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Cancer Epidemiol Biomarkers Prev. Author manuscript; available in PMC 2024 Jan 5.
Published in final edited form as:
Cancer Epidemiol Biomarkers Prev. 2023 Jul 5; 32(7): 957–962.
PMCID: PMC10244480
NIHMSID: NIHMS1856244
PMID: 36480272
Melissa B. Gilkey,1,2 Jennifer Heisler-MacKinnon,1 Marcella H. Boynton,2,3,4 William A. Calo,5 Jennifer L. Moss,5,6 and Noel T. Brewer1,2
Author information Copyright and License information PMC Disclaimer
The publisher's final edited version of this article is available at Cancer Epidemiol Biomarkers Prev
Associated Data
- Data Availability Statement
Abstract
Background.
Health departments in the United States routinely conduct quality improvement (QI) coaching to help primary care providers optimize vaccine delivery. In a prior trial focusing on multiple adolescent vaccines, this light-touch intervention yielded only short-term improvements in HPV vaccination. We sought to evaluate the impact of an enhanced, HPV vaccine-specific QI coaching intervention when delivered in person or virtually.
Methods.
We partnered with health departments in 3 states to conduct a pragmatic cluster randomized trial in 2015–2016. We randomized 224 primary care clinics to receive no intervention (control), in-person coaching, or virtual coaching. Health department staff delivered the brief (45–60 minute) coaching interventions, including HPV vaccine-specific training with assessment and feedback on clinics’ vaccination coverage (i.e., proportion of patients vaccinated). States’ immunization information systems provided data to assess coverage change for HPV vaccine initiation (≥1 doses) at 12-month follow-up, among patients ages 11–12 (primary outcome) and 13–17 (secondary outcome) at baseline.
Results.
Clinics served 312,227 patients ages 11–17. For ages 11–12, coverage change for HPV vaccine initiation was higher in the in-person and virtual coaching arms than in the control arm at 12-month follow-up (1.2% and 0.7% point difference, both p<0.05). For ages 13–17, coverage change was higher for virtual coaching than control (1.4% point difference, p<0.001), but in-person coaching did not yield an intervention effect.
Conclusions.
Our brief QI coaching intervention produced small long-term improvements in HPV vaccination.
Impact.
Health departments may benefit from targeting QI coaching to specific vaccines, like HPV vaccine, that need them most.
Keywords: Human Papillomavirus, vaccination, adolescent medicine, quality improvement, primary care
Low uptake of HPV vaccine remains a widespread problem in the United States (U.S.). Despite national recommendations for routine administration at ages 11–12, less than half of U.S. adolescents complete the 2-dose HPV vaccine series by age 13.1 Furthermore, with the exception of Rhode Island, no U.S. state has met the Healthy People 2030 goal of 80% series completion among adolescents ages 13–15.1 The pervasiveness of HPV vaccine underuse suggests that interventions to address the problem must be both effective and highly scalable.
State and regional health departments offer a broad-reaching opportunity to improve HPV vaccine delivery. Most notably, the Centers for Disease Control and Prevention’s Immunization Quality Improvement for Providers program (IQIP; formerly known as AFIX) provides support for all 64 state and regional immunization programs to routinely conduct quality improvement (QI) coaching with primary care clinics in their jurisdictions.2,3 These coaching sessions typically involve an in-person meeting with a clinic representative, in which the QI coach provides education on vaccine QI strategies and assessment and feedback on the clinic’s vaccination coverage. In our previous research, we found that traditional QI coaching that focused on multiple adolescent vaccines produced short-term improvements in vaccination coverage for patients ages 11–12.4,5 At 5-month follow-up, clinics in the intervention arm achieved coverage changes that exceeded those in the control arm by 3.4% points for tetanus, diphtheria, and acellular pertussis (Tdap) vaccine and by 4.7% points for meningococcal conjugate vaccine.4 However, the relative advantage for HPV vaccine was smaller at 1.5% points and did not persist at 12-month follow-up.4 It is unclear whether QI coaching could be more effective at increasing HPV vaccination coverage if focused specifically on addressing the unique barriers to HPV vaccination, such as lack of provider recommendations.6,7
To address this research gap, we designed a pragmatic cluster randomized trial that used existing public health infrastructure to evaluate an HPV vaccine-focused QI coaching intervention to increase HPV vaccination coverage among adolescents. To maximize intervention scalability, we tested both in-person and virtual delivery modes, hypothesizing that both would increase HPV vaccination coverage over the no-intervention control arm. Our goal was to build the evidence base for leveraging existing networks of health department QI coaches to improve HPV vaccination coverage using a light-touch, highly scalable approach.
MATERIALS AND METHODS
Clinic selection, randomization, and recruitment
We partnered with health departments in Illinois, Michigan, and Washington State to conduct our trial with primary care clinics serving adolescents. We prioritized these states because they offered immunization information systems (IISs) with high rates of adolescent participation, as well as HPV vaccination rates similar to the national average.8,9 Clinics within each state were eligible if they: 1) were pediatric or family medicine practices; 2) participated in their state’s IIS; and 3) served ≥ 500 patients, ages 11–17, according to IIS records. We generated a census of eligible clinics from IIS records and randomly assigned each clinic to trial arm. Our biostatistician (MB) used an online random number generator (random.org) to randomize eligible clinics in a 1:1:1 ratio to receive: 1) no intervention (control); 2) an in-person QI coaching consultation; or 3) a virtual QI coaching consultation. To promote balance by trial arm, we conducted randomization stratified by state and in blocks by clinic size (i.e., number of patients).
From April through October 2015, immunization QI coaches within each partnering health department led recruitment