Published Online: August 05, 2014
Yang Liu, MD; Renee H. Lawrence, PhD; Yngve Falck-Ytter, MD; Brook Watts, MD; and Amy A. Hirsch, PharmD
Diagnosis of chronic hepatitis C virus (HCV) is a 2-step process involving hepatitis C antibody (HCVab) testing followed by viral ribonucleic acid (RNA) testing. The HCV status of those with a positive HCVab without viral testing cannot be determined. This study sought to describe the HCV-related care provided to patients in this care gap.
Retrospective cohort study of active patients with a positive HCVab test who did not complete viral testing.
Electronic medical records (EMRs) were reviewed to determine if each subject’s first positive HCVab result was acknowledged by a provider. For results acknowledged, we described provider actions in response to the result. When providers performed specific clinical actions within 1 year of the positive HCVab test, we captured the type of action taken. When the unsubstantiated diagnosis was documented in the EMR, we determined if the diagnosis was mentioned by subsequent providers.
Positive HCVab results were not acknowledged in 31% of subjects. In 35%, providers added chronic HCV to the problem list in the EMR, resulting in a higher likelihood of subsequent providers mentioning the diagnosis in their EMR documentation. In 143 subjects whose providers recommended HCV-related clinical actions within 1 year of the positive result, 45% were educated about HCV and 42% had their liver enzymes monitored.
With more widespread testing anticipated and more effective treatments available, health systems should ensure the HCV diagnostic process results in the delivery of an accurate and timely HCV diagnosis, to reduce the risk of harm to patients.
Am J Manag Care. 2014;20(7):e257-e264
Given expanded hepatitis C virus (HCV) screening recommendations, management of positive screening results needs optimization to ensure that tested patients can benefit from recent treatment advances.
For patients with a positive HCV antibody and no viral RNA testing, 31% of the antibody results were not acknowledged by any provider, including the ordering provider.
HCV care was performed in the absence of viral testing, leading to unnecessary treatments or stigma in those without chronic HCV.
An unsubstantiated diagnosis of chronic HCV in a patient’s electronic medical record’s problem list leads to a large percentage of providers referencing this diagnosis.
Chronic hepatitis C is a blood-borne virus affecting approximately 4 million Americans. After exposure to the hepatitis C virus (HCV), about 20% of people spontaneously clear the virus within the first 6 months of exposure, and the remaining 80% develop chronic HCV.1 Chronic HCV contributes significantly to the rising incidence of cirrhosis and hepatocellular carcinoma (HCC) in the United States.2-6 The cost of care increases with the severity of liver disease and chronic HCV-related cirrhosis is now the most common indication for liver transplantation in adults.7,8
The diagnosis of chronic HCV is a 2-step process. Step 1 is initial HCV antibody (HCVab) testing (Figure 1). If the HCVab test is positive, Step 2 is an additional test to determine if viral RNA is present in the blood;9,10 it is required to establish or refute the diagnosis of chronic HCV. A positive HCVab test and a positive RNA test indicate the presence of chronic HCV, whereas a positive HCVab result and a negative RNA result indicate that the exposed person has either spontaneously cleared the virus or has achieved a sustained virologic response from treatment.
Individuals who have a positive HCVab but have never completed viral testing cannot be classified as chronic or not because there is no virologic evidence to establish the diagnosis. The chronic HCV status of these patients remains unknown until viral RNA testing is complete. These individuals represent an important care gap in the management of HCV because their undetermined status can lead to missed opportunities for appropriate HCV-related care, such as alcohol cessation counseling, screening for HCC for those at risk, and/or timely receipt of potentially curative therapies.11
Several recent investigations have highlighted this issue and indicated that a significant proportion of their study populations fell into this care gap.12-15 Additionally, recent recommendations to broaden HCV testing beyond a risk-based model to include all patients in the birth cohort of 1945-1965 would translate to an additional 20 million people being candidates for HCV testing.16-18 Given this volume and the need to reduce HCV-related morbidity, it is important to gain a better understanding of why RNA testing is not completed and what the consequences of this care gap are to patients.
To determine this, we conducted a retrospective cohort study of all active patients at our institution who had at least 1 positive HCVab test but who did not complete viral RNA testing to address the following questions: 1) What actions were and were not taken by medical providers after a positive HCV antibody result?, and 2) What were the downstream effects of documentation of a HCV diagnosis in the absence of viral testing?
