Improving Hepatitis Vaccination Series Completion in Patients Awaiting Liver Transplantation Shari T. Perez, DNP-C, Noel M. Arring, DNP, Hugo E. Vargas, MD, Bryn M. Corbett, RN, Shawn Ehler, MSN, MBA, Gerald L. Beck, M’hamed Temkit, PhD, Bashar A. Aqel, MD, and Jorge Rakela, MD ABSTRACT
The aim of this quality improvement project was to improve hepatitis A and B vaccination rates by 20% in patients listed for liver transplant by improving vaccine tracking, ordering/scheduling practices, out-ofnetwork vaccinations, and ﬂagging electronic health records. We audited 101 records; 44 patients were vaccine-deﬁcient. Combined vaccine completion rates improved 94.6% (44.7%-87.0%) after implementing the educational and health record interventions. We believe the results of this study have implications for improving survival and decreasing complication rates for patients with chronic liver disease. Keywords: electronic health record, hepatitis A, hepatitis B, liver transplant, vaccination Ó 2017 Elsevier Inc. All rights reserved.
irrhosis is the 12th leading cause of death in the United States, with 27,000 deaths occurring annually and the only curative therapy coming from transplantation.1 As of August 2016, approximately 15,000 people were awaiting liver transplants.1,2 The prolonged wait-list times for transplant and an overwhelming demand for organs have underscored the need for prevention strategies, including hepatitis A and hepatitis B immunizations.3,4 In patients with cirrhosis, acute hepatitis A or B infection is associated with the development of acuteon-chronic liver disease, which has a mortality rate ranging from 20% to 35%.4,5 However, according to a 2012 report from the US Centers for Disease Control and Prevention, only 25% of individuals with chronic liver disease worldwide were vaccinated against hepatitis A, and the global rate of hepatitis B vaccination increased from 3% in 1992 to 75% in 2010.6 In addition to mortality risk, patients who are not immune to hepatitis B before transplant and receive a hepatitis B core antibodyepositive donor require antiviral therapy for the ﬁrst year posttransplant and often lifelong. The cost for this therapy is approximately $1,324 per month.7 www.npjournal.org
Hence, vaccination completion before liver transplantation is recommended by the Advisory Committee on Immunization Practices, the American Association for the Study of Liver Diseases, and the National Institutes of Health. Furthermore, hepatitis A and B vaccination in patients diagnosed with cirrhosis has been recognized as a quality of care indicator by the US Centers for Medicare & Medicaid Services. The purpose of this quality improvement project was to evaluate whether a nurse practitioner (NP)-led initiative could improve vaccination completion rates for hepatitis A and B among patients awaiting liver transplantation. The project was designed to compare existing clinical processes for hepatitis A and B vaccination delivery with those from a newly introduced NP-led education program to improve ordering and scheduling practices through use of electronic health record (EHR) patienttracking tools. The need for improved vaccination completion rates for hepatitis A and B in our patients listed for liver transplant became evident after disparities in completion rates were found from benchmark data collection. A gap analysis identiﬁed key barriers to The Journal for Nurse Practitioners - JNP
vaccination practices, including: (1) lack of an information technology system for vaccine tracking, scheduling, and dose monitoring; (2) incorrect ordering processes by clinical providers; (3) absence of patient involvement and ownership of care for completing vaccinations outside of the transplant center; and (4) an absence of a patient ﬂagging system in the EHR. METHODS
The institutional review board approved the study at the southwestern center of a 3-campus national transplant program and waived written informed consent for those who provided authorization. Approximately 450 liver transplants are done annually among the 3 campuses, and approximately 120 of these are performed at the southwestern location. Approximately 250 patients undergo evaluation for liver transplant at the southwestern center and, of these, approximately 115 are listed for liver transplant annually. This project was designed to include patients who required vaccination for hepatitis A and B from April 2014 through September 2014 (N ¼ 44). Each patient had a hepatitis B surface antibody titer and an immunoglobulin G antibody to hepatitis A serum marker performed as part of routine laboratory testing for their liver transplant evaluation. All patients who had a hepatitis B surface antibody level < 10 mIU/ mL, as per National Institutes of Health guidelines, were considered nonimmune for hepatitis B; a negative laboratory result for immunoglobulin G antibody to hepatitis A determined nonimmunity for hepatitis A. Eligibility was determined on the basis of an identiﬁed need for vaccination at time of evaluation for liver transplant. For a benchmark (preintervention) patient population, used for comparison, we included patients requiring vaccination for hepatitis A and B from April 2013 through September 2013. For the study group, we included all patients who were listed for transplant and required vaccination between April 2014 and September 2014 (for 24 weeks). We included the outcomes of these patients’ vaccinations, which occurred 6 months forward from their start date, beginning in September 2014 and ending February e442
