Immunizations have made substantial contributions to improving the health of the public and may be the most significant achievement of modern medicine. A recent review of the decrease in morbidity from vaccine preventable diseases in the United States showed a 95% improvement from baseline in pertussis morbidity, a 98% improvement for tetanus, mumps, rubella, Haemophilus influenzae type B, and a 100% improvement for smallpox, diphtheria, polio, and measles.' Rapid advances have produced myriad new vaccines and vaccine combinations, with the potential for prevention of not only communicable diseases but also some forms of cancer.
Despite tremendous strides in vaccine technology, immunization rates, particularly for age-appropriate immunizations, lag behind. Barriers to more universal "on time" immunizations include vaccine shortages, missed opportunities to immunize, families moving from one provider to another, language difficulties, poor documentation on medica! records, infrequent visits to a provider, and an overestimation by many primary care providers about the percentage of children in thenpractices that are fully immunized.2,3
The Centers for Disease Control and Prevention (CDC) and the National Vaccine Advisory Committee (NVAC) have promulgated standards for immunization practices in an effort to develop best practice guidelines.4 These include recommendations for the availability and distribution of vaccines, assessment of vaccination status, effective communication about vaccine benefits and risks, proper storage and documentation, and implementation strategies to improve vaccination coverage. For most practices, many of the NVAC guidelines are not followed. These guidelines were developed with the aim of changing immunization delivery from a component of well-child visits to a stand-alone process that needs visibility, monitoring, feedback, and problem solving. Vaccine availability, monitoring of proper storage, assessment of vaccine status, protocols for giving immunizations, documentation, informed consent, patient education, and implementation of strategies to improve vaccination coverage are essential elements of a preventive service delivery system that requires clear objectives and proactive processes. These include identifying patient needs, prompts for providers, operationalizing delivery procedures, documenting and tracking, reinforcing, educating health professionals, and implementing follow-up procedures.5
Most immunizations in the US are given in primary care practices. Traditionally, state and local public health departments have carried the responsibility to monitor and improve coverage rates. However, immunization coverage has become a key measure of practicelevel preventive service quality. The road to improvement, therefore, leads more and more to the private primary care office. Even so, although immunization delivery is now almost solely through office-based practices, primary care is not configured routinely to provide an organized process to ensure uniform delivery of on-time immunization to all children in the practice panel. Thus, a large chasm exists between primary care immunizations and community-wide protection.
BENEFITS OF A STATEWIDE, COMMUNITY-BASED IMMUNIZATION REGISTRY
One of the most robust and useful tools for implementing many of the preventive service systems for office-based immunizations is the electronic immunization registry. Registries are confidential, population-based computerized information systems containing immunization records of all children within a geographic area. Registries pool records from multiple providers in a region. Children are entered at birth into a state registry that often is linked with electronic birth records. If all providers in a region report immunization information, the registry can provide single-source data storage for all children in the community.
A recent study demonstrated the importance of such pooled data. Of 1,300 children 19 to 36 months old, 22% received immunizations from more than one provider; provider records underestimated immunizations by 10% to 20%.6 Families may move, change providers, or fail to show up for well-child visits. Therefore, electronic registries housed only at the practice level may benefit that practice but fail to capture the breadth of information of a broader, communitybased registry.
The community-wide repository of data is considered fully operational when more than 95% of the children younger than 6 with two or more immunizations are enrolled.7 Immunization database records maintain strict confidentiality and security policies. Most states have passed laws to establish the registries and allow input of information only by authorized users. These laws include clear provisions and penalties for improper disclosure and immunities from civil and criminal liability for providers who make good faith disclosures of information. These laws also include allowances for parents to refuse entry of data for religious or other reasons.
There are many positive benefits to a primary care office for participation in an immunization registry. As described, one major advantage is the one-source repository of immunization information for any child in a community. This consolidation into one data source allows easy access to information that often is not kept by families. Office staff can access immunization status quickly for a child visiting an office for any reason.
The registry also provides current information on available and new vaccines. The database can produce reminders and recalls for immunizations that are due or past due, allowing a practice to manage its care process, track patients who need immunizations, and reach out with appointment reminders. In an era noted for regular vaccine shortages, this component of a registry fosters easy provider access for those children who were not able to receive vaccines because of the shortages.
