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Major Article| Volume 48, ISSUE 3, P290-296, March 01, 2020

Maximizing the impact of, and sustaining standing orders protocols for adult immunization in outpatient clinics

Open AccessPublished:October 18, 2019DOI:https://doi.org/10.1016/j.ajic.2019.07.023
Maximizing the impact of, and sustaining standing orders protocols for adult immunization in outpatient clinics
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      Highlights

      • •
        Standing orders provide a starting point for improving adult immunization coverage.
      • •
        Sustaining higher adult immunization rates needs intervention beyond standing order.
      • •
        Prioritization of adult immunization is challenging without incentives.
      • •
        Better integration of clinic and state data may increase adult immunization rates.

      Background

      Low adult immunization rates leave adults at risk from infectious disease, and the resulting complications of vaccine-preventable diseases. Standing orders protocols (SOPs) for adult immunization have not been implemented widely in clinics serving adult patients. Our purpose was to evaluate the impact of SOPs on adult immunization rates and identify challenges to sustaining adult immunization coverage rates after implementation of SOPs.

      Methods

      Baseline adult vaccination rates were calculated for the year prior to SOPs implementation in 5 diverse clinics. Vaccines included in the implemented standing orders included Tdap, influenza, pneumococcal, human papillomavirus, herpes zoster, and hepatitis B. Adult vaccination rates were tracked for 1 year after SOPs implementation.

      Results

      Sites generally sustained modest gains in coverage rates (4%-8% increase) after SOP implementation, but greater success was found in practices that used SOPs as a foundation on which additional interventions were built. Challenges to increasing coverage rates included prioritization of acute and chronic conditions over adult vaccination, Medicare Part D reimbursement policies, electronic medical record issues related to data reporting and programming for patient alerts, and the lack of interoperability between the state immunization information system (missing patient vaccination history) and electronic medical record.

      Conclusions

      SOPs may provide a good starting point for increasing adult immunization coverage rates. Using additional interventions, quality-based metrics, or incentives could lead to sustained adult immunization prioritization.

      Key Words

      Vaccine-preventable diseases in adults can cause serious illness, related complications, hospitalizations, and death, placing a significant burden on the health care system and economy.
      • McLaughlin JM
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      Estimated human and economic burden of four major adult vaccine-preventable diseases in the United States, 2013.
      J Prim Prev. 2015; 36: 259-273
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      Modeling the economic burden of adult vaccine-preventable disease in the United States.
      Health Aff. 2016; 35: 2124-2132
      Adult vaccination rates are well below goals set by public health agencies,

      Office of Disease Prevention and Health Promotion. Healthy people 2020 immunization and infectious diseases. Available from: https://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases. Accessed February 8, 2018.

      and 80% of the economic burden of adult vaccine-preventable diseases lies in the unvaccinated population.
      • Ozawa S
      • Portnoy A
      • Getaneh H
      • Clark S
      • Knoll M
      • Bishai D
      • et al.
      Modeling the economic burden of adult vaccine-preventable disease in the United States.
      Health Aff. 2016; 35: 2124-2132
      During the 2017-2018 influenza season, only 37.1% of adults over age 18 years received an influenza vaccine.

      Centers for Disease Control and Prevention. Estimates of influenza vaccination coverage among adults—United States, 2017–18 flu season. Available from:https://www.cdc.gov/flu/fluvaxview/coverage-1718estimates.htm. Accessed November 12, 2018.

      In 2015, only 24.6% of eligible adults received vaccination for hepatitis B, whereas only 23% of high-risk adults were vaccinated for pneumococcal disease, and 30.6% of eligible adults received vaccination for herpes zoster.
      • Williams W
      • Lu P-J
      • O'Halloran A
      • Kim D
      • Grohskopf L
      • Pilishvili T
      • et al.
      Surveillance of vaccination coverage among adult populations–United States, 2015.
      MMWR Surveill Summ. 2017; 66: 1-21
      The Centers for Disease Control and Prevention and the National Vaccine Advisory Committee recommend that the patient's immunization history be reviewed at every health care visit.

      Centers for Disease Control and Prevention. Standards for Practice.Adult vaccine administration and referral. Available from: https://www.cdc.gov/vaccines/hcp/adults/for-practice/standards/referral.html. Accessed March 1, 2018.

      , 

      National Vaccine Advisory Committee. Recommendations from the National Vaccine Advisory Committee: standards for adult immunization practice. Public Health Rep 129; 2014. p. 115-23.

      , 

      Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine-Preventable Diseases. Hamborsky J, Kroger A, Wolfe S, eds. 13th ed. Washington D.C. Public Health Foundation, 2015, Chapter 6. Available from:https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/vac-admin.pdf. Accessed September 18, 2019.