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2015, to allow for the 6 months required to complete a vaccine series. For example, a patient starting a vaccination series in April 2014 ﬁnished in September 2014, and a patient starting in May 2014 ﬁnished in October 2014. Therefore, the last patients enrolled in this study were entered in September 2014, and we evaluated their outcomes 6 months later in February 2015. Hence, we had a total of 24 weeks of patient enrollment to then evaluate 24 weeks of patient outcomes. Interventions included adding patients to a tracking system, correcting the vaccination ordering and scheduling process, and improving documentation of vaccination administration within the EHR, beginning in April 2014. Vaccination-speciﬁc tracking measures for patients awaiting liver transplant did not exist at the initiation of this quality improvement project. To correct this deﬁciency, the transplant data analyst was instructed to add hepatitis A and B vaccination status information to the departmental database for all actively listed patients. During root-cause analysis, a deﬁciency was identiﬁed in vaccine order entry. Pretransplant registered nurse coordinators, advanced practice providers, and physicians were given group and individual training on correct vaccine ordering using simulated patient charts in the EHR. In addition, we identiﬁed barriers to making 6-month calendar appointments for future vaccine doses. Transplant department schedulers were educated on how to identify pending vaccine orders in the EHR until future calendars opened for scheduling. In December 2015, we introduced another intervention. To improve outside vaccination processes, documentation, and tracking, we created a trifold mail-in card for recording information about hepatitis A and B vaccination, including dosing and timing instructions. Patients who were unable to come to the vaccine clinic at the Transplant Center were given the trifold card, which was to be completed by their primary care provider. Last, many patients were not completing their vaccination series because the vaccines were not being tracked in the institutional health maintenance module in the EHR, which meant that the patients were not being ﬂagged for provider notiﬁcation. Our Ofﬁce of Population Health Management agreed to Volume 13, Issue 9, October 2017
add ﬂagging for hepatitis A and B vaccine monitoring to the Cerner EHR maintenance tool (Cerner Corp.), an intervention introduced in February 2015. Our primary aim was to increase the overall vaccination completion rate by 20% within 6 months through hepatitis A vaccination with Havrix, hepatitis B with Engerix-B, and hepatitis A/hepatitis B with Twinrix. Our target goal was to improve each of the interventions in the study to occurring 95% of the time: (1) patients were added to the Transplant Center’s patient tracking system with identiﬁed current vaccination status and timing for future dosespeciﬁc measures; (2) individual vaccine doses were correctly ordered, scheduled, and documented within the EHR; (3) patients whose vaccination was completed outside our institution were provided the mail-in card; and (4) patients were correctly identiﬁed as requiring vaccination through the patientﬂagging system in the EHR. Dashboard reports and control charts were created to measure outcomes of each intervention performed during the project. RESULTS
Forty-four patients listed for liver transplant and requiring vaccination for hepatitis A, hepatitis B, or both, met the inclusion criteria for the quality improvement project during the intervention period. Demographic characteristics of the intervention group are shown in the Table. The numbers per month were small in this quality improvement project, because, on average, this transplant center lists about 115 patients per year for liver transplant or about 10 per month. Of these 10, not all need vaccination. Hence, fewer patients were available for this project; however, this number reﬂects a normal population for a transplant center. The completion rates for all vaccines combined improved from 45% to 87% (odds ratio [OR] 9.54; 95% conﬁdence interval [CI] 2.92-31.16; P < .001) during the postintervention period. This was a 93.3% improvement. Hepatitis A vaccinations with Havrix increased by 20%, with 100% (n ¼ 3) of patients in the postintervention group completing the series. Hepatitis B vaccination completion rates with Engerix-B improved by 143% (OR 0.04; 95% CI 0.22-0.65; P ¼ .001) (n ¼ 12), and combination hepatitis A and B vaccination rates with Twinrix www.npjournal.org
Table. Demographic Characteristics
Characteristic Age [mean (SD)]
Preintervention Postintervention Group Group (N ¼ 57) (N ¼ 44) 58 (7.01)
Male [n (%)]
Female [n (%)]
Primary biliary cirrhosis
Primary sclerosing cholangitis
Cryptogenic or other causes
Cause of end-stage liver disease [n (%)]
MELD score [n (%)]
MELD ¼ Model for End-stage Liver Disease.
