Otology & Neurotology 35:246Y252 2014, Otology & Neurotology, Inc.
Documenting Immunization of Children in a Cochlear Implant Program *Peter G. Volsky, †Daniel A. Ballard, and *†Stephanie Moody-Antonio *Department of OtolaryngologyYHead and Neck Surgery, ÞEastern Virginia Medical School, Norfolk, Virginia, U.S.A.
Purpose: Assess the effectiveness of an immunization verification protocol (IVP) to achieve and document pneumococcal vaccination of patients with cochlear implants. Study Design: Chart review. Setting: Academic tertiary medical center. Patients: Pediatric patients with cochlear implants (n = 76). Outcome Measures: 1) Status of pneumococcal immunization for cochlear implant patients, before and after initiation of the IVP; 2) final number of existing cochlear implant patients successfully immunized after institution of the IVP; and 3) effectiveness of communication between our office and patient/ parent or pediatrician. Results: Subjects were grouped according to whether their cochlear implantation was performed before (Group 1, n = 63) or after (Group 2, n = 18) initiation of the IVP in September 2010. In the 28 months between IVP initiation and January 2013, the number of fully immunized age-eligible patients increased in
Group 1 from 2% (n = 1) to 63% (n = 40). Of 18 subjects in Group 2, 56% (n = 10) were fully vaccinated at the time of surgery, and 94% were fully vaccinated at the conclusion of the study (n = 17). Of all 81 children, complete immunization was documented in 70% (n = 57), incomplete documentation was noted in 16% (n = 13); and 14% (n = 11) were lost to follow-up. Conclusion: It is a challenge to achieve and document immunizations recommended for cochlear implantation, even in a relatively small cochlear implant program. In our practice, those patients who were required to document immunizations before surgery had the highest rates of compliance. Access to a vaccination registry and the ability to administer vaccines in the otolaryngology office also improved compliance. Level of Evidence: 4 Key Words: Cochlear ImplantsVImmunizationVMeningitisV PneumococcalVPediatricsVPneumococcal vaccinesVStreptococcus pneumoniaeVVaccination. Otol Neurotol 35:246Y252, 2014.
Children and adults who receive a cochlear implant (CI) have a heightened risk of developing bacterial meningitis and remain susceptible years after implantation (1Y3). The risk of meningitis is reduced by appropriate immunization. The United States Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) first recommended pneumococcal vaccination in 2002 for patients with cochlear implants (4,5). Since that time, government agencies and experts have called on surgeons, physicians, and parents of CI patients to become aware of the meningitis risk, promote pneumococcal immunity, and facilitate early diagnosis and treatment (6Y9). Despite these efforts, meningitis and death among CI patients, although rare, still occurs (10).
Beginning in 2002, the CDC recommended that cochlear implant candidates and recipients receive age-appropriate vaccination against Streptococcus pneumoniae based on the Advisory Committee of Immunization Practices (ACIP) schedule for all persons at higher risk for pneumococcal disease. The recommended schedule included 4 doses of 7-valent pneumococcal conjugate vaccine (PCV-7) and one dose of 23-valent pneumococcal polysaccharide vaccine (PPSV-23) after 24 months of age. The 7 serotypes targeted by PCV-7 accounted for 80% of invasive pneumococcal disease in young children and use of the vaccination reduced the rate of pneumococcal disease by 99% (11). On February 24, 2010, the FDA licensed a 13-valent pneumococcal conjugate vaccine (PCV-13) to replace the PCV-7. The PCV-13 targeted S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, accounting for 62% of pneumococcal disease not covered by PCV-7 (11). Later that year, the CDC issued formal recommendations incorporating PCV-13 in the pneumococcal immunization schedule for CI patients, which remain in effect today (12,13). According to the requirements, CI patients who were previously vaccinated with 7-valent conjugate vaccine should
Address correspondence and reprint requests to Stephanie MoodyAntonio, M.D., Department of OtolaryngologyYHead and Neck Surgery, Eastern Virginia Medical School, 600 Gresham Drive, Suite 1100, Norfolk, VA 23507; E-mail: [email protected] The authors disclose no conflicts of interest. This study received no financial support. All work was performed at Eastern Virginia Medical School.
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DOCUMENTING IMMUNIZATION OF CI PATIENTS TABLE 1.
Immunization verification protocol
•The goal was 100% pneumococcal immunization for all CI patients and candidates. •All patients undergoing cochlear implantation had to provide documentation of vaccination before surgery. (Historically, we required only verbal assurance of full immunization, as appropriate for age, before surgery.) •The ‘‘Immunization Verification’’ form (Appendix) summarized current recommendations and provided a central place to document vaccination dates. Forms were distributed to parents and primary-care physicians and collected by fax and mail and became part of every CI patient chart. •We registered with a statewide immunization database, the Virginia Immunization Vaccination System (VIIS), to access government records. •Charts were affixed with special vaccine labels containing ‘‘due dates’’ and ‘‘given dates’’ for PCV-13 and PPSV-23. •An intradepartmental watch list of children with missing vaccines was circulated (audiology, social work, etc.) At each office visit, the chart documentation and VIIS (if needed) were checked for updates. •Notification of missing/required vaccines was made by fax, certified mail, phone, and in person as needed. •Office nurses were approved and trained to administer vaccines to patients in our office when needed. •An electronic vaccination database was created; annual reminders were sent to patients out of compliance.