      Documented immunization history is required to substantiate proof of vaccination, with the exception of influenza and pneumococcal polysaccharide (PPSV23) vaccines, which can be self-reported by the patient according to the Centers for Disease Control and Prevention.

      Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine-Preventable Diseases. Hamborsky J, Kroger A, Wolfe S, eds. 13th ed. Washington D.C. Public Health Foundation, 2015, Chapter 6. Available from:https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/vac-admin.pdf. Accessed September 18, 2019.

      A national immunization information system (IIS) is not currently available, but all 50 states

      New Hampshire Department of Health and Human Services. NH Department of Health and Human Services applauds legislature's vote to approve immunization registry. Available from:https://www.dhhs.nh.gov/media/pr/2016/05262016registry.htm. Accessed October 31, 2018.

      , 
      • Martin DW
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      • Horlick G
      Immunization information systems: a decade of progress in law and policy.
      J Public Heal Manag Pract. 2015; 21: 296-303
      do have an IIS in place to record patient immunization history.
      Missed opportunities during health care visits are one reason adult vaccination rates have remained low.
      • Williams W
      • Lu P-J
      • O'Halloran A
      • Kim D
      • Grohskopf L
      • Pilishvili T
      • et al.
      Surveillance of vaccination coverage among adult populations–United States, 2015.
      MMWR Surveill Summ. 2017; 66: 1-21
      , 
      • Ofstead CL
      • Sherman BW
      • Wetzler HP
      • Dirlam Langlay AM
      • Mueller NJ
      • Ward JM
      • et al.
      Effectiveness of worksite interventions to increase influenza vaccination rates among employees and families.
      J Occup Environ Med. 2013; 55: 156-163
      , 

      Ofstead CL. The Value of Worksite-based Influenza Vaccination Campaigns Targeting Both Employees and Families. Presented at the National Influenza Vaccine Summit, Atlanta GA, May 17, 2012. Available from: https://www.izsummitpartners.org/content/uploads/2012/NIVS/NIVS-3_ofstead_worksite.pdf. Accessed September 18, 2019.

      Standing orders protocols (SOPs) are written protocols signed by a physician that preauthorize nonphysician health care professionals to independently assess each patient's vaccination needs and administer vaccines and reduce missed opportunities.

      Community Preventive Services Task Force. Increasing appropriate vaccination: standing orders. Task force finding and rationale statement. Available from:https://www.thecommunityguide.org/sites/default/files/assets/Vaccination-Standing-Orders.pdf.Accessed February 9, 2018.

      SOPs are recommended by the Centers for Medicare and Medicaid Services,

      Department of Health and Human Services. Change in requirement for signed physician's order for influenza and pneumonia vaccine. Available from:https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/downloads/SCLetter03-02.pdf. Accessed February 9, 2018.

      the Advisory Committee on Immunization Practices (ACIP),
      • Koplan JP
      Adult immunization programs in nontraditional settings: quality standards and guidance for program evaluation and use of standing orders programs to increase adult vaccination rates.
      MMWR. 2000; 49: 1-26
      and the National Vaccine Advisory Committee to improve adult immunization rates.

      National Vaccine Advisory Committee. Recommendations from the National Vaccine Advisory Committee: standards for adult immunization practice. Public Health Rep 129; 2014. p. 115-23.

      SOPs streamline vaccine administration. Their inclusion in vaccination programs can improve rates in outpatient health care settings by making vaccination routine, rather than relying on individual clinician orders for each dose of vaccine.

      Centers for Disease Control and Prevention. Standards for Practice.Adult vaccine administration and referral. Available from: https://www.cdc.gov/vaccines/hcp/adults/for-practice/standards/referral.html. Accessed March 1, 2018.

      , 

      Community Preventive Services Task Force. Increasing appropriate vaccination: standing orders. Task force finding and rationale statement. Available from:https://www.thecommunityguide.org/sites/default/files/assets/Vaccination-Standing-Orders.pdf.Accessed February 9, 2018.

