Mailed Outreach Invitations Significantly Improve HCC Surveillance Rates in Patients With Cirrhosis: A Randomized Clinical Trial.

Hepatocellular carcinoma (HCC) surveillance is associated with early tumor detection and improved survival in patients with cirrhosis; however, effectiveness is limited by underuse. We compared the effectiveness of mailed outreach and patient navigation strategies to increase HCC surveillance in a racially diverse cohort of patients with cirrhosis. We conducted a pragmatic randomized clinical trial comparing mailed outreach for screening ultrasound (n = 600), mailed outreach plus patient navigation (n = 600), or usual care with visit-based screening (n = 600) among 1800 patients with cirrhosis at a large safety-net health system from December 2014 to March 2017. Patients who did not respond to outreach invitations within 2 weeks received reminder telephone calls. Patient navigation included an assessment of barriers to surveillance and encouragement of surveillance participation. The primary outcome was HCC surveillance (abdominal imaging every 6 months) over an 18-month period. All 1800 patients were included in intention-to-screen analyses. HCC surveillance was performed in 23.3% of outreach/navigation patients, 17.8% of outreach-alone patients, and 7.3% of usual care patients. HCC surveillance was 16.0% (95% confidence interval [CI]: 12.0%-20.0%) and 10.5% (95% CI: 6.8%-14.2%) higher in outreach groups than usual care (P < 0.001 for both) and 5.5% (95% CI: 0.9%-10.1%) higher for outreach/navigation than outreach alone (P = 0.02). Both interventions increased HCC surveillance across predefined patient subgroups. The proportion of HCC patients detected at an early stage did not differ between groups; however, a higher proportion of patients with screen-detected HCC across groups had early-stage tumors than those with HCC detected incidentally or symptomatically (83.3% versus 30.8%, P = 0.003). Conclusion: Mailed outreach invitations and navigation significantly increased HCC surveillance versus usual care in patients with cirrhosis.

Effects of program scale-up on time to resolution for patients with abnormal screening mammography results.

PURPOSE: Effects of geographic program expansion to rural areas on screening program outcomes are understudied. We sought to determine whether time-to-resolution (TTR) varied significantly by service delivery time period, location, and participant characteristics across 19 North Texas counties. METHODS: We calculated proportions undergoing diagnostic follow-up and resolved ≤ 60 days. We calculated median TTR for each time period and abnormal result BI-RADS 0, 4, 5. Cox proportional hazards regressions estimated time period and patient characteristic effects on TTR. Wilcoxon rank sum tests evaluated whether TTR differed between women who did or did not transfer between counties for services. RESULTS: TTR ranged from 14 to 17 days for BI-RADs 0, 4, and 5; 12.4% transferred to a different county, resulting in longer median TTR (26 vs. 16 days; p < .001). Of those completing follow-up, 92% were resolved ≤ 60 days (median 15 days). For BI-RAD 3, TTR was 208 days (including required 180 day waiting period). Follow-up was significantly lower for women with BI-RAD 3 (59% vs. 96%; p < .0001). CONCLUSION: Expansion maintained timely service delivery, increasing access to screening among rural, uninsured women. Policies adding a separate quality metric for BI-RAD 3 could encourage follow-up monitoring to address lower completion and longer TTR among women with this result.

Mailed Outreach Program Increases Ultrasound Screening of Patients With Cirrhosis for Hepatocellular Carcinoma.

BACKGROUND & AIMS: Surveillance of patients with cirrhosis increases early detection of hepatocellular carcinoma (HCC) and prolongs survival. However, its effectiveness is limited by underuse, particularly among racial/ethnic minorities and individuals of low socioeconomic status. We compared the effectiveness of mailed outreach strategies, with and without patient navigation, in increasing the numbers of patients with cirrhosis undergoing surveillance for HCC in a racially diverse and socioeconomically disadvantaged cohort. METHODS: We performed a prospective study of patients with documented or suspected cirrhosis at a large safety-net health system from December 2014 through March 2016. Patients were assigned randomly (1:1:1) to groups that received mailed invitations for an ultrasound screening examination (n = 600), mailed invitations for an ultrasound screening examination and patient navigation (barrier assessment and motivational education for patients who declined screening; n = 600), or usual care (visit-based screening; n = 600). Patients who did not respond to outreach invitations within 2 weeks received up to 3 reminder telephone calls. The primary outcome was completion of abdominal imaging within 6 months of randomization. RESULTS: Baseline characteristics were similar among groups. Cirrhosis was documented, based on International Classification of Diseases, 9th revision, codes, for 79.6% of patients, and suspected, based on noninvasive markers of fibrosis, for 20.4%. In an intent-to-treat analysis, significantly greater proportions of patients who received the mailed invitation and navigation (47.2%) or the mailed invitation alone (44.5%) underwent HCC screening than patients who received usual care (24.3%) (P < .001 for both comparisons). However, screening rates did not differ significantly between outreach the outreach groups (P = .25). The effects of the outreach program were consistent in all subgroups, including Caucasian vs non-Caucasian race, documented vs suspected cirrhosis, Child-Pugh A vs B cirrhosis, and receipt of gastroenterology care. CONCLUSIONS: In a prospective study, we found outreach strategies to double the percentage of patients with cirrhosis who underwent ultrasound screening for HCC. However, adding patient navigation to telephone reminders provided no significant additional benefit. ClinicalTrials.gov no: NCT02312817.