Evidence-based interventions often fail the test of translation into clinical practice [9
Our study of the FLU-FOBT Program provides an example of how an evidence-based intervention, developed through an iterative process involving the participation of the end users of the intervention, can be rigorously tested and evaluated, with lasting benefits for participating clinics. The FLU-FOBT Program was first adapted for primary care office visits [6
], shown effective in an RCT [5
] and then, in this present study, shown to have benefits for participating clinics that lasted for at least 1 year after completion of the RCT.
During the RCT, the proportion of influenza vaccination recipients who completed FOBT increased substantially and remained increased above baseline in the following year. Clinic staff and clinic leaders reported behavior and systems changes that they felt would support higher CRCS rates for their clinics into the future, although also described challenges to maintaining the FLU-FOBT program long term.
Adoption, implementation and maintenance of specific components of the FLU-FOBT Program specific component in the year after the RCT varied from clinic to clinic. While screening rates increased in several of the clinics, they did not increase in all clinics. While we do not know the exact reasons that not all clinics were successful in increasing and maintaining screening rates, barriers most commonly cited by clinic leaders were inadequate time, not enough space and staffing issues, including having enough available staff and having staff committed to the program.
The FLU-FOBT Program was implemented as a multi-component package, and it is not possible to separate out the effect of individual components of the program. The RCT was designed to allow considerable adaptation of the intervention by clinic staff, and this adaptation continued in the year after the RCT was completed. An important question is to what extent the success of the intervention can be attributed to the coupling of FOBT with influenza vaccinations, the empowerment of the clinic staff members to identify eligible patients and offer FOBT without a physician order, and/or to the use of a more organized way of providing FOBT to eligible patients. It is possible that the FLU-FOBT RCT became a more general means to an end, providing a simple and focused way for clinic staff to get involved in screening and for clinical teams to begin to work together on a whole range of CRCS issues.
Our study has several limitations. First, CRCS screening rates among influenza vaccination recipients may be subject to many external influences, such as fluctuations in the availability of influenza vaccination and changes in patient populations served in these clinics over time, or other unrelated quality improvement activities. However, the fact that CRCS screening rates remained higher than baseline, even 1 year after the RCT was completed, suggests that our intervention had a durable impact. Second, our intervention only targets individuals who come in for influenza vaccines, and these individuals may be different from those who do not come in for influenza vaccines. Third, our data on practice changes relied on self-report, and could have been biased. However, staff survey respondents were not identified individually and participants had anonymity to respond honestly and critically to all the questions. The interviews with nurse managers and medical directors were conducted by an investigator less known to them, rather than by the study principal investigator, so that respondents would feel able to speak freely about their experiences and future plans. The results of the surveys and interviews are largely corroborated by the increased number of influenza vaccines being given and FOBT kits being completed by primary care patients in these clinics. Finally, we evaluated the adoption, implementation and maintenance of the FLU-FOBT Program just for 1 year after the RCT, which may not be enough to be certain of the lasting impact of the intervention. On the other hand, we wanted to capture feedback from staff while they still had vivid memories of participating in the RCT. We feel therefore that the post-intervention evaluation was timed as well as possible to get accurate and relevant information from clinic leader and clinic staff participants.
In summary, many components of the FLU-FOBT Program were maintained after the trial was completed, and the evidence suggests that primary care clinic participation in the FLU-FOBT Program RCT resulted in continued improvements in CRCS processes and outcomes at least a year beyond their introduction. Future research should address the extent to which fidelity to and adaptation of individual FLU-FOBT Program components contribute to these improved outcomes and to their long term sustainability.