      , 
      • Goebel LJ
      • Neitch SM
      • Mufson MA
      Standing orders in an ambulatory setting increases influenza vaccine usage in older people.
      J Am Geriatr Soc. 2005; 53: 1008-1010
      Despite strong recommendations, health care providers are not using SOPs. A 2011 study by Albert et al
      • Zimmerman RK
      • Albert SM
      • Nowalk MP
      • Yonas MA
      • Ahmed F
      Use of standing orders for adult influenza vaccination: a national survey of primary care physicians.
      Am J Prev Med. 2011; 40: 144-148
      reported only 42% of physicians used SOPs for adult influenza vaccination. In a separate study, Zimmerman et al
      • Albert SM
      • Nowalk MP
      • Yonas MA
      • Zimmerman RK
      • Ahmed F
      Standing orders for influenza and pneumococcal polysaccharide vaccination: correlates identified in a national survey of US primary care physicians.
      BMC Fam Pract. 2012; 13: 22
      found that only 23% of internal and family medicine physicians reported using SOPs consistently for both influenza and pneumococcal vaccines.
      We evaluated the impact of implementing SOPs for routine ACIP-recommended adult vaccines in 5 participating clinics, comparing immunization coverage rates for a 12-month baseline period with coverage rates for 12 months postimplementation of SOPs. Insights about challenges to SOPs implementation were solicited from the clinics during regularly scheduled conference calls and a site visit to each clinic.

      Methods

      During 2015 and 2016, a multidisciplinary team created, promoted, and conducted 26 workshops in 15 states to facilitate implementation of adult immunization SOPs. The team recruited sites from workshop attendees to participate in an evaluation of SOPs effectiveness. Clinics were eligible if they provided outpatient services to adult patients, routinely offered at least 1 adult immunization, implemented a new SOP for at least 1 adult vaccine after attending the workshop, used electronic medical records (EMR), and had a minimum 12-month history tracking vaccine administration. Each site that volunteered for the study had a vaccination champion who was passionate about adult immunization. These champions collaborated closely with site personnel and the research team to implement standing orders and evaluate outcomes.
      Study sites provided immunization services in accordance with ACIP recommendations and clinical standards for care. Each site determined the adult vaccines for which they would implement SOPs. The study protocol required submission of aggregate data by each site; no identifiable patient data were used. The western institutional review board reviewed the protocol and determined that the study qualified as a quality improvement project not requiring institutional review board review.
      Site champions and clinic personnel determined their adult vaccination SOP implementation dates. Baseline vaccination rates were calculated for the year prior to SOP implementation. Vaccination rates were tracked for 1 year after SOP implementation. During the intervention year, cumulative vaccination rates were calculated every quarter. Reports with comparison data were provided to each site to support their internal initiatives.
      Researchers collaborated with site personnel to develop a strategy for calculating vaccination rates compatible with the capabilities of their EMR systems. The research team developed an Excel version 2016 (Microsoft Corporation, Santa Rosa, CA) template for data extraction, and a data dictionary with relevant definitions to guide site data extraction.
      Vaccination rates were calculated by the number of “vaccinated adults” (numerator) divided by the number of adult individuals eligible for vaccination with an office visit during the study period (denominator). A “vaccinated adult” was a patient vaccinated during the study period onsite or offsite, or who had been previously vaccinated. After 1 full year of implementation, researchers compared vaccination rate changes between the baseline year and the intervention year. Statistical analyses were performed using Excel and R version 3.4.3 (R Core Team, Vienna, Austria). The Fisher exact tests were used to assess differences between baseline vaccination rates and intervention vaccination rates. A P value of .01 was considered statistically significant.
      After the end of each quarter, sites participated in individualized webinar/conference calls. Researchers provided status reports including summary data from all sites in addition to site-specific reporting. During each webinar, researchers solicited feedback from site personnel about their experiences implementing SOPs. Midway through the study, researchers visited every site to provide an educational presentation on vaccinating adults. In addition, researchers conducted structured interviews of vaccine champions and key project personnel, obtaining feedback on their SOP implementation experiences.

      Results

      Five sites participated in the study and submitted complete datasets. In addition to immunization data, participants submitted administrative data about their institutions and demographic information for their patient populations. Sites were diverse in terms of sizes, locations, ownership structures, and patient demographics (Table 1).
      Table 1Characteristics and demographics of study sites
      Site ASite BSite CSite DSite E
      SpecialtyPrimary careOB/GYNPrimary carePrimary carePrimary care
      Implementation start datesAugust 15, 2016September 19, 2016October 20, 2016July 1, 2016October 31, 2016
      Number of adult patients
      Reflects the number of unique patients age ≥19 years with at least 1 visit during the baseline year.
      		2000-35002000-35007500+5000-75003500-5000
      Location (state)PADCFLCAND
      Community sizeSuburbanUrbanSuburbanRuralSuburban
      Health system affiliationNoNoYesNoYes
      OwnershipFor-profitFor-profitMixed
      Part of a nonprofit health system (owned by a for-profit subsidiary).
      		NonprofitNonprofit
      Patient ages
      Under 25
      Not all categories add up to 100% due to rounding: demographic data from Sites B, C, and D pertain only to adult patients; data from Sites A and E reflect demographics for all patients, including patients under age 18 years.
      		13%8%4%8%24%
      25-4437%65%23%22%26%
      45-6432%22%44%40%32%
      65-7410%5%18%17%10%
      75+8%1%11%13%8%
      Patient sex
      Male55%0%47%42%47%
      Female45%100%53%58%53%
      Patient race
      White46%61%55%96%92%
      African American2%17%15%0%2%
      Asian50%5%1%1%0%
      Latino/a1%2%8%0%4%
      Other2%15%21%3%3%
      OB/GYN, obstetrics/gynecology.
      low asterisk Reflects the number of unique patients age ≥19 years with at least 1 visit during the baseline year.
      † Part of a nonprofit health system (owned by a for-profit subsidiary).
      ‡ Not all categories add up to 100% due to rounding: demographic data from Sites B, C, and D pertain only to adult patients; data from Sites A and E reflect demographics for all patients, including patients under age 18 years.