Registries also help monitor vaccine inventory and track expiration dates as well as supplies. They can generate reports for managed care for National Committee for Quality Assurance Health Plan Employer Data and Information Set data and records for schools, day care, and camps. A registry can simplify recordkeeping and provide immediate access to information from any source, reducing office staff time and effort. Some registries also contain other state-based prevention data, such as lead screening results.
PRACTICE-LEVEL OPERATIONAL ISSUES
A major concern for many providers is that entering information into a registry takes extra time and often extra staff, thus costing more than many practices are willing or able to allocate. Registry advocates counter that the time saved on phone calls and filling out forms more than outweighs any additional time for registry upkeep. Most practices with an electronic medical record (EMR) can connect electronically with a community registry, permitting single data entry. Recent studies have documented the low cost and financial benefits to practices that use an immunization registry7,8 and have shown that immunization entry can be performed in real time, without increasing time for office staff.9
Other documented barriers to use of registries include perceived difficulties of adding a new procedure to office routines, lack of staff training, and concerns about confidentiality and Health Insurance Portability and Accountability Act (HIPAA) privacy and security. Additionally, lack of coordination within an office between clinical and administrative systems often impedes immunization registry uptake. Sidebar 1 (see page 503) summarizes the benefits and challenges to implementing an immunization registry.
A report by the American Immunization Registry Association10 presents best practice examples regarding how to overcome provider concerns and office-based barriers. Recommendations include use of web-based systems to increase ease of use, focused education and on-site training for providers and staff by state immunization personnel, a toll-free help desk, a parent notification system to inform parents about the registry and their child's inclusion, and close relationships with billing and EMR vendors to ensure connectivity with the electronic data already being produced by primary care offices.
To date, registries appear to be more actively used by physicians working in health maintenance organizations. A review of use in the state of Washington showed positive attitudes toward immunization tracking but only a 25% use rate - lowest for family physicians and for physicians who take fewest opportunities to immunize." The study calls for focused interventions and education to reinforce positive attitudes about registries.
Every state is attempting to develop population-based, statewide immunization registries.1 The most recent review of registry use showed that end-user practices had few complaints about operational aspects.12 Users' benefits included ability to enter data on immunizations, review individual patient records, and print forms. At the same time, users considered the practice-wide coverage rates and reminder-recall as less vital. In surveys of nonusers, almost half of respondents stated they were likely to use the state's registries, with benefits seen as easy access to records and printable immunization records. Notably, lower on the benefit scale for nonusers and users was the ability to assess the practice's immunization coverage rates and to generate reminder-recall notices.
Longstanding office-based processes of care can pose impediments to introducing new service delivery approaches.13 For example, organized staff training is highly correlated with registry use, along with ease of access to registry data. Terminals not placed in locations conducive to the usual flow of work prevent the ability to log on. Because office staff members generally are responsible for routine registry maintenance, their perceptions and comfort levels in downloading and uploading data, record searching, and the courtesy of help desk staff to help solve problems play a major role in the practice's usage rates.
Thus, immunization registries are powerful tools for monitoring and tracking immunizations in practices. Most users clearly see the benefit for individual patient care. Fewer users place as high a benefit on overall coverage rates, a function still seen as a responsibility for public health programs, not private offices. Education, training, and data feedback have been successful in increasing provider awareness and willingness to consider their role in promoting the greater good of the community.
NEW JERSEY IMPROVING PREVENTIVE SERVICES PROJECT
In 2002, the National Initiative for Children's Healthcare Quality (NICHQ),14 an education and research organization dedicated to improving the quality of health care provided to children and adolescents, launched an effort to increase immunization rates in primary care practice. A partnership was formed between the American Academy of Pediatrics New Jersey chapter (AAPNJ) and the New Jersey Department of Health and Senior Services' Vaccine Preventable Disease Program (VPDP), with a goal of improving immunization rates. Objectives were to support deployment and use of the New Jersey immunization registry and increase individual practices' ability to immunize their patients on time and fully, using quality improvement and office system change methods.