receive a supplemental dose of PCV-13. Catch-up schedules for children with incomplete or undocumented previous vaccination were also defined. The CDC recommended health-care providers take the responsibility of providing and ensuring appropriate vaccination for cochlear implant patients: ‘‘health-care providers should review vaccination records of their patients who are cochlear implant recipients or candidates to ensure that they have received pneumococcal vaccinations based on the age-appropriate schedules for persons at high risk.’’ (13) Examples of cochlear implant centers and professional organizations highlighting the importance of vaccination of CI patients are available in the literature (14Y16). The American Academy of OtolaryngologyY Head and Neck Surgery (AAO-HNS), in coordination with the CDC and FDA, began a campaign in 2009 to increase awareness about the importance of pneumococcal vaccinations for all cochlear implant patients (15). Following the approval of PCV-13 and as we began contacting our patients to receive this vaccine, the cochlear implant team of Eastern Virginia Medical School and Children’s Hospital of the King’s Daughters became aware of noncompliance and missing documentation in our records. To address these deficiencies, we developed an immunization verification protocol (IVP) to educate parents and primary-care physicians, retrieve missing documentation, complete recommended vaccination, vaccinate candidates scheduled for cochlear implantation, and provide a mechanism to ensure compliance as patients become ageeligible for the PPSV-23. The IVP is detailed in Table 1. To evaluate the vaccine status of our program 2 years after implementation of the IVP, we reviewed medical records and online databases for overall vaccine status both before and subsequent to the initiation of the IVP as well as communication efforts involved in obtaining
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compliance with vaccination and documentation. In this report, we share the challenges and successes of retrospective documentation of vaccination status and of achieving immunization with the PCV-13 for children who have already received a cochlear implant. We also explore the value of a systematic method of documenting and providing vaccines during the process of preoperative evaluation for cochlear implantation. Significant obstacles impede successful implementation of new vaccines and completion of immunization schedules. We will explore some options to facilitate this ongoing process. METHODS In September 2012, we sought to assess the effectiveness of the IVP, identify the obstacles, and if possible, identify ways to improve compliance and documentation. The project was approved by the institutional review board of Eastern Virginia Medical School. The chart review included any patient younger than 18 who underwent cochlear implantation through the Eastern Virginia Medical School and Children’s Hospital of the King’s Daughters (EVMS/CHKD) Cochlear Implant Program between 1995 and December 2012 and any patient who transferred to our program after an implant at another institution. We reviewed medical records, both electronic and paper, for evidence of vaccination with PCV-7, PCV-13, and PPSV-23. We also reviewed the records of the Virginia Immunization Vaccination System (VIIS), an online registry maintained by the Commonwealth of Virginia and voluntarily populated by the Virginia Department of Health and individual health providers. The conclusion of our review and final update for each patient occurred on January 25, 2013. Subjects were divided into 2 groups. Subjects in Group 1 received cochlear implants before September 2010 when the IVP was initiated. Data recorded during the chart review for Group 1 subjects included the following: 1) individual dates of vaccinations, 2) vaccination status at the time of surgery, 3) cumulative vaccination status after implementation of the IVP over time including status of PCV-13, 4) the number of interventions and time (months) required to obtain compliance, and (5) overall rate of compliance at the completion of the study. Secondary outcome measures for Group 1 included the following: 1) the number of attempts to contact the patient/parent and primary care physician until documentation of immunization was obtained, and in the case of an incompletely immunized patient, until needed vaccines were administered; and 2) the time elapsed between first contact and complete immunization. Group 2 consisted of subjects who underwent cochlear implantation after the initiation of the IVP, presumably when compliance for immunization could be emphasized and confirmed before surgery. For these subjects, the goals of the IVP included documentation of vaccination before surgery, presence of a plan for vaccination if medical or age ineligible for full immunization at the time of surgery, compliance with PPSV once eligible, and status of compliance at the completion of the study. To determine immunization status for each subject, charts reviewed for the ‘‘immunization verification’’ form, primary immunization records, and clinical notes. Vaccination status was determined through a process of cross-referencing information in our medical records and from primary physicians with VIIS. Information was authenticated by investigating lot numbers as needed to resolve conflicting information. Substantiation of vaccination by provider signature (or name in VIIS) was required. Otology & Neurotology, Vol. 35, No. 2, 2014
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Status was characterized as complete, incomplete, complete but undocumented, age-ineligible, medical delay, or lost to follow-up. A status of ‘‘complete’’ required administration and documentation of all immunizations for which the patient was eligible based on age. In cases where a parent reported a vaccination had been performed but verification by a medical professional or VIIS was not available, the vaccination was recorded as complete with missing documentation. Medical delay was used to indicate situations when a vaccination was delayed during the 8-week interval required between vaccination doses. In some cases, vaccination was incomplete but scheduled, and these were indicated as such. A 3-month grace period was allowed between the date a vaccination was due before the vaccine was recorded as incomplete. Patients who had not been seen for more than 2 years and who could not be contacted for lack of a current address were indicated as lost to follow-up. In cases of sequential cochlear implantation or a reimplantation, only the primary surgery was determined in deciding vaccination status at the time of surgery.
analysis of vaccination status at the time of surgery, 9 of the 63 subjects in Group 1 were excluded because there was either no data, and the subject was lost to follow-up, or the patient had surgery at another institution (n = 3) and subsequently transferred their care to our center, leaving 54 subjects who received cochlear implants at our institution before September 10, 2010, (Group 1) and had adequate records to review vaccination status at the time of surgery.