      Vaccination rates comparison: Baseline versus intervention year

      Vaccination rates differed by site, vaccine, patient age and sex, and the presence of high-risk conditions (Table 2). In general, end-of-intervention-year vaccination rates were higher than baseline rates with a 4%-8% increase for most vaccines at most sites (Table 2).
      Table 2Vaccination coverage rates for baseline (Pre) versus intervention (Post) years
      Site ASite BSite CSite DSite E
      PrePostPrePostPrePostPrePostPrePost
      Influenza44%48%3%9%
      Indicates statistically significant change from baseline year (P < .01).
      		51%54%
      Indicates statistically significant change from baseline year (P < .01).
      		18%16%
      Indicates statistically significant change from baseline year (P < .01).
      		50%51%
      Tdap (aged 19-64 years)20%39%
      Indicates statistically significant change from baseline year (P < .01).
      		0%1%53%59%
      Indicates statistically significant change from baseline year (P < .01).
      		24%30%
      Indicates statistically significant change from baseline year (P < .01).
      		76%80%
      Indicates statistically significant change from baseline year (P < .01).
      Tdap (aged ≥65 years)8%12%____33%38%
      Indicates statistically significant change from baseline year (P < .01).
      		75%77%
      PPSV23 (aged ≥65 years)____63%62%21%26%
      Indicates statistically significant change from baseline year (P < .01).
      		82%82%
      PPSV23 (high-risk
      High-risk indications per Advisory Committee on Immunization Practices guidelines were as follows: PPSV23: Chronic heart disease, receiving hemodialysis, end-stage renal disease, chronic lung disease, chronic alcoholism, chronic liver disease, asplenia, diabetes; PCV13: Receiving hemodialysis, end-stage renal disease, asplenia; Hepatitis B: Receiving hemodialysis, end-stage renal disease, chronic liver disease, diabetes, HIV.
      aged 19-64 years)      		______10%23%
      Indicates statistically significant change from baseline year (P < .01).
      		24%60%
      Indicates statistically significant change from baseline year (P < .01).
      PCV13 (aged ≥65 years)____84%72%
      Indicates statistically significant change from baseline year (P < .01).
      		28%36%
      Indicates statistically significant change from baseline year (P < .01).
      		71%75%
      PCV13 (high-risk
      High-risk indications per Advisory Committee on Immunization Practices guidelines were as follows: PPSV23: Chronic heart disease, receiving hemodialysis, end-stage renal disease, chronic lung disease, chronic alcoholism, chronic liver disease, asplenia, diabetes; PCV13: Receiving hemodialysis, end-stage renal disease, asplenia; Hepatitis B: Receiving hemodialysis, end-stage renal disease, chronic liver disease, diabetes, HIV.
      aged 19-64 years)      		______4%100%
      Indicates statistically significant change from baseline year (P < .01).
      		30%41%
      Herpes zoster (aged 60-64 years)____37%42%__45%52%
      Herpes zoster (aged ≥65 years)________58%61%
      Hepatitis B (high-risk
      High-risk indications per Advisory Committee on Immunization Practices guidelines were as follows: PPSV23: Chronic heart disease, receiving hemodialysis, end-stage renal disease, chronic lung disease, chronic alcoholism, chronic liver disease, asplenia, diabetes; PCV13: Receiving hemodialysis, end-stage renal disease, asplenia; Hepatitis B: Receiving hemodialysis, end-stage renal disease, chronic liver disease, diabetes, HIV.
      aged ≥19 years who completed series)      		________8%8%
      HPV (women aged 19-26 years who completed series)________46%48%
      HPV (men aged 19-26 years who completed series)________12%24%
      Indicates statistically significant change from baseline year (P < .01).
      HPV, human papillomavirus; PPSV23, Pneumovax; PVC13, Prevnar.
      – indicates site did not implement standing orders protocols for that vaccine.
      low asterisk Indicates statistically significant change from baseline year (P < .01).
      † High-risk indications per Advisory Committee on Immunization Practices guidelines were as follows: PPSV23: Chronic heart disease, receiving hemodialysis, end-stage renal disease, chronic lung disease, chronic alcoholism, chronic liver disease, asplenia, diabetes; PCV13: Receiving hemodialysis, end-stage renal disease, asplenia; Hepatitis B: Receiving hemodialysis, end-stage renal disease, chronic liver disease, diabetes, HIV.
      All sites reported SOP-related increases in the number of onsite influenza vaccinations administered (Fig 1A-E), but vaccination rates did not necessarily increase significantly because vaccination delivery shifted from outside the practice to onsite. The Site D influenza coverage rate declined although the number of influenza vaccines given increased (Fig 1D) during the data collection period because the site inherited patients from another practice that closed. The other 4 sites demonstrated modest (1%-6%) improvements in influenza vaccination coverage (Fig 1A,B,C,E).
      Fig 1
      Fig 1(A-E) Detailed findings for influenza vaccination at the 5 study sites. Reprinted with permission.
      Immunization rates generally increased during the first quarter after implementation of SOPs, but then flattened out or declined during subsequent quarters. Figure 2 depicts the baseline year and cumulative quarterly vaccination rates for influenza (Fig 2A), Tdap (Fig 2B), pneumococcal conjugate (PCV13) (Fig 2C), and PPSV23 (Fig 2D).
      Fig 2
      Fig 2Baseline year and cumulative quarterly results for influenza (A), Tdap (B), PCV13 (C), and PPSV23 (D).