Composite Outcome Measures
Clinician-reported Immunization Delivery Changes and Their Effectiveness and Ease of Adoption
The intervention that developed, the New Jersey Improving Preventive Services Project (NJIPSP), was a modified Breakthrough Learning Collaborative15 and involved the following key components:
* Identification of key quality measures to be adopted by all practices;
* Dissemination of a "change-package" that included a set of practice changes (change concepts) expected to lead to improvement if successfully implemented (Sidebar 2, see page 503);
* Learning sessions to provide didactic education around immunization and quality improvement;
* Ongoing communication and collaboration among practices, registry specialists, and the department of public health; and
* Monthly measurement of quality improvement.
A similar approach used in Vermont and North Carolina substantially improved immunization rates.16,17 Nine practices, selected from low-income, low-immunization-rate communities, participated in the NJIPSP. All of the sites were trained in the use of the registry. Sites that had electronic medical records were able to use their system and have the immunization data sent electronically to the state web-based registry. Sites that lacked basic computers were provided with them. Practices were urged regularly to use the registry for collective storage of immunization data and also as a mechanism for reminder-recall for their patients and for vaccine inventory; as a tool to print out school, camp, and day care forms; and as a source of patient education and information about immunizations.
An online survey (Zoomerang) was developed to assess the effectiveness and ease of adoptability of the change concepts. The chart review protocol was repeated, using a common assessment date one year after the first review, to give another "snapshot" of the immunization status for each practice's 2-year-old population. The Vaccines for Children Quality Assurance Review also was repeated by each practice.
The effects of participation in the NJIPSP were evaluated in two primary areas, changes in vaccination coverage (Table 1 , see page 504) and changes in immunization delivery practice (Table 2, see page 504). Changes in vaccination coverage were measured directly from data in the New Jersey Immunization Information System (NUIS). Changes in immunization delivery practice were assessed by self-report via a web-based survey.
Participation in NJIPSP was associated with substantially improved immunization coverage (as reflected in the registry) during the project, as well as sustained improvement after ending formal participation in the project. A particularly impressive example of improvement is shown in the sample run charts shown in the Figure. As shown in Table 1, the proportion of NJIPSP children Usted as up-to-date in the NJIIS was more than twice as high as before the project, and the improvements were sustained for the 6 months after the project. Similar improvements were seen for children ages 7 to 11 months.
Figure. Sample run charts from one New Jersey Improving Preventive Services Project practice.
Improvements in the development of a practice-based population (a major focus for the project) were reflected in the proportion of children identified as being members of a practice and who had two or more immunizations in the registry. This number increased by more than 50% (Table I), and the improvements were sustained. Participation in the NJIPSP also was associated with substantial improvement in the time to enter immunization data, although 36% of immunizations were still being entered into the registry more than 7 days after administration.
Numerous changes in immunization delivery practice were adopted during the NJIPSP (Table 2). Two-thirds of practices who were not previously conducting pre- visit immunization planning or routine clinician prompting reported initiating the practice during the project. All the practices that were not reviewing immunization needs at all visits (including sick and chronic care) or doing reminder-recall before the project began reported initiation of the practice during the project. Major delivery changes also were noted in the areas of vaccine inventory management, NJIIS access throughout the practice, and initiation of real-time data entry.
When asked to rate both the effectiveness in improving care and the ease of adoption of these changes, an overwhelming number of clinicians reported that the changes improved care and were either adoptable or easily adopted (Table 2). For example, when asked whether the NJIIS (or EMR) could be used to identify immunization needs before every visit, 84% of practices said this improved immunization service delivery (17% more, 67% hghly), and 67% said this was easily adopted.
The NJIPSP was successful in encouraging a group of small urban practices to adopt the use of immunization registry and to transform immunization delivery from a mechanistic well-child service to a visible, monitored process of care. The project represents a unique combination of technology, public-private collaboration, and well-established quality improvement techniques. The change process involved the whole office as a team in adopting new immunization delivery roles and services.
The greatest barrier to acceptance of the registry was (and continues to be) the need for manual data entry as the primary source of data collection, rather than electronic data transfer from other systems. The manual entry of data was labor intensive for participating practices and affected data measurement. Despite this barrier, however, the majority of practices substantially improved the quality of their immunization delivery practices in multiple areas. The rapid movement of primary care practices toward some form of electronic record may reduce this barrier and increase the percentage of practices willing to use a community registry.
