1. Primary Care Innovations in the Treatment of Hepatitis C: Implementation of HCV screening and Project ECHO in a Rural Primary Care Practice
STFM: Conference on Practice Improvement
Friday, December 5, 2014
Lauren Linken, MD
Kosta Deligiannidis, MD, MPH
Stephen Earls, MD
Stephen Martin, MD, EdM
Dan Mullin, PsyD

2. Disclosures
None of today’s presenters have any financial agreements to disclose.

3. Learning Objectives
On completion of this session, participants will be able to:
Describe the current guidelines for HCV screening.
Articulate a plan for routine HCV screening in their own primary care practice.
Describe strategies for successful implementation of a program of HCV screening

4. Discussion Outline HCV prevalence and need for screening
Newest USPSTF recommendations
Daily process to alert physicians which patients are due for screening
Evaluation of patients that screen positive (lab data)
Referral to Project ECHO and discussion about further work up or plan for treatment
Outcomes of our QI Project

5. Barre Family Health Center (BFHC)
Rural site for the UMass Worcester – FMR
PCMH site
4/4/4 residency at 3 different sites (12/12/12 total)
9 attending physicians
2 Behavioral Health (1 PsyD and 1 LCSW)
2 mid-level (one PA and one NP)
Medical students and pharmacy students
3rd year QI project required for each resident
Site for Project ECHO partnering with Beth Israel Deaconess Medical Center in Boston, MA

6. Barre Family Health Center

7. Project ECHO Extension for Community Health Outcomes
Originated at the University of New Mexico
Telemedicine model allowing PCPs to connect with specialists to learn how to take care of patients with diseases who would otherwise have to be referred elsewhere to receive care.

8. The Project ECHO Model
People need access to specialty care for their complex health conditions.
There aren't enough specialists to treat everyone who needs care, especially in rural and underserved communities
ECHO trains primary care clinicians to provide specialty care services. This means more people can get the care they need.
Patients get the right care, in the right place, at the right time. This improves outcomes and reduces costs. (Accomplishing the IHI Triple Aim)

9. Our QI Project
Beginning to follow the new CDC/USPSTF guidelines for HCV screening
How can we make this work at our clinic?
Who will be responsible for making sure patients get this needed screening?
What will we do to get those patients who screen positive, the evaluation and treatment that they will need?

10. HCV Incidence

11. HCV Prevalence

12. Hep C: Burden of Disease in USA
Leading cause for liver transplantation and liver cancer (HCC)
37% lifetime risk of HCV-related mortality for patients with chronic HCV1
Number of patients with morbidity and mortality from HCV is increasing2
Estimated cases of advanced liver disease will increase from 195,000 in 2008 to 601,000 in 2015.
74% of advanced liver disease cases will be in patients who were undiagnosed in 2008
1Rein et al. Dig Liver Dis 2011; 43:66. 2Zalesak et al PLOS ONE 2013; 8(5):e63959. .

13. Chronic HCV Infection May Lead to Chronic Liver Disease and Liver Cancer
Fibrosis1
Chronic HCV infection can lead to the development of fibrous scar tissue within the liver
Fibrosis
Cirrhosis
Hepatocellular Carcinoma (with cirrhosis)
Cirrhosis1,2
Over time, fibrosis can progress, causing severe scarring of the liver, restricted blood flow, impaired liver function, and eventually liver failure
HCC3
Cancer of the liver can develop after years of chronic HCV infection
Chronic liver disease includes fibrosis, cirrhosis, and hepatic decompensation; HCC=hepatocellular carcinoma. 1. Highleyman L. Hepatitis C Support Project. Accessed August 18, 2011; 2. Bataller R et al. J Clin Invest. 2005;115: ; 3. Medline Plus. Accessed August 28, 2012; 4. Centers for Disease Control and Prevention. Accessed May 8, 2012.