RESULTS
Immunization Compliance At the time of surgery: documentation of compliance for both PCV-7/13 and PPSV-23 according to medicaland age-appropriate needs at the time of surgery could be documented retrospectively in 32 (59%) of 54 Group 1 subjects. Thirty-six or 54 (67%) subjects had documentation that PCV had been completed at the time of surgery, and 3 additional subjects had aged out of need for PCV7, resulting in a compliance of 39 (72%) of 54 for PCV. Twenty-one subjects were age ineligible for PPSV at the time of surgery, and of the remaining 33 subjects, 20 subjects (61%) had documentation that they had received PPSV-23 before the day of surgery. Thirteen subjects were age eligible, but documentation is not available to indicate that vaccination for PPSV was performed at the time of surgery. Documentation of vaccination compliance was more readily available for subjects in Group 2 and confirmed documentation of compliance for both vaccines according to age eligibility in 10 (56%) of 18 on
Patients Review of the EVMS/CHKD cochlear implant registry identified 91 patients who were 18 years or younger at the time of cochlear implantation. Ten patients were excluded from review because of lack of any medical recordVelectronic, paper, or online with VIIS. (Some were seen by an audiologist but did not see a physician for more than an initial visit. For these patients, records were inadequate to evaluate given that most arrived without any documentation, did not provide documentation at a later time, and were lost to follow-up.) Eighteen subjects were implanted after September 10, 2010, and comprise Group 2. The remaining 63 subjects comprised Group 1 for the analysis of compliance over time because they had records adequate to review status of vaccinations, had some contact with the center over the course of time, or had been contacted during the IVP process. For the
Demographics Group 1 patients were aged 1 to 15 years (median, 2.5 yr) at the time of their first implant and 1 to 17 years (median, 6.8 yr) at initiation of the IVP on September 10, 2010. Group 2 patients were aged 10 months to 7 years (median, 3.1 yr) at the time of implantation and 1 year 10 months to 9 years (median, 4.6 yr) at the conclusion of the study on January 25, 2013.
FIG. 1. Overall immunization status (PCV-13 and PPSV-23), at the time of surgery and at conclusion of the study, of all subjects receiving cochlear implants after September 10, 2010 (Group 2). Otology & Neurotology, Vol. 35, No. 2, 2014
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FIG. 2. Immunization status with respect to Prevnar (PCV-7/PCV-13) requirements, at the onset and at 4- to 7-month intervals after implementation of IVP, of subjects who received cochlear implants before September 10, 2010 (Group 1).
the day of surgery, with an additional 2 subjects who were in full compliance but had not yet provided written documentation (11%) and 6 subjects (33%) who were incompletely vaccinated because of medical delay but scheduled to be vaccinated on follow-up (Fig. 1). After initiation of immunization verification protocol Group 1: For this analysis, we reviewed the records of 63 subjects who had at least some documentation of vaccination either in the medical record or in VIIS. We were able to contact either the parent or provider for all but 8 patients in Group 1 during the IVP process. At the initiation of the IVP in September 2010 (7 mo after the release of PCV-13), only 1 patient in Group 1 (2%) had received the supplemental dose of PCV-13. After implementation
of the IVP with initial contact of most patients over the first 3 months, we observed a rapid increase in compliance with supplemental dose of PCV-13 (Fig. 2). For PCV-13, 34 patients (54%) achieved compliance in 12 months, increasing to 41 patients (65%) at 28 months (Fig. 2). PPSV23 compliance rose from 79% (50 of 63 subjects) at the onset of the IVP to 92% (58 subjects) at the completion of the study (Fig. 3). Overall compliance for vaccination with both PCV-13 and PPSV-23 improved from 2% to 63% between September 2010 and the completion of the study (Fig. 4). Group 2: Of 18 subjects who underwent implantation after the initiation of the IVP, 1 patient missed a supplemental dose of PCV-13 and had not provided documentation or presented
FIG. 3. Immunization status with respect to Pneumovax (PPSV-23) requirements, at the onset and 4- to 7-month intervals after implementation of IVP for subjects in Group 1. Otology & Neurotology, Vol. 35, No. 2, 2014
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FIG. 4. Overall pneumococcal immunization status (PCV-13 and PPSV-23), at the onset and 4- to 7-month intervals after implementation of IVP for subjects in Group 1.
for vaccination so that compliance with PCV was 94% at the time the study was complete (Fig. 5). During the study, 3 patients became age eligible for PPSV-23 and received it, resulting of compliance 100% for PPSV-23 for the 15 of the 18 patients who were older than 2 years and overall vaccinate rate of 83% for PPSV-23 (Fig. 6). All but 1 subject (94%) achieved full compliance according to age eligibility with both PCV and PPSV at the time of the conclusion of the study (Fig. 1). Overall, the IVP succeeded in achieving documentation of compliance with both PCV and PPSV immunization for 57 (70%) of 81 subjects, whereas 13 (16%) had incomplete documentation and 11 (14%) were lost to follow-up. Obtaining vaccination compliance required a significant amount of effort. Primary care physicians and parents were contacted specifically about vaccination status
on average 1.4 and 1.5 times, respectively, before documentation was secured. Additional contact between the parent and CI team was made in most cases, although specific mention of vaccination status was not recorded for the purposes of this study. The mean lag time between initial contact with the PCP and completion of vaccination was 109 days (SD, 154.6) and with the parent and completion of vaccination was 111 days (SD, 156.6).
