An automated intervention with stepped increases in support to increase uptake of colorectal cancer screening: a randomized trial

Abstract

Background: Screening decreases colorectal cancer (CRC) incidence and mortality, yet almost half of age-eligible patients are not screened at recommended intervals.

Objective: To determine whether interventions using electronic health records (EHRs), automated mailings, and stepped increases in support improve CRC screening adherence over 2 years.

Design: 4-group, parallel-design, randomized, controlled comparative effectiveness trial with concealed allocation and blinded outcome assessments. (ClinicalTrials.gov: NCT00697047)

Setting: 21 primary care medical centers.

Patients: 4675 adults aged 50 to 73 years not current for CRC screening.

Intervention: Usual care, EHR-linked mailings ("automated"), automated plus telephone assistance ("assisted"), or automated and assisted plus nurse navigation to testing completion or refusal ("navigated"). Interventions were repeated in year 2.

Measurements: The proportion of participants current for screening in both years, defined as colonoscopy or sigmoidoscopy (year 1) or fecal occult blood testing (FOBT) in year 1 and FOBT, colonoscopy, or sigmoidoscopy (year 2).

Results: Compared with those in the usual care group, participants in the intervention groups were more likely to be current for CRC screening for both years with significant increases by intensity (usual care, 26.3% [95% CI, 23.4% to 29.2%]; automated, 50.8% [CI, 47.3% to 54.4%]; assisted, 57.5% [CI, 54.5% to 60.6%]; and navigated, 64.7% [CI, 62.5% to 67.0%]; P < 0.001 for all pair-wise comparisons). Increases in screening were primarily due to increased uptake of FOBT being completed in both years (usual care, 3.9% [CI, 2.8% to 5.1%]; automated, 27.5% [CI, 24.9% to 30.0%]; assisted, 30.5% [CI, 27.9% to 33.2%]; and navigated, 35.8% [CI, 33.1% to 38.6%]).

Limitation: Participants were required to provide verbal consent and were more likely to be white and to participate in other types of cancer screening, limiting generalizability.

Conclusion: Compared with usual care, a centralized, EHR-linked, mailed CRC screening program led to twice as many persons being current for screening over 2 years. Assisted and navigated interventions led to smaller but significant stepped increases compared with the automated intervention only. The rapid growth of EHRs provides opportunities for spreading this model broadly.

Figure 1. Study flow diagram

CRC = colorectal cancer. * Provided written request to be withdrawn from the study and to have data removed from study databases.

Figure 2. Type of colorectal testing completed for those current for testing, both years 1 and 2

Current is defined as receiving a FS or CS in year 1 or FOBT in year 1 plus FOBT, colonoscopy, or flexible sigmoidoscopy in year 2. Patients with FOBT in year 1 and who were ineligible in year 2 (death, colorectal cancer, or disenrollment in year 1) were defined as current for the primary analysis (n = 68). CS = colonoscopy; FOBT = fecal occult blood test; FS = flexible sigmoidoscopy.