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Getting it Right: The Impact of Point-of-Care Testing for Gonorrhea and Chlamydia in the Urgent Care Setting
The Journal for Nurse Practitioners xxx (xxxx) xxx
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Original Research
Getting it Right: The Impact of Point-of-Care Testing for Gonorrhea and Chlamydia in the Urgent Care Setting Kayla M. Fisk, DNP, FNP-C, Anne Derouin, DNP, CPNP, Gregory Holm, PhD, NP, LuAnne Hicks, MSN, FNP-BC a b s t r a c t Keywords: nucleic acid amplification test point of care sexually transmitted infections/sexually transmitted diseases sexually transmitted infection screening urgent care clinics
Sexually transmitted infections (STIs), including Neisseria gonorrhea and Chlamydia trachomatis, have been at the forefront of public health and world health initiatives because of increasing prevalence, antimicrobial resistance trends, and immense economic health care burdens. Current STI laboratory-based testing impedes timely and accurate treatment in urgent care clinics (UCCs) and emergent care settings; the typical 3- to 5day turnaround for testing results is not efficient in these settings. Of significance, UCCs and emergency settings often serve as the only point of contact for many exposed or affected individuals, further complicating appropriate treatment and follow-up care. This quality improvement project was conducted at a highvolume, suburban UCC to evaluate the implementation of nucleic acid amplification test (NAAT) point-of-care (POC) STI screening for gonorrhea and chlamydia. Analysis included comparison of appropriate STI treatment based on laboratory results among 100 patients preintervention and 100 patients postintervention, financial feasibility of the POC testing intervention, and staff satisfaction measurement. Results show that STI treatment appropriateness dramatically improved with NAAT; the innovation exceeded cost neutrality by creating revenue through appropriate billing and coding, and clinical staff were highly satisfied using the new testing protocol. The results of this study support the use of POC testing using NAAT for the diagnosis of urogenital gonorrhea and chlamydia infections in urgent and emergent care settings and highlight implications for adoption, sustainability, and expansion into other clinic settings. © 2020 Elsevier Inc. All rights reserved.
Neisseria gonorrhea (GC) and Chlamydia trachomatis (CT) are the most commonly reported sexually transmitted infections (STIs) in the United States.1 According to the Centers for Disease Control and Prevention (CDC), nearly 2.1 million new cases were reported in 2016, with STIs yielding approximately $16 billion in health care costs annually.1 Gonorrhea and chlamydia, although relatively simple to treat with proper clinical screening and antibiotic treatment, can have devastating implications if left untreated.2 To reduce the risk of further infection among sexual partners and prevent long-term health consequences of the most common STIs, the CDC recommends empiric treatment while awaiting confirmatory test results for high-risk patients, patients with limited ability for follow-up care while results are pending, and those who are symptomatic or have a known exposure. Despite these guidelines, the use of antibiotics without confirmation of infection has unintended consequences; the overuse and misuse of antimicrobials result in resistant STIs and other bacterial species.2 Of significance, various gonococcal strains have developed resistance to all drugs used for treatment in regions
https://doi.org/10.1016/j.nurpra.2020.01.006 1555-4155/© 2020 Elsevier Inc. All rights reserved.
outside of the US; GC was deemed in the top 3 urgent infectious public health threats in 2015.3 Inappropriate treatment, including overtreatment, undertreatment, and lack of treatment, for GC and CT is particularly concerning in urgent and emergent care settings. A study conducted in 2015 evaluating 2 large inner-city emergency departments found 86% of patients tested for urogenital GC and CT symptoms were treated with antibiotics in the absence of infection.4 Additionally, 17 of the 412 individuals who tested positive for GC or CT did not receive antibiotics. Another study tracking treatment of GC/CT in an emergency department (ED) found only 54% of the 500 patients included in the study were treated appropriately in the ED at the initial visit.5 Although an additional 31% were successfully contacted after discharge and treated within the recommended follow-up interval, 15% of patients neither received appropriate treatment in the ED nor follow-up.5 Another study showed that even with a follow-up system in place to contact ED patients who tested positive for GC or CT by phone or mail, large undertreatment rates ensued; 42% of patients identified (n ¼ 861) were under- or untreated, and 60% never returned for treatment.6
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Traditional STI testing includes urine, provider-collected endocervical swab, or urethral swabs that are sent out to a laboratory for polymerase chain reaction testing, requiring a wait time of testing results of 3 to 5 days. Upon receipt of the laboratory results, on-site providers review the encounter note for the patient, determine if the patient received appropriate treatment, and, if needed, facilitate treatment. An emerging innovation to improve STI testing includes pointof-care (POC) tests, reducing the testing to results time to 90 minutes or less. The emerging technology promises to streamline results, thereby reducing overuse and inappropriate use of antimicrobials, the rate of patients untreated in the community, and the risk of infection and sequela and resultantly reducing economic cost and improving population health outcomes. Historically, POC test comparisons showed varying results; the pooled sensitivity of antigen detection tests was 53%, 37%, and 63% for cervical swabs, vaginal swabs, and urine, and specificity was 99%, 97%, and 98%, respectively.7-9 However, a recent Food and Drug Administrationeapproved POC test, the GeneXpert (Cepheid, Sunnyvale, CA), has successfully yielded confirmatory GC/CT results in less than 90 minutes, maintaining a sensitivity and specificity greater than 95% and 99%, respectively.7-9 This nucleic acid amplification test (NAAT) is comparable with the current gold standard laboratory-based nucleic acid test, which has a sensitivity and specificity between 95% and 99%, respectively,10 and has been widely used in Europe. In the United Kingdom, Whitlock et al11 compared 2 highvolume clinics, one using the rapid GeneXpert and one with standard laboratory testing for GC/CT. Of the 81,352 patient tests during the 1-year study period, the mean time to notification was reduced from 8.95 days to 0.27 days, was estimated to have prevented 196 GC/CT transmissions, averted 854 partner attendances, and resulted in an annual savings of 124,283 euros. Gradually being introduced to the US, Rivard et al12 found significant improvement in optimal diagnosis and treatment using POC testing for GC/CT, along with cost savings of $24.46 per patients in an American convenience care center. In a noninferiority study, both rapid testing and traditional testing were completed on 1,162 patient samples to test for real confounding variables in clinical practice and how it influences accuracy (staff knowledge and appropriate use/sample collection). The results yielded “robust enough data to support practice change”; accuracy in testing for both men and women was between 82% and 100%, despite a lack of control on appropriate sample collection (first catch vs midstream), which could greatly alter sensitivity.10 To further evaluate practice change, a quality improvement study evaluated outcomes of the rapid GeneXpert POC testing implementation for urogenital STI screening of GC/CT in an urgent care clinic (UCC) setting. The goal of implementation was to assess STI identification and treatment accuracy while showing financial feasibility and improved clinical staff satisfaction in the reduced testing to result time. Methods Setting This pre/postquality improvement project was conducted in a busy suburban UCC located in Colorado. The UCC is open daily from 8 AM to 9 PM, 363 days per year, employing a full-time staff serving an average volume of 15,000 patient visits annually. The clinic accepts most commercial insurance and private payment and is 1 of only a few in the metropolitan area that accepts Medicare/ Medicaid, accounting for approximately 60% of the UCC patient population.