DISCUSSION Despite the many efforts to raise awareness of the importance of pneumococcal vaccination of cochlear implant patients, it remains tremendously difficult to gain full compliance with the recommended schedules. A 2010 review of 225 pediatric cochlear implant recipients
FIG. 5. Pneumococcal immunization status with respect to Prevnar (PCV-7/PCV-13), at the time of surgery and at present, of subjects in Group 2. Otology & Neurotology, Vol. 35, No. 2, 2014
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FIG. 6. Pneumococcal immunization status, with respect to Pneumovax (PPSV-23) requirements, at the time of surgery and at present, of subjects in Group 2.
reported 56% documentation of age-appropriate immunizations (16). Implementation of the recommendation of a supplemental dose of PCV-13 in patients previously vaccinated with PCV-7 required cochlear implant centers to contact patients and either refer them to primary care for immunization. Few have reported on their attempts to achieve vaccination compliance.The efforts of Carpenter et al. (17) published in 2010 are laudable for their successes; nevertheless, the authors stressed it was ‘‘an immense challenge.’’ Carpenter and colleagues launched a communication campaign to document vaccination status of their cochlear implant patients. They noted in 2007 that despite standard notices and verbal recommendations issued at office visits, only 20% to 30% of their cochlear implant patients were immunized at the time of surgery. Through more aggressive efforts, including a database documenting vaccination status, and contacting patients through mail, e-mail, and telephone, they were able to achieve nearly 100% immunization of new cochlear implant recipients at the time of surgery. However, despite successful immunization of new patients, they could not garner the cooperation of past implant patients. Complete vaccination was only documented in 49% of adults and 58% of children with prior implants (17). These challenges led the authors to conclude that most patientsVeven after documenting their willingness to complyVwill not reliably obtain vaccinations on their own (17). The difficulties of Carpenter et al. are echoed by our own experience. When the 13-valent conjugate vaccine became available, we used the opportunity to attempt to obtain and document vaccination status on all of the patients who have received an implant in our program or who had transferred to our program. We developed a formal policy requiring vaccination documentation at the time of implantation and a protocol for following patients over time so that compliance with the recommended schedule could be maintained. Our team made multiple attempts to contact both primary care physicians and parents, by mail, fax, and phone. Every 3 to
4 months, the database was reviewed, and another attempt was made to contact providers and parents until documentation was received or an appointment was scheduled for vaccination. We implemented new procedures in our office, such as providing vaccines and becoming active users of the Virginia Immunization Information System. We created watch lists and shared them with audiologists, speech pathologists, and social workers involved with our patients so that noncompliant patients could be reminded when seen for care. At the end of the study period, we were able to obtain and document compliance for only 70% of 81 patients, whereas 16% of our patients were still active in follow-up yet noncompliant. Fourteen percent of our patients had not been seen for 2 years or longer and did not respond to communications from the CI program. Certified letters were sent to these patients as a final attempt to gain an opening for communication at the completion of this study. Additional reminders will be generated through an annual review of a vaccination registry. We encountered several issues that complicated the process of vaccination verification: 1) inaccurate identification of the primary care physician; 2) change in primary care physician and new physician did not have complete record of vaccinations; 3) inaccurate documentation of vaccination, such as mislabeling of PCV as PPSV and vice versa; 4) incomplete or inaccurate VIIS entries that were verifiably accurate in the patient’s chart; and 5) parents’ failure to respond to communication and/or failure to fill prescribed vaccine prescriptions. Virginia’s online immunization record proved to be very beneficial to this process.
CONCLUSION Compliance with the recommended schedule for pneumococcal prevention in patients with cochlear implants remains a significant challenge. The most valuable means of achieving compliance in our practice included the policy of requiring vaccination documentation before Otology & Neurotology, Vol. 35, No. 2, 2014
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surgery. Access to a statewide immunization registry and availability of PCV and PPSV vaccinations in the otolaryngology office also provided a means to improve compliance.
9. 10.
REFERENCES 1. Reefhuis J, Honein MA, Whitney CG, et al. Risk of bacterial meningitis in children with cochlear implants. N Engl J Med 2003; 349:435Y45. 2. Biernath KR, Reefhuis J, Whitney CG, et al. Bacterial meningitis among children with cochlear implants beyond 24 months after implantation. Pediatrics 2006;117:284Y9. 3. Lalwani AK, Cohen NL. Longitudinal risk of meningitis after cochlear implantation associated with use of the positioner. Otol Neurotol 2011;32:1082Y5. 4. Food and Drug Administration. FDA Public Health Web Notification*: Risk of Bacterial Meningitis in Children with Cochlear Implants. Issued July 24, 2002. Available at: http://www.fda.gov/ MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ ucm064526.htm. Accessed January 11, 2013. 5. Centers for Disease Control and Prevention. Notice to Readers: Pneumococcal Vaccination for Cochlear Implant Recipients. MMWR Morb Mortal Wkly Rep. October 18, 2002; 51(41); 931. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5141a5.htm. Accessed January 11, 2013. 6. Whitney CG. Cochlear implants and meningitis in children. Pediatr Infect Dis J 2004;23:767Y8. 7. Hey C, Rose MA, Kujumdshiev S, et al. Does the 23-valent pneumococcal vaccine protect cochlear implant recipients? Laryngoscope 2005;115:1586Y90. 8. Wei BP, Robbins-Browne RM, Shepherd RK, et al. Assessment of the Protective effect of pneumococcal vaccination in preventing
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meningitis after cochlear implantation. Arch Otolaryngol Head Neck Surg 2007;33:987Y94. Wei BP, Robbins-Browne RM, Shepherd RK, et al. Can we prevent cochlear implant recipients from developing pneumococcal meningitis? Clin Infect Dis 2008; 46:e1Y7. Lalwani AK, Cohen NL. Does meningitis after cochlear implantation remain a concern in 2011? Otol Neurotol 2012;33:93Y5. FDA News Release February 24, 2010. ‘‘FDA approves pneumococcal disease vaccine with broader protection.’’ Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ 2010/ucm201758.htm. Accessed March 12, 2013. Centers for Disease Control and Prevention. Prevention of Pneumococcal Disease Among Infants and ChildrenVUse of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep 2010;59:1Y15. MMWR Weekly. ‘‘Pneumococcal vaccination for Cochlear Implant Candidates and Recipients: Updated recommendations of the Advisory Committee for Immunization Practices.’’ August 8, 2003. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5231a5.htm. Accessed March 12, 2013. Wei BP, Shepherd RK, Robins-Browne RM, et al. Pneumococcal meningitis post-cochlear implantation: Preventative measures. Otolaryngol Head Neck Surg 2010;143:S9Y14. American Academy of OtolaryngologyVHead and Neck Surgery. Pneumococcal vaccination is key to protecting cochlear implant patients (2009). Available at: http://www.entnet.org/CIHealth. Accessed September 2, 2012. Ou H, Cleary P, Sie K. Assessing the immunization status of pediatric cochlear implant recipients using a state-maintained immunization registry. Otolaryngol Head Neck Surg 2010;143:487Y91. Carpenter RM, Limb CJ, Francis HW, et al. Programmatic challenges in obtaining and confirming the pneumococcal vaccination status of cochlear implant recipients. Otol Neurotol 2010;31:1334Y6.
