Abstract
Introduction: In 2012, the Advisory Committee on Immunization Practices recommended 13-valent pneumococcal conjugate vaccine (PCV13) in series with 23-valent pneumococcal polysaccharide vaccine (PPSV23) for at-risk adults ≥19; in 2014, it expanded this recommendation to adults ≥65. Primary care physicians' practice, knowledge, attitudes, and beliefs regarding these recommendations are unknown.
Methods: Primary care physicians throughout the U.S. were surveyed by E-mail and post from December 2015 to January 2016.
Results: Response rate was 66% (617 of 935). Over 95% of respondents reported routinely assessing adults' vaccination status and recommending both vaccines. A majority found the current recommendations to be clear (50% “very clear,” 38% “somewhat clear”). Twenty percent found the upfront cost of purchasing PCV13, lack of insurance coverage, inadequate reimbursement, and difficulty determining vaccination history to be “major barriers” to giving these vaccines. Knowledge of recommendations varied, with 83% identifying the PCV13 recommendation for adults ≥65 and only 21% identifying the recommended interval between PCV13 and PPSV23 in an individual <65 at increased risk.
Conclusions: Almost all surveyed physicians reported recommending both pneumococcal vaccines, but a disconnect seems to exist between perceived clarity and knowledge of the recommendations. Optimal implementation of these recommendations will require addressing knowledge gaps and reported barriers.
In the United States, Streptococcus pneumoniae bacteria causes an estimated 445,000 hospitalizations annually.1 In 2015 it caused approximately 29,500 cases of invasive pneumococcal disease and 3,350 deaths.2 Adult pneumococcal disease is a major source of pneumococcal disease–related health care utilization and costs.1
Vaccines are an effective way to prevent pneumococcal disease and thereby reduce the burden and cost of pneumococcal disease. In the United States, the 23-valent pneumococcal polysaccharide vaccine (PPSV23) has been recommended since 1984 for adults aged ≥65 years and adults with high-risk conditions.3 These recommendations have been revised4⇓–6, expanding indications for the vaccination and introducing revaccination for some high-risk groups and for adults aged ≥65 years who received their first dose of PPSV23 before age 65. However, PPSV23 remained the only available product for pneumococcal disease prevention among adults through 2011. In terms of efficacy, strong evidence demonstrates that PPSV23 protects against invasive pneumococcal disease; however, PPSV23 does not consistently protect against pneumonia.7
In 2011 the pneumococcal conjugate vaccine (PCV13) was approved by the US Food and Drug Administration for use among adults aged ≥50 years.8 In 2012, the Advisory Committee on Immunization Practices (ACIP) recommended PCV13 in a series with PPSV23 for high-risk adults aged ≥19 years.9 In 2014, based on data demonstrating vaccine-preventable disease burden and on results of the CAPITA trial10, which show the efficacy of PCV13 to prevent nonbacteremic pneumonia and invasive pneumococcal disease caused by vaccine serotypes in adults aged ≥65 years, ACIP expanded recommendations for the use of PCV13 to include recommending PCV13 in series with PPSV23 for all adults aged ≥65 years.11 In June 2015 ACIP revised the recommended intervals between PCV13 and PPSV23 for adults aged ≥65 years from 6 months to 1 year.12 Adults are recommended to receive both types of pneumococcal vaccine because PCV13 offers some protection against pneumonia, and a large portion of invasive pneumococcal disease in the United States is a result of serotypes unique to PPSV23.13 A complete timeline of adult pneumococcal vaccine recommendations is presented in Table 1.
Despite longstanding ACIP recommendations for PPSV23 in adults, recent vaccination coverage was 64% among adults aged ≥65 years and only 23% among high-risk adults aged 19 to 64 years14—both well below HealthyPeople 2020 goals. Physician perceptions of these changes to the adult pneumococcal vaccine recommendations is unknown. Because physician recommendation is so important to patients' receipt of vaccines15⇓⇓–18, we sought to describe the current practice, knowledge, attitudes, and beliefs of primary care physicians regarding the current adult pneumococcal vaccine recommendations.
Methods
Study Setting
From December 2015 to January 2016 we administered a survey to a national network of physicians who spent at least half their time practicing primary care. The human subjects review board at the University of Colorado Denver approved this study as exempt research that did not require written informed consent.