      Challenges in achieving and sustaining increased adult vaccination coverage rates

      Table 3 describes numerous challenges reported by sites related to maintaining staff engagement and achieving and sustaining increases in adult vaccination rates during the study.
      Table 3Challenges reported by participating sites
      Reported by sitesChallenges in achieving and sustaining increased adult vaccination rates
      All sitesEMRs had varied capability to provide administrative data required for reporting on adult immunization.
      All sitesEMRs were unable to easily implement clinical decision support systems. It was difficult to program EMRs to identify risk-based patients eligible for immunizations.
      All sitesMedicare Part D coverage of Tdap and zoster vaccines was a barrier to vaccine administration. Patients over age 65 years were referred to pharmacies for Tdap and zoster, but many patients did not receive recommended vaccines.
      A, B, C, DSites experienced suboptimal access to adult immunization histories via EMR systems and state IIS. Not all providers report vaccine administration of adults and not all providers have real-time access to IIS to allow uploading or downloading of patient history.
      A, B, C, DThere was reluctance by providers to vaccinate adult patients without documented vaccination history due to financial risk.
      B, C, DDoctors and advanced care practitioners have limited time with each patient to provide vaccination and other preventive care services.
      B, C, DNursing staff workflow (rooming patients, taking vitals, etc) allowed little time for vaccination-related activities.
      C, DChampions reported a lack of engagement by staff and speculated this could be owing to a lack of incentives (gift cards, pay differentials, additional paid time off, etc) for additional responsibilities.
      C, DThere was low prioritization of adult immunization by administrators and providers because results did not contribute to current quality metrics.
      EMR, electronic medical record; IIS, immunization information system.

      Discussion

      Vaccination rates for adults have been stagnant nationally,
      • Williams W
      • Lu P-J
      • O'Halloran A
      • Kim D
      • Grohskopf L
      • Pilishvili T
      • et al.
      Surveillance of vaccination coverage among adult populations–United States, 2015.
      MMWR Surveill Summ. 2017; 66: 1-21
      and it is important to try to figure out how to help clinicians improve coverage rates. The implementation of SOPs provided critical infrastructure and successfully integrated adult immunization into office routines. The diversity of the patient population and practice type (Table 1), as well as the vaccine(s) that was/were chosen by the sites (Table 2), likely contributed to the broad range of results. The study was designed with flexibility to give the sites ownership of SOP implementation.
      One consideration is a potential Hawthorne effect at the sites that participated in the study. All sites received targeted training, encouragement, and educational opportunities for key staff members from outside sources. Comparisons with other sites and quarterly data reporting provided opportunity for friendly competition. Sites found the support helpful and were excited to share what they learned during the process. Using similar strategies on a larger scale could help support sustaining improved coverage rates.
      Participating sites and their immunization champions reported challenges using adult immunization SOPs that are not experienced by immunizers of children. Based on the results from our year-long study, additional interventions

      Community Preventive Services Task Force. Increasing appropriate vaccination: health care system-based interventions implemented in combination. Available from:https://www.thecommunityguide.org/sites/default/files/assets/Vaccination-Community-Based-in-Combination.pdf. Accessed February 15, 2018.

