Materials and Methods
Participants
The project sample included staff and providers from 6 obstetrician-gynecologist practices: 5 private clinics and 2 obstetrician-gynecologist clinics in one large safety-net system. Staff members worked at both safety-net clinics and were therefore combined for analytic purposes. Key personnel involved in immunization program administration and implementation (such as medical directors, practice administrators, nurses, and medical assistants [MA]) were identified at each site, approached to participate, and provided informed consent.
In total, 39 individuals at 6 practices were recruited and 38 took part in 51 interviews over 2 years. The same individuals were interviewed after the intervention if available or were replaced by qualified personnel. ( Table 1 ) At 3 practice sites, additional staff were interviewed after the intervention because of an increase in the number of staff involved in the immunization program after the intervention.
| Practice characteristics | Private practices | Safety-Net system | ||||
|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 6 a | |
| Setting type | Suburban | Suburban | Rural | Rural | Urban | Urban |
| Providers by FTE, n b | 19.4 | 4 | 2 | 2.25 | 6.1 | 5.8 |
| Patients per year, n b | 21,259 | 3017 | 1023 | 2472 | 10,000 c | 5192 |
| Obstetric patients, % | 15 | 41 | 31 | 20 | 17 | 35 |
| Interviews completed by role and by time point (before and after intervention) | ||||||
| Provider | (2-2) | (1-1) d | (1-1) | (1-1) d | (1-1) d | (3-5) |
| Nurse | NA | NA | (0-1) | (1-1) | NA | NA |
| Medical assistant | (2-2) | (1-1) | NA | (0-1) | (1-1) | (2-2) |
| Clinic administrator | (1-1) | (1-1) | NA | (0-1) | (1-1) d | (1-3) |
| Clinic administrator and nurse/MA | NA | NA | (1-1) | (1-0) | NA | (1-0) |
| Total interviews (n = 51) | (5-5) | (3-3) | (2-3) | (3-4) | (3-3) | (7-10) |
a Characteristics represent both clinical sites
c Estimate (data not available)
Intervention
We received institutional review board approval prior to the project initiation. Participating sites’ clinical staff were trained in best practices in immunization delivery. All clinical staff and administrative personnel at each site were invited to participate. Five of the 6 practices required participation of providers and clinical staff. The sixth and largest practice highly encouraged participation and had a high rate of participation.
Medical assistants and nurses were the target audience of the trainings because of their increased responsibility under standing orders. The interventions involved in the larger trial were all evidence-based practices in immunization delivery in other ambulatory settings adapted to the needs of the obstetrician-gynecologist setting.
The intervention practices included the following: standing orders for influenza, Tdap, and HPV vaccination; documentation of all patients’ historical vaccinations; using survey tools for assessing vaccination eligibility; assessing practice vaccination rates using electronic health records; using an electronic system to recall patients due for a vaccine; identifying and utilizing an immunization champion; auditing vaccination billing practices; and assessing current documentation using chart review and feedback.
Following a pragmatic trials design, each site selected procedures best suited to their practice needs. Minimum intervention requirements included stocking and offering Tdap, HPV, and influenza vaccines; designating an immunization liaison to project personnel; and provider/staff willingness to consider establishing immunization standing orders for Tdap, HPV, and influenza vaccines.
Study staff provided templated immunization standing orders for practices to modify as needed (see www.immunize.org/standing-orders for templates). Finalized versions were approved by study staff before implementation. All sites were required to implement at least 1 standing order protocol. Extent of successful implementation was determined through a combination of regular clinic observations, report from the immunization liaison at each site, and interviews.
Practice sites had staggered starts to their intervention activities. Baseline interviews occurred within the initial 6 months of launch of intervention activities at each site (in 2012 and 2013), and follow-up interviews occurred after sites had implemented standing orders for a minimum of 10 months (between 2013 and 2014).
Interviews
Semistructured, in-depth interviews focused on facilitators and barriers to the immunization program overall, standing order establishment and implementation, and vaccination delivery. Interviews were digitally recorded, lasted an average of 1 hour, and were transcribed verbatim.
Qualitative coding and analysis of themes
Data analysis followed a general inductive approach that began with initial data collection and continued throughout analysis. Inductive analytic method has code creation based on the ideas expressed by the interviewee rather than concepts known prior to the interview (from the interview guide, for instance).
Two trained qualitative data analysts iteratively read transcripts and debriefed to achieve immersion in the ideas expressed during interviews and developed a near-to-complete list of codes. Analysts then compared their independently coded transcripts and worked to edit codes and coded text until agreement in code definitions and extent of codes was reached and no new codes were being developed.
The 2-person primary analytical team coded the remainder of the data following reflexive team analysis, which emphasizes inclusion of emergent rather than a priori themes, and utilized the broader study team to discuss emergent understandings of the data and check on analysts’ preconceived assumptions and biases about the data. The team met regularly while coding the data set to confirm intercoder reliability and triangulate data. Coding and analysis were completed using ATLAS.ti 7.0, Scientific Software Development GmbH, Berlin, Germany.