Otology & Neurotology, Vol. 35, No. 2, 2014
Copyright © 2014 Otology & Neurotology, Inc. Unauthorized reproduction of this article is prohibited.
Documenting Immunization of Children in a Cochlear Implant Program *Peter G. Volsky, †Daniel A. Ballard, and *†Stephanie Moody-Antonio *Department of OtolaryngologyYHead and Neck Surgery, ÞEastern Virginia Medical School, Norfolk, Virginia, U.S.A.
Purpose: Assess the effectiveness of an immunization verification protocol (IVP) to achieve and document pneumococcal vaccination of patients with cochlear implants. Study Design: Chart review. Setting: Academic tertiary medical center. Patients: Pediatric patients with cochlear implants (n = 76). Outcome Measures: 1) Status of pneumococcal immunization for cochlear implant patients, before and after initiation of the IVP; 2) final number of existing cochlear implant patients successfully immunized after institution of the IVP; and 3) effectiveness of communication between our office and patient/ parent or pediatrician. Results: Subjects were grouped according to whether their cochlear implantation was performed before (Group 1, n = 63) or after (Group 2, n = 18) initiation of the IVP in September 2010. In the 28 months between IVP initiation and January 2013, the number of fully immunized age-eligible patients increased in
Group 1 from 2% (n = 1) to 63% (n = 40). Of 18 subjects in Group 2, 56% (n = 10) were fully vaccinated at the time of surgery, and 94% were fully vaccinated at the conclusion of the study (n = 17). Of all 81 children, complete immunization was documented in 70% (n = 57), incomplete documentation was noted in 16% (n = 13); and 14% (n = 11) were lost to follow-up. Conclusion: It is a challenge to achieve and document immunizations recommended for cochlear implantation, even in a relatively small cochlear implant program. In our practice, those patients who were required to document immunizations before surgery had the highest rates of compliance. Access to a vaccination registry and the ability to administer vaccines in the otolaryngology office also improved compliance. Level of Evidence: 4 Key Words: Cochlear ImplantsVImmunizationVMeningitisV PneumococcalVPediatricsVPneumococcal vaccinesVStreptococcus pneumoniaeVVaccination. Otol Neurotol 35:246Y252, 2014.
Children and adults who receive a cochlear implant (CI) have a heightened risk of developing bacterial meningitis and remain susceptible years after implantation (1Y3). The risk of meningitis is reduced by appropriate immunization. The United States Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) first recommended pneumococcal vaccination in 2002 for patients with cochlear implants (4,5). Since that time, government agencies and experts have called on surgeons, physicians, and parents of CI patients to become aware of the meningitis risk, promote pneumococcal immunity, and facilitate early diagnosis and treatment (6Y9). Despite these efforts, meningitis and death among CI patients, although rare, still occurs (10).
Beginning in 2002, the CDC recommended that cochlear implant candidates and recipients receive age-appropriate vaccination against Streptococcus pneumoniae based on the Advisory Committee of Immunization Practices (ACIP) schedule for all persons at higher risk for pneumococcal disease. The recommended schedule included 4 doses of 7-valent pneumococcal conjugate vaccine (PCV-7) and one dose of 23-valent pneumococcal polysaccharide vaccine (PPSV-23) after 24 months of age. The 7 serotypes targeted by PCV-7 accounted for 80% of invasive pneumococcal disease in young children and use of the vaccination reduced the rate of pneumococcal disease by 99% (11). On February 24, 2010, the FDA licensed a 13-valent pneumococcal conjugate vaccine (PCV-13) to replace the PCV-7. The PCV-13 targeted S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, accounting for 62% of pneumococcal disease not covered by PCV-7 (11). Later that year, the CDC issued formal recommendations incorporating PCV-13 in the pneumococcal immunization schedule for CI patients, which remain in effect today (12,13). According to the requirements, CI patients who were previously vaccinated with 7-valent conjugate vaccine should
Address correspondence and reprint requests to Stephanie MoodyAntonio, M.D., Department of OtolaryngologyYHead and Neck Surgery, Eastern Virginia Medical School, 600 Gresham Drive, Suite 1100, Norfolk, VA 23507; E-mail: [email protected] The authors disclose no conflicts of interest. This study received no financial support. All work was performed at Eastern Virginia Medical School.