Genitourinary concerns are among the top 5 chief patient complaints; an average of 40þ GC/CT tests per month are sent from the clinic to the local laboratory. At the time of this project, more than 25,000 reported CT cases, and nearly 6,000 GC cases had been reported the previous year, resulting in the surrounding community being ranked 5th highest in per capita rates of gonorrhea diagnosis and 7th for chlamydia diagnosis in the state of Colorado.13 The rates of infection and clinic traffic represented a clear need for accurate STI screening, diagnosis, and treatment to reduce prevalence and improve the health status of the population. Design After institutional review board approval and the development of an implementation plan, a 90-day evaluation of NAAT POC testing was conducted from August to November 2018, replacing traditional testing methods (laboratory send-out tests). NAAT POC patient testing criteria included all patients 13 years of age presenting to the clinic with urogenital complaints potentially related to STIs. Risk criteria for STI screening included patientreported history of present illness, specifically urethral discharge, vaginal discharge, genital pain, or painful urination correlated with known exposure or unprotected sexual encounters. The inclusion of minors was determined in accordance with the Colorado minor consent law, CO Rev Stat x 25-4-409 (2017), which permits confidential STI screening and treatment to be provided upon the minor’s consent. A randomized sample of 100 patients from a historic group of patients with traditional urogenital GC/CT laboratory-based testing and treatment (preinnovation) was compared with 100 NAAT POC test result and treatment outcomes (postinnovation). Cost analysis and staff satisfaction evaluation were conducted during the postinnovation phase of the project. Before implementing the NAAT POC testing protocol, the clinic underwent laboratory changes to acquire moderate complexity licensure from the prior Clinical Laboratory Improvement Amendments (CLIA) waived status. Moderate complexity licensure was granted before innovation testing. During this phase, 5 fulltime providers and 4 medical assistants were trained to operate the Cepheid testing device in accordance with the GeneXpert training guide.14 During the 90-day testing period, all patients presenting with a urogenital complaint were screened upon check-in with written intake questions that included the following: 1. Are you experiencing burning with urination or penile/vaginal discharge that you believe may be related to an STI? 2. Have you had a known exposure to an STI, and this is the reason for your visit today? If a patient selected “yes” for either question, the front desk staff would notify a medical assistant to collect a sample from the patient immediately and begin testing. While the specimen was processing, the patient would complete the check-in process and wait in queue for the provider consultation. Once the provider assessed the patient, if the specimen test was not complete at the time of provider evaluation, patients were asked to remain in the waiting room until test results were available. Additionally, if a patient was not prescreened (did not select “yes” for corresponding screening questions) but a provider deemed GC/CT testing necessary after history and assessment were attained, a specimen was collected and processed in the same manner. Once test results were complete, the patient returned to an examination room and was given his or her test results. Patients with positive test results were treated with appropriate antimicrobials at the time of visit in
K.M. Fisk et al. / The Journal for Nurse Practitioners xxx (xxxx) xxx Table 1 Centers for Disease Control and Prevention 2015 Guidelines for Treatment of Chlamydia 1st line 2nd line Alternative regimen
Azithromycin 1 g orally in a single dose Doxycycline 100 mg orally twice a day for 7 days Erythromycin base 500 mg orally 4 times a day for 7 days OR Erythromycin ethylsuccinate 800 mg orally four times a day for 7 days OR Levofloxacin 500 mg orally once daily for 7 days OR Ofloxacin 300 mg orally twice a day for 7 days
accordance with the CDC 2015 treatment guidelines15 (Tables 1 and 2).
Analysis Methods The primary outcome of treatment appropriateness was measured by comparing a retrospective sample of 100 randomized patients preintervention and 100 patients in the NAAT POC group. Retrospective data extraction was conducted using the 4 most frequent International Classification of Diseases, Tenth Revision (ICD10) diagnostic codes used for GC/CT testing within the electronic health record (EHR) system. The codes used for extraction of patient encounters included contact with and (suspected) exposure to infections with a predominantly sexual mode of transmission (Z20.2), encounter for screening for infections with a predominantly sexual mode of transmission (Z11.3), unspecified sexually transmitted disease (A64), and nonspecific urethritis (N34.1). Retrospective inclusion parameters included 100 randomized encounters of the codes noted among patients seen between September 1, 2017, through August 1, 2018, 13 years of age or older in which GC/CT testing was ordered and reconciled in the EHR. Patient encounters were excluded if testing was ordered but because of laboratory, specimen, or handling error, no results were recorded; if testing included extragenital sites (oropharyngeal or rectal); or if given the diagnosis of pelvic inflammatory disease or epididymitis because treatment may overlap. Each of the selected encounters was deidentified and assigned a study number and included the following demographic information: sex, age, and payer (Medicare/Medicaid, Tricare, Commercial, or private pay). Data were recorded for gonorrhea and chlamydia test results (positive or negative) and assigned a category based on the recorded treatment as follows: 1, overtreatment (yes or no); 2, undertreatment (yes or no); and 3, appropriate treatment (yes or no). Overtreatment was defined as the receipt of antimicrobials (empiric treatment) in the absence of infection, undertreatment was defined as a lack of antimicrobials in the presence of GC and/or CT infection, and appropriate treatment was defined as antimicrobials for confirmed infection and/or no antimicrobials in the absence of infection.
Table 2 Centers for Disease Control and Prevention 2015 Guidelines for Treatment of Gonorrhea 1st line
Alternative regimen
Ceftriaxone 250 mg intramuscularly in a single dose PLUS Azithromycin 1g orally in a single dose If ceftriaxone is not available: Cefixime 400 mg orally in a single dose PLUS Azithromycin 1 g orally in a single dose
3
The NAAT intervention POC testing group was deidentified in the same way (ie, collected during the testing period through the EHR encounter notes and the laboratory collection log). Upon NAAT POC test completion, results were recorded within the Cepheid device in addition to printed results validating internal control checks with confirmatory results recorded as follows: CT DETECTED/CT NOT DETECTED and GC DETECTED/GC NOT DETECTED. All test results were noted in the patient record, and the deidentified collection logs were stored in a locked cabinet. Chi-square analysis was conducted on the 3 categories to determine if the intervention improved treatment accuracy for urogenital gonorrhea and chlamydia compared with standard testing. The minimum sample size needed based on a 90% power, medium effect size (.30), and alpha set to .05 was calculated to be 141, which includes both pre- and postintervention samples. We selected the 90-day test period to aim for a larger sample size of 100 pre- and 100 postintervention patients. The financial feasibility of NAAT POC testing was measured using a balance log, comparing send-out (preintervention) STI testing with the cost of the GeneXpert innovation. Preintervention testing was neither revenue generating nor cost incurring because gonorrhea and chlamydia tests were billed directly to the patient or payer by the laboratory. Postintervention testing with the GeneXpert was measured factoring any overhead cost for the testing device, test cartridges (1 cartridge runs both GC/CT), moderate complexity CLIA certification, triannual proficiency testing pursuant to CLIA regulations, external control reagents, and reimbursement for each POC testing included in the billed encounters from various payer types. Staff satisfaction was measured preintervention and postintervention with a 5-point Likert scale survey through Qualtrics survey software (Qualtrics, Provo, UT) (1 ¼ strongly disagree, 5 ¼ strongly agree). All providers (physicians, nurse practitioners, and physician assistants) and medical assistants involved in the testing process for GC/CT were included in the satisfaction survey. Questionnaires were sent via e-mail to each staff member with 2 automatic reminders, leaving the survey open for 2 weeks for an elective response. The 5 questions were identical pre- and postintervention, simply replacing the subject with questions regarding “send-out, lab-based testing for urogenital gonorrhea and chlamydia,” and “point-of-care testing for urogenital gonorrhea and chlamydia” postintervention (Table 3). Questions inquired about perceptions on general satisfaction with the method of testing and clinical implications with timeliness and accuracy of care provided with each modality. Some questions were worded to reflect agreement with satisfaction of testing, whereas others were worded to reflect agreement as dissatisfaction with care; items Table 3 Pre- and Poststaff Satisfaction Survey 1
2
3 4
5
I am satisfied with current (laboratory-based/ point-of-care) testing for urogenital gonorrhea and chlamydia. (Laboratory-based/point-of-care) testing for gonorrhea and chlamydia inhibits timely and accurate treatment of sexually transmitted infections. The methods by which (laboratory-based/point-of-care) testing for gonorrhea and chlamydia is done does not meet my expectations. Current (laboratory-based/point-of-care) testing methods enable timely and accurate care for patients tested for urogenital gonorrhea and chlamydia. If it were up to me, I would keep the (laboratory-based/point-ofcare) process in place for gonorrhea and chlamydia testing.
