Outreach Invitations Improve HCC Surveillance Rates: Results Of A Randomized Controlled Trial

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1 Outreach Invitations Improve HCC Surveillance Rates: Results Of A Randomized Controlled Trial Amit G. Singal MD MS UT Southwestern Medical Center and Parkland Health & Hospital System Dallas, TX, USA 1

2 Hepatocellular carcinoma is a global problem Age-adjusted incidence rates per 100,000 person-years 2

3 Incidence of HCC is rapidly increasing Black race White race 3 Created by statecancerprofiles.cancer.gov on December 8, 2013

4 Mortality rate of HCC is rapidly increasing Created by statecancerprofiles.cancer.gov on December 8,

5 Curative options exist for early stage HCC 5 Bruix et al Hepatology 2010

6 HCC screening is recommended 6

7 HCC screening reduces mortality in chronic hepatitis B Screening Control Stage I 60.5% 0% Stage II 13.9% 37.3% Stage III 25.6% 62.7% Curative treatment 2-year survival 46.5% 7.5% 59.9% 7.2% 7 Zhang et al Cancer Res Oncol 2004

8 HCC screening associated with early stage detection in patients with cirrhosis 8 Singal et al PLOS Medicine 2014

9 HCC Screening is underutilized 9 Singal et al, J Gen Intern Med 2012

10 There are racial and socioeconomic disparities in HCC screening receipt Screening rates assessed in 904 patients Inconsistent surveillance: 66.7% Consistent annual surveillance: 13.4% Consistent biannual surveillance: 1.7% Predictors of Screening Multivariate analysis Insurance status OR 1.43, 95%CI African American race OR 0.61, 95%CI Extrahepatic cancer OR 0.43, 95%CI Multiple primary care visits OR 2.63, 95%CI Hepatology care OR 3.75, 95%CI Singal et al Am J Medicine 2015

11 Why is screening not being utilized? 11 Singal et al, Cancer Prevent Research 2012

12 Primary care providers report multiple barriers to HCC screening Provider-reported barriers Percent Lack of knowledge about guidelines 68.2% Competing interests in clinic 51.6% Lack of time in clinic 40.5% Difficulty recognizing at-risk patients 35.4% Ultrasound capacity 23.0% Doubt patients will complete 9.3% 12 Dalton-Fitzgerald et al Clin Gastro Hep (in press)

13 Patients are knowledge and accepting of HCC screening Patient knowledge and attitudes Percent (n=541) HCC surveillance is important to perform 88.8% Knowledge about surveillance is important 89.5% Patients with cirrhosis are high risk for HCC 90.8% Ultrasound should be done every 6-12 mo 88.4% Lack of trust in ultrasound quality 13.9% Fear of pain related to ultrasound 9.5% Fear of finding cancer 11.3% Costs of screening tests 25.3% 13 Farvardin et al (submitted)

14 Population-based management can increase surveillance rates Study # Pts Intervention Effect size Aberra Quasi study of nurse-based protocol 74% vs. 93% Wigg RCT of automated reminders 89% vs. 100% Beste Quasi study of point-of-care reminders 18% vs. 28% 14

15 Specific Aims Compare the clinical effectiveness and patient acceptability of intervention strategies to increase one-time HCC screening rates Evaluate whether intervention effects are moderated by patient characteristics including sex, race, ethnicity, and English proficiency 15

16 Study Setting Randomized trial comparing 3 strategies for HCC surveillance Arm 1: Usual visit-based surveillance by clinic providers Arm 2: Mailed surveillance outreach Arm 3: Mailed surveillance outreach + patient navigation Setting: Parkland Health & Hospital System Publicly funded integrated health system that serves as sole safety-net institution for Dallas County, TX Medical assistance plan for underinsured and uninsured patients 16

17 Inclusion and Exclusion Criteria Inclusion: Patients with documented or suspected cirrhosis Documented cirrhosis was defined using ICD-9 codes for cirrhosis or cirrhosis-related complications Suspected cirrhosis defined as AST to platelet ratio index (APRI) 1.5 in the presence of liver disease Exclusion: Patients with Child C cirrhosis who were not transplant candidates and those with significant comorbid conditions given limited benefit of HCC surveillance 17

18 Outreach Intervention Patients in Arms 2 and 3 received one-page letter Basic information about HCC risk Invitation with phone number to schedule ultrasound for HCC surveillance Low-literacy letters in English and Spanish Telephone reminder calls for patients who did not respond within 2 weeks Patients in Arm 3 also received reminder telephone calls one week prior to ultrasound Staff could help reschedule exams as needed 18

19 Copy of Patient Letter 19

20 Patient Stakeholder engagement Patient experiences prompted research I don t get it. I ve been seeing my doctors for years and do everything he says. How come they didn t find it earlier? Feedback from patients Liked idea of Parkland reaching out to them and reminding them vs. waiting to be seen in clinic Found invitation letter helpful and telephone call script clear but provided specific input for minor changes 20

