Examining Hepatitis C Virus Testing Practices in Primary Care Clinics

From Journal of Viral Hepatitis

C. V. Almario; M. Vega; S. B. Trooskin; V. J. Navarro

Posted: 02/14/2012; J Viral Hepat. 2012;19(2):e163-e169. © 2012 Blackwell Publishing

Abstract and Introduction

Abstract

Prior studies found that hepatitis C virus (HCV) risk assessment and testing in primary care clinics were suboptimal. We aimed to determine the actual HCV testing rate among patients with HCV risk factors and to identify variables predictive of testing. In order to do so, we performed a prospective cohort study among patients seen in four urban primary care clinics. At the initial visit, patients were given a questionnaire that listed HCV risk factors and they were instructed to check 'yes' or 'no' if they did or did not have a risk factor, respectively. Patients then handed this questionnaire to their physician during their initial visit. Among those who acknowledged having a HCV risk factor via the questionnaire, we determined the subsequent HCV testing rate and calculated adjusted odds ratios (aOR) with 95% confidence intervals (CI) to identify variables predictive of testing. Of the 578 individuals who acknowledged having a HCV risk factor via the questionnaire, only 8% (46/578) were tested for HCV within 2 months of their initial visit. Among those tested, 11% (5/46) had a positive HCV antibody test result. The only variable predictive of HCV testing after adjusting for confounders was having a specific HCV risk factor identified and documented in the chart by physicians [16% (26/159) vs 5% (20/419); aOR 4.5, 95% CI 2.1–9.5]. In summary, 92% of patients with a HCV risk factor were not tested for HCV in the primary care setting, and efforts to improve such rates are clearly warranted.

Introduction

Hepatitis C virus (HCV) is the most common bloodborne infection in the United States, as 3.2 million individuals are chronically infected nationwide.^[1] Furthermore, 40% of chronic liver disease is related to HCV, and HCV-associated end-stage liver disease is the most frequent indication for liver transplantation.^[2] Given the significant morbidity and mortality associated with HCV, the Centers for Disease Control and Prevention (CDC),^[2] National Institutes of Health (NIH),^[3] and American Association for the Study of Liver Diseases (AASLD)^[4] all recommend HCV testing for persons at high risk. However, previous studies, most of which were survey based, showed that HCV risk assessment and testing in primary care settings were suboptimal.^[5–11] Shehab et al.^[5] noted that among primary care physicians (PCPs) surveyed nationwide, only 59% asked all patients about HCV risk factors. A retrospective chart review by Trooskin et al.^[11] revealed that PCPs documented a history (positive or negative) of intravenous drug use and blood transfusion prior to 1992 for 12% and 2% of patients, respectively. Furthermore, they also found that of those who admitted intravenous drug use, only 55% were subsequently tested for HCV.^[11]

Patient care in primary care settings has become increasingly complex. While the time physicians spent with patients has increased over the years,^[12,13] the number of clinical items addressed per visit also increased.^[13] Yet, the increase in the number of addressed clinical diagnoses outpaced the increase in visit duration, thereby leading to a decrease in the amount of time devoted to each clinical item.^[13] Given the increased demands placed on PCPs along with the fact that most prior studies that examined HCV testing practices were survey based, we aimed to perform a prospective cohort study to determine the actual rate of HCV testing among primary care patients with a HCV risk factor and to identify factors predictive of testing.

Materials and Methods

We performed a prospective cohort study among patients seen at four urban primary care clinics in Philadelphia, Pennsylvania, from October 2004 to June 2005. Two clinics were university-based primary care practices (an internal medicine practice and a family medicine practice) at Thomas Jefferson University Hospital, while the other two clinics were federally qualified community health clinics. Each of the four primary care clinics served a unique population. The internal medicine university-based practice provided care for a population of which 45% were African American. A majority of the internal medicine patients had private insurance. For the family medicine university-based practice, 60% of the patients were African American and approximately 50% had private insurance. Regarding the community clinics, one served a predominantly Latino population (85%), of which approximately 25% were undocumented immigrants. The second community clinic served a predominantly African American population (70%). The majority of patients receiving care at the two community health clinics were either uninsured or covered by a Medicaid Health Maintenance Organization.

Our group previously performed a retrospective chart review among patients seen in the four clinics described previously. The aim of the prior study was to examine HCV risk factor ascertainment, testing and referral for treatment, with particular attention to the role of race and ethnicity.^[11] For our current prospective study, we focused on examining HCV testing practices and determining factors predictive of testing. Participants in our current study included patients, 18 years of age or older, who had not been seen in the clinic for 5 years or more. Individuals were asked to participate in the study while they were in the waiting room, and those who agreed to participate were given a HCV risk factor questionnaire that listed risk factors for HCV. The questionnaire asked patients whether they ever had any of the following: a blood transfusion before 1992, an organ transplant before 1992, long-term dialysis, a spouse or significant other who was diagnosed with HCV, been in prison or jail for more than 24 h, worked as a healthcare worker and accidentally been stuck with a needle, injected recreational drugs even if it was just one time or a tattoo or body piercing (ear piercing not included). At the bottom of the questionnaire, participants were instructed to check 'yes' or 'no' if they did or did not have any of the above HCV risk factors, respectively. Those who had a HCV risk factor were told to simply check 'yes' and to not identify their specific HCV risk factor on the questionnaire. The questionnaire was made in duplicate with one copy given to the study's personnel. Patients were instructed to hand the other copy of the questionnaire to their PCP during their initial visit. Of note, the HCV risk factor questionnaire did not include any language prompting the PCP to order HCV testing if the patient acknowledged having a HCV risk factor via the questionnaire.