      and incentives may be needed to advance a cultural shift among clinicians, and address adult vaccination barriers to achieve and sustain higher adult vaccination rates. The immunization champion at Site D expressed the desire to vaccinate adults and provide other preventive care services but had limited time with each patient. The Site B immunization champion was passionate about vaccination but acknowledged that clinic visits focus first on fertility and gynecologic health concerns, leaving vaccination a lower priority.
      Fundamentally, providers who vaccinate adults do not have the same immunization volumes compared with pediatric providers. For healthy adults, ACIP routinely recommends only 11 vaccine doses (excluding influenza)

      Centers for Disease Control and Prevention. Recommended immunization schedule for adults aged 19 years or older, United States, 2019. Available from: https://www.cdc.gov/vaccines/schedules/hcp/imz/adult.html. Accessed September 18, 2019.

      compared with 32 doses per healthy child through age 18 years (excluding influenza, meningococcal B, PPSV23).

      Centers for Disease Control and Prevention. Recommended Child and Adolescent Immunization Schedule for Ages 18 Years or Younger, United States, 2019. Available from:https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html. Accessed September 18, 2019.

      Higher numbers of vaccine doses provide more provider opportunities to vaccinate, and potentially increase bulk purchasing power. There are long intervals between doses of some recommended adult vaccines.

      Centers for Disease Control and Prevention. Recommended immunization schedule for adults aged 19 years or older, United States, 2019. Available from: https://www.cdc.gov/vaccines/schedules/hcp/imz/adult.html. Accessed September 18, 2019.

      Consequently, providers realize less benefit from vaccine volume ordering or automating adult immunization processes. This can result in decreased motivation to sustain and improve adult coverage rates, despite the addition of SOPs.
      Studies have found that standing orders alone resulted in a 16% increase in vaccination rates,

      Community Preventive Services Task Force. Increasing appropriate vaccination: standing orders. Task force finding and rationale statement. Available from:https://www.thecommunityguide.org/sites/default/files/assets/Vaccination-Standing-Orders.pdf.Accessed February 9, 2018.

      and a combination of interventions involving 2 or 3 strategic approaches was more successful than single interventions at increasing vaccination rates (17% vs 4%).

      Community Preventive Services Task Force. Increasing appropriate vaccination: health care system-based interventions implemented in combination. Available from:https://www.thecommunityguide.org/sites/default/files/assets/Vaccination-Community-Based-in-Combination.pdf. Accessed February 15, 2018.

      Multiple interventions at 2 public health obstetrics and gynecology clinics resulted in significant increases for influenza (35.4%-46%), Tdap (87.6%-94.5%), and HPV (7.1%-23.7%) vaccines.
      • Mazzoni SE
      • Brewer SE
      • Pyrzanowski JL
      • Durfee MJ
      • Dickinson LM
      • Barnard JG
      • et al.
      Effect of a multi-modal intervention on immunization rates in obstetrics and gynecology clinics.
      Am J Obstet Gynecol. 2016; 214 (617.e1-7)
      Incorporation of incentives and adult immunization goals into quality metrics such as the Centers for Medicare and Medicaid Services “Meaningful Measures”

      Centers for Medicare & Medicaid Services. Overview of the CMS Meaningful Measures Initiative. Available from:https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/CMS-Meaningful-Measures_Overview-Fact-Sheet_508_2018-02-28.pdf. Accessed October 1, 2018.

      could motivate sustained change. Indeed, there are now 2 new Healthcare Effectiveness Data and Information Set measures being implemented for 2019. The Healthcare Effectiveness Data and Information Set is an industry performance standard used to address how well health plans are serving their members. These 2 new adult immunization measures are an adult composite measure and a prenatal composite measure.

      NCQA. Updates quality measures for HEDIS 2019-NCQA. Available from:https://www.ncqa.org/news/ncqa-updates-quality-measures-for-hedis-2019/. Accessed February 25, 2019.

      These types of measures could provide a rationale for practices to incentivize not only immunization champions, but also administration, leadership, and support staff. None of the study champions received fiscal support from their practice/systems, nor did they receive financial incentives to improve immunization coverage rates for adult patients. The immunization champions were motivated because they saw a gap in performance within their systems/practices and chose to do better. The study was a way for them to evaluate the processes of implementing and sustaining their adult immunization program.

