Mailed Outreach Invitations Significantly Improve HCC Surveillance Rates in Patients With Cirrhosis

A Randomized Clinical Trial

Amit Singal, Jasmin A Tiro, Caitlin Claffey Murphy, Jorge A Marrero, Katharine McCallister, Hannah Fullington, Caroline Mejias, Akbar K. Waljee, Wendy Pechero Bishop, Noel O. Santini, Ethan A Halm

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
JournalHepatology
DOIs
StateAccepted/In press - Jan 1 2018

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Hepatocellular Carcinoma
Fibrosis
Randomized Controlled Trials
Patient Navigation
Confidence Intervals
Patient Care
Pragmatic Clinical Trials
Telephone
Neoplasms
Safety
Survival
Health

ASJC Scopus subject areas

  • Hepatology

Cite this

Mailed Outreach Invitations Significantly Improve HCC Surveillance Rates in Patients With Cirrhosis : A Randomized Clinical Trial. / Singal, Amit; Tiro, Jasmin A; Murphy, Caitlin Claffey; Marrero, Jorge A; McCallister, Katharine; Fullington, Hannah; Mejias, Caroline; Waljee, Akbar K.; Pechero Bishop, Wendy; Santini, Noel O.; Halm, Ethan A.

In: Hepatology, 01.01.2018.

Research output: Contribution to journalArticle

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title = "Mailed Outreach Invitations Significantly Improve HCC Surveillance Rates in Patients With Cirrhosis: A Randomized Clinical Trial",
abstract = "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.",
author = "Amit Singal and Tiro, {Jasmin A} and Murphy, {Caitlin Claffey} and Marrero, {Jorge A} and Katharine McCallister and Hannah Fullington and Caroline Mejias and Waljee, {Akbar K.} and {Pechero Bishop}, Wendy and Santini, {Noel O.} and Halm, {Ethan A}",
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AU - Marrero, Jorge A

AU - McCallister, Katharine

AU - Fullington, Hannah

AU - Mejias, Caroline

AU - Waljee, Akbar K.

AU - Pechero Bishop, Wendy

AU - Santini, Noel O.

AU - Halm, Ethan A

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AB - 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.

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