Results
Overarching themes and successes
All practices believed they were successful in establishing or expanding some form of standing orders. However, only 2 practices met their preproject goals for standing order implementation of all 3 immunizations, and several practices chose to implement standing orders for Tdap or influenza vaccines for only obstetric patients to prioritize a high-risk patient population ( Table 2 ).
| Practice | Before intervention (in place) | Target | Postintervention implementation a |
|---|---|---|---|
| Private practices | |||
| 1 | Influenza: full obstetrics only Tdap: none HPV: none | Influenza: full obstetrics only Tdap: full HPV: full | Influenza: full obstetrics only Tdap: full obstetrics only HPV: partial |
| 2 | Influenza: partial obstetrics only Tdap: none HPV: none | Influenza: full Tdap: full obstetrics only HPV: full | Influenza: full Tdap: full obstetrics only HPV: none |
| 3 | Influenza: none Tdap: none HPV: none | Influenza: full Tdap: full obstetrics only HPV: full | Influenza: full Tdap: full HPV: full |
| 4 | Influenza: none Tdap: none HPV: none | Influenza: full Tdap: full HPV: full | Influenza: full Tdap: full HPV: full |
| 5 | Influenza: partial obstetrics and gynecology Tdap: none HPV: none | Influenza: full Tdap: full obstetrics only HPV: full | Influenza: full obstetrics only Tdap: full obstetrics only HPV: Partial |
| Safety-Net system | |||
| 6 | Influenza: partial obstetrics and gynecology Tdap: partial gynecology only HPV: partial for insured only | Influenza: full Tdap: full HPV: full | Influenza: full obstetrics; partial gynecology Tdap: full HPV: partial |
a Green color signifies meeting or exceeding target. Standing order implementation categorization included the following: none (no standing order in place); partial (vaccine delivered in practice without a written order or a written standing order in place but not delivered in practice); full (vaccine written standing order in place and delivered in practice); obstetrics only (standing orders for obstetrics patients only); and gynecology only (standing orders for gynecology patients only).
Prior to establishing standing orders at practices, the responsibility for assessing immunization history and eligibility had fallen to the medical providers. Yet by establishing standing orders for immunizations, providers and staff reported overall improved immunization delivery to their patient population. As one provider emphasized, “… for me as a provider to get this set up to where our nurses … have the ability to really be helpful in getting that (immunization assessment and delivery) done … (means) I can be much more successful (at immunizing my patients).”
Several aspects that facilitated establishing/expanding immunization standing orders were identified: process standardization, commitment to an iterative process, and staff training and empowerment ( Table 3 ). Important impediments included competing staff demands, hesitation from some pregnant women to trust vaccine-related information from nonproviders, and, uncertainty with standing orders for HPV vaccines specifically. Of note, provider engagement level in the immunization program did not emerge as a theme in our analysis of the interviews, likely because the willingness to consider standing orders for immunizations was a requirement for practice study participation.
| Major themes | Subthemes |
|---|---|
| Facilitator factors to standing order implementation | |
| Standardization of processes |
|
| Continual modification process |
|
| Staff training and empowerment |
|
| Barriers to standing order Implementation | |
| Competing demands for MAs and nurses |
|
| Pregnant patients prefer information from provider |
|
| HPV standing orders especially challenging |
|
Facilitators to implementing standing orders
Standardization of standing order processes
All private practices needed to establish new processes and associated documentation for at least the Tdap and HPV immunization standing orders. A significant facilitator to this was receiving standing order templates from the project team that could be tailored to each practice’s processes ( www.immunize.org/standing-orders ). This reportedly saved time and provided guidance on standing order language and requirements. As one MA told us, standing order templates “… were kind of fill-in-the-blanks and that was hugely helpful.” Furthermore, we heard from several staff members that the process of practice staff reviewing standing order templates helped to build staff consensus around integrating immunization standing orders into routine care.
Additionally, practices were highly aware that new processes were needed to routinely assess immunization eligibility and that these processes needed to fit within the practice’s flow and work for both obstetrical and gynecology patients (for whom distinct clinical processes were often in place). Interviewees told us that adding immunization questions to standard intake forms was an efficient and effective method to collect immunization history that fit into already established patient check-in processes. This allowed for routinization of immunization assessment for all patients. “… Once we started ordering the vaccines and giving them, I think it [assessing vaccination status] just became part of our daily routine. …”
Although all practices experienced a drag on practice flow initially, they were ultimately able to accommodate these new processes. As a practice manager said, “… It has not taken the amount of time I think that everybody has thought it would … [and immunization standing orders had] very little if any (impact on practice flow).” A few practice staff even said that using immunization standing orders with established and supportive processes in place resulted in improving practice flow: “If you keep on top of it and don’t have to wait for the doctor to come out and say, ‘Hey, by the way, she needs her Tdap’ and be able to get that done before the doctor sees them, I think it is a time saver.”
