Increasing Zostavax Awareness and Uptake at Optimus Health Care. Background of Need

Transcription

1 1 SEARCH Project Abstract Student: Colleen Linari, RN Preceptor: Luis Rojas, APRN July 2012 Increasing Zostavax Awareness and Uptake at Optimus Health Care Background of Need Herpes zoster (HZ) or shingles is a common virus with nearly one million estimated cases diagnosed in the United States each year (Insinga, Itzler, Pellissier, Saddier, & Nikas, 2005). HZ results in a painful, cutaneous, vesicular rash that is usually localized to one to three adjacent dermatomes. The most common complication of HZ is postherpetic neuralgia (PHN), pain that can persist in the area where the rash was present for months to years after the rash has resolved, and this pain often severely impacts a patient s quality of life (Opstelten, van Essen, & Hak, 2009). Additional medical complications of HZ include other nervous system complications, involvement of the eye leading to visual impairment, bacterial superinfections, and disfiguring scarring (CDC, 2011(Harpaz, Ortega-Sanchez, & Seward, 2008). HZ results in more than 2 million healthcare visits annually in the United States, costing an estimated $566 million in direct healthcare costs. Indirect costs are substantial as well, causing an average loss of more than 129 hours of work per episode (Lu, Euler, & Harpaz, 2011). The incidence of HZ increases with age, as does the incidence, duration and severity of PHN (Harpaz, et al., 2008). Though antiviral treatments for HZ infections are available, administration must be initiated within 72 hours of rash onset for maximum benefit, available treatments for PHN often do not completely alleviate the pain of HZ, and these treatments may be poorly tolerated in the elderly.

2 2 A live-attenuated vaccine for shingles called Zostavax has been licensed in the United States since 2006 and it offers an opportunity to decrease the burden of this disease and its complications among persons at risk. Clinical trials have demonstrated that the HZ vaccine is well tolerated and effective in subjects over age 50 (Oxman et al., 2005; Schmader et al., 2012). The vaccine has been shown to reduce the incidence of HZ with an effectiveness of 51%, reduce the burden of HZ pain by 61%, and reduce the incidence of PHN by 67% as compared to a placebo group (Oxman, et al., 2005). The FDA has approved the vaccine for all persons >50 years of age, and the ACIP now recommends routine vaccination for all immunocompetent persons >60 years of age with 1 dose of zoster vaccine. In 2008, 7% of adults over age 60 reported ever having received the zoster vaccine (CDC, 2008). Healthy People 2020 objectives, which provide science-based 10-year national objectives for improving the health of all Americans, include increasing the percentage of adults who are vaccinated against zoster to 30% (US Department of Health & Human Services, 2012). Available data suggests that the HZ vaccine is cost effective for its intended population, and its cost effectiveness is comparable to other adult health prevention measures (Pellissier, Brisson, & Levin, 2007). The risk for HZ and its associated complications is much greater among immunodeficient patients. Unfortunately, because it is a live vaccine, Zostavax is contraindicated in fully immunocompromised patients (CDC, 2008). The vaccine is, however, recommended for several groups of people that may seem unapparent to providers, including those with mild illness, persons anticipating immunosupporession, those on low-moderate dose or short-term corticosteroid

3 3 therapy, and for HIV positive patients without clinical manifestations of the virus (CDC, 2008). Zostavax uptake among eligible patients has been generally poor since its introduction, particularly among minorities. A 2011 study found that vaccination coverage was statistically higher for non-hispanic whites (7.6%) compared with non-hispanic blacks (2.5%) and Hispanics (2.1%). This same study found lower incidence of vaccination among those who were not married, did not have at least a high-school education, and were living below the federal poverty level (Lu, et al., 2011). Barriers to widespread uptake of the HZ vaccine have been identified in the literature and include: lack of patient awareness, lack of provider recommendation, vaccine cost, stringent vaccine storage and handling requirements, cumbersome reimbursement requirements from Medicare Part D, vaccine shortages, and modest manufacturer promotion (Lu, et al., 2011). Positive provider recommendation is one factor that has the potential to significantly impact a patient s decision to receive the vaccine (Lu, Euler, Jumaan, & Harpaz, 2009). Optimus Health Care is a Federally Qualified Health Care (FQHC) practice with nineteen community health centers located throughout southwestern CT. The Optimus mission is to improve the overall health of the communities it serves, particularly the medically underserved, by providing preventive, primary care and supplemental health care services, along with health education in a culturally sensitive manner regardless of ones ability to pay. The population served at Optimus Health Care is predominantly Hispanic and black patients. In 2011 Optimus providers saw 51,698 unduplicated patients with a racial distribution of