Study Population
The Vaccine Policy Collaborative Initiative19, a survey mechanism to assess physician attitudes about vaccine issues, in collaboration with the Centers for Disease Control and Prevention (CDC), conducted the survey. We developed a network of primary care physicians by recruiting general internists (GIMs) and family physicians (FPs) from the memberships of the American College of Physicians and the American Academy of Family Physicians. We performed quota sampling20 to ensure that networks of physicians were similar to the American College of Physicians and American Academy of Family Physicians memberships with respect to region, urban/rural locations, and practice setting. We previously demonstrated that survey responses from network physicians compared with those of physicians randomly sampled from American Medical Association physician databases were similar with respect to reported demographic characteristics, practice attributes, and attitudes about vaccination issues.20
Survey Design
We developed the survey collaboratively with the CDC. The survey asked about physician practices regarding assessing the need for, recommending, and stocking PCV13 and PPSV23 vaccines, and whether physicians referred patients for either vaccine if the vaccine(s) was not stocked. We used 4-point Likert scales to assess physician perceptions of the clarity of (“very clear” to “very unclear”), ease of implementation of (“very easy” to “very difficult”), and barriers to following (“not a barrier” to “major barrier”) the 2015 ACIP adult pneumococcal vaccine recommendations. Physicians were asked what type of resources would help clarify the recommendations and whether they had a computerized way to identify adults <65 years old who needed either pneumococcal vaccine. Physicians were presented a series of case scenarios and asked questions aimed to assess knowledge of specific elements of the ACIP adult pneumococcal vaccine recommendations (Table 2). To encourage them to answer these questions without referring to other sources, “I would need to look this up” was an available response option. A national advisory panel of GIMs (n = 6) and FPs (n = 7) pretested the survey, which we modified based on their feedback. We pilot-tested the survey among 50 GIMs and 23 FPs nationally and further modified it based on their feedback.
Survey Administration
Based on physician preference, we sent the survey over the internet (Vovici Feedback; Verint Systems Inc., Melville, NY) or through US post. We sent the internet group an initial E-mail with up to 8 E-mail reminders, and we sent the post group an initial mailing and up to 2 additional reminders. Nonrespondents in the internet group were also sent by post up to 2 surveys in case of problems with E-mail correspondence. We patterned the mail protocol on the tailored design method described by Dillman et al.21
Statistical Analysis
Analyses were conducted January 2016 through September 2016. We pooled internet and post surveys for analyses because other studies have found that physician attitudes are similar when obtained through either method.21⇓–23 We compared respondents with nonrespondents on all available characteristics using t tests, χ2, and Mantel-Haenszel χ2 analyses; characteristics of nonrespondents were obtained from the recruitment survey for the sentinel networks. Results were very similar for GIMs and FPs and are therefore presented together. After excluding physicians who responded that they were not familiar with the recommendations (n = 5), we used χ2 analysis to compare physicians who perceived the recommendations as “very clear” or “somewhat clear” versus those who perceived them as “somewhat unclear” or “very unclear” in terms of what resources they reported would help clarify the recommendations. All analyses were performed using SAS version 9.4 (SAS Institute, Cary, NC).
Results
Survey Responses and Respondent Characteristics
The overall response rate was 66% (617 of 935). Respondents and nonrespondents did not differ significantly by census location (urban, suburban, or rural). Male and older physicians, and physicians from private practices or practicing in the South, were less likely to respond, whereas physicians from the Midwest or larger practices were more likely to respond. Characteristics of respondents and nonrespondents and other characteristics of respondents' practices and patient populations are shown in Table 3. Of those who responded, 15 reported they do not give immunizations to adult patients and were excluded from further analysis, leaving a final cohort of 602 physicians.
Current Pneumococcal Vaccination Practices
Nearly all respondents reported assessing the need for (96%) and recommending (95%) PCV13; 86% reported stocking it. Almost all respondents reported assessing the need for (98%) and recommending (97%) PPSV23; 92% reported stocking it. A total of 31% and 38% reported having a computer-based way to identify adults aged <65 who needed PCV13 or PPSV23, respectively. Of those physicians who reported not stocking PCV13 (n = 72) or PPSV23 (n = 49), 81% and 72%, respectively, referred patients elsewhere for the vaccine.
Perceptions of ACIP Adult Pneumococcal Vaccine Recommendations
The majority of respondents reported that the recommendations were clear (50% “very clear” and 38% “somewhat clear”); 11% reported that they are “somewhat unclear” or “very unclear,” and 1% said they were not familiar with the recommendations. Most also reported the recommendations were easy to implement in practice (48% “very easy,” 34% “somewhat easy”); 17% reported it was “somewhat difficult” or “very difficult” to implement the recommendations. Physicians reported that the following resources would help clarify the recommendations: a simplified fact sheet/flow diagram with patient scenarios (82%); an electronic medical record prompt (81%); an online self-paced continuing medical education course (56%); an interactive, patient-specific mobile app (45%); or an online webinar (36%). We found no statistical difference in responses to what resources would help clarify the recommendations between physicians who perceived the recommendations as clear versus those who perceived them as unclear. Figure 1 shows the perceived barriers to giving PCV13 and PPSV23 in series.