      Connection of IIS and EMRs to adult immunization coverage rates

      The ability for provider sites to quickly, in real-time, determine the immunization history of a patient facilitates efficient provision of needed vaccines and plays to the strength of SOPs. However, our study demonstrates that the lack of bidirectional data exchange between the facilities’ EMR and the state IIS continues to be a barrier to improving adult immunization rates under SOPs due to incomplete or outdated immunization history. Figure 1 illustrates IIS impact to immunization coverage rates. Sites A (Fig 1A), B (Fig 1B), and C (Fig 1C) had limited or no access to their IIS for patients who received influenza vaccine offsite; their vaccination rates primarily reflect immunizations given onsite. In contrast, Sites D (Fig 1D) and E (Fig 1E) had good access to their state IIS; their data included larger numbers of patients receiving offsite immunizations. The result was that Sites D and E received credit for vaccines they did not administer (that were received elsewhere), whereas Sites A, B, and C were limited to reporting on vaccines that were administered onsite.
      Streamlining adult vaccination procedures facilitates prioritization by easing the burden on providers. Yonas et al
      • Yonas MA
      • Nowalk MP
      • Zimmerman RK
      • Ahmed F
      • Albert SM
      Examining structural and clinical factors associated with implementation of standing orders for adult immunization.
      J Healthc Qual. 2012; 34: 34-42
      noted that the ability to integrate immunization and SOPs within the EMR should be a key consideration when evaluating a system. Researchers and sites found the EMRs had varied capabilities. Each site had a different EMR and all reported that functional limitations created difficulty obtaining basic immunization data for reporting requirements. In response to limitations and reporting requirements, Sites A and D recognized long-term benefit to data accessibility and augmented their EMR reporting capacity. Sites B, D, and E found prompt reporting of immunization data critical to foster accountability.
      In particular, we found that comprehensive immunization alerts (age, time, and risk-based) for eligible adult patients incorporated into the clinics’ EMRs increase efficiency and may be more effective than ad hoc administration of adult vaccines. Many ACIP adult immunization recommendations are risk-based,

      Centers for Disease Control and Prevention. Recommended immunization schedule for adults aged 19 years or older, United States, 2019. Available from: https://www.cdc.gov/vaccines/schedules/hcp/imz/adult.html. Accessed September 18, 2019.

      and none of the participating clinics’ current EMR configurations provided for simple integration of algorithms to flag risk-based indications for adult immunization, nor did clinics have sufficient resources to address their EMR shortcomings.
      Four sites reported that SOP implementation could be better facilitated by clinical decision support systems that identified patients eligible for immunization. Site E elected to program clinical decision support into its EMR for risk-based recommendations for pneumococcal vaccinations (PCV13 and PPSV23),

      Centers for Disease Control and Prevention. Pneumococcal vaccine timing for adults. Available from: https://www.cdc.gov/vaccines/vpd/pneumo/downloads/pneumo-vaccine-timing.pdf. Accessed September 18. 2019.

      although the process was complex and took >12 months to implement. Their baseline immunization rate for PPSV23 high-risk patients was 24%; it increased to 60% (Table 2) during the intervention. PCV13 increases were not as robust, staff may have been more accustomed to only administering PPSV23 and did not prioritize administration of PCV13 to elderly and/or high-risk patients. Site E also made a strategic decision, after implementation of SOPs and reviewing the initial study reports, to prioritize improving vaccination coverage rates in high-risk patients for hepatitis B, pneumococcal, and HPV for male patients.
      Because of competing priorities within the health care system's information technologies department, Site E was unable to program risk-based alerts for hepatitis B vaccination

      Centers for Disease Control and Prevention. Recommended immunization schedule for adults aged 19 years or older, United States, 2019. Available from: https://www.cdc.gov/vaccines/schedules/hcp/imz/adult.html. Accessed September 18, 2019.

      during the study. Both measurements of hepatitis B vaccination (initiated series and completed series) increased, but neither were statistically significant (Table 2). Site E reported similar numbers of high-risk patients eligible for pneumococcal and hepatitis B vaccination; EMR alerts accounted for the difference in immunization coverage rates.

      Impact of Medicare Part D on adult immunization coverage rates

      Most study sites did not provide onsite Tdap and zoster immunizations for patients aged ≥65 years, citing inconsistent and inadequate payment for patients with Medicare Part D coverage. Instead, providers recommended that patients get these immunizations at other facilities (eg, pharmacies), but reported concern that many patients did not follow their recommendation to get vaccinated at a pharmacy.
      An example of the impact of Medicare Part D on adult immunization coverage rates was documented in the Site A Tdap coverage rates. During the study, Site A used multiple interventions (office signage, staff training, reminder calls to patients, and walk-in immunization services), in addition to SOPs, to promote Tdap vaccination. Within their population aged 19-64 years, the baseline Tdap immunization rate doubled from 20%-39%, a statistically significant increase (Table 2). However, for patients aged ≥65 years, the rate increased from 8% at baseline to only 12% during the implementation year (Table 2). Although this is a 50% increase, vaccine coverage remained very low. Site A attributed the difference to challenges of Medicare Part D payment and attempted to provide these vaccines before the patient turned 65 years of age, whenever possible.