5. Strongly agree 4. Somewhat agree 3. Neither agree nor disagree 2. Somewhat disagree 1. Strongly disagree.
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Table 4 Group Characteristics
Age, years (mean ± SD) Sex (n, %) Female Male Payer (n, %) Medicaid/Medicare Commercial Insurance Private pay Tricare Chlamydia positive (n, %) Gonorrhea positive (n, %)
Table 5 Treatment Appropriateness Pre-/Standard Testing Group (n ¼ 100)
Post-/POC Group (n ¼ 100)
P Value
28.6 ± 9.4
29.4 ± 8.3
.57 .393
53 47
59 41
58 34 6 2 12 9
50 32 13 5 11 5
.21
Overtreatment (n, %) Undertreatment (n,%) Appropriate treatment (n, %)
Pre-/Standard Testing Group (n ¼ 100)
Post-/POC Group (n ¼ 100)
P Value
Cramer V
40% 8% 52%
0% 0% 100%
.000 .004 .000
0.50 0.20 0.56
POC ¼ point-of-care.
.83 .27
POC ¼ point-of-care; SD ¼ standard deviation.
reflecting dissatisfaction were reverse coded with calculation to maintain internal consistency. A paired sample t test was performed to analyze responses using the mean score from each respondent. A score of 1 represents dissatisfaction with testing, whereas a score of 5 represents a high level of satisfaction with testing; thus, the higher the score, the greater level of reported satisfaction. SPSS software (IBM SPSS Statistics for Windows, Version 24.0; IBM Corp, Armonk, NY) was used for all statistical analyses. Results Demographic Results Two hundred patients were included in the analysis, 100 per test group. One hundred forty-eight patients with the specified diagnostic codes were reviewed for eligibility during the study period. Of those 148 patients, 27 encounters were excluded for a lack of GC/ CT testing results in the chart because of laboratory or collection error. Of the 121 eligible encounters, 100 were randomly selected for inclusion in the study using the Excel (Microsoft, Redmond, WA) randomizer function. One hundred two patients were tested during the 90-day test period using the GeneXpert POC testing in which 2 were excluded; 1 encounter did not meet the age criteria (>13 years of age) and 1 test for early termination of testing because of a lack of insurance confirmation before initiating testing (no provider visit). Sample characteristics were similar for each group (Table 4). STI Treatment Appropriateness Appropriate treatment was administered at the initial visit in 52% of patients from the traditional group compared with 100% of patients in the POC group (P ¼ .000, Table 5). Overtreatment (empirically) was administered in 40% of patients from the traditional group (n ¼ 40) versus 0% in the POC group (P ¼ .000). The effect size for these findings, Cramer V, was large (.56 and .50, respectively; Table 6). Undertreatment was found in 8% of test patients from the traditional group (n ¼ 8) versus 0% in the POC group (P ¼ .004). The effect size for the undertreatment category was small to moderate, Cramer V ¼ .20 (Table 5). Financial Analysis Results Costs above traditional testing using the GeneXpert include the cost for moderate complexity CLIA certification ($400 biennial), the cost for proficiency testing ($400 annually), the cost for control reagents ($500 annually), and the cost of each cartridge (approximately $33). Reimbursement was tracked for each patient
encounter to determine reimbursement from each payer (Table 6). Using the calculated payer mix from pre- and postintervention testing, with an estimated 40 tests per month, 2 figures were calculated for revenue potential, one using the lowest commercial payer and the second using the median reimbursement from commercial payers. Using the reimbursement for the lowest commercial payer minus the associated annual cost, the minimum annual revenue potential for the clinic is $18,275.56. The median reimbursement from available commercial payer reimbursement data is $86.30; when calculated using this figure, the annual revenue potential for testing is $25,556.20. Staff Satisfaction Staff reported overall improved satisfaction with testing using the POC GeneXpert compared with traditional send-out STI testing. Of the 9 staff members included in the satisfaction survey, 8 responses were received both pre- and postintervention. Of the 8 respondents, 1 response was excluded because of a partially complete survey. A paired samples t test was conducted on the 2 groups. The mean satisfaction score for preintervention testing was 2.4 (standard deviation ¼ 0.79) compared with a mean postintervention satisfaction score of 4.97 (standard deviation ¼ .08). The mean satisfaction increased 2.49 points from standard to POC testing. Overall, increased staff satisfaction with POC testing was statistically significant (t6 ¼ 7.9, P ¼ .000). Discussion The significant results of this quality improvement project strongly support the use of NAAT POC testing for urogenital GC and CT as the new standard of care, replacing send out, laboratorybased testing. Findings are consistent with the emerging literature for use in ED settings, with this study being the first known project of its kind in an urgent care setting. The findings of the project are particularly relevant in the trend of health care use within the US because reliance on UCCs grew approximately 2.5fold from 2010 to 2014, with a 6-fold increase in the number of visits that involved chlamydia diagnosis, a 3-fold increase in the number of visits that involved gonorrhea diagnosis, and a 6-fold
Table 6 GeneXpert Reimbursement by Payer Type Payer Type
Reimbursement for GC/CT (CPT 87491 and 87591)
Medicaid/Medicare Commercial 1 Commercial 2 Commercial 3 Tricare Private pay
$90.86 $132.40 $40.22 a
$67.64 $88
CPT ¼ Current Procedural Terminology; CT ¼ Chlamydia trachomatis; GC ¼ Neisseria gonorrhea. a See discussion.
K.M. Fisk et al. / The Journal for Nurse Practitioners xxx (xxxx) xxx
increase in the number of visits that involved a diagnosis of unspecified STI.16 Benefits of NAAT POC testing not only positively affect the appropriate and timely treatment of individual patients but also optimize public and global health initiatives. The NAAT POC test, the GeneXpert, is on the forefront of this initiative, providing confirmatory diagnostics within 90 minutes compared with the 3- to 5-day margin for laboratory-based polymerase chain reaction testing. Efficacy in reducing inappropriate treatment for GC/CT infection was astounding; in only the 90-day test period, treatment appropriateness improved from 52% to 100% treatment accuracy. Before the implementation of POC testing, almost half of the patients seen for urogenital GC/CT testing either received antibiotics in the absence of infection or did not receive antibiotics in the presence of infection, leading to increased cost and sequelae of untreated infection and providing a reservoir for bacteria to mutate and gain resistance. Our secondary outcome measuring financial feasibility, with a goal of cost neutrality or revenue generation, was also achieved. Clinically, the use of the GeneXpert supports itself, and, therefore, even a cost neutral finding would have been acceptable to adopt into practice. By bringing GC/CT testing in house, our annual revenue potential is estimated to be between $17,000 and $25,000. The financial benefit also extends to private pay patients because the cost for laboratory-based nucleic acid testing for urogenital gonorrhea and chlamydia is $206.97 versus $88 for POC testing; cost savings for the private pay patient equate to approximately $118.97. Future clinical implications of real-time NAATs as standard of care are promising. Because of the unmatched sensitivity of NAATs, multiple regulatory bodies including the CDC and the United Kingdom Health Protection Agency recommend the use of these tests over any other test type, including gram stain/culture.17,18 Screening guidelines for high-risk populations, specifically men who have sex with men, include testing for GC/CT at rectal and pharyngeal sites because of the high, yet often asymptomatic, nature of such infections. As the technology continues to evolve in the future, NAATs are expected to be validated for routine testing of extragenital sites such as oropharyngeal and rectal specimens. The results of this project are especially pertinent to vulnerable populations, including adolescents, individuals of lower socioeconomic status, uninsured/underinsured, transient populations, and, as mentioned, men who have sex with men and transgender communities, who have limited health care access and are at risk for follow-up care when send-out testing is completed. Testing with the GeneXpert ensures the individual receives the treatment he or she needs at the time of the visit and reduces the risk of loss to follow-up. Limitations Limitations to this study design exist because of the EHR implementation prevented accurate extraction of data using Current Procedural Terminology codes in which retrospective data were extracted using the 4 most commonly assigned ICD-10 codes associated with urogenital gonorrhea and chlamydia testing to review for eligibility. The retrospective sample may not have included every patient tested for urogenital GC/CT if an alternative ICD-10 code was used by a provider. Financial data were analyzed using reimbursement for the 2 specified Current Procedural Terminology codes associated with GC/CT testing on the GeneXpert; however, commercial payers with case rate contracts (Table 5, commercial payer 3) are not calculated into reimbursement because this cannot be anticipated. Commercial payers with case rate contracts pay a flat rate, which includes the provider visit and all associated
5
services performed in the clinic such as in-house testing and procedures, excluding send-out tests. This, too, is unlikely to have affected results because of the lower acuity nature of most visits in which GC/CT testing is ordered, limiting other diagnostics or procedures incurring cost. Assumptions cannot be applied to all UCCs across the US given the demographic and socioeconomic factors that may contribute to a higher prevalence of visits for STIs at the project site. Lastly, we elected to use identical “pre and post” Likert scales rather than reversing or mixing up the order of survey questions, which may have biased the clinic team who was surveyed.