Knowledge of ACIP's Adult Pneumococcal Vaccine Recommendations
Table 4 shows respondent results for the series of case-based questions we used to evaluate respondents' knowledge of the ACIP's adult pneumococcal vaccine recommendations. We identified variability in the proportion of correct responses. Physicians were most knowledgeable about which pneumococcal vaccine to give first to adults aged ≥65 and least knowledgeable about the recommended interval between PCV13 and PPSV23 vaccines in patients <65 who are at high risk; respondents often (54%) provided the correct response for the interval recommended for adults ≥65 years old. Despite being given the option to say they would need to look the answer up, approximately a third or more of physicians answered half of the questions incorrectly.
Discussion
Almost all physicians reported assessing the need for, recommending, and stocking both pneumococcal vaccines and, if they did not stock pneumococcal vaccines, referring patients to receive them elsewhere. While most physicians reported that the recommendations were clear, we identified several knowledge gaps regarding the recommendations. Physicians reported that prompts in the electronic medical record would help clarify the recommendations, and the majority reported not having them in place. The top reported barriers to giving pneumococcal vaccines in series were financial concerns and difficulty determining a patient's pneumococcal vaccination history.
In previous surveys, physicians have reported financial barriers to providing adult vaccines24,25—primarily that they are inadequately reimbursed.26 The specific barriers reported in this study about Medicare not covering the pneumococcal vaccines in series and insurance not paying for pneumococcal vaccines if the appropriate time had not elapsed may be rooted in initial disparities between Medicare policy and the recommendations. ACIP recommended both pneumococcal vaccines to be given in series to adults aged ≥65 years in August 2014, and while the Centers for Medicare and Medicaid Services responded swiftly to change regulations to allow coverage of the series in February 2015, months went by when the recommendations and Medicare policy were not aligned. In addition, even though the ACIP initially recommended different intervals between the 2 pneumococcal vaccines depending on which was given first, Centers for Medicare and Medicaid Services would only pay for both vaccines if a year elapsed between administration of the 2 vaccines, regardless of which vaccine had been given first. ACIP subsequently reevaluated their adult pneumococcal recommendations and in September 2015 recommended a year interval between the vaccines regardless of which vaccine was given first. The main reason for this change was to simplify the recommendation; the evidence supported the longer interval for immunocompetent adults, but part of the rationale was to coordinate the ACIP recommendations with Medicare payment. Both vaccines are covered under Medicare Part B, and >90% of Medicare beneficiaries have Medicare Part B.27 That physicians still reported these barriers to giving pneumococcal vaccines in series in 2016 suggests a need to evaluate why physicians perceive this and to investigate how to better communicate policy changes.28,29
Physicians also reported private insurance and Medicaid not covering pneumococcal vaccines as barriers to giving these vaccines in series. Most private insurance companies should be covering these vaccines because the Affordable Care Act (ACA) mandates that ACIP-recommended vaccines be covered with no cost-sharing in nongrandfathered insurance plans. The perception that these vaccines are not covered by private insurance may have a couple of explanations. Because pneumococcal vaccine recommendations for high-risk adults younger than 65 and for adults older than 65 are relatively new, there may have been a lag between ACIP making these recommendations and private insurance companies covering them. In addition, some private insurance plans are “grandfathered” and do not have to adhere to the ACA mandate that all ACIP-recommended vaccines be covered; 23% of employer-based insurance met these criteria in 2017.30 State Medicaid agencies variably cover PPSV23 for adults, and this might partially explain several physicians reporting that Medicaid does not cover these vaccines in series. Medicaid provider reimbursement for adult immunizations in 2012 found that at least 3 state Medicaid agencies did not cover PPSV2331; state Medicaid coverage of PCV13 is not published but may presumably be lower given how much more expensive PCV13 is than PPSV23.32 The ACA did not affect physicians' vaccine purchasing costs, so it is not surprising that physicians found the up-front costs of purchasing pneumococcal vaccines to be a deterrent to giving these vaccines in series.