The charts of all patients who identified themselves as having a HCV risk factor on the questionnaire were reviewed 2 months after their initial visit by a team of trained chart reviewers. Demographics collected included age, sex, race/ethnicity, primary care clinic setting (university-based vs community), total number of clinic visits within a 2-month period after the initial visit, insurance status, highest level of education and annual income. All pre-existing medical comorbidities documented in the chart were recorded. Anyone with a known prior diagnosis of HCV was excluded from the study. We checked to see whether the HCV risk factor questionnaire was present in the chart and determined whether physicians identified and documented in the chart the specific HCV risk factor that each patient possessed. We also determined whether a HCV antibody test was subsequently performed by searching the chart for a HCV antibody test result or documentation from the physician clearly stating that the patient was referred for HCV antibody testing.

Statistical tests were performed using SPSS 17.0 (SPSS Inc., Chicago, IL, USA). Student's t-test and the chi-square test were used to analyse continuous and categorical variables, respectively. When sample sizes for categorical variables were small, the Fisher's exact test was used in place of the chi-square test. A P value <0.05 was considered statistically significant. A binary logistic regression model was used to calculate adjusted odds ratios (aOR) with 95% confidence intervals (CI) to find variables predictive of HCV testing. Variables from univariate analysis with a P < 0.20 were included as covariates in the regression model. This cut-off value was chosen so that we could liberally include variables in the model and therefore assess confounding by more variables. This study was approved by the Institutional Review Board of Thomas Jefferson University Hospital

Results

Overall, 1848 individuals from four urban primary care clinics agreed to complete the HCV risk factor questionnaire during their initial primary care visit. Of the 1848 individuals who participated, 658 (36%) acknowledged on the questionnaire that they had a risk factor for HCV. On the subsequent chart review 2 months after their initial visit, 58 individuals either had charts with incomplete data or charts that could not be located. We excluded 22 individuals because they had a known prior diagnosis of HCV. Therefore, our study population included 578 patients with a HCV risk factor.

Demographic characteristics of the study population are presented in Table 1. Only 46 of 578 (8%) individuals with a HCV risk factor were tested for HCV within 2 months after their initial visit. Among those tested, five of 46 (11%) had a positive HCV antibody test result, 39 of 46 (85%) were negative, and two of 46 (4%) had pending results at the time of chart review.

When comparing those who were tested for HCV vs those who were not, we found that those tested had a higher proportion of Latinos, were more often seen in the community primary care clinic setting, had more clinic visits during the 2 months after their initial visit and were less educated. They were also more likely to have the HCV risk factor questionnaire present in their chart and to have a physician who identified and documented a specific HCV risk factor in the chart. No statistically significant differences were found in regard to age, sex, insurance status, annual income and number of comorbidities.

Of the 578 individuals who acknowledged having a HCV risk factor via the questionnaire, only 159 of 578 (28%) had physicians who identified and documented a specific HCV risk factor in the chart. Twenty-one of 159 (13%) patients had two documented risk factors while 138 of 159 (87%) only had one. Table 2 lists the specific risk factors documented in the chart by physicians and their associated rates of HCV testing. No association was found between HCV testing and the number of identified HCV risk factors, as one of 21 (5%) individuals with two risk factors were tested vs 25 of 138 (18%) of those with one risk factor (P = 0.20).

Table 3 presents the rate of HCV testing associated with each medical comorbidity. The only comorbidity with a statistically significant association with HCV testing was hyperlipidemia. All other medical comorbidities were not predictive of HCV testing. Among individuals with 0, 1, 2 or ≥3 medical comorbidities, the rate of HCV testing was 22 of 343 (6%), 12 of 135 (9%), six of 64 (9%) and six of 36 (17%), respectively (P = 0.16).

Table 4 shows the unadjusted and aOR for variables predictive of HCV testing. In our unadjusted analysis, we noted that patients with ≥3 medical comorbidities were more likely to undergo HCV testing when compared to those without medical comorbidities. However, after adjusting for confounders with a binary logistic regression, no statistically significant difference was seen in HCV testing rates between patients with 0, 1, 2 or ≥3 medical comorbidities. The only variable that remained predictive of HCV testing after adjusting for confounders was having a physician who identified and documented a specific HCV risk factor in the chart.

