A Multilevel Primary Care Intervention to Improve Follow-Up of Overdue Abnormal Cancer Screening Test Results A Cluster Randomized Clinical Trial

IMPORTANCE Realizing the benefits of cancer screening requires testing of eligible individuals and processes to ensure follow-up of abnormal results.OBJECTIVE To test interventions to improve timely follow-up of overdue abnormal breast, cervical, colorectal, and lung cancer screening results.DESIGN, SETTING, AND PARTICIPANTS Pragmatic, cluster randomized clinical trial conducted at44 primary care practices within 3 health networks in the US enrolling patients with at least 1abnormal cancer screening test result not yet followed up between August 24, 2020, and December 13, 2021.INTERVENTION Automated algorithms developed using data from electronic health records(EHRs) recommended follow-up actions and times for abnormal screening results. Primary care practices were randomized in a 1:1:1:1 ratio to (1) usual care, (2) EHR reminders, (3) EHR reminders and outreach (a patient letter was sent at week 2 and a phone call at week 4), or(4) EHR reminders, outreach, and navigation (a patient letter was sent at week 2 and a navigator outreach phone call at week 4). Patients, physicians, and practices were unblinded to treatment assignment.MAIN OUTCOMES AND MEASURES The primary outcome was completion of recommended follow-up within 120 days of study enrollment. The secondary outcomes included completion of recommended follow-up within 240 days of enrollment and completion of recommended follow-up within 120 days and 240 days for specific cancer types and levels of risk.RESULTS Among 11 980 patients (median age, 60 years [IQR, 52-69 years]; 64.8% were women; 83.3% were White; and 15.4% were insured through Medicaid) with an abnormal cancer screening test result for colorectal cancer (8245 patients [69%]), cervical cancer(2596 patients [22%]), breast cancer (1005 patients [8%]), or lung cancer (134 patients [1%])and abnormal test results categorized as low risk (6082 patients [51%]), medium risk (3712patients [31%]), or high risk (2186 patients [18%]), the adjusted proportion who completed recommended follow-up within 120 days was 31.4% in the EHR reminders, outreach, and navigation group (n = 3455), 31.0% in the EHR reminders and outreach group (n = 2569),22.7% in the EHR reminders group (n = 3254), and 22.9% in the usual care group (n = 2702)(adjusted absolute difference for comparison of EHR reminders, outreach, and navigation group vs usual care, 8.5% [95% CI, 4.8%-12.0%],P< .001). The secondary outcomes showed similar results for completion of recommended follow-up within 240 days and by subgroups for cancer type and level of risk for the abnormal screening result.CONCLUSIONS AND RELEVANCE A multilevel primary care intervention that included EHRreminders and patient outreach with or without patient navigation improved timely follow-up ofoverdue abnormal cancer screening test results for breast, cervical, colorectal, and lung cancer.