Aside from financial barriers, the most common barrier was difficulty determining vaccination history; a similar finding to that of a survey of GIMs concerning PPSV23.33 Giving unnecessary vaccines leads to unwarranted expense and denial of insurance claims; although the risk of severe adverse events from PCV13 and PPSV23 is low, it also exposes patients to potential vaccine-related adverse events. Adults may receive pneumococcal vaccines at various locations, including primary care physicians' and subspecialists' offices and retail pharmacies. Pharmacies in all states have jurisdiction to administer the pneumococcal vaccine to adults.34 Adults also move around and do not necessarily keep good vaccination records. These factors combine to complicate determining patients' pneumococcal vaccination history. Immunization information systems (IISs) are confidential computerized systems that collect and consolidate vaccination data from multiple vaccine providers; broad use of IISs could partially address this identified barrier.35,36 Although the National Vaccine Advisory Committee standards and Community Preventive Services Task Force guideline encourage IIS use37, 72% of FPs and only 27% of GIMs who administer vaccines use them.38
While physicians did not generally report confusion about pneumococcal vaccines as a major barrier to giving these vaccines in series, their responses to knowledge questions tell a different story. Physicians were most knowledgeable about the recommendation to give PCV13 first to adults aged ≥65. This is possibly related to age-based recommendations being easier to understand and/or media campaigns specifically targeting seniors. Physicians were less knowledgeable about other adult PCV13 recommendations, and this is possibly attributable to the newness of the recommendations and the complexity of the risk-based recommendations. The confusion about the timing between PCV13 and PPSV23 in adults aged ≥65 may be due to the recommendation changes that occurred in a short time.11,12 Physicians were least knowledgeable about the recommended interval between PCV13 and PPSV23 for high-risk adults <65 years old, yet they often gave the correct response for adults aged ≥65, suggesting a lack of recognition of the differences in the recommendations for these 2 populations. Knowledge gaps were not limited to the new pneumococcal vaccine recommendations. Physicians were also confused about asthma being a qualifying condition for PPSV23 and the timing between PPSV23 doses for high-risk adults <65 years old, and for adults ≥65 when the first dose of PPSV23 was received before age 65. PPSV23 has been recommended since 2010 for patients with asthma,6 and the recommended revaccination intervals between doses of PPSV23 have not been changed since 1997.5
Another notable issue with the knowledge questions is that large percentages of physicians (11% to 58%) still answered questions incorrectly despite being offered the response option of needing to look the answer up. This may indicate that they feel confident in their incorrect answers and would not use resources that would need to be sought out to guide their decisions.39 This has implications on optimal vaccine delivery and possibly contributes to the low observed rates for pneumococcal vaccine coverage among adults.14
The confusion identified here suggests that having an active clinical decision support system (CDSS) to identify adult patients who need pneumococcal vaccines at a visit, and not relying on physician knowledge, could help implement pneumococcal vaccine recommendations. Electronic health record (EHR) technology makes CDSSs possible. Over 90% of physicians reported using an EHR, but only approximately a third indicated having a computerized way to identify high-risk patients who need either pneumococcal vaccine. However, the majority (81%) indicated that prompts in the EHR would help clarify the recommendations. Because of the challenge of interpreting clinically written ACIP recommendations, current CDSS engine outputs often vary and are inconsistent in accurately reflecting ACIP recommendations.40 The CDC created and continues to work on CDSS resources that can be integrated into EHRs to capture ACIP recommendations and could prove useful to adult pneumococcal vaccination efforts.40
Our study has strengths and limitations. Results were generated from primary care physicians from across the nation, and we achieved an excellent response rate for a physician survey.41,42 Although our sample was designed to be representative of American College of Physicians and the American Academy of Family Physicians memberships, the attitudes, experiences, and practices of sentinel physicians may not be fully generalizable. Nonrespondents may have held different views than respondents. The survey relied on self-report of practice rather than observation of practice.
The practices reported by primary care physicians with regard to stocking and recommending pneumococcal vaccines suggest a positive outlook for implementation of the ACIP recommendations. However, realizing optimal implementation will require ensuring coverage for these vaccines, making physicians aware of this coverage, and addressing knowledge gaps regarding these recommendations. Our data support harnessing EHR capability to create accurate CDSSs for these complex recommendations that would actively prompt physicians to accurately apply ACIP pneumococcal recommendations, as opposed to looking up information they think they know.
Acknowledgments
The authors thank Bellinda Schoof, MHA, and Jennifer Frost, MD, at the American Academy of Family Physicians; Darilyn Moyer, MD, Wendy Nichel, MPH, and Sandra Fryhofer, MD, from the American College of Physicians; and the participating physicians.
Notes
This article was externally peer reviewed.
Funding: This publication was supported by Cooperative Agreement 1 U01 IP000849-02, funded by the Centers for Disease Control and Prevention, Atlanta, GA.
Conflict of interest: none declared.
Disclaimer: The contents of this publication are solely the responsibility of the authors and do not necessarily represent the official views of the Centers for Disease Control and Prevention or the US Department of Health and Human Services.
To see this article online, please go to: http://jabfm.org/content/31/1/94.full.
- Received for publication May 31, 2017.
- Revision received August 17, 2017.
- Accepted for publication August 31, 2017.