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Copyright © 2014 Otology & Neurotology, Inc. Unauthorized reproduction of this article is prohibited.
DOCUMENTING IMMUNIZATION OF CI PATIENTS TABLE 1.
Immunization verification protocol
•The goal was 100% pneumococcal immunization for all CI patients and candidates. •All patients undergoing cochlear implantation had to provide documentation of vaccination before surgery. (Historically, we required only verbal assurance of full immunization, as appropriate for age, before surgery.) •The ‘‘Immunization Verification’’ form (Appendix) summarized current recommendations and provided a central place to document vaccination dates. Forms were distributed to parents and primary-care physicians and collected by fax and mail and became part of every CI patient chart. •We registered with a statewide immunization database, the Virginia Immunization Vaccination System (VIIS), to access government records. •Charts were affixed with special vaccine labels containing ‘‘due dates’’ and ‘‘given dates’’ for PCV-13 and PPSV-23. •An intradepartmental watch list of children with missing vaccines was circulated (audiology, social work, etc.) At each office visit, the chart documentation and VIIS (if needed) were checked for updates. •Notification of missing/required vaccines was made by fax, certified mail, phone, and in person as needed. •Office nurses were approved and trained to administer vaccines to patients in our office when needed. •An electronic vaccination database was created; annual reminders were sent to patients out of compliance.
receive a supplemental dose of PCV-13. Catch-up schedules for children with incomplete or undocumented previous vaccination were also defined. The CDC recommended health-care providers take the responsibility of providing and ensuring appropriate vaccination for cochlear implant patients: ‘‘health-care providers should review vaccination records of their patients who are cochlear implant recipients or candidates to ensure that they have received pneumococcal vaccinations based on the age-appropriate schedules for persons at high risk.’’ (13) Examples of cochlear implant centers and professional organizations highlighting the importance of vaccination of CI patients are available in the literature (14Y16). The American Academy of OtolaryngologyY Head and Neck Surgery (AAO-HNS), in coordination with the CDC and FDA, began a campaign in 2009 to increase awareness about the importance of pneumococcal vaccinations for all cochlear implant patients (15). Following the approval of PCV-13 and as we began contacting our patients to receive this vaccine, the cochlear implant team of Eastern Virginia Medical School and Children’s Hospital of the King’s Daughters became aware of noncompliance and missing documentation in our records. To address these deficiencies, we developed an immunization verification protocol (IVP) to educate parents and primary-care physicians, retrieve missing documentation, complete recommended vaccination, vaccinate candidates scheduled for cochlear implantation, and provide a mechanism to ensure compliance as patients become ageeligible for the PPSV-23. The IVP is detailed in Table 1. To evaluate the vaccine status of our program 2 years after implementation of the IVP, we reviewed medical records and online databases for overall vaccine status both before and subsequent to the initiation of the IVP as well as communication efforts involved in obtaining
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compliance with vaccination and documentation. In this report, we share the challenges and successes of retrospective documentation of vaccination status and of achieving immunization with the PCV-13 for children who have already received a cochlear implant. We also explore the value of a systematic method of documenting and providing vaccines during the process of preoperative evaluation for cochlear implantation. Significant obstacles impede successful implementation of new vaccines and completion of immunization schedules. We will explore some options to facilitate this ongoing process. METHODS In September 2012, we sought to assess the effectiveness of the IVP, identify the obstacles, and if possible, identify ways to improve compliance and documentation. The project was approved by the institutional review board of Eastern Virginia Medical School. The chart review included any patient younger than 18 who underwent cochlear implantation through the Eastern Virginia Medical School and Children’s Hospital of the King’s Daughters (EVMS/CHKD) Cochlear Implant Program between 1995 and December 2012 and any patient who transferred to our program after an implant at another institution. We reviewed medical records, both electronic and paper, for evidence of vaccination with PCV-7, PCV-13, and PPSV-23. We also reviewed the records of the Virginia Immunization Vaccination System (VIIS), an online registry maintained by the Commonwealth of Virginia and voluntarily populated by the Virginia Department of Health and individual health providers. The conclusion of our review and final update for each patient occurred on January 25, 2013. Subjects were divided into 2 groups. Subjects in Group 1 received cochlear implants before September 2010 when the IVP was initiated. Data recorded during the chart review for Group 1 subjects included the following: 1) individual dates of vaccinations, 2) vaccination status at the time of surgery, 3) cumulative vaccination status after implementation of the IVP over time including status of PCV-13, 4) the number of interventions and time (months) required to obtain compliance, and (5) overall rate of compliance at the completion of the study. Secondary outcome measures for Group 1 included the following: 1) the number of attempts to contact the patient/parent and primary care physician until documentation of immunization was obtained, and in the case of an incompletely immunized patient, until needed vaccines were administered; and 2) the time elapsed between first contact and complete immunization. Group 2 consisted of subjects who underwent cochlear implantation after the initiation of the IVP, presumably when compliance for immunization could be emphasized and confirmed before surgery. For these subjects, the goals of the IVP included documentation of vaccination before surgery, presence of a plan for vaccination if medical or age ineligible for full immunization at the time of surgery, compliance with PPSV once eligible, and status of compliance at the completion of the study. To determine immunization status for each subject, charts reviewed for the ‘‘immunization verification’’ form, primary immunization records, and clinical notes. Vaccination status was determined through a process of cross-referencing information in our medical records and from primary physicians with VIIS. Information was authenticated by investigating lot numbers as needed to resolve conflicting information. Substantiation of vaccination by provider signature (or name in VIIS) was required. Otology & Neurotology, Vol. 35, No. 2, 2014
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Status was characterized as complete, incomplete, complete but undocumented, age-ineligible, medical delay, or lost to follow-up. A status of ‘‘complete’’ required administration and documentation of all immunizations for which the patient was eligible based on age. In cases where a parent reported a vaccination had been performed but verification by a medical professional or VIIS was not available, the vaccination was recorded as complete with missing documentation. Medical delay was used to indicate situations when a vaccination was delayed during the 8-week interval required between vaccination doses. In some cases, vaccination was incomplete but scheduled, and these were indicated as such. A 3-month grace period was allowed between the date a vaccination was due before the vaccine was recorded as incomplete. Patients who had not been seen for more than 2 years and who could not be contacted for lack of a current address were indicated as lost to follow-up. In cases of sequential cochlear implantation or a reimplantation, only the primary surgery was determined in deciding vaccination status at the time of surgery.