      Significant adult immunization coverage rates achieved on a large scale combining SOPs and other interventions

      There is precedent for success and return on investment for improving adult immunization coverage rates by combining SOPs with other evidence-based interventions. The Indian Health Service implemented SOPs supported by widespread involvement of medical and pharmacy staff, and leveraged the functionality of their EMR to assess patient vaccination status, generate reminders for providers and patients, and monitor vaccination coverage levels.
      • Bridges CB
      • Hurley LP
      • Williams WW
      • Ramakrishnan A
      • Dean AK
      • Groom AV
      Meeting the challenges of immunizing adults.
      Vaccine. 2015; 33: D114-D120
      These efforts generated significant improvements in adult immunization coverage rates in 2017; 79% of patients aged ≥19 years received Tdap vaccine, 60% of patients aged ≥60 years received zoster vaccine, and 79% of patients aged ≥65 years received a dose of PPSV23 or PCV13.

      Groom A. Fourth Quarter FY 2017 Immunization Report. Available from: https://www.ihs.gov/sites/epi/themes/responsive2017/display_objects/documents/vaccine/reports/FY17_4thQuarter.pdf. Accessed September 18, 2019.

      Their results show that adult immunization coverage rates can be increased on a large scale by using SOPs as a fundamental building block for routine assessment and delivery of adult vaccines, and coupling that foundation with EMRs to assist in risk-based assessments, send out patient and provider reminders, and report data to medical and pharmaceutical staff.
      The Indian Health Service data coupled with our findings of an increase of immunization rates within first quarter of intervention suggest that for adult populations, SOPs may provide a meaningful starting point for building an adult immunization program, but that other interventions should be considered to maximize vaccinations rates for adults. The immunization champion from Site D stated he would not have been able to convince his board to authorize the program without SOPs. The incorporation of SOPs provided an essential framework for his team to effectively implement necessary structural changes for vaccination administration, addressing all aspects of vaccine administration and building staff confidence.

      Limitations

      Our study included only 5 clinics; consequently, our results may not be generalizable. Study sites were selected from participants at workshops focused on adult immunization, and as such they may have been more highly motivated than other institutions. The study did not involve tracking outcomes associated with adult vaccination, and more research is needed to evaluate the impact of increasing vaccine uptake on the incidence of vaccine-preventable illnesses. The study was limited to a year-long study. Although providing evidence that practices initially increased their vaccination coverage rates, it cannot address longer term sustainability of improved coverage rates accomplished by SOPs.

      Conclusions

      SOPs empower nonphysician health care professionals to independently assess patients and administer vaccines, promoting practice efficiency. Our results suggest that SOPs generated modest increases in adult immunization coverage rates and varied depending on the vaccine. We identified systemic barriers to adult immunizations, including the lack of bidirectional data integration between EMRs and state IISs, and challenges with Medicare Part D payment that prevent greater improvement in adult immunization coverage rates after SOPs implementation. When additional interventions (such as implementation of clinical decision support system, staff training, office signage, reminder calls to patients, and walk-in immunization services) were coupled with SOPs implementation, greater gains in coverage rates were achieved. Although it may be beneficial to include SOPs within a comprehensive plan to increase coverage rates, our findings suggest that these additional interventions may be necessary to sustain increased adult immunization rates.

      Acknowledgements

      The authors would like to acknowledge the staff and immunization champions from each of the 5 study sites for their exceptional efforts to protect and improve the health of their community through the implementation of standing orders for adult vaccination. The authors are indebted to Miriam R. Amelang and Angela Lax of Ofstead & Associates, Inc. for their support with data collection, analysis, and site coordination. In addition, the authors are grateful to Marian Deegan of Fortuni for editing this manuscript, which was funded by Pfizer .

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      Article Info

      Publication History

      Published online: October 18, 2019

      Footnotes

      Funding/support: Funding for the Take a Stand program and this study of program effectiveness was provided by Pfizer Inc. as part of a multiyear collaboration agreement with the Immunization Action Coalition. Pfizer did not provide workshop content, have contact with study participants, or participate in data collection or analysis. In addition, Pfizer did not provide any free or discounted vaccines to study sites. Participating institutions were not required to use any particular products for adult vaccination.

      Conflicts of interest: None to report.

      Identification

      DOI: https://doi.org/10.1016/j.ajic.2019.07.023

      Copyright

      © 2019 The Author(s). Published by Elsevier Inc. on behalf of Association for Professionals in Infection Control and Epidemiology, Inc.

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