Screening for CRC presents a unique set of barriers that reduces the number of individuals who participate in FOBT screening programs. The Health Belief Model and social cognitive theories state that patient health prevention behaviors are largely determined by perceived susceptibility and seriousness of a health threat or personal risk.18
Other tenets of the model are the patients' consideration of benefits and barriers to action, including interactions with the health care system, adequacy of information to cue action, and self-efficacy or confidence in the ability to successfully take action.18
Major patient barriers to FOBT testing are consistent with this model and include limited knowledge of CRC and screening tests for CRC, low perception of personal risk for CRC, inconvenience, the perception that FOBT is time consuming, lack of confidence in the ability to do FOBT, aversion to stool testing, and fear of the consequences of screening (cancer fatalism).14,16,19–22
Numerous studies have evaluated patient participation in CRC screening programs and FOBT card return rates and all of these showed that patient adherence was suboptimal.16,23–25
Overall, the median compliance rate with FOBT is between 40.0% and 50.0%, depending on the population studied.16
The compliance rates with FOBT were 59.6% to 75.2% in randomized trials for CRC screening,2–4
but were lower in community-based mass screening programs (26.0% to 48.0%).24–27
Studies of relatively impersonal or minimal interventions where patients were asked to pick up a test kit or to mail in a reply card in order to receive a test kit reported even lower compliance rates of 10.0% to 30.0%.16
The 51.3% compliance rate with return of the FOBT cards in the standard education arm in our study was similar to what has been reported in other studies and was nearly identical to the guaiac-based FOBT card return rate of 47.1% in the primary care clinics at the VA Puget Sound Healthcare System.16,28
An important challenge for CRC screening programs is to improve screening participation rates and compliance with FOBT. To date, attempts to promote CRC screening have used both a public health model that targets communities and a medical model that targets individuals, and these studies have been summarized by Vernon.16
Various patient interventions have been evaluated to increase compliance with FOBT, including telephone reminders and instructional telephone calls, postal reminders, letters signed by personal physicians, interventions based on theories or models of behavior change, and other education strategies.16
More recently, Pignone et al.29
conducted a randomized, controlled trial to examine whether a strategy to reduce a combination of barriers would increase adherence rates. The investigators evaluated an educational videotape, a brochure for patients, and chart reminders for physicians and found that these additional tools increased FOBT completion rates to 28.5% compared with 20.2% among controls.
Overall, the most intensive patient-directed interventions delivered to a well-defined population of eligible persons rarely increased adherence to FOBT above 50.0%.16
However, patient education and educational brochures about CRC and the importance of screening can be effective in improving patient knowledge and compliance with FOBT.30–32
Our randomized study demonstrated that intensive patient education significantly increased patient compliance with FOBT to 65.9% compared with 51.3% in the control group. Our study expands on previously published data and shows that one-on-one patient education can significantly improve patient compliance with FOBT. The intensive teaching emphasized the importance of the test and may have increased the patients' confidence in their ability to complete the FOBT. Our study showed that teaching patients exactly how to do the test and giving them the time to ask questions while they were at the clinic enabled them to perform FOBT at home and return the cards as requested.
Although our intervention was effective in improving FOBT return rates, one-on-one patient education by registered nurses is costly and time consuming. A substantial proportion of the cost of our intervention was due to the use of registered nurses to individually educate each patient. It may be more cost-effective to utilize less costly health care personnel, such as certified medical assistants. Another alternative is to educate patients in a group setting as opposed to the one-on-one approach used in the present study. Future studies to evaluate the cost and effectiveness of these educational strategies are needed.
Previous studies have shown that patient adherence to repeat annual FOBT is low.33
Therefore, the long-term success of a CRC screening program will require policy-, institution-, and system-level changes. Public health programs to increase awareness of CRC screening, as well as a patient educational intervention similar to our intervention combined with clinician education, patient and clinician reminders, and a strong clinician-patient partnership are needed in order to deliver an effective annual FOBT screening program.
The strengths of this study include the large sample size, randomized design with concealed allocation, inclusion of a control group, and long-term follow-up to allow adequate time for participants to return the FOBT cards. However, some limitations also need to be considered in the interpretation of our findings. First, our population included predominantly male subjects who were enrolled at a single VA medical center and compliance rates may differ with females, in other primary care clinics, or in non-VA settings. Second, our study utilized 12 primary care nurses to teach patients and different teaching styles may have impacted patient compliance. Third, health care providers, staff, and patients were not blinded and this may have influenced the effect size of our intervention. Finally, we did not evaluate the reasons for noncompliance in those who did not return the FOBT cards. Therefore, our results may not be fully generalizable to other clinic settings.
In conclusion, patients in the intensive education group were significantly more likely to return the FOBT cards and called the clinic with additional questions less often than those in the standard education group. The question of whether our educational intervention can further increase patient compliance with FOBT when added to patient and clinician reminder systems is an important topic for future investigation. Screening for CRC requires ongoing adherence to be effective and, therefore, further studies are needed to determine whether these behaviors can be sustained over time. In addition, research is needed to identify novel means of reaching persons at risk for CRC who currently are not served or are underserved by the existing health care system.