Conclusion GC and CT have undoubtedly earned their spot at the forefront of public and global health initiatives, augmenting morbidity, mortality, and economic strain. The public health threat of increased disease prevalence and bacterial mutation lending to antimicrobial resistance is an issue that can be addressed with timely screening, accurate diagnostics, and antimicrobial stewardship. POC NAATs have proven diagnostic accuracy and cost-effectiveness and are deemed highly satisfactory by clinical staff. Although particularly relevant in emergent and urgent care settings, the findings of this project could be replicated in many clinic settings. The expansion of this relevant POC testing could potentiate our ability to meet the national and global health needs, optimizing initiatives put forth by the CDC and World Health Organization.
References 1. CDC fact sheet: reported STDs in the United States, 2016. https://www. cdc.gov/nchhstp/newsroom/docs/factsheets/STD-Trends-508.pdf. Accessed February 19, 2018. 2. Unemo M, Bradshaw CS, Hocking JS, et al. Sexually transmitted infections: challenges ahead. Lancet Infect Dis. 2017;17(8):e235-e279. https://doi.org/ 10.1016/s1473-3099(17)30310-9. 3. Blank S, Daskalakis DC. Neisseria gonorrhoeae - rising infection rates, dwindling treatment options. N Engl J Med. 2018;379(19):1795-1797. https:// doi.org/10.1056/NEJMp1812269. 4. Holley CE, Van Pham T, Mezzadra HM, Willis GC, Witting MD. Overtreatment of gonorrhea and chlamydial infections in 2 inner-city emergency departments. Am J Emerg Med. 2015;33(9):1265-1268. https://doi.org/10.1016/ j.ajem.2015.06.009. 5. Schechter-Perkins EM, Jenkins D, White LF, Mitchell PM. Treatment of cases of Neisseria gonorrhoeae and Chlamydia trachomatis in emergency department patients. Sex Transm Dis. 2015;42(7):353-357. https://doi.org/10.1097/ olq.0000000000000299. 6. Lolar SA, Sherwin RL, Robinson DM, Courage C, Welch RD. Effectiveness of an urban emergency department call-back system in the successful linkage to treatment of sexually transmitted infections. South Med J. 2015;108(5): 268-273. https://doi.org/10.14423/smj.0000000000000273. 7. Guy RJ, Causer LM, Klausner JD, et al. Performance and operational characteristics of point-of-care tests for the diagnosis of urogenital gonococcal infections. Sex Transm Infect. 2017;93(S4):S16-S21. https://doi.org/10.1136/ sextrans-2017-053192. 8. Herbst de Cortina S, Bristow CC, Joseph Davey D, Klausner JD. A systematic review of point of care testing for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Infect Dis Obstet Gynecol. 2016;2016: 4386127. https://doi.org/10.1155/2016/4386127. 9. Kelly H, Coltart CEM, Pant Pai N, et al. Systematic reviews of point-of-care tests for the diagnosis of urogenital Chlamydia trachomatis infections. Sex Transm Infect. 2017;93(S4):S22-S30. https://doi.org/10.1136/sextrans-2016-053067. 10. Wilson SP, Vohra T, Goldberg J, et al. Reliable rapid assay for gonorrhea and chlamydia in the emergency department. J Emerg Med. 2017;53(6):890-895. https://doi.org/10.1016/j.jemermed.2017.08.094. 11. Whitlock GG, Gibbons DC, Longford N, Harvey MJ, McOwan A, Adams EJ. Rapid testing and treatment for sexually transmitted infections improve patient care and yield public health benefits. Int J STD AIDS. 2018;29(5):474-482. https:// doi.org/10.1177/0956462417736431. 12. Rivard KR, Dumkow LE, Draper HM, Brandt KL, Whalen DW, Egwuatu NE. Impact of rapid diagnostic testing for chlamydia and gonorrhea on appropriate antimicrobial utilization in the emergency department. Diagn Microbiol Infect Dis. 2017;87(2):175-179. https://doi.org/10.1016/j.diagmicrobio.2016.10.019.
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13. Centers for Disease Control and Prevention. NCHHSTP AtlasPlus. Updated 2017. https://www.cdc.gov/nchhstp/atlas/index.htm. Accessed February 19, 2018. 14. Xpert CT/NG. 2014. http://www.cepheid.com/us/cepheid-solutions/clinicalivd-tests/sexual-health/xpert-ct-ng. Accessed February 19, 2018. 15. CDC: 2015 sexually transmitted diseases treatment guidelines. https://www. cdc.gov/std/tg2015/gonorrhea.htm. 2015 Accessed February 19, 2018. 16. Pearson WS, Tao G, Kroeger K, Peterman TA. Increase in urgent care center visits for sexually transmitted infections, United States, 2010e2014. Emerg Infect Dis. 2017;3(2):367-369. https://doi.org/10.3201/eid2302.161707. 17. Papp J, Schachter J, Gaydos C, Van Der Pol B. Recommendations for the laboratory-based detection of Chlamydia trachomatis and Neisseria gonorrhoeaed2014. MMWR Morb Mortal Wkly Rep. 2014;63:1-19. 18. Bignell C, Fitzgerald M; Guideline Development Group; British Association for Sexual Health and HIV UK. UK national guideline for the management of
gonorrhoea in adults, 2011. Int J STD AIDS. 2011;22(10):541-547. https:// doi.org/10.1258/ijsa.2011.011267.
Kayla M. Fisk, DNP, FNP-C, is a nurse practitioner at Rocky Mountain Urgent Care & Family Medicine, Aurora, CO, and can be contacted at [email protected]. Anne Derouin, DNP, CPNP, FAANP, is an associate professor and director of the master of science in nursing program at Duke University in Durham, NC. Gregory Holm, PhD, NP, FAANP, is a nurse practitioner in occupation medicine at UCHealth Occupational Medicine Clinic in Steamboat Springs, CO. LuAnne Hicks, MSN, FNP-BC, is the director of clinical compliance at Rocky Mountain Urgent Care & Family Medicine. In compliance with national ethical guidelines, the authors report no relationships with business or industry that would pose a conflict of interest.