analysis of vaccination status at the time of surgery, 9 of the 63 subjects in Group 1 were excluded because there was either no data, and the subject was lost to follow-up, or the patient had surgery at another institution (n = 3) and subsequently transferred their care to our center, leaving 54 subjects who received cochlear implants at our institution before September 10, 2010, (Group 1) and had adequate records to review vaccination status at the time of surgery.
RESULTS
Immunization Compliance At the time of surgery: documentation of compliance for both PCV-7/13 and PPSV-23 according to medicaland age-appropriate needs at the time of surgery could be documented retrospectively in 32 (59%) of 54 Group 1 subjects. Thirty-six or 54 (67%) subjects had documentation that PCV had been completed at the time of surgery, and 3 additional subjects had aged out of need for PCV7, resulting in a compliance of 39 (72%) of 54 for PCV. Twenty-one subjects were age ineligible for PPSV at the time of surgery, and of the remaining 33 subjects, 20 subjects (61%) had documentation that they had received PPSV-23 before the day of surgery. Thirteen subjects were age eligible, but documentation is not available to indicate that vaccination for PPSV was performed at the time of surgery. Documentation of vaccination compliance was more readily available for subjects in Group 2 and confirmed documentation of compliance for both vaccines according to age eligibility in 10 (56%) of 18 on
Patients Review of the EVMS/CHKD cochlear implant registry identified 91 patients who were 18 years or younger at the time of cochlear implantation. Ten patients were excluded from review because of lack of any medical recordVelectronic, paper, or online with VIIS. (Some were seen by an audiologist but did not see a physician for more than an initial visit. For these patients, records were inadequate to evaluate given that most arrived without any documentation, did not provide documentation at a later time, and were lost to follow-up.) Eighteen subjects were implanted after September 10, 2010, and comprise Group 2. The remaining 63 subjects comprised Group 1 for the analysis of compliance over time because they had records adequate to review status of vaccinations, had some contact with the center over the course of time, or had been contacted during the IVP process. For the
Demographics Group 1 patients were aged 1 to 15 years (median, 2.5 yr) at the time of their first implant and 1 to 17 years (median, 6.8 yr) at initiation of the IVP on September 10, 2010. Group 2 patients were aged 10 months to 7 years (median, 3.1 yr) at the time of implantation and 1 year 10 months to 9 years (median, 4.6 yr) at the conclusion of the study on January 25, 2013.
FIG. 1. Overall immunization status (PCV-13 and PPSV-23), at the time of surgery and at conclusion of the study, of all subjects receiving cochlear implants after September 10, 2010 (Group 2). Otology & Neurotology, Vol. 35, No. 2, 2014
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FIG. 2. Immunization status with respect to Prevnar (PCV-7/PCV-13) requirements, at the onset and at 4- to 7-month intervals after implementation of IVP, of subjects who received cochlear implants before September 10, 2010 (Group 1).
the day of surgery, with an additional 2 subjects who were in full compliance but had not yet provided written documentation (11%) and 6 subjects (33%) who were incompletely vaccinated because of medical delay but scheduled to be vaccinated on follow-up (Fig. 1). After initiation of immunization verification protocol Group 1: For this analysis, we reviewed the records of 63 subjects who had at least some documentation of vaccination either in the medical record or in VIIS. We were able to contact either the parent or provider for all but 8 patients in Group 1 during the IVP process. At the initiation of the IVP in September 2010 (7 mo after the release of PCV-13), only 1 patient in Group 1 (2%) had received the supplemental dose of PCV-13. After implementation
of the IVP with initial contact of most patients over the first 3 months, we observed a rapid increase in compliance with supplemental dose of PCV-13 (Fig. 2). For PCV-13, 34 patients (54%) achieved compliance in 12 months, increasing to 41 patients (65%) at 28 months (Fig. 2). PPSV23 compliance rose from 79% (50 of 63 subjects) at the onset of the IVP to 92% (58 subjects) at the completion of the study (Fig. 3). Overall compliance for vaccination with both PCV-13 and PPSV-23 improved from 2% to 63% between September 2010 and the completion of the study (Fig. 4). Group 2: Of 18 subjects who underwent implantation after the initiation of the IVP, 1 patient missed a supplemental dose of PCV-13 and had not provided documentation or presented
FIG. 3. Immunization status with respect to Pneumovax (PPSV-23) requirements, at the onset and 4- to 7-month intervals after implementation of IVP for subjects in Group 1. Otology & Neurotology, Vol. 35, No. 2, 2014
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FIG. 4. Overall pneumococcal immunization status (PCV-13 and PPSV-23), at the onset and 4- to 7-month intervals after implementation of IVP for subjects in Group 1.
