Published Online: August 08, 2011
Michael B. Potter, MD; Carol P. Somkin, PhD; Lynn M. Ackerson, PhD; Vicky Gomez, MPH; T. Teresa Dao, MD; Michael A. Horberg, MD; and Judith M. E. Walsh, MD, MPH
Objective: To determine whether offering home fecal immunochemical tests (FITs) to eligible patients during a high volume influenza vaccination clinic could lead to increased colorectal cancer screening (CRCS) rates in a managed care setting.
Study Design: Observational study.
Methods: During influenza vaccination clinics in 2008, trained staff provided FITs to patients who were eligible for CRCS (FLU-FIT group) (FLU indicates influenza vaccine). Screening outcomes for this cohort of patients were compared with those of a similar group of influenza clinic attendees who were not exposed to the intervention (FLUonly group).
Results: Among eligible participants in the FLU-only group (N = 4653), 13.7% completed FIT within 90 days of their influenza vaccine, and in the FLU-FIT group (N = 2812), 30.3% completed FIT (P <.0001). In the FLU-FIT group, 1447 (51.4%) were provided with a FIT kit, and 653 (45.1%) of these patients completed a FIT kit within 90 days. In multivariate analyses, FLU-FIT group participants were significantly more likely to complete FITs compared with FLU-only group participants (odds ratio = 2.76 [95% confidence interval, 2.45-3.11]). Overall, the CRCS rate for the FLU-only group increased from 51.5% to 56.3% (increase of 4.8 percentage points), compared with an increase from 49.2% to 63.2% (increase of 14.0 percentage points) in the FLU-FIT group (P <.0001 for change difference).
Conclusions: The FLU-FIT Program is feasible to implement in a high volume influenza vaccination clinic conducted in a managed care setting and increases colorectal cancer screening activity among eligible influenza vaccination recipients who are reached with the intervention.
(Am J Manag Care. 2011;17(8):577-583)
Many managed care organizations provide annual influenza vaccination clinics each autumn.
Many influenza vaccination clinic attendees are over the age of 50 and due for colorectal cancer screening.
Offering annual home fecal immunochemical test kits to influenza vaccination clinic attendees is a relatively simple and effective way to reach many patients who are due for colorectal cancer screening.
Colorectal cancer is the second leading cause of cancer death in the United States, and colorectal cancer mortality can be reduced with screening.1 The American Cancer Society and US Preventive Services Task Force (USPSTF) recommend colorectal cancer screening (CRCS) for average-risk adults using high-sensitivity home fecal occult blood tests (FOBTs) such as fecal immunochemical tests (FITs), flexible sigmoidoscopy, or colonoscopy.2,3 CRCS rates in the United States are gradually increasing. Among United States residents aged 50 to 75 years, the self-reported prevalence of having completed FOBT in the last year or lower endoscopy (sigmoidoscopy or colonoscopy) within the last 10 years increased from 51.9% in 2002 to 62.9% in 2008.4 While these trends are encouraging, there is still much work needed to reach the American Cancer Society’s goal of having 75% of Americans up-to-date with guideline-recommended screening by 2015.5
Achieving high rates of CRCS may require a variety of approaches. Some of the strongest interventions to increase CRCS include a structure for non-physician staff to interact directly with patients and offer CRCS when indicated.6 One evidence-based intervention to increase CRCS rates is the FLU-FOBT (FLU indicates influenza vaccine) Program, a nurse-run program designed to allow hospital- or clinic-based nursing staff to offer FOBT to eligible patients at the time of influenza vaccination.7,8 The FLU-FOBT Program was initially designed for use in safety net settings, but it may also be effective in health maintenance organizations where patients often attend influenza vaccination clinics by the thousands, and where the simpler-to-use high-sensitivity FIT has often taken the place of guaiac FOBT. In preparation for a randomized trial to test this hypothesis and to increase the potential for future dissemination and implementation of this program for diverse practice settings, the researchers developed a FLU-FIT Program for Kaiser Permanente Northern California’s Santa Clara Medical Center. This is the first study to describe the development of this FLUFIT Program and to evaluate its effectiveness in increasing screening rates for influenza vaccination clinic attendees in health maintenance organizations.
Study Setting. Kaiser Permanente Northern California (KPNC) is an integrated healthcare delivery system with over 3 million members. The study was conducted at KPNC’s Santa Clara Medical Center (KPNC Santa Clara), which provides care to over 300,000 members. Each autumn, KPNC Santa Clara organizes drop-in influenza vaccination clinics in several different facility locations. These clinics, in 2008, were managed by facility nursing administrators and took place on weekends and evenings during the months of October and November. The study idea was presented by the principal investigator (MBP) to one of the co-authors (TTD), who introduced the idea to KPNC administrators, who in turn agreed to participate.