Contents lists available at ScienceDirect
The Journal for Nurse Practitioners journal homepage: www.npjournal.org
Original Research
Getting it Right: The Impact of Point-of-Care Testing for Gonorrhea and Chlamydia in the Urgent Care Setting Kayla M. Fisk, DNP, FNP-C, Anne Derouin, DNP, CPNP, Gregory Holm, PhD, NP, LuAnne Hicks, MSN, FNP-BC a b s t r a c t Keywords: nucleic acid amplification test point of care sexually transmitted infections/sexually transmitted diseases sexually transmitted infection screening urgent care clinics
Sexually transmitted infections (STIs), including Neisseria gonorrhea and Chlamydia trachomatis, have been at the forefront of public health and world health initiatives because of increasing prevalence, antimicrobial resistance trends, and immense economic health care burdens. Current STI laboratory-based testing impedes timely and accurate treatment in urgent care clinics (UCCs) and emergent care settings; the typical 3- to 5day turnaround for testing results is not efficient in these settings. Of significance, UCCs and emergency settings often serve as the only point of contact for many exposed or affected individuals, further complicating appropriate treatment and follow-up care. This quality improvement project was conducted at a highvolume, suburban UCC to evaluate the implementation of nucleic acid amplification test (NAAT) point-of-care (POC) STI screening for gonorrhea and chlamydia. Analysis included comparison of appropriate STI treatment based on laboratory results among 100 patients preintervention and 100 patients postintervention, financial feasibility of the POC testing intervention, and staff satisfaction measurement. Results show that STI treatment appropriateness dramatically improved with NAAT; the innovation exceeded cost neutrality by creating revenue through appropriate billing and coding, and clinical staff were highly satisfied using the new testing protocol. The results of this study support the use of POC testing using NAAT for the diagnosis of urogenital gonorrhea and chlamydia infections in urgent and emergent care settings and highlight implications for adoption, sustainability, and expansion into other clinic settings. © 2020 Elsevier Inc. All rights reserved.
Neisseria gonorrhea (GC) and Chlamydia trachomatis (CT) are the most commonly reported sexually transmitted infections (STIs) in the United States.1 According to the Centers for Disease Control and Prevention (CDC), nearly 2.1 million new cases were reported in 2016, with STIs yielding approximately $16 billion in health care costs annually.1 Gonorrhea and chlamydia, although relatively simple to treat with proper clinical screening and antibiotic treatment, can have devastating implications if left untreated.2 To reduce the risk of further infection among sexual partners and prevent long-term health consequences of the most common STIs, the CDC recommends empiric treatment while awaiting confirmatory test results for high-risk patients, patients with limited ability for follow-up care while results are pending, and those who are symptomatic or have a known exposure. Despite these guidelines, the use of antibiotics without confirmation of infection has unintended consequences; the overuse and misuse of antimicrobials result in resistant STIs and other bacterial species.2 Of significance, various gonococcal strains have developed resistance to all drugs used for treatment in regions
https://doi.org/10.1016/j.nurpra.2020.01.006 1555-4155/© 2020 Elsevier Inc. All rights reserved.
outside of the US; GC was deemed in the top 3 urgent infectious public health threats in 2015.3 Inappropriate treatment, including overtreatment, undertreatment, and lack of treatment, for GC and CT is particularly concerning in urgent and emergent care settings. A study conducted in 2015 evaluating 2 large inner-city emergency departments found 86% of patients tested for urogenital GC and CT symptoms were treated with antibiotics in the absence of infection.4 Additionally, 17 of the 412 individuals who tested positive for GC or CT did not receive antibiotics. Another study tracking treatment of GC/CT in an emergency department (ED) found only 54% of the 500 patients included in the study were treated appropriately in the ED at the initial visit.5 Although an additional 31% were successfully contacted after discharge and treated within the recommended follow-up interval, 15% of patients neither received appropriate treatment in the ED nor follow-up.5 Another study showed that even with a follow-up system in place to contact ED patients who tested positive for GC or CT by phone or mail, large undertreatment rates ensued; 42% of patients identified (n ¼ 861) were under- or untreated, and 60% never returned for treatment.6
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Traditional STI testing includes urine, provider-collected endocervical swab, or urethral swabs that are sent out to a laboratory for polymerase chain reaction testing, requiring a wait time of testing results of 3 to 5 days. Upon receipt of the laboratory results, on-site providers review the encounter note for the patient, determine if the patient received appropriate treatment, and, if needed, facilitate treatment. An emerging innovation to improve STI testing includes pointof-care (POC) tests, reducing the testing to results time to 90 minutes or less. The emerging technology promises to streamline results, thereby reducing overuse and inappropriate use of antimicrobials, the rate of patients untreated in the community, and the risk of infection and sequela and resultantly reducing economic cost and improving population health outcomes. Historically, POC test comparisons showed varying results; the pooled sensitivity of antigen detection tests was 53%, 37%, and 63% for cervical swabs, vaginal swabs, and urine, and specificity was 99%, 97%, and 98%, respectively.7-9 However, a recent Food and Drug Administrationeapproved POC test, the GeneXpert (Cepheid, Sunnyvale, CA), has successfully yielded confirmatory GC/CT results in less than 90 minutes, maintaining a sensitivity and specificity greater than 95% and 99%, respectively.7-9 This nucleic acid amplification test (NAAT) is comparable with the current gold standard laboratory-based nucleic acid test, which has a sensitivity and specificity between 95% and 99%, respectively,10 and has been widely used in Europe. In the United Kingdom, Whitlock et al11 compared 2 highvolume clinics, one using the rapid GeneXpert and one with standard laboratory testing for GC/CT. Of the 81,352 patient tests during the 1-year study period, the mean time to notification was reduced from 8.95 days to 0.27 days, was estimated to have prevented 196 GC/CT transmissions, averted 854 partner attendances, and resulted in an annual savings of 124,283 euros. Gradually being introduced to the US, Rivard et al12 found significant improvement in optimal diagnosis and treatment using POC testing for GC/CT, along with cost savings of $24.46 per patients in an American convenience care center. In a noninferiority study, both rapid testing and traditional testing were completed on 1,162 patient samples to test for real confounding variables in clinical practice and how it influences accuracy (staff knowledge and appropriate use/sample collection). The results yielded “robust enough data to support practice change”; accuracy in testing for both men and women was between 82% and 100%, despite a lack of control on appropriate sample collection (first catch vs midstream), which could greatly alter sensitivity.10 To further evaluate practice change, a quality improvement study evaluated outcomes of the rapid GeneXpert POC testing implementation for urogenital STI screening of GC/CT in an urgent care clinic (UCC) setting. The goal of implementation was to assess STI identification and treatment accuracy while showing financial feasibility and improved clinical staff satisfaction in the reduced testing to result time. Methods Setting This pre/postquality improvement project was conducted in a busy suburban UCC located in Colorado. The UCC is open daily from 8 AM to 9 PM, 363 days per year, employing a full-time staff serving an average volume of 15,000 patient visits annually. The clinic accepts most commercial insurance and private payment and is 1 of only a few in the metropolitan area that accepts Medicare/ Medicaid, accounting for approximately 60% of the UCC patient population.