4 4 69% white, 26% black and the remaining 5% included Asian, Hawaiian/Pacific Islander, and more than one race. The ethnic distribution of Optimus patients was 57% Hispanic, 42% Non-Hispanic, and 1% unreported. Because the majority of Optimus patients may be statistically less likely to receive HZ vaccination than non- Hispanic whites, an initiative to improve vaccine uptake among Optimus patients can potentially reduce the incidence of shingles and its associated complications within the practice, and help our population as a whole in meeting the Healthy People 2020 HZ immunization goal. Zostavax has not traditionally been stocked at Optimus locations due to its high cost ($158 per dose) and often challenging reimbursement requirements. The HZ vaccine is the most expensive vaccine currently recommended for older adults and there are large up front costs to buying the vaccine for a practice. In the past, Optimus patients wishing to receive the vaccine could be given a prescription to be filled at a pharmacy if the vaccine was recommended. Zostavax is a live attenuated virus that must be stored frozen and must be administered via subcutaneous injection within 30 minutes of reconstitution, therefore if the distributing pharmacy did not offer vaccine administration services, the patient would need to bring the injection back to Optimus for administration within this brief 30 minute window, and possibly pay an additional vaccine administration fee, adding to the challenge of the vaccine s widespread utilization (Lu, et al., 2011). Optimus Stratford Community Health Center in Stratford, CT is an urban community health center with a variety of providers including a physician, a physicians assistant (PA) and a nurse practitioner (NP). The Stratford location is

5 5 one of Optimus moderately sized health centers, seeing 2,575 patients in This location was chosen by Optimus Health Care s Performance Improvement (PI) staff as a pilot site to implement and test a Zostavax improvement initiative because of its diverse patient population and its size, which is large enough to provide a good sample size but yet small enough to remain manageable for administration and monitoring purposes. The Optimus Zostavax pilot project seeks to increase shingles vaccine coverage among Optimus patients without loss of revenue for the organization. Ten vials of Zostavax were initially stocked at the health center for appropriate use, and providers and staff were briefly informed of specific reimbursement requirements for patients with Medicare, Medicaid or private insurance, as well as assistance options for uninsured patients. The following eligible patients may receive a dose of Optimus stocked vaccine through this pilot program: Medicare patients (>65) who are approved through TransactRx, an online database that instantly determines patient copays and practice reimbursement amounts before vaccine is administered Uninsured patients (>50) who are approved through Merck patient assistance program before vaccine is administered; Merck will replace the vial at no cost to Optimus Privately insured (>60) patients for whom the vaccine is covered and verified before vaccine is administered Medicaid patients aged are eligible for vaccination at a pharmacy at no cost to the patient, however they should not receive Optimus stocked vaccines because the

6 6 practice will not be fully reimbursed. Locally, Walgreens and Rite-Aid locations stock and administer Zostavax. If the Zostavax pilot project in Stratford is found to be successful in increasing vaccination coverage for patients without loss of revenue for Optimus, other sites may begin to stock the vaccine as well. The Community Health Center Association of Connecticut in collaboration with the National Health Service Corps sponsors the Student/Resident Experiences and Rotations in Community Health (SEARCH) program. The SEARCH program allows students in various health professions to work on interdisciplinary teams treating patients in underserved settings. In CT the program seeks to retain students who have experience and training in the state s FQHCs who have a clear sense of the health needs of the underserved and an ability to provide culturally competent care in that setting. The CT SEARCH summer internship includes clinical experience working with a preceptor in a FQHC, completion of a project for the FQHC, and professional development presentations and discussions. The implementation of the Optimus Zostavax pilot project was coincident with the start of the summer SEARCH program, and the Optimus PI staff were excited to partner with SEARCH to enhance the utility of the project for the practice and to provide the SEARCH intern a rich opportunity for practical research. Therefore, this SEARCH project aims to increase Zostavax awareness at Optimus Health Care, and in turn, improve vaccination coverage among Optimus patients. Objectives The purpose of this SEARCH project is to:

7 7 Evaluate the incidence of shingles, its associated complications, and Zostavax uptake among patients at Optimus Health Care in the recent past Increase awareness of Zostavax among providers at Optimus Health Care by creating a short presentation about the vaccine and its appropriate indications to be presented to providers and staff at the Stratford Community Health Center, and to be given to the PI office for wider distribution throughout the organization Increase awareness of Zostavax among patients at Optimus Health Care by providing vaccination brochures and posters in both Spanish and English in exam rooms and waiting rooms Monitor the progress of the Zostavax pilot project at the Stratford Community Health Center and evaluate the viability of Optimus-wide implementation Methods An extensive literature review was performed to develop a strong understanding of the incidence of HZ, the incidence and impact of its potential complications, and the indication for and benefits of vaccination. This information provided a background that soundly justified the practical utility of this project, and was used in creating the project presentation for Optimus providers and staff about shingles and Zostavax. In order to evaluate the incidence of shingles and its associated complications at Optimus Health Care, electronic health record (EHR) data was reviewed with the assistance of the PI office staff. Records were queried from the

8 8 HER database that is shared for all Bridgeport and Stratford Optimus locations to determine the incidence of shingles and all shingles-related complications within the past 12 months based on ICD-9 code. The incidence of patient records at Optimus Health Care s Bridgeport and Stratford locations that included documentation of having received a dose of Zostavax was previously investigated by the PI staff as part of the pilot project initiative. Additional demographic data was also collected from the EHR. Patient-focused informational brochures and posters about Zostavax in both English and Spanish have been provided to Optimus Health Care from the local Merck Vaccine Specialist, and these materials have been placed in the waiting room and some exam rooms at the Stratford Community Health Center. These brochures and posters intend to educate patients about their susceptibility to shingles and to open the door for a discussion with their primary care provider (PCP) about their eligibility for the vaccine. An educational presentation about shingles and Zostavax was prepared and was presented to the providers and staff at the Stratford Community Health Center on July 10, 2012 by the SEARCH intern. An outline of the presentation is below: Clinical features & complications of herpes zoster Shingles incidence: USA & Optimus Healthcare Vaccine information Zostavax indications, contraindications and precautions Barriers to vaccination

9 9 Pilot project specifics Next steps This presentation has also been given to the Optimus PI office staff for distribution and presentation to providers and staff at other Optimus locations. Finally, close contact has been maintained with the PI office and office staff at the Stratford Community Health Center to monitor the progress of the pilot program. Prior to the SEARCH provider presentation no vials of stocked Zostavax had been used. Conclusions 29,278 patients were seen at Optimus Bridgeport and Stratford locations over the past 12 months, and 4,718 of these patients were over age 50 and eligible for the shingles vaccine. 43 cases of herpes zoster were identified over the past 12 months at Optimus Bridgeport and Stratford locations based on all shingles-related ICD-9 codes: Herpes zoster without complication: Herpes zoster with unspecified complication: Herpes zoster with other specified complications: Herpes zoster keratoconjunctivitis: Herpes zoster dermatitis of eyelid: Herpes zoster with other nervous system complications: Geniculate herpes zoster: 1 These 43 cases of shingles-related diagnoses may be under-representative of the true shingles incidence among Optimus patients however, as cases that may not

10 10 have presented in a straightforward manner may have been coded as a variety of other conditions (i.e. rash, dermatitis, neuropathy, etc.). Additionally, an audit of charts initially queried for herpes zoster revealed an apparent case of herpes simplex as interpreted from the provider note that had been coded as herpes zoster. Therefore it is equally possible that cases of herpes zoster may have been incorrectly coded as herpes simplex when selected from a drop-down list in the EHR, and these cases would not have been revealed when herpes zoster codes were queried. Based on data from before the start of the Zostavax pilot project, only 20 patients had been vaccinated against shingles among Optimus patients during the preceding 2 years. This number may not include patients who may have been vaccinated at a pharmacy without a prescription. These cases may not have been documented in the chart at the time the data was gathered, as it is the responsibility of the PCP to update the immunization records in the EHR during routine health maintenance visits. Bearing in mind these limitations, these numbers indicate that in the past year shingles has affected a small number of Optimus patients at the Bridgeport and Stratford locations (0.15%), but an equally small number (0.42%) of eligible patients (>50 years) in these locations have received the shingles vaccine. While this percentage is well below the Healthy People 2020 goal of 30% coverage for adults, the Zostavax pilot program has the potential to improve shingles protection among Optimus patients.