21 Patient Stakeholder engagement Patient Advocacy Groups Reviewed invitation letter and phone scripts Interested in help with dissemination of results Providers Primary care providers, Liver Tumor Clinic providers, and radiologists re: study logistics of ordering/scheduling exams and follow-up System administration Discussed increased healthcare utilization and costs but benefit to Parkland patients 21

22 Statistical Analysis Primary outcome was one-time screening completion Abdominal imaging within 6 months of randomization Pearson chi-square analysis to compare across 3 arms Secondary outcomes Time-to-response to outreach invitations: early responders vs. late responders vs. non-responders Proportion of HCC detected at an early stage Pearson chi-square analysis to compare both secondary outcomes across 3 arms 22

23 Study Consort Diagram 23

24 Patient Characteristics Overall (N=1800) Arm 1 (n=600) Arm 2 (n=600) Arm 3 (n=600) Age (years) 55 (21-87) 54 (22-83) 55 (24-87) 55 (28-85) Sex (% male) 1069 (59.4%) 350 (58.3%) 361 (60.2%) 358 (59.7%) Race/ethnicity White Black Hispanic Other 510 (28.3%) 578 (32.1%) 681 (37.8%) 31 (1.7%) 182 (30.3%) 186 (31.0%) 217 (36.2%) 15 (2.5%) 165(27.5%) 197 (32.8%) 230 (38.3%) 8 (1.3%) 163 (27.2%) 195 (32.5%) 234 (39.0%) 8 (1.3%) Cirrhosis etiology HCV Alcohol-related NASH HBV 918 (51.0%) 317 (17.6%) 299 (16.6%) 62 (3.4%) 320 (53.3%) 98 (16.3%) 104 (17.3%) 21 (3.5%) 285 (47.5%) 115 (19.2%) 101 (16.8%) 27 (4.5%) 313 (52.2%) 104 (17.3%) 94 (15.7%) 14 (2.3%) Child Pugh A 1291 (71.7%) 432 (72.0%) 435 (72.5%) 424 (70.7%) 24

25 One-time HCC Screening Rates Imaging-based HCC screening rates were significantly higher in the outreach alone (Arm 2) and outreach/patient navigation (Arm 3) arms than usual care (Arm 1) (p<0.001 for both comparisons) Imaging-based HCC screening rates did not significantly differ between the two outreach arms 25

26 One-time HCC Screening Rates No difference in intervention effect by gender, race, or known cirrhosis status 26

27 Subgroup Analyses: Arm 1 vs. 2 27

28 Subgroup Analyses: Arm 2 vs. 3 28

29 Predictors of Screening Receipt Variable Univariate analysis Multivariate analysis* Outreach Strategy Usual Care Outreach Alone Outreach + Navigation Age (years) Ref ( ) 3.34 ( ) Ref ( ) 3.47 ( ) Ref ( ) 1.39 ( ) Ref ( ) 1.15 ( ) Male gender 0.77 ( ) 0.80 ( ) Race/ethnicity Caucasian Hispanic Black Reference 1.52 ( ) 1.21 ( ) Reference 1.56 ( ) 1.14 ( ) Suspected cirrhosis 1.70 ( ) 0.82 ( ) Number primary care visits 1.07 ( ) 1.05 ( ) Receipt of hepatology care 2.01 ( ) 1.74 ( ) * Also adjusted for Charlson comorbidity index and Child Pugh class 29

30 Early vs. Late Responders Early Responders Late Responders Non Responders Any outreach (n=1200) 161(13.4%) 424 (35.3%) 615 (51.3%) Arm 2 (n=600) 78 (13.0%) 210 (35.0%) 312 (52.0%) Arm 3 (n=600) 83 (13.8%) 214 (35.7%) 303 (50.5%) Early responder median time to response was 8 days Late responder median time to response was 32 days 30

31 Hepatocellular carcinoma outcomes Usual care (n=9) Any outreach (n=10) Screening US Missed by US Incidental CT/MRI Detected between 6-12 months 1 (11.1%) 1 (11.1%) 2 (22.2%) 5 (55.5%) 1 (10.0%) 1 (10.0%) 5 (50.0%) 3 (30.0%) 66.7% (n=6) usual care patients found at early stage 80.0% (n=8) intervention patients found at early stage 31

32 Summary Outreach strategies can significantly increase onetime HCC screening rates among patients with cirrhosis Adding patient navigation to telephone screening reminders provided no significant additional benefit. Our ongoing study is evaluating the effectiveness of outreach strategies for increasing repeat HCC surveillance rates and downstream outcomes, including early tumor detection 32

33 Next Steps Expansion to assess if can be generalized to other health systems CPRIT multi-investigator grant at 3 sites (safety-net, academic system, and VA) Effectiveness for screening process completion Repeat testing over one-year period, follow-up for abnormal screening results, and evaluation if diagnosed with HCC Qualitative interviews among non-responders Screening participation rates still <50% so can inform future interventions 33

34 Acknowledgements Katharine McCallister Joanne Sanders Caroline Mejias Jasmin Tiro Ethan Halm Jorge Marrero Conducted as part of the Center for Patient-Centered Outcomes Research with support from AHRQ Grant R24 HS