Discussion

The rate of HCV testing among primary care patients with a HCV risk factor was very low, as only 8% underwent HCV testing. We found that having a specific HCV risk factor identified and documented in the chart by physicians predicted HCV testing.

Our study has a number of unique features that differentiate it from prior studies examining HCV testing in primary care settings. Most notable was the prospective design of our study and our focus on actual PCP practices, as we examined individual medical charts. Prior investigators primarily used surveys to study how PCPs identified and managed HCV,^[5–10] but surveys are prone to bias and may not reflect true practices. In fact, our HCV testing rate of 8% is in stark contrast to the 70% of surveyed PCPs who stated that they test all patients with risk factors.^[5] This strongly suggests that actual practices differ markedly from surveyed responses. The low rate of HCV testing among our study population was especially surprising given that all PCPs were handed a questionnaire from each patient at the initial visit identifying themselves as having a HCV risk factor. This strongly suggests that HCV testing was not a high priority for PCPs at the initial visit. The low rate may also reflect PCPs' unfamiliarity with HCV testing guidelines from national organizations. This is supported by our finding that only 47% and 7% of patients with a history of intravenous drug use and blood transfusion before 1992 were tested for HCV, respectively. These two risk factors are arguably the most important ones for HCV acquisition, and the CDC,^[2] NIH,^[3] and AASLD^[4] all recommend testing these two cohorts for HCV. Further supporting the idea that PCPs are unfamiliar with HCV testing guidelines was a prior survey that found that 42% of PCPs were unaware of the national guidelines regarding HCV testing.^[8] Other surveys administered among primary care residents^[9] and family physicians^[10] revealed their insufficient knowledge about HCV testing guidelines and that they often tested for HCV in inappropriate clinical situations.

Another unique aspect of our study was our examination of the impact of medical comorbidities on HCV testing rates. Originally, we hypothesized that patients with comorbidities would be less likely to undergo testing for HCV. Given the increasing demands placed on PCPs,^[12,13] we theorized that PCPs would prioritize the management of comorbidities they perceived as having a more immediate impact on the patient's health and be less concerned with testing for HCV, which is often asymptomatic for years. We also thought that PCPs would be more likely to manage or screen for medical conditions for which effective therapies are available. At the time of our study, the standard HCV treatment of peginterferon-α and ribavirin led to sustained virological response in only 41–52% of those with HCV genotype 1.^[14–16] However, our results showed that the presence of comorbidities did not negatively impact the HCV testing rate, thus disproving our original hypothesis. In fact, we found a trend, albeit not statistically significant, towards increased testing with increasing number of medical comorbidities. There are several possible explanations for this finding. PCPs may have given more attention to sicker patients in regard to assessing risk factors for other disease processes, including HCV. Also, patients with multiple medical conditions often receive frequent laboratory tests, and PCPs may have been more likely to order HCV serological testing for a patient already going for blood work.

Other interesting findings from our study included our examination of the rates of HCV testing associated with specific HCV risk factors. Notably, only 47% of patients with a history of intravenous drug use were tested for HCV. This rate is comparable to our prior retrospective study that discovered that 55% of intravenous drug users were tested.^[11] These findings are surprising given that 98% of surveyed family physicians stated that they offer HCV testing to this group.^[7] Such a low rate of testing among intravenous drug users is troubling because prior studies found that 35% to 57% were HCV antibody positive.^[17,18]

A limitation of our study included our data being limited to what was documented in the chart. We may have missed specific HCV risk factors and medical comorbidities that went undocumented. We also may have missed patient refusals for HCV testing that were not documented by the PCP. Another limitation relates to the fact that our study population only included patients new to each primary care clinic and that we only looked for HCV antibody test results within the 2 months after their initial visit. It is possible that HCV testing could have occurred at later visits. However, the initial visit is often the most comprehensive visit, and we would expect that most referrals for HCV testing would occur during the first visit. Our study was also limited by the fact that we were unable to determine why PCPs did not offer HCV testing to most individuals who admitted to having a HCV risk factor. Lastly, our study did not examine a realistic clinical situation, as patients were 'prelabelled' as being high risk for HCV via the HCV risk factor questionnaire. Yet, we should point out that despite 'prelabelling' patients as high risk for HCV, only 8% were tested and the true HCV testing rate is likely much lower.

In summary, we found that 92% of patients with a HCV risk factor were not tested for HCV. Testing those at high risk for HCV is critical, as it can lead to early identification of infection and find those who will benefit from antiviral therapy.^[19] This is especially important given the new and effective protease inhibitors that are now available.^[20,21] Aside from referring for antiviral treatment, PCPs can also immunize patients with the hepatitis A and B virus vaccines, recommend abstinence from alcohol and provide education regarding behaviours that transmit HCV to others.^[22–24] Given these benefits, PCPs should make every effort in increasing HCV testing rates among patients with a HCV risk factor. Future studies that further define the barriers associated with HCV testing in primary care settings as well as the development of novel strategies to improve HCV testing rates are clearly needed.

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