14. Need for Screening
In 2012 the USPSTF put out new recommendations for HCV screening
All baby-boomers (born ) should be screened at least once in their lifetime for HCV
In addition to high risk groups who we are already screening
This is something we should be doing in our primary care practices
We need to know what to do with a positive result

15. Who Should Be Tested for HCV
CDC Recommendations
Everyone born from 1945 through 1965 (one-time)
Persons who ever injected illegal drugs
Persons who received clotting factor concentrates produced before 1987
Chronic (long-term) hemodialysis
Persons with persistently abnormal ALT levels.
Recipients of transfusions or organ transplants prior to 1992
Persons with recognized occupational exposures
Children born to HCV-positive women
HIV positive persons
USPSTF Grade B Recs*
Everyone born from 1945 through 1965 (one-time)
Past or present injection drug use
Sex with an IDU; other high-risk sex
Blood transfusion prior to 1992
Persons with hemophilia
Long-term hemodialysis
Born to an HCV-infected mother
Incarceration
Intranasal drug use
Receiving an unregulated tattoo
Occupational percutaneous exposure
Surgery before implementation of universal precautions
*Only pertains to persons with normal liver enzymes; if elevated liver enzymes need HBV and HCV testing
Smith at al. Ann Intern Med 2012; 157: Moyer et al. Ann Intern Med epub 25 June 2013

16. Baby Boomers (Born in 1945–1965) Account for 76.5% of HCV in the US1
Estimated Prevalence by Age Group2
Birth Year Group
1.6
1.4
1.2
1.0
0.8
0.6
0.4
0.2
1990+
1980s
1970s
1960s
1950s
1940s
1930s
1920s
<1920
Number with chronic HCV (millions)
An estimated 35% of undiagnosed baby boomers with HCV currently have advanced fibrosis (F3-F4; bridging fibrosis to cirrhosis)3
1. Centers for Disease Control and Prevention. MMWR. 2012;61:1-32; Adapted from Pyenson B, et al. Consequences of Hepatitis C Virus (HCV): Costs of a baby boomer Epidemic of Liver Disease. New York, NY: Milliman, Inc; May 18, Milliman report was commissioned by Vertex Pharmaceuticals; 3. McGarry LJ et al. Hepatology. 2012;55(5):

17. Distribution of HCV Becoming Bimodal: Second Younger Group Generally with IDU-Related Infection1
1. Hepatitis C virus infection among adolescents and young adults:Massachusetts, MMWR Morb Mortal Wkly Rep. 2011;60(17):537–41.

18. Screening Example: PCP Clinic
3 with more advanced fibrosis
1,000 adult patients
330 baby boomers
10 HCV antibody positive
7 HCV RNA positive     
4 with mild fibrosis    
Efficiently identify birth cohort :
Electronic prompt
~1/3 of adults are in cohort
1 of 30 baby boomers
1 of 23 men baby boomers
1 of 12 African American men baby boomers
15%-30% of HCV antibody patients will spontaneously clear
Up to 25% of baby boomers may have
cirrhosis
75% of cirrhotic patients are men
Davis, Gastro 2010; 138: 513

19. “Huddling” and The Registry
“Let’s Huddle” – That special time before your clinic session starts where you chat with your nursing staff about the plan for each patient’s appointment
i.e. specific VS, vaccines, forms, etc.
The Registry: a database for our patients that includes information about what screenings are needed (i.e. Pap, colonoscopy, mammogram, LDL, A1C, BP, Well-child exams, GC/C screening)

21. Alerting Providers
Patient lists are printed before each clinic session (am/pm) for each provider
MA’s look at DOB for each patient and * anyone who is a “baby-boomer”
MA’s check those charts to see if HCV screening has already been done
If so – nothing more to be done
If screening is needed they alert the provider during the “huddle”
The MA can send the patient to the lab before seeing the provider if patient does not have any questions

22. +HCV Patient - Evaluation
If implementing screening, providers must be familiar with evaluating this result
Screening test – HCV antibody
Confirmatory test – HCV PCR (viral load)
If positive patient needs further evaluation
If negative patient has a h/o HCV but has cleared the virus and no further evaluation or treatment is required