Study Design and Participants
Our cohort included all active patients who had at least 1 positive HCVab result between January 1, 1991, and January 1, 2010, but no subsequent history of completing HCV viral RNA testing at the Louis Stokes Cleveland Veterans Affairs Medical Center (LSCVAMC), its 13 associated community-based outpatient clinics, or any other Veterans Affairs (VA) facility. Active patients were defined as any patient with a medication refill or patient encounter (including test result/ vital sign) within 730 days of the date of the data query. The start and end dates were selected because 1) the availability of EMRs became more widespread in the VA system around the beginning of 1991, and 2) in early 2010, our facility implemented the VA national directive calling for HCV Reflex Testing at all VA facilities. This directive was designed to prevent additional patients from failing to complete viral testing in a timely manner, and calls for an additional blood sample to be collected when the screening antibody test is drawn.19 If the antibody test is positive, the second blood sample is to be used for viral testing, circumventing the need for another blood draw to complete this step. Thus, these dates were chosen to provide the highest likelihood of ascertaining the outcomes of interest while also capturing the majority of cases.
Our locally created Hepatitis C Population Management Application was used to identify subjects for this investigation. This application captures and stores data from the VA Region 3 Data Warehouse and has been previously validated through an iterative development process. A query of this application was conducted on May 20, 2011, and identified 419 subjects.
Medical records of all subjects were systematically reviewed by a single co-investigator over a 5-month period to evaluate the outcomes of interest. Weekly meetings between this co-investigator and the senior investigator were held to ensure consistency and accuracy in the adjudication of outcomes. This investigation was reviewed and approved by the Institutional Review Board at LSCVAMC. Given the retrospective nature, obtaining informed consent was not required.
During 1999, our facility underwent transitions in medical record system configurations, resulting in uncertainties about completeness of transfer of progress notes prior to December 31, 1999. These uncertainties became apparent during our review of the 78 subjects (18.6%) who had HCVab testing prior to this date. Twenty-nine of the 78 subjects had only mental health encounter progress notes available for review while the remaining subjects had both mental health and medical provider progress notes for review. As a result, we could not determine with absolute certainty if all progress notes did transfer or if some patients had only mental healthcare during that time period. This uncertainty may limit our ability to evaluate outcomes determined by review of provider progress notes; however, since fewer than 10% of our total subjects were potentially affected and because other outcomes could still be evaluated, these patients were not excluded from the investigation.
Subject Demographics and Clinical Characteristics
We collected the following demographic information on all subjects: age at date of data query, gender, race, and presence of current or previous alcohol abuse (by International Classification of Diseases, Ninth Revision, Clinical Modification code 350.0x) in the EMR. We collected the number of subjects with a most recent serum albumin value <3.5 g/dL, platelet count <150 X 103 /μL, alanine aminotransferase (ALT) >45 U/L, and aspartate aminotransferase (AST) >36 U/L. The value immediately preceding the query date (May 20, 2011) was chosen to provide a snapshot of the current health of this cohort. We also calculated the total number of consecutive years that each subject had received healthcare from our VA facility. The time span between the first test result, vital sign, or patient encounter ever and the date of the data query was used to calculate this parameter. These variables were able to be collected for all subjects as its determination was not dependent on review of provider documentation in progress notes (Table 1).
Positive Hepatitis C Antibody Test Characteristics
For each subject, we identified the first positive HCVab test result, then conducted a detailed review of entries to the subject’s EMR made after the date of this first positive HCVab test. For each subject’s first positive HCVab test, we determined which healthcare service (eg, inpatient medicine, psychiatry service, etc) ordered the test. The number of subsequent HCVab tests per subject was also captured.
Provider Management of Positive HCVab Screening Results
To determine if the positive HCVab test was acknowledged by a healthcare provider, we reviewed all progress notes after the date of the first positive HCVab test. We classified an HCVab test as “acknowledged” if, at any point in time after the date of the positive result, a provider did one of the following: 1) mentioned viral RNA testing in their progress note, although the testing was never completed, or 2) completed other types of management, which included “documentation actions” and/or “clinical actions.”
“Documentation actions” were defined as provider documentation of chronic HCV in the subject’s EMR, either by recording chronic HCV in a subsequent progress note, or by entering the diagnosis of “Chronic Hepatitis C” into the subject’s problem list at any time after the positive HCVab result.
“Clinical actions” were defined as any mention of an HCV-related medical recommendation in any subsequent progress note after the positive HCVab test. To characterize the recommendations that occurred in response to the positive HCVab we captured HCV-related medical recommendations made within the 12 months after the positive HCVab test result. These included: 1) documentation of HCV education provided during a medical encounter, 2) documentation of provider request for HCV genotype testing, 3) recommendation for or administration of a Hepatitis A and/or B vaccine, 4) documentation of alcohol reduction counseling, 5) request for an alpha-fetoprotein test or imaging of the liver, 6) a referral to the HCV clinic, or 7) serial monitoring liver function tests (LFTs).
Downstream Effects of Documentation of Chronic Hepatitis C
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