Practices that engaged collectively in the change process gained momentum from the group effort. Equally important was the public health partnership that helped identify and reduce improvement obstacles. Sustainability of practicebased immunization changes will rely, in part, on the registry's ease of use and the continued visibility of public health at the practice level. Active practice level collaboration by public health adds great value to change efforts.
We believe that the best possible immunization delivery relies on both technology (registries and the EMR) and effective office systems. Projects like the NJIPSP are models for systems that integrate technology, practice change, and quality improvement, and their success has the potential to foster the spread of this approach to other primary care practices (especially in New Jersey). The NJIPSP combination of office-based change approaches and an active partnership and hands on involvement with public health has the potential to support the delivery of consistently excellent immunization delivery.
1. Centers for Disease Control and Prevention. Immunization information system progress - United States, 2004. MMWR Morb Mortal Wkly Rep. 2005;54(45):1156-1157.
2. Kahane SM, Watt JP, Newell K, et al. Immunization levels and risk factors for low immunization coverage among private practices. Pediatrics. 2000;105(6):E73.
3. Taylor JA, Darden PM, Slora E, et al. The influence of provider behavior, parental characteristics, and a public policy initiative on the immunization status of children followed by private pediatricians: a study from Pediatric Research in Office Settings. Pediatrics. 1997;99(2):209-215.
4. National Vaccine Advisory Committee. Standards for child and adolescent immunization practices. Pediatrics. 2003;112(4):958-963.
5. Leininger LS, Finn L, Dickey L, et al. An office system for organizing preventive services: a report by the American Cancer Society Advisory Group on Preventive Health Care Reminder Systems. Arch Fam Med. 1996;5(2):108-115.
6. Stokley S, Rodewald LE, Maes EF. The impact of record scattering on the measurement of immunization coverage. Pediatrics. 2001 ;107(1):91-96.
7. Rask KJ, LeBaron CW, Staraes DM. The costs of registry-based immunization interventions. Am J Prev Med. 2001;21(4):267-271.
8. Glazner JE, Beaty BL, Pearson KA, et al. Using an immunization registry: effect on practice costs and time. Ambul Pediatr. 2004;4(1):34-40.
9. Adams WG, Conners WP, Mann AM, Palfrey S. Immunization entry at the point of service improves quality, saves time, and is well-accepted. Pediatrics. 2000; 106(3);489-492.
10. Turning Barriers into Opportunities; Survey and Best Practice Report. American Immunization Registry Association. December 2005. Available at: http://www.immregistries.org/ pdf/Provider_Participation_Final_2005.pdf. Accessed May 4, 2006.
11. Gaudino JA, deHart MP, Cheadle A, et al. Childhood immunization registries: gaps between knowledge and action among family practice physicians and pediatricians in Washington state, 1998. Arch Pediair Adolesc Med. 2002;156(10):978-985.
12. Clark SJ, Cowan AE, Battle« DL. Private provider participation in statewide immunization registries. BMC Public Health. 2006;6:33 [Epub ahead of print].
13. Wells KJ, Holmes AK, Kohler SA, Rust CT, Rask KJ. Qualitative study of clinic staff members' experiences using an immunization registry. Arch Pediatr Adolesc Med. 2000;154(11):1118-1122.
14. National Initiative for Children's Healthcare Quality. Available at: http://www.nichq.org. Accessed May 8, 2006.
15. The Breakthrough Series: IHI's Collaborative Model for Achieving Breakthrough Improvement. Institute for Healthcare Improvement. 2003. Available at: http://www.ihi.org/IHL· Results/WhitePapers/TheBreakthrough SeriesIHIsCollaborativeModelforAchieving +Breakthroughlmprovement.htm. Accessed June 15, 2006.
16. Bordley WC, Margolis PA, Stuart J, Lannon C, Keyes L. Improving preventive service delivery through office systems. Pediatrics. 2001;108(3):E41.
17. Shaw J, Wasserman R, Barry S, et al. Statewide QI outreach improves preventive services for young children [abstract]. Pediatr Res. 2003:53(1):21A.
Composite Outcome Measures
Clinician-reported Immunization Delivery Changes and Their Effectiveness and Ease of Adoption