for vaccination so that compliance with PCV was 94% at the time the study was complete (Fig. 5). During the study, 3 patients became age eligible for PPSV-23 and received it, resulting of compliance 100% for PPSV-23 for the 15 of the 18 patients who were older than 2 years and overall vaccinate rate of 83% for PPSV-23 (Fig. 6). All but 1 subject (94%) achieved full compliance according to age eligibility with both PCV and PPSV at the time of the conclusion of the study (Fig. 1). Overall, the IVP succeeded in achieving documentation of compliance with both PCV and PPSV immunization for 57 (70%) of 81 subjects, whereas 13 (16%) had incomplete documentation and 11 (14%) were lost to follow-up. Obtaining vaccination compliance required a significant amount of effort. Primary care physicians and parents were contacted specifically about vaccination status
on average 1.4 and 1.5 times, respectively, before documentation was secured. Additional contact between the parent and CI team was made in most cases, although specific mention of vaccination status was not recorded for the purposes of this study. The mean lag time between initial contact with the PCP and completion of vaccination was 109 days (SD, 154.6) and with the parent and completion of vaccination was 111 days (SD, 156.6).
DISCUSSION Despite the many efforts to raise awareness of the importance of pneumococcal vaccination of cochlear implant patients, it remains tremendously difficult to gain full compliance with the recommended schedules. A 2010 review of 225 pediatric cochlear implant recipients
FIG. 5. Pneumococcal immunization status with respect to Prevnar (PCV-7/PCV-13), at the time of surgery and at present, of subjects in Group 2. Otology & Neurotology, Vol. 35, No. 2, 2014
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FIG. 6. Pneumococcal immunization status, with respect to Pneumovax (PPSV-23) requirements, at the time of surgery and at present, of subjects in Group 2.
reported 56% documentation of age-appropriate immunizations (16). Implementation of the recommendation of a supplemental dose of PCV-13 in patients previously vaccinated with PCV-7 required cochlear implant centers to contact patients and either refer them to primary care for immunization. Few have reported on their attempts to achieve vaccination compliance.The efforts of Carpenter et al. (17) published in 2010 are laudable for their successes; nevertheless, the authors stressed it was ‘‘an immense challenge.’’ Carpenter and colleagues launched a communication campaign to document vaccination status of their cochlear implant patients. They noted in 2007 that despite standard notices and verbal recommendations issued at office visits, only 20% to 30% of their cochlear implant patients were immunized at the time of surgery. Through more aggressive efforts, including a database documenting vaccination status, and contacting patients through mail, e-mail, and telephone, they were able to achieve nearly 100% immunization of new cochlear implant recipients at the time of surgery. However, despite successful immunization of new patients, they could not garner the cooperation of past implant patients. Complete vaccination was only documented in 49% of adults and 58% of children with prior implants (17). These challenges led the authors to conclude that most patientsVeven after documenting their willingness to complyVwill not reliably obtain vaccinations on their own (17). The difficulties of Carpenter et al. are echoed by our own experience. When the 13-valent conjugate vaccine became available, we used the opportunity to attempt to obtain and document vaccination status on all of the patients who have received an implant in our program or who had transferred to our program. We developed a formal policy requiring vaccination documentation at the time of implantation and a protocol for following patients over time so that compliance with the recommended schedule could be maintained. Our team made multiple attempts to contact both primary care physicians and parents, by mail, fax, and phone. Every 3 to
4 months, the database was reviewed, and another attempt was made to contact providers and parents until documentation was received or an appointment was scheduled for vaccination. We implemented new procedures in our office, such as providing vaccines and becoming active users of the Virginia Immunization Information System. We created watch lists and shared them with audiologists, speech pathologists, and social workers involved with our patients so that noncompliant patients could be reminded when seen for care. At the end of the study period, we were able to obtain and document compliance for only 70% of 81 patients, whereas 16% of our patients were still active in follow-up yet noncompliant. Fourteen percent of our patients had not been seen for 2 years or longer and did not respond to communications from the CI program. Certified letters were sent to these patients as a final attempt to gain an opening for communication at the completion of this study. Additional reminders will be generated through an annual review of a vaccination registry. We encountered several issues that complicated the process of vaccination verification: 1) inaccurate identification of the primary care physician; 2) change in primary care physician and new physician did not have complete record of vaccinations; 3) inaccurate documentation of vaccination, such as mislabeling of PCV as PPSV and vice versa; 4) incomplete or inaccurate VIIS entries that were verifiably accurate in the patient’s chart; and 5) parents’ failure to respond to communication and/or failure to fill prescribed vaccine prescriptions. Virginia’s online immunization record proved to be very beneficial to this process.
CONCLUSION Compliance with the recommended schedule for pneumococcal prevention in patients with cochlear implants remains a significant challenge. The most valuable means of achieving compliance in our practice included the policy of requiring vaccination documentation before Otology & Neurotology, Vol. 35, No. 2, 2014
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surgery. Access to a statewide immunization registry and availability of PCV and PPSV vaccinations in the otolaryngology office also provided a means to improve compliance.
9. 10.
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