By Sara C. Miller, Med-IQ, LLC; Bruce Nitsche, M.D., Virginia Mason; Andrew Crim, FACEHP, University of North Texas Health Sciences Center; Chitra Subramaniam, PhD, Premier Research Services; Be’Ledda Dixon, Duke University School of Medicine
MT, a 63-year-old woman, presented to her physician for a routine physical examination in the summer of 2015. At that time, she had medically controlled hypertension but was described by her physician as “otherwise healthy.” She had no current or recent social history that raised concern for chronic infection with hepatitis C virus (HCV). However, her clinician had participated in a quality improvement (QI) initiative focused on improving HCV identification and decided to order an HCV-antibody assay. MT’s test result was positive, and her follow-up ribonucleic acid (RNA) assay revealed a viral load of 203,628 IU/mL, which is illustrative of chronic infection. Liver evaluation revealed cirrhosis and ascites with varices. Although she received immediate treatment for her HCV, she had late-stage liver disease and was found to require a transplant.
MT’s only risk factor for HCV was cocaine use, which occurred 30 years ago. Her primary care physician was speechless. How often do patients speak to their healthcare clinicians about activities of their youth?
MT’s story is real, and it is avoidable.
Chronic infection with HCV represents an escalating national and global public health concern. The disease burden of HCV is increasing, driven in large part by a high prevalence among those born between 1945 and 1965 (the baby boomer generation). Like other individuals with chronic HCV, many HCV-positive baby boomers (up to 75 percent) are unaware of their infection.1,2 Although risk-based screening guidelines have been in place for many years, the Centers for Disease Control and Prevention (CDC), United States Preventive Services Task Force (USPSTF) and others have more recently published recommendations for one-time testing for HCV infection among all baby boomers, regardless of the presence of other risk factors.3-5
Improvements in the identification of patients with chronic HCV are critically important. Advanced liver disease due to HCV is the main driver of liver transplants in the United States, and data from National Health and Nutrition Examination Survey (NHANES) demonstrate that the prevalence of HCV-related cirrhosis has more than doubled over the past 14 years.2,3,6 In the absence of interventions, HCV-related cirrhosis is anticipated to peak at 1 million in 2020.7 However, hepatic decompensation and liver cancer prevalence is anticipated to increase for another 10 to 13 years.7 The responsibility for identifying patients with unrecognized chronic HCV and linking those patients with appropriate specialty care falls largely onto primary care clinicians.3,8 However, the barriers related to the identification of patients with chronic HCV in the primary care setting are numerous, including factors related to time, patient willingness for testing, inadequate clinician knowledge and acceptance of the need for testing, and system-related processes.1,8
Shortly after the release of the birth-cohort–based testing guidelines, Med-IQ and Duke University conducted a pilot QI initiative designed to demonstrate the effectiveness of data-driven education and continuous cycles of audit and feedback for improving HCV testing practices among a small cohort of primary care practices.
Although the framework used in the Duke University/Med-IQ pilot and other QI initiatives has been proven effective within single institutions, the continuing education (CE) industry has been challenged to demonstrate its scalability. We were able to design and execute a QI initiative in which collaborators from several different institutions worked together to implement the HCV screening initiative in three institutions with different cultures in an efficient and, so far, effective manner.
In 2014, Med-IQ and Duke University partnered with Virginia Mason, the University of North Texas, and MedStar Health in a unique collaboration designed to expand the success of our pilot program and demonstrate the scalability of QI efforts. This initiative maximized the strengths of each participating organization, and the specific roles of each group are outlined below:
- HCV expertise: Duke University, Virginia Mason
- Primary care clinical leadership: Duke University, Virginia Mason
- QI initiative conception, coordination, and management: Med-IQ
- Educational design, implementation, and accreditation: Med-IQ, DukeCME
- Clinician recruitment, engagement, and encouragement: MedStar Health, University of North Texas, Virginia Mason
- Patient recruitment and engagement: MedStar Health, Virginia Mason
The process of improving care within these systems started with an assessment of current testing practices through electronic health record (EHR) review by researchers at each of the three clinical sites and an evaluation of local barriers to guideline-recommended HCV testing and linkage to care through clinician surveys facilitated by the clinical leaders. Clinical leadership and HCV experts made specific recommendations for improvement based on these baseline data, and, when possible, patients with HCV shared their personal experiences related to the testing and linkage-to-care process within participating institutions to elucidate patient-specific barriers. Data illustrated profound differences between clinician beliefs regarding their testing patterns among baby boomer patients and actual clinical practice (Figure 1).