Dedication to continual modification process
Interviewees at sites that reported success establishing immunization standing orders had staff that showed dedication to a continual modification process directed by staff from all areas of the practice (particularly MAs and nurses). For instance, in a practice that struggled initially with slowed practice flow from standing orders, a provider emphasized the need for providers and nurses to routinely meet to amend practice processes until they worked for all staff and patients.
The importance of including front-line staff in designing practice-based change was echoed by many interviewed staff. As one practice’s lead MAs told us, “… Knowing from the MA side what is going to be helpful and what’s not is extremely important to successfully implementing a standing order for immunizations.”
Staff training and empowerment
Staff training was cited as another important facilitator because it provided the entire staff with a foundation of common knowledge. Following training by her practice to deliver Tdap, influenza, and HPV by standing order, one MA told us she became quite comfortable with having immunization eligibility discussions with her patients. “I go over as much of it as I can. And if their questions are above what I know, I have them talk to the doctor.”
Several providers underscored their responsibility to ensure that nurses and MAs are appropriately trained. A provider told us, “I think that not only pregnant women have anxieties about getting things. I think a lot of times nurses … have anxieties about giving pregnant women things (like vaccinations) … and educating the nurses … I think was helpful.”
A sense of empowerment and comfort followed staff training. According to one practice administrator and nurse, staff training helped them because “just getting them [MAs/nurses] to feel comfortable with ‘yes, it’s okay. You can go ahead and give a vaccine without the doctor coming in’” was an essential aspect that allowed their practice to fully implement immunization standing orders.
Barriers to immunization standing orders
Competing demands for MAs and nurses
A common difficulty cited by both private and public practices was competing demands for the MAs and nurses. Localizing the assessment of immunization eligibility and delivery of vaccines to MA’s/nurse’s purview added work into an already brief office visit. In fact, one MA described skipping immunization eligibility assessment whenever “… you have them [providers] snipping at your heels (to start their portion of the visit).”
One MA estimated that new laboratory tasks assigned to MAs plus this intervention meant that standing orders were skipped 10% of the time. Perceived time needed to answer HPV-related questions from patients resulted in one private practice dropping standing orders for HPV. As the clinic manager told us, “Well, the physicians really like their patients ready in a timely fashion. So I think that the MAs are a little worried that … (patients) are going to have 100 questions and they are going to be stuck in the room for longer than they should be.”
Finally, because of competing demands during problem-based visits, the private practices, with one exception, chose to restrict standing orders for gynecology patients to only annual examination visits. The safety-net system clinics did not officially restrict standing orders to annual gynecology visits, yet, in practice, they reported to us that problem-based visits were often too time constrained to assess a woman’s immunization eligibility. Thus, all but 1 practice in this intervention excluded standing orders from problem-based visits.
Obstetric patients may prefer vaccine information from their provider
Another limitation experienced by both public and private practices was implementing immunization standing orders with pregnant patients. Several staff members perceived that pregnant women might prefer to have a vaccine-related discussion with their medical provider instead of an MA/nurse. “I think that pregnant women in general feel quite anxious about receiving different kinds of medications … in pregnancy, and so they may not have been completely sold on ‘the nurse told me I need this vaccination’… Almost all pregnant women I feel like have wanted to just kind of talk with a provider and just ask a few questions … before they get their flu shot or their Tdap (vaccination).” One MA estimated that 70% of their pregnant patients hesitate to consent to an immunization when an MA or nurse offered it to them because they wanted to discuss the vaccine and their vaccine eligibility with their obstetrician.
Fragmentary provider support for HPV standing orders
Three of 5 participating private practices and the safety-net system practices had incomplete or no implementation of standing orders for HPV vaccines. These practices’ providers chose to maintain the determination of HPV eligibility within the provider’s purview because they believed it more of a nuanced and detailed conversation than MAs had time and training to handle.
This was true, even after the practice staff received immunization training. Furthermore, the assessment of eligibility is complicated by the fact that HPV is a series of 3 vaccinations that a woman could have initiated as an adolescent elsewhere. One provider explained, “… It’s just tough to get the information about it. … Patients don’t remember the documentation. It was just much simpler with the Tdap (vaccine)—you either got it or you didn’t at 28 weeks of pregnancy— … even flu (vaccine because it is annual).”
Another provider said, “I’m most concerned about HPV. … They [Mas] don’t feel qualified to really speak about HPV, as well as they shouldn’t have to be knowledgeable about every single thing that’s not in their scope of practice.”
Finally, some providers interviewed told us they generally care for middle- to older-aged women who are not recommended to receive the HPV vaccine, thus further complicating the routine offering of the vaccine.
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