Study Population. The study population consisted of patients aged 50 to 80 years on the date of receiving influenza vaccination at KPNC Santa Clara’s main campus location during the months of October and November in 2008, who also had neither had FIT in the current calendar year (since January 1, 2008) nor colonoscopy in the last 10 years (since January 1, 1999). January 1 was selected as the date from which to determine eligibility for screening to make it easy for clinic staff to quickly determine which patients were eligible for CRCS screening and to allow for a proactive approach to keep people up-to-date for screening who might otherwise become due by the end of the calendar year. Because recent USPSTF guidelines had recommended that patients receiving flexible sigmoidoscopy also receive periodic FIT, patients with flexible sigmoidoscopy in the last 5 years but neither FIT in the current year nor colonoscopy in the last 10 years were considered eligible for FIT.2 The 50-to-80-year age group was selected as a compromise between USPSTF guidelines, which recommend age 75 as the upper limit for routine screening, and American Cancer Society Guidelines, which recommend no fixed upper age limit.2,3
FLU-FIT Program Development and Training. The FLU-FIT Program was pilot tested during the 2007 influenza vaccination season. The project team identified areas for improvement, including the need to: (1) provide pre-intervention staff training, including an opportunity to practice procedures before the intervention began, (2) establish eligibility for FIT with the assistance of the electronic medical record instead of reliance on self-report, and (3) provide FIT in a sequence immediately before influenza vaccinations were offered, rather than after, in order to efficiently reach as many eligible patients as possible. These improvements were implemented for the study we conducted in the fall of 2008: a 90-minute staff training session was developed, participating medical assistants were each provided with a training manual and sample scripts for offering FIT to patients waiting in line for their influenza vaccination, and patients aged 50 to 80 years were directed by a volunteer to a “FIT counter” where the medical assistants checked the electronic health records for eligibility for FIT before administering the influenza vaccination. Patients identified as eligible for FIT were provided with a FIT kit (the single-sample 100 ng OC-Micron test that is currently in use at all KPNC facilities). The FIT kit included multilingual written instructions (in English, Spanish, Chinese, and Vietnamese) with a pictorial demonstration of how to complete the kit, a lab slip, and an envelope for mailing the completed kit to the KPNC Regional Laboratory. Patients were also given a 1-page multilingual educational flyer explaining why annual FIT is important. Materials were written at the 8th grade reading level in English and at the 6th grade reading level in Spanish.9 Chinese and Vietnamese versions were written at a similar level of simplicity. Staff recorded the medical record numbers of patients who were given FIT kits. These patients were sent a reminder postcard within 1 month of receiving their FIT kit. Results of completed tests were reported into the KPNC electronic health record and to patient primary care providers as usual or to the KP Santa Clara chief of medicine for the small number of patients without an assigned primary care provider.
Influenza vaccination clinics were run from October 12, 2008, until November 21, 2008. The FLU-FIT Program was implemented on weekday evenings and Saturdays during this time period (FLU-FIT group), and FLU-only clinics were run as usual during weekday hours, providing a comparison group (FLU-only group). A research associate (VG) was present onsite during part of most FLU-FIT dates to make observations and provide implementation support when needed.
Data Analysis. At the conclusion of the influenza season, medical record numbers for participants were collected and merged with other available electronic health record patient data held by KPNC to create a database including participant age, gender, race, language preference, CRCS history, and number of primary care visits in the prior year. To capture possible socioeconomic differences between the FLU-FIT and FLU-only groups, each study subject was also assigned a “neighborhood deprivation” index score and grouped into 1 of 4 quartiles, with the first quartile indicating residence in a less deprived neighborhood and the fourth quartile indicating residence in a relatively more deprived neighborhood. This score is based on 2000 US Census data including income, poverty, employment, education, and occupation by neighborhood.10 The index has a mean of 0 and a standard deviation of 1, with scores below 0 indicating residence in a neighborhood with less social deprivation and scores above 0 indicating greater social deprivation. Baseline characteristics of the FLU-FIT and FLU-only groups were compared, using 2-sample t-tests for continuous variables and Pearson X2 tests for categorical variables.
The primary outcome of this study was completion of FIT among eligible influenza vaccination clinic attendees. To estimate the impact of the FLU-FIT Program on CRCS rates for all influenza vaccination clinic participants between the ages of 50 and 80 years, we used a generalized estimating equation model to compare differences in CRCS rates from time of vaccination to 90 days later for the FLU-FIT and FLU-only groups among all influenza vaccination recipients. For this analysis, we defined up-to-date as having FIT within the 365 days prior or colonoscopy within the 10 years prior to the date on which screening status was assessed. We calculated P values for baseline differences in CRCS rates between groups for patients at the time of receiving their influenza vaccine, at a time 90 days after getting their influenza vaccination, and for the change difference observed in CRCS rates for each group during this 3 month time period.
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