Clinical change was supported by a series of educational initiatives (one CE/CME-certified publication and six brief reinforcement pieces) and an iterative process of reevaluation of current practice and data sharing.
Success and Lessons Learned
Since this initiative began in August 2014, we have evaluated HCV testing and linkage-to-care data for more than 44,000 patients. According to electronic survey data, most clinicians were aware of the birth-cohort–based HCV testing guidelines at baseline, and the vast majority reported that their practice aligned with guidelines. HER data, however, showed low baseline rates of HCV testing within the baby boomer population (1 percent to 7 percent). Following the deployment of a series of data-driven educational offerings, some significant improvements were observed in the recognition of patients with chronic HCV infection. For example, testing rates have risen as much as 188 percent in one healthcare system. However, inter- and intrasystem variability exists regarding improvements.
Although the initiative is still ongoing, collectively we have already learned several valuable lessons, including:
- Electronic health prompts embedded within an EHR can be useful for improving clinical practice, but change happens more quickly when these tools are supported with education, continuous audit and feedback cycles, and peer-to-peer interactions
- Clinical leadership is crucial; without a clinician champion who speaks the language of participants and has firsthand knowledge of their daily challenges, change is likely to be slow or nonexistent
- A top-down strategy may be ineffective in the midst of many competing priorities and system-wide changes
- Data sharing and education should be delivered in a manner that is customizable to local practice patterns
- Sharing case-based success stories with participating clinicians helps contextualize improvement
- There are many patients like MT who need to be identified
One clinician participant said about her experience with this initiative, “I was disappointed to have a woman come in with positive Hep C from Planned Parenthood. I did not do the appropriate screen at her annual last year, which was before we started this, or I would have caught this then!”
Making a Difference
This ongoing QI initiative has improved testing such that, even if no additional improvements are made, 6,360 patients who otherwise would not have been tested will be tested for HCV in the next 12 months, and approximately 228 new cases of HCV will be identified. Here is one example: LS is a 62-year-old woman who presents to her physician for her annual physical examination. She has a history of diabetes, hypertension and breast cancer. She does not have any traditional risk factors for HCV infection, but her physician is a participant in our QI initiative and thus conducts an HCV-antibody assay based on her date of birth. LS’s HCV antibody test is positive, and her RNA load is 1,770,035 IU/mL. Evaluation of her liver illustrates likely stage two fibrosis without cirrhosis. HCV treatment is initiated. When LS returns to her primary care clinician five months later, she reports that her HCV-RNA load is less than 12 IU/mL. She has been cured.
- Rein DB, Smith BD, Wittenborn JS, et al. The cost-effectiveness of birth-cohort screening for hepatitis C antibody in U.S. primary care settings. Ann Intern Med. 2012;156(4):263-270.
- Udompap P, Mannalithara A, Heo N, Kim D, Ray Kim W. Increasing prevalence of cirrhosis among US adults aware or unaware of their chronic hepatitis C virus. J Hepatol. 2016. [Epub ahead of print].
- Smith BD, Morgan RL, Beckett, GA, et al; Centers for Disease Control and Prevention. Recommendations for the identification of hepatitis C virus infection among persons born from 1945 through 1965. MMWR Recomm Rep. 2012;61(RR-4):1-32.
- Moyer VA, on behalf of the U.S. Preventive Services Task Force. Screening for hepatitis C virus infection in adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2013;159(5):349-357.
- AASLD/IDSA/IAS–USA. Recommendations for testing, managing, and treating hepatitis C. www.hcvguidelines.org. Accessed January 28, 2016.
- Ward JW. The epidemiology of chronic hepatitis C and one-time hepatitis C virus testing of persons born during 1945 to 1965 in the United States. Clin Liver Dis. 2013;17(1):1-11.
- Davis GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Aging of hepatitis C virus (HCV)-infected persons in the United States: a multiple cohort model of HCV prevalence and disease progression. Gastroenterology. 2010;138(2):513-521.
- S. Department of Health and Human Services. Combating the Silent Epidemic of Viral Hepatitis: Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis. Washington, DC: U.S. Department of Health and Human Services; 2011.