11 11 Two providers, several nursing and medical assistant staff, Optimus Clinical Pharmacist, and the Merck Vaccine Specialist for southern CT attended the Zostavax presentation at the Stratford Community Health Center that was given by the SEARCH intern on July 10, The presentation was well received and providers indicated that their reservations about giving the vaccine included: Questions regarding true Zostavax indications and contraindications Personal experience of the vaccine not being covered by private insurance Questions about reimbursement specifics of the pilot project and who exactly is eligible to receive Optimus stocked vaccines Though no vials of Optimus stocked Zostavax had been given as of the date of the provider presentation, one PA at the Stratford Community Health Center reported that he had sent about 5 eligible patients to the pharmacy for the injection in recent weeks. Following the presentation the providers suggested generating a list from the EHR of all established patients over age 50 that could be flagged to include a discussion about Zostavax eligibility and gauge patient interest at their next visit. The practice manager will follow through with this task and report back to the PI office. The waiting room at the Stratford Community Health Center has several shelves of patient information brochures, including one about Zostavax. After visiting this site with the Merck Vaccine Specialist, additional brochures in both Spanish and English have been placed in a new location more easily accessible to patients as they check in for their appointments, and small posters have been hung in the waiting room and some exam rooms.

12 12 Based upon the overall positive feedback about the SEARCH presentation from the providers and staff at Optimus Stratford Community Health Center and because provider recommendation is one factor that can strongly increase patient uptake of the vaccine (Lu, Euler, Jumaan, & Harpaz, 2009), it appears that more Optimus patients will receive Zostavax in the near future. Giving providers and staff clear guidelines about who is eligible for the vaccine and what is the best route for them to receive it (pharmacy or in-house if available) to ensure no financial loss for Optimus seems to be an essential factor in the effort to increase Zostavax uptake among Optimus patients. The SEARCH provider presentation has been given to the Optimus PI staff and they intend to show it to providers at the Park City and Barnum Avenue Optimus locations in the upcoming weeks to increase provider awareness about Zostavax. A decision on whether to stock more vials of the vaccine at these other locations will be made after monitoring the use of stocked vaccines at the Stratford location over the next several weeks, however in the mean time providers at these other locations can send patients to local Walgreens and Rite-Aid locations to receive the vaccine.

13 13 References CDC, (2011). Varicella (chicken pox) and herpes zoster (shingles): Overview of VZV disease and vaccination for healthcare professionals. (Powerpoint slides), Retrieved from: Harpaz, R., Ortega-Sanchez, I. R., & Seward, J. F. (2008). Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). [Practice Guideline]. MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports / Centers for Disease Control, 57(RR-5), 1-30; quiz CE Insinga, R. P., Itzler, R. F., Pellissier, J. M., Saddier, P., & Nikas, A. A. (2005). The incidence of herpes zoster in a United States administrative database. [Research Support, Non-U.S. Gov't]. Journal of general internal medicine, 20(8), doi: /j x Lu, P.J., Euler, G.L., Jumaan, A.O., & Harpaz, R. (2009). Herpes zoster vaccination among adults aged 60 years or older in the United States, 2007: uptake of the first new vaccine to target seniors. Vaccine, 27(6), Lu, P. J., Euler, G. L., & Harpaz, R. (2011). Herpes zoster vaccination among adults aged 60 years and older, in the U.S., American journal of preventive medicine, 40(2), e1-6. doi: /j.amepre Opstelten, W., van Essen, G. A., & Hak, E. (2009). Determinants of non-compliance with herpes zoster vaccination in the community-dwelling elderly. Vaccine, 27(2), doi: /j.vaccine

14 14 Oxman, M. N., Levin, M. J., Johnson, G. R., Schmader, K. E., Straus, S. E., Gelb, L. D.,... Silber, J. L. (2005). A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. [Clinical Trial Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't Research Support, U.S. Gov't, Non-P.H.S.]. The New England journal of medicine, 352(22), doi: /NEJMoa Pellissier, J. M., Brisson, M., & Levin, M. J. (2007). Evaluation of the cost-effectiveness in the United States of a vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. Vaccine, 25(49), doi: /j.vaccine Schmader, K. E., Levin, M. J., Gnann, J. W., Jr., McNeil, S. A., Vesikari, T., Betts, R. F.,... Parrino, J. (2012). Efficacy, safety, and tolerability of herpes zoster vaccine in persons aged years. [Research Support, Non-U.S. Gov't]. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 54(7), doi: /cid/cir970 US Department of Health & Human Services (2012), Healthy People (2012, June 21). Immunizations and Infectious Diseases: Objectives. Retrieved from: px?topicid=23