Genitourinary concerns are among the top 5 chief patient complaints; an average of 40þ GC/CT tests per month are sent from the clinic to the local laboratory. At the time of this project, more than 25,000 reported CT cases, and nearly 6,000 GC cases had been reported the previous year, resulting in the surrounding community being ranked 5th highest in per capita rates of gonorrhea diagnosis and 7th for chlamydia diagnosis in the state of Colorado.13 The rates of infection and clinic traffic represented a clear need for accurate STI screening, diagnosis, and treatment to reduce prevalence and improve the health status of the population. Design After institutional review board approval and the development of an implementation plan, a 90-day evaluation of NAAT POC testing was conducted from August to November 2018, replacing traditional testing methods (laboratory send-out tests). NAAT POC patient testing criteria included all patients 13 years of age presenting to the clinic with urogenital complaints potentially related to STIs. Risk criteria for STI screening included patientreported history of present illness, specifically urethral discharge, vaginal discharge, genital pain, or painful urination correlated with known exposure or unprotected sexual encounters. The inclusion of minors was determined in accordance with the Colorado minor consent law, CO Rev Stat x 25-4-409 (2017), which permits confidential STI screening and treatment to be provided upon the minor’s consent. A randomized sample of 100 patients from a historic group of patients with traditional urogenital GC/CT laboratory-based testing and treatment (preinnovation) was compared with 100 NAAT POC test result and treatment outcomes (postinnovation). Cost analysis and staff satisfaction evaluation were conducted during the postinnovation phase of the project. Before implementing the NAAT POC testing protocol, the clinic underwent laboratory changes to acquire moderate complexity licensure from the prior Clinical Laboratory Improvement Amendments (CLIA) waived status. Moderate complexity licensure was granted before innovation testing. During this phase, 5 fulltime providers and 4 medical assistants were trained to operate the Cepheid testing device in accordance with the GeneXpert training guide.14 During the 90-day testing period, all patients presenting with a urogenital complaint were screened upon check-in with written intake questions that included the following: 1. Are you experiencing burning with urination or penile/vaginal discharge that you believe may be related to an STI? 2. Have you had a known exposure to an STI, and this is the reason for your visit today? If a patient selected “yes” for either question, the front desk staff would notify a medical assistant to collect a sample from the patient immediately and begin testing. While the specimen was processing, the patient would complete the check-in process and wait in queue for the provider consultation. Once the provider assessed the patient, if the specimen test was not complete at the time of provider evaluation, patients were asked to remain in the waiting room until test results were available. Additionally, if a patient was not prescreened (did not select “yes” for corresponding screening questions) but a provider deemed GC/CT testing necessary after history and assessment were attained, a specimen was collected and processed in the same manner. Once test results were complete, the patient returned to an examination room and was given his or her test results. Patients with positive test results were treated with appropriate antimicrobials at the time of visit in
K.M. Fisk et al. / The Journal for Nurse Practitioners xxx (xxxx) xxx Table 1 Centers for Disease Control and Prevention 2015 Guidelines for Treatment of Chlamydia 1st line 2nd line Alternative regimen
Azithromycin 1 g orally in a single dose Doxycycline 100 mg orally twice a day for 7 days Erythromycin base 500 mg orally 4 times a day for 7 days OR Erythromycin ethylsuccinate 800 mg orally four times a day for 7 days OR Levofloxacin 500 mg orally once daily for 7 days OR Ofloxacin 300 mg orally twice a day for 7 days
accordance with the CDC 2015 treatment guidelines15 (Tables 1 and 2).
Analysis Methods The primary outcome of treatment appropriateness was measured by comparing a retrospective sample of 100 randomized patients preintervention and 100 patients in the NAAT POC group. Retrospective data extraction was conducted using the 4 most frequent International Classification of Diseases, Tenth Revision (ICD10) diagnostic codes used for GC/CT testing within the electronic health record (EHR) system. The codes used for extraction of patient encounters included contact with and (suspected) exposure to infections with a predominantly sexual mode of transmission (Z20.2), encounter for screening for infections with a predominantly sexual mode of transmission (Z11.3), unspecified sexually transmitted disease (A64), and nonspecific urethritis (N34.1). Retrospective inclusion parameters included 100 randomized encounters of the codes noted among patients seen between September 1, 2017, through August 1, 2018, 13 years of age or older in which GC/CT testing was ordered and reconciled in the EHR. Patient encounters were excluded if testing was ordered but because of laboratory, specimen, or handling error, no results were recorded; if testing included extragenital sites (oropharyngeal or rectal); or if given the diagnosis of pelvic inflammatory disease or epididymitis because treatment may overlap. Each of the selected encounters was deidentified and assigned a study number and included the following demographic information: sex, age, and payer (Medicare/Medicaid, Tricare, Commercial, or private pay). Data were recorded for gonorrhea and chlamydia test results (positive or negative) and assigned a category based on the recorded treatment as follows: 1, overtreatment (yes or no); 2, undertreatment (yes or no); and 3, appropriate treatment (yes or no). Overtreatment was defined as the receipt of antimicrobials (empiric treatment) in the absence of infection, undertreatment was defined as a lack of antimicrobials in the presence of GC and/or CT infection, and appropriate treatment was defined as antimicrobials for confirmed infection and/or no antimicrobials in the absence of infection.
Table 2 Centers for Disease Control and Prevention 2015 Guidelines for Treatment of Gonorrhea 1st line
Alternative regimen
Ceftriaxone 250 mg intramuscularly in a single dose PLUS Azithromycin 1g orally in a single dose If ceftriaxone is not available: Cefixime 400 mg orally in a single dose PLUS Azithromycin 1 g orally in a single dose
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The NAAT intervention POC testing group was deidentified in the same way (ie, collected during the testing period through the EHR encounter notes and the laboratory collection log). Upon NAAT POC test completion, results were recorded within the Cepheid device in addition to printed results validating internal control checks with confirmatory results recorded as follows: CT DETECTED/CT NOT DETECTED and GC DETECTED/GC NOT DETECTED. All test results were noted in the patient record, and the deidentified collection logs were stored in a locked cabinet. Chi-square analysis was conducted on the 3 categories to determine if the intervention improved treatment accuracy for urogenital gonorrhea and chlamydia compared with standard testing. The minimum sample size needed based on a 90% power, medium effect size (.30), and alpha set to .05 was calculated to be 141, which includes both pre- and postintervention samples. We selected the 90-day test period to aim for a larger sample size of 100 pre- and 100 postintervention patients. The financial feasibility of NAAT POC testing was measured using a balance log, comparing send-out (preintervention) STI testing with the cost of the GeneXpert innovation. Preintervention testing was neither revenue generating nor cost incurring because gonorrhea and chlamydia tests were billed directly to the patient or payer by the laboratory. Postintervention testing with the GeneXpert was measured factoring any overhead cost for the testing device, test cartridges (1 cartridge runs both GC/CT), moderate complexity CLIA certification, triannual proficiency testing pursuant to CLIA regulations, external control reagents, and reimbursement for each POC testing included in the billed encounters from various payer types. Staff satisfaction was measured preintervention and postintervention with a 5-point Likert scale survey through Qualtrics survey software (Qualtrics, Provo, UT) (1 ¼ strongly disagree, 5 ¼ strongly agree). All providers (physicians, nurse practitioners, and physician assistants) and medical assistants involved in the testing process for GC/CT were included in the satisfaction survey. Questionnaires were sent via e-mail to each staff member with 2 automatic reminders, leaving the survey open for 2 weeks for an elective response. The 5 questions were identical pre- and postintervention, simply replacing the subject with questions regarding “send-out, lab-based testing for urogenital gonorrhea and chlamydia,” and “point-of-care testing for urogenital gonorrhea and chlamydia” postintervention (Table 3). Questions inquired about perceptions on general satisfaction with the method of testing and clinical implications with timeliness and accuracy of care provided with each modality. Some questions were worded to reflect agreement with satisfaction of testing, whereas others were worded to reflect agreement as dissatisfaction with care; items Table 3 Pre- and Poststaff Satisfaction Survey 1
2
3 4
5
I am satisfied with current (laboratory-based/ point-of-care) testing for urogenital gonorrhea and chlamydia. (Laboratory-based/point-of-care) testing for gonorrhea and chlamydia inhibits timely and accurate treatment of sexually transmitted infections. The methods by which (laboratory-based/point-of-care) testing for gonorrhea and chlamydia is done does not meet my expectations. Current (laboratory-based/point-of-care) testing methods enable timely and accurate care for patients tested for urogenital gonorrhea and chlamydia. If it were up to me, I would keep the (laboratory-based/point-ofcare) process in place for gonorrhea and chlamydia testing.
