CRC screening by screening rates of at least 70% (5). Effective behavioral interventions must be identified and applied in primary care to achieve this goal. The Guide to Community Pre- ventive Services has reported that patient-oriented mailed fi 1 2 Authors' Af liations: Departments of Medical Oncology, Pharmacology contacts and reminders, along with methods for increas- & Experimental Therapeutics, and 3Family and Community Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania; 4Christiana Care ing access or reducing structural barriers (e.g., patient Health System, Wilmington, Delaware; and 5Division of Health Promotion navigation contacts) can increase CRC screening adher- and Behavioral Sciences, School of Public Health, University of Texas Health Science Center at Houston, Texas ence (6). It has been suggested that providing patients access to Note: Supplementary data for this article are available at Cancer Epide- miology, Biomarkers & Prevention Online (http://cebp.aacrjournals.org/). their preferred CRC screening test is a new strategy that could further boost screening adherence (7–9). To date, Corresponding Author: Ronald E. Myers, Department of Medical Oncol- ogy, Thomas Jefferson University, 1025 Walnut Street, Suite 1014, Phila- little research has been reported concerning the impact delphia, PA 19107. Phone: 215-503-4085; Fax: 215-503-9506; E-mail: of CRC screening test preference on screening adher- [email protected] ence. Recently, Inadomi and colleagues (9) found that doi: 10.1158/1055-9965.EPI-12-0701 primary care patients were more likely to screen when Ó2012 American Association for Cancer Research. they were given access to a screening test that was in www.aacrjournals.org 109 Downloaded from cebp.aacrjournals.org on September 24, 2021. © 2013 American Association for Cancer Research. Published OnlineFirst November 1, 2012; DOI: 10.1158/1055-9965.EPI-12-0701 Myers et al. accord with their personal preference than when they prior diagnosis of colorectal neoplasia or inflammatory were provided with tests they did not prefer. In a bowel disease, had visited one of the participating prac- randomized, controlled trial of interventions designed tices within the previous 2 years, had complete contact to increase CRC screening, Myers and colleagues (10) information, and were not compliant with ACS CRC reported that screening decision stage (i.e., decided screening guidelines. against, never heard of, not considering, undecided, Potentially eligible patients were mailed an introduc- and decided to do), which is based on the Precaution tory letter and were called to verify eligibility and obtain Adoption Process Model (PAPM), was a strong pre- verbal consent. Patients who were not initially reached by dictor of screening adherence. Decision staging has telephone were considered for inclusion in later study been incorporated into the Preventive Health Model waves. Patients who consented and enrolled were mailed (PHM). The PHM is an explanatory framework devel- a $20 gift card. oped to identify predictors of health behavior and to guide interventions that aim to influence health behav- Baseline telephone survey ior. In the PHM, personal representations related to Potentially eligible patients were mailed an introduc- given behaviors (e.g., salience and coherence, perceived tory letter and were called to verify eligibility, obtain susceptibility, worries and concerns, response efficacy, verbal consent, and administer a baseline survey ques- and social support) and decision stage are conceived of tionnaire. The baseline (prerandomization) survey col- as factors that condition one’s preference for available lected data on participant sociodemographic character- behavioral alternatives and influence the likelihood of istics, as well as a number of PHM items used in earlier action. research (11, 12). This paper presents findings from an NCI-funded PHM items were measured on a 5-point Likert-type randomized controlled trial designed to determine the scale (1 ¼ strongly disagree to 5 ¼ strongly agree) and impact of a preference-based tailored navigation inter- items were averaged to construct 5 separate PHM scales vention (TNI) versus a standard intervention and usual (1 ¼ low to 5 ¼ high): perceived susceptibility to CRC care on CRC screening outcomes. The tailored naviga- (3 items, a ¼ 0.84), screening salience and coherence, tion arm of the study provided adult primary care (3 items, a ¼ 0.73), screening response efficacy (2 items, patients access to their preferred CRC screening test a ¼ 0.48), screening worries and concerns (2 items, a ¼ (colonoscopy and/or SBT), whereas the standard inter- 0.77), and screening social support and influence (4 items vention provided access to both tests. To our knowl- a ¼ 0.64). To complement these measures that have been edge, this study is the first time a preference-based previously reported to be valid across population sub- navigation intervention has been used to promote CRC groups (13), we added a global PHM measure (14 items, screening adherence. Cronbach’s a ¼ 0.74). In accordance with prior research (14, 15), we deter- mined each respondent’s test-specific SDS for both Materials and Methods colonoscopy and SBT screening (1 ¼ decided against, Study design and participants 2 ¼ never heard of, 3 ¼ not considering, 4 ¼ undecided, The study, which was conducted between 2007 and or 5 ¼ decided to do). We defined each participant’s 2011, included 10 primary care practices affiliated with the preferred screening test as the one with the highest Christiana Care Health System (CCHS) in Delaware that reported stage in a head-to-head comparison of test- used a common medical record system (Centricity). The specific SDS. For example, if a participant reported that CCHS provides health care services across the spectrum she/he had decided to do colonoscopy screening, of care and provides more than two-thirds of all health and was undecided about doing SBT, we identified care in Delaware. The system includes primary care, colonoscopy as the preferred screening test. Equal pre- specialty referral care, tertiary care, home health care, ference was assigned when test-specific SDS was the and long-term care. The system includes 2 acute care same for both tests. We also defined each participant’s hospitals with more than 42,000 inpatient admissions
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