Three studies were reviewed for this summary. Located in the San Francisco and Fresno, California, metropolitan areas, the study sites included:
- Six community-based primary care clinics offering flu shots (Study 1)
- A hospital-based primary care clinic offering flu clinics (Study 2)
- Five flu shot clinics operated by an integrated managed care organization (Study 3)
Study 1, published in 2011, was conducted in six community-based adult primary care clinics providing flu shots to eligible patients during primary care visits, with nurses often offering the vaccinations proactively without waiting for a physician's order. At the start of the study, CRCS was typically provided at these clinics only by physician order. Each clinic was randomly assigned to provide FOBT with flu shots (FLU-FOBT) or flu shots only (FLU-only) in alternating 1-week blocks. During FLU-FOBT weeks, nurses were given standing orders to offer FOBT, if due, to patients aged 50-75 years who received a flu shot. During FLU-only weeks, nurses had standing orders to provide FOBT to patients who received flu shots only if the primary care clinician ordered the FOBT as part of usual care. The blocks were arranged so that in any given week, three clinics performed the FLU-FOBT protocol and three clinics performed the FLU-only protocol, thereby balancing exposure to the intervention and control arms over the 18-week study period.
The study included 677 patients in the control group and 695 in the intervention group, for a total of 1,372 participants. The average age was 60. The sample was 54.9% male and 37.1% African American, 29.5% non-Latino White, 20.4% Latino, and 11.1% Asian American. Outcomes examined include completion of FOBT and any other CRCS tests, tracked using electronic medical records.
Study 2, published in 2009, was conducted at a primary care clinic providing flu shots within a large hospital. The flu shot clinics were run by multilingual medical assistants and health workers. Over a 3-month period, 17 half-day flu clinics were randomized into 9 intervention sessions, in which clinic staff provided flu shots and FOBT kits to patients eligible for CRCS by the end of the flu season, and 8 control sessions, in which staff provided flu shots only. The day before each flu shot clinic, a member of the research team reviewed the electronic medical records of scheduled patients to determine who was eligible for FOBT. The list of eligible patients was provided to the clinic staff so they would know in advance who needed FOBT. After their flu shots, eligible patients attending the intervention sessions were offered an FOBT kit with instructions and postage-paid return envelopes. Patients who did not return a completed kit within 3 weeks of receiving the kit received a telephone call reminder; those who did not return a completed kit within 6 weeks received another telephone call reminder.
The study included 246 patients in the control group and 268 in the intervention group, for a total of 514 participants. The average age was 64.7. The sample was 63.6% female and 52.1% Asian/Pacific Islander, 30.5% Latino, 8.8% non-Latino White, and 5.9% African American. The primary outcome, tracked using electronic medical records, was change in up-to-date CRCS status from being due for a screening test to having completed the FOBT. Patients were considered due for a screening test if they did not have FOBT in the past year, a flexible sigmoidoscopy or double-contrast barium enema in the past 5 years, or a colonoscopy in the past 10 years, or if they had any previously unevaluated abnormal FOBT results or recent unevaluated rectal bleeding.
Study 3, published in 2013, was conducted at five flu shot clinic sites operated by an integrated managed care organization for its members. Two sites participated in the first 2-month study period, and the remaining three sites participated in a second 2-month study period one year later. Each site provided a list of flu shot clinic dates to be randomly assigned to the intervention or control arms. Using blocks of 2 or 4 days, each date within each site was assigned to either the intervention arm (FLU-FIT arm providing FIT kits to eligible patients along with flu shot) or to the control arm (FLU-Only arm, providing flu shots only). On FLU-FIT days, the clinic staff were asked to provide FIT kits to eligible patients either immediately before their flu shot or while they registered for the shot. Patients' member cards and electronic medical records were used to identify patients eligible for CRCS. The clinic staff provided FIT kits to eligible members they identified, with any combination of brief verbal messages, such as "Just like a flu shot, you need to complete a colon test every year", "This test is free and could save your life", or "You can do FIT today and mail it in tomorrow." Patients with questions were directed to read the kit instructions (available in multiple languages with an added message about the importance of CRCS) or contact their primary care clinician.
The study included 2,884 patients in the FLU-only control group and 3,351 in the FLU-FIT treatment group, for a total of 6,235 participants. The average age was 61.5. The sample was 57.4% female and 46.6% White, 16.7% Asian/Pacific Islander, 5.7% Black, and 5.1% multiracial. Almost 22% identified themselves as Hispanic (21.7%). The primary outcome, tracked using electronic medical records, was change in CRCS up-to-date status from being due for a screening test to having completed the FIT. Patients were considered due for a screening test if they did not have FIT in the past year, a flexible sigmoidoscopy in the past 5 years, or a colonoscopy in the past 10 years.