5. Strongly agree 4. Somewhat agree 3. Neither agree nor disagree 2. Somewhat disagree 1. Strongly disagree.
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Table 4 Group Characteristics
Age, years (mean ± SD) Sex (n, %) Female Male Payer (n, %) Medicaid/Medicare Commercial Insurance Private pay Tricare Chlamydia positive (n, %) Gonorrhea positive (n, %)
Table 5 Treatment Appropriateness Pre-/Standard Testing Group (n ¼ 100)
Post-/POC Group (n ¼ 100)
P Value
28.6 ± 9.4
29.4 ± 8.3
.57 .393
53 47
59 41
58 34 6 2 12 9
50 32 13 5 11 5
.21
Overtreatment (n, %) Undertreatment (n,%) Appropriate treatment (n, %)
Pre-/Standard Testing Group (n ¼ 100)
Post-/POC Group (n ¼ 100)
P Value
Cramer V
40% 8% 52%
0% 0% 100%
.000 .004 .000
0.50 0.20 0.56
POC ¼ point-of-care.
.83 .27
POC ¼ point-of-care; SD ¼ standard deviation.
reflecting dissatisfaction were reverse coded with calculation to maintain internal consistency. A paired sample t test was performed to analyze responses using the mean score from each respondent. A score of 1 represents dissatisfaction with testing, whereas a score of 5 represents a high level of satisfaction with testing; thus, the higher the score, the greater level of reported satisfaction. SPSS software (IBM SPSS Statistics for Windows, Version 24.0; IBM Corp, Armonk, NY) was used for all statistical analyses. Results Demographic Results Two hundred patients were included in the analysis, 100 per test group. One hundred forty-eight patients with the specified diagnostic codes were reviewed for eligibility during the study period. Of those 148 patients, 27 encounters were excluded for a lack of GC/ CT testing results in the chart because of laboratory or collection error. Of the 121 eligible encounters, 100 were randomly selected for inclusion in the study using the Excel (Microsoft, Redmond, WA) randomizer function. One hundred two patients were tested during the 90-day test period using the GeneXpert POC testing in which 2 were excluded; 1 encounter did not meet the age criteria (>13 years of age) and 1 test for early termination of testing because of a lack of insurance confirmation before initiating testing (no provider visit). Sample characteristics were similar for each group (Table 4). STI Treatment Appropriateness Appropriate treatment was administered at the initial visit in 52% of patients from the traditional group compared with 100% of patients in the POC group (P ¼ .000, Table 5). Overtreatment (empirically) was administered in 40% of patients from the traditional group (n ¼ 40) versus 0% in the POC group (P ¼ .000). The effect size for these findings, Cramer V, was large (.56 and .50, respectively; Table 6). Undertreatment was found in 8% of test patients from the traditional group (n ¼ 8) versus 0% in the POC group (P ¼ .004). The effect size for the undertreatment category was small to moderate, Cramer V ¼ .20 (Table 5). Financial Analysis Results Costs above traditional testing using the GeneXpert include the cost for moderate complexity CLIA certification ($400 biennial), the cost for proficiency testing ($400 annually), the cost for control reagents ($500 annually), and the cost of each cartridge (approximately $33). Reimbursement was tracked for each patient
encounter to determine reimbursement from each payer (Table 6). Using the calculated payer mix from pre- and postintervention testing, with an estimated 40 tests per month, 2 figures were calculated for revenue potential, one using the lowest commercial payer and the second using the median reimbursement from commercial payers. Using the reimbursement for the lowest commercial payer minus the associated annual cost, the minimum annual revenue potential for the clinic is $18,275.56. The median reimbursement from available commercial payer reimbursement data is $86.30; when calculated using this figure, the annual revenue potential for testing is $25,556.20. Staff Satisfaction Staff reported overall improved satisfaction with testing using the POC GeneXpert compared with traditional send-out STI testing. Of the 9 staff members included in the satisfaction survey, 8 responses were received both pre- and postintervention. Of the 8 respondents, 1 response was excluded because of a partially complete survey. A paired samples t test was conducted on the 2 groups. The mean satisfaction score for preintervention testing was 2.4 (standard deviation ¼ 0.79) compared with a mean postintervention satisfaction score of 4.97 (standard deviation ¼ .08). The mean satisfaction increased 2.49 points from standard to POC testing. Overall, increased staff satisfaction with POC testing was statistically significant (t6 ¼ 7.9, P ¼ .000). Discussion The significant results of this quality improvement project strongly support the use of NAAT POC testing for urogenital GC and CT as the new standard of care, replacing send out, laboratorybased testing. Findings are consistent with the emerging literature for use in ED settings, with this study being the first known project of its kind in an urgent care setting. The findings of the project are particularly relevant in the trend of health care use within the US because reliance on UCCs grew approximately 2.5fold from 2010 to 2014, with a 6-fold increase in the number of visits that involved chlamydia diagnosis, a 3-fold increase in the number of visits that involved gonorrhea diagnosis, and a 6-fold
Table 6 GeneXpert Reimbursement by Payer Type Payer Type
Reimbursement for GC/CT (CPT 87491 and 87591)
Medicaid/Medicare Commercial 1 Commercial 2 Commercial 3 Tricare Private pay
$90.86 $132.40 $40.22 a
$67.64 $88
CPT ¼ Current Procedural Terminology; CT ¼ Chlamydia trachomatis; GC ¼ Neisseria gonorrhea. a See discussion.
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increase in the number of visits that involved a diagnosis of unspecified STI.16 Benefits of NAAT POC testing not only positively affect the appropriate and timely treatment of individual patients but also optimize public and global health initiatives. The NAAT POC test, the GeneXpert, is on the forefront of this initiative, providing confirmatory diagnostics within 90 minutes compared with the 3- to 5-day margin for laboratory-based polymerase chain reaction testing. Efficacy in reducing inappropriate treatment for GC/CT infection was astounding; in only the 90-day test period, treatment appropriateness improved from 52% to 100% treatment accuracy. Before the implementation of POC testing, almost half of the patients seen for urogenital GC/CT testing either received antibiotics in the absence of infection or did not receive antibiotics in the presence of infection, leading to increased cost and sequelae of untreated infection and providing a reservoir for bacteria to mutate and gain resistance. Our secondary outcome measuring financial feasibility, with a goal of cost neutrality or revenue generation, was also achieved. Clinically, the use of the GeneXpert supports itself, and, therefore, even a cost neutral finding would have been acceptable to adopt into practice. By bringing GC/CT testing in house, our annual revenue potential is estimated to be between $17,000 and $25,000. The financial benefit also extends to private pay patients because the cost for laboratory-based nucleic acid testing for urogenital gonorrhea and chlamydia is $206.97 versus $88 for POC testing; cost savings for the private pay patient equate to approximately $118.97. Future clinical implications of real-time NAATs as standard of care are promising. Because of the unmatched sensitivity of NAATs, multiple regulatory bodies including the CDC and the United Kingdom Health Protection Agency recommend the use of these tests over any other test type, including gram stain/culture.17,18 Screening guidelines for high-risk populations, specifically men who have sex with men, include testing for GC/CT at rectal and pharyngeal sites because of the high, yet often asymptomatic, nature of such infections. As the technology continues to evolve in the future, NAATs are expected to be validated for routine testing of extragenital sites such as oropharyngeal and rectal specimens. The results of this project are especially pertinent to vulnerable populations, including adolescents, individuals of lower socioeconomic status, uninsured/underinsured, transient populations, and, as mentioned, men who have sex with men and transgender communities, who have limited health care access and are at risk for follow-up care when send-out testing is completed. Testing with the GeneXpert ensures the individual receives the treatment he or she needs at the time of the visit and reduces the risk of loss to follow-up. Limitations Limitations to this study design exist because of the EHR implementation prevented accurate extraction of data using Current Procedural Terminology codes in which retrospective data were extracted using the 4 most commonly assigned ICD-10 codes associated with urogenital gonorrhea and chlamydia testing to review for eligibility. The retrospective sample may not have included every patient tested for urogenital GC/CT if an alternative ICD-10 code was used by a provider. Financial data were analyzed using reimbursement for the 2 specified Current Procedural Terminology codes associated with GC/CT testing on the GeneXpert; however, commercial payers with case rate contracts (Table 5, commercial payer 3) are not calculated into reimbursement because this cannot be anticipated. Commercial payers with case rate contracts pay a flat rate, which includes the provider visit and all associated
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services performed in the clinic such as in-house testing and procedures, excluding send-out tests. This, too, is unlikely to have affected results because of the lower acuity nature of most visits in which GC/CT testing is ordered, limiting other diagnostics or procedures incurring cost. Assumptions cannot be applied to all UCCs across the US given the demographic and socioeconomic factors that may contribute to a higher prevalence of visits for STIs at the project site. Lastly, we elected to use identical “pre and post” Likert scales rather than reversing or mixing up the order of survey questions, which may have biased the clinic team who was surveyed.