improved by 65% (OR 0.17; 95% CI 0.04-0.79; P ¼ .04) (n ¼ 13). The rate of dose 1 administration completion improved to 95%. The dose 2 completion rates for the benchmark preintervention group began at 56% and ended for the study group at 95%: a 70% improvement (OR 11.89; 95% CI 2.56-55.07; P < .001). Dose 3 completion rates increased from 41% to 86%, a 110% improvement (OR 10.06; 95% CI 3.00-33.70; P < .001). With the introduction of the electronic tracking system, 100% of patients added monthly to the transplant list had their speciﬁc vaccination needs correctly identiﬁed and documented. Correct ordering and scheduling practices improved at the The Journal for Nurse Practitioners - JNP
time of implementation from 89% to 100% completion, exceeding the goal of 95% compliance. Registered nurse coordinators had 100% compliance for use of the trifold mail-in card for out-of-state patients (n ¼ 6) who needed to complete their hepatitis B vaccination. At the end of this project, the patient-ﬂagging system correctly identiﬁed 100% (n ¼ 9) of patients with pending hepatitis vaccination needs. DISCUSSION
The primary aim of this quality improvement project was to improve overall vaccination completion rates for hepatitis A and B for patients listed for liver transplantation during a 24-week time frame. We found that most signiﬁcant improvements to vaccination completion occurred at the start of the project with the implementation of the tracking tool and with the improvement in appropriate ordering and scheduling practices. Implementation of ﬂagging systems in the EHR produced positive and progressive improvements in completion rates for vaccination dosing. After completion of the quality improvement project, patients were nearly 9.5 times more likely to complete a vaccination series at no additional cost to the department and with no increase in workload for the key participants involved. In addition, hepatitis B vaccination completion rates improved by 143%, potentially decreasing the posttransplant costs for oral antiviral prophylaxis. However, we had limited time to implement the project because of the 6-month time period required to complete a vaccination series. Therefore, data from 2 of the interventions (use of the vaccination mail-in trifold card and the patientﬂagging system) could not be incorporated into the ﬁnal vaccination outcome data. Through NP-led educational and technological interventions, vaccination series completion rates at a major southwestern liver transplant center were signiﬁcantly improved. We believe that the results of this study have implications for improving survival and decreasing complication rates, ultimately improving the quality of life for patients with chronic liver disease.
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References 1. Dong MH, Saab S. Complications of cirrhosis. Dis Mon. 2008;54(7):445-456. 2. US Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau, Division of Transplantation, Rockville (MD); United Network for Organ Sharing, Richmond (VA); University Renal Research and Education Association, Ann Arbor (MI). 2004 annual report of the US Organ Procurement and Transplantation Network and the Scientiﬁc Registry of Transplant Recipients: transplant data. December 9, 2016. http:// optn.transplant.hrsa.gov/. Accessed January 1, 2017. 3. Kramer JR, Hachem CY, Kanwal F, Mei M, El-Serag HB. Meeting vaccination quality measures for hepatitis A and B virus in patients with chronic hepatitis C infection. Hepatology. 2011;53(1):42-52. 4. Aouﬁ S, Pascasio JM, Sousa JM, et al. Prevalence of hepatitis A and B markers and vaccine indication in cirrhotic patients evaluated for liver transplantation in Spain. Transplant Proc. 2008;40(9):2946-2948. 5. Arguedas MR, McGuire BM, Fallon MB. Implementation of vaccination in patients with cirrhosis. Dig Dis Sci. 2002;47(2):384-387. 6. Lavanchy D. Hepatitis B virus epidemiology, disease burden, treatment, and current and emerging prevention and control measures. J Viral Hepatol. 2004;11(2):97-107. 7. Lok ASF, Esteban R, Mitty J, eds. Hepatitis B treatment with entecavir. UpToDate. May 2, 2014. http://www.uptodate.com/. Accessed June 1, 2014.
Shari T. Perez, DNP, ANP-C, is an nurse practitioner in the Division of Gastroenterology and Hepatology and the Transplant Center at Mayo Clinic Hospital in Phoenix, AZ. She can be reached at [email protected]
Noel M. Arring, DNP, is a director of nursing research in the Department of Nursing at Mayo Clinic Hospital in Phoenix, AZ. Hugo E. Vargas, MD, is a hepatologist in the Division of Gastroenterology and Hepatology at Mayo Clinic Hospital in Phoenix, director of research for Mayo Clinic School of Medicine, vice chair of Mayo Clinic Research Operations Team at the Mayo Clinic Hospital in Phoenix, and medical director for the Clinical Trials Ofﬁce at the Mayo Clinic Hospital in Phoenix. Bryn M. Corbett, RN, is a chair of the Nursing Quality Subcommittee in the Department of Nursing at Mayo Clinic Hospital in Phoenix. Shawn Ehler, MSN, MBA, RN-BC, is a manager in the Department of Nursing Informatics at Mayo Clinic Hospital in Phoenix. Gerald L. Beck, is a data analyst at the Transplant Center of Mayo Clinic Hospital in Phoenix. M’hamed Temkit, PhD, is a biostatistician in the Biostatistics group at Mayo Clinic in Scottsdale, AZ. Bashar A. Aqel, MD, is medical director in the Division of Gastroenterology and Hepatology and the Transplant Center of Mayo Clinic Hospital in Phoenix. Jorge Rakela, MD, is a hepatologist in the Division of Gastroenterology and Hepatology and the Transplant Center at Mayo Clinic Hospital in Phoenix. In compliance with national ethical guidelines, the authors report no relationships with business or industry that would pose a conﬂict of interest. 1555-4155/17/$ see front matter © 2017 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.nurpra.2017.07.006
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