23. Hepatitis C Antibody (HCV Ab)
If no concern for acute infection or immunosuppression, STOP here. If so, screen further with HCV RNA.
Hepatitis C Antibody (HCV Ab)
Negative (-)
Positive (+)
Check HCV RNA (viral load)
Pt has likely cleared prior infection
Consider retesting RNA in 4-6 months
Negative (-)
Positive (+)
A survey of 8 US sites found 49.2% of 217,755 patients only had HCV antibody testing and no HCV RNA test (MMWR 2013)
Hepatitis C infection
Evaluation and referral

24. Project ECHO at BFHC
As PCPs in rural Massachusetts, the BFHC is bridging the gap between diagnosis and treatment of HCV.
Access to HCV eval/tx is difficult for two reasons:
1) They reside remote from tertiary care centers (and often also lack transportation)
2) These tertiary care centers may have waiting lists.
The Project ECHO model addresses access to care issues.
PCPs at BFHC partner with Hepatology & Infectious Disease specialists at Beth Israel Deaconess Medical Center (BIDMC)
bimonthly videoconference
First program in New England to implement Project ECHO with the active involvement of residents.
Project ECHO endeavors to accomplish the Institute for Healthcare Improvement (IHI) Triple Aim: improved health at lower cost with increased patient satisfaction.

25. Objectives of our QI Project
Develop a process to implement recent USPSTF screening guidelines for HCV – “all persons born between the years should be screened for HCV once in their lifetime.”
Develop a process to evaluate patients that are HCV positive, and refer them to Project ECHO.
Screen 85% of baby-boomers who come in for a visit between Nov 2013 and April 2014, for HCV.

26. Our Intervention
Educate providers and staff about the new recommendations for HCV screening.
Place reminders at nursing stations.
Empower MA’s and RN’s to alert providers during the daily huddle which patients should receive HCV screening that day.
Collect registry data for patients screening status.
Work with EMR staff to create lab panels for easy ordering of labs needed.
START SCREENING! (approx March 2014)
Alert PCPs of patients with +HCV known about need for workup.
Refer all new +HCV patients to Project ECHO.
Survey providers before and after interventions to assess education success.

27. 1. Educate providers and staff
Provider’s meetings
Monthly nurse meeting
All-staff meeting
Get everyone on board!

28. 2. Place reminders at nursing stations

29. 3. Empower MA’s and RN’s to alert providers during the daily huddle which patients should receive HCV screening that day.
Can send patients to the lab while waiting for provider
Important to decide during the huddle if patients will need other labs as well

30. 4. Collect registry data for patients screening status
This was accomplished using our Clinical IT department
Pulls data on
# of baby boomers in the clinic
# who have been screened
# who are positive
Add HCV + patients to our HCV registry

31. HCV Registry at BFHC

32. 5. Work with EMR staff to create lab panels for easy ordering of labs needed.
Teaches providers what labs to order
Lab Panels for quicker ordering
HEPC1 panel for those who screen positive
HEPC2 panel for those who have + viral load

34. 6. Start Screening! Pilot screening of baby boomers in 1 Pod
Figure out workflow that is most successful using PDSA cycles
Nurse meeting
Spread screening to all 4 Pods

35. 7. Alert PCPs of patients with +HCV known about need for workup.
Task the PCP in patient’s chart about need for workup
Order labs for eval
Refer to Project ECHO if needed

36. 8. Referral to Project ECHO
Patients are presented in a standardized format to a team of BIDMC specialists (Hepatology, Infectious Disease, and Pharmacy)
During this discussion, there is no exchange of personal health information.
Primary care team can use these recommendations to care for other HCV patients in similar clinical situations (and also learn from other providers’ patients)
If needed, in-person evaluation for patients who are complex or severe can be expedited with our specialist partners, including clinical trials.

39. Outcomes

40. Patient Screening

41. Please evaluate this session at: stfm.org/sessionevaluation