Conclusion GC and CT have undoubtedly earned their spot at the forefront of public and global health initiatives, augmenting morbidity, mortality, and economic strain. The public health threat of increased disease prevalence and bacterial mutation lending to antimicrobial resistance is an issue that can be addressed with timely screening, accurate diagnostics, and antimicrobial stewardship. POC NAATs have proven diagnostic accuracy and cost-effectiveness and are deemed highly satisfactory by clinical staff. Although particularly relevant in emergent and urgent care settings, the findings of this project could be replicated in many clinic settings. The expansion of this relevant POC testing could potentiate our ability to meet the national and global health needs, optimizing initiatives put forth by the CDC and World Health Organization.
References 1. CDC fact sheet: reported STDs in the United States, 2016. https://www. cdc.gov/nchhstp/newsroom/docs/factsheets/STD-Trends-508.pdf. Accessed February 19, 2018. 2. Unemo M, Bradshaw CS, Hocking JS, et al. Sexually transmitted infections: challenges ahead. Lancet Infect Dis. 2017;17(8):e235-e279. https://doi.org/ 10.1016/s1473-3099(17)30310-9. 3. Blank S, Daskalakis DC. Neisseria gonorrhoeae - rising infection rates, dwindling treatment options. N Engl J Med. 2018;379(19):1795-1797. https:// doi.org/10.1056/NEJMp1812269. 4. Holley CE, Van Pham T, Mezzadra HM, Willis GC, Witting MD. Overtreatment of gonorrhea and chlamydial infections in 2 inner-city emergency departments. Am J Emerg Med. 2015;33(9):1265-1268. https://doi.org/10.1016/ j.ajem.2015.06.009. 5. Schechter-Perkins EM, Jenkins D, White LF, Mitchell PM. Treatment of cases of Neisseria gonorrhoeae and Chlamydia trachomatis in emergency department patients. Sex Transm Dis. 2015;42(7):353-357. https://doi.org/10.1097/ olq.0000000000000299. 6. Lolar SA, Sherwin RL, Robinson DM, Courage C, Welch RD. Effectiveness of an urban emergency department call-back system in the successful linkage to treatment of sexually transmitted infections. South Med J. 2015;108(5): 268-273. https://doi.org/10.14423/smj.0000000000000273. 7. Guy RJ, Causer LM, Klausner JD, et al. Performance and operational characteristics of point-of-care tests for the diagnosis of urogenital gonococcal infections. Sex Transm Infect. 2017;93(S4):S16-S21. https://doi.org/10.1136/ sextrans-2017-053192. 8. Herbst de Cortina S, Bristow CC, Joseph Davey D, Klausner JD. A systematic review of point of care testing for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Infect Dis Obstet Gynecol. 2016;2016: 4386127. https://doi.org/10.1155/2016/4386127. 9. Kelly H, Coltart CEM, Pant Pai N, et al. Systematic reviews of point-of-care tests for the diagnosis of urogenital Chlamydia trachomatis infections. Sex Transm Infect. 2017;93(S4):S22-S30. https://doi.org/10.1136/sextrans-2016-053067. 10. Wilson SP, Vohra T, Goldberg J, et al. Reliable rapid assay for gonorrhea and chlamydia in the emergency department. J Emerg Med. 2017;53(6):890-895. https://doi.org/10.1016/j.jemermed.2017.08.094. 11. Whitlock GG, Gibbons DC, Longford N, Harvey MJ, McOwan A, Adams EJ. Rapid testing and treatment for sexually transmitted infections improve patient care and yield public health benefits. Int J STD AIDS. 2018;29(5):474-482. https:// doi.org/10.1177/0956462417736431. 12. Rivard KR, Dumkow LE, Draper HM, Brandt KL, Whalen DW, Egwuatu NE. Impact of rapid diagnostic testing for chlamydia and gonorrhea on appropriate antimicrobial utilization in the emergency department. Diagn Microbiol Infect Dis. 2017;87(2):175-179. https://doi.org/10.1016/j.diagmicrobio.2016.10.019.
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13. Centers for Disease Control and Prevention. NCHHSTP AtlasPlus. Updated 2017. https://www.cdc.gov/nchhstp/atlas/index.htm. Accessed February 19, 2018. 14. Xpert CT/NG. 2014. http://www.cepheid.com/us/cepheid-solutions/clinicalivd-tests/sexual-health/xpert-ct-ng. Accessed February 19, 2018. 15. CDC: 2015 sexually transmitted diseases treatment guidelines. https://www. cdc.gov/std/tg2015/gonorrhea.htm. 2015 Accessed February 19, 2018. 16. Pearson WS, Tao G, Kroeger K, Peterman TA. Increase in urgent care center visits for sexually transmitted infections, United States, 2010e2014. Emerg Infect Dis. 2017;3(2):367-369. https://doi.org/10.3201/eid2302.161707. 17. Papp J, Schachter J, Gaydos C, Van Der Pol B. Recommendations for the laboratory-based detection of Chlamydia trachomatis and Neisseria gonorrhoeaed2014. MMWR Morb Mortal Wkly Rep. 2014;63:1-19. 18. Bignell C, Fitzgerald M; Guideline Development Group; British Association for Sexual Health and HIV UK. UK national guideline for the management of
gonorrhoea in adults, 2011. Int J STD AIDS. 2011;22(10):541-547. https:// doi.org/10.1258/ijsa.2011.011267.
Kayla M. Fisk, DNP, FNP-C, is a nurse practitioner at Rocky Mountain Urgent Care & Family Medicine, Aurora, CO, and can be contacted at [email protected]. Anne Derouin, DNP, CPNP, FAANP, is an associate professor and director of the master of science in nursing program at Duke University in Durham, NC. Gregory Holm, PhD, NP, FAANP, is a nurse practitioner in occupation medicine at UCHealth Occupational Medicine Clinic in Steamboat Springs, CO. LuAnne Hicks, MSN, FNP-BC, is the director of clinical compliance at Rocky Mountain Urgent Care & Family Medicine. In compliance with national ethical guidelines, the authors report no relationships with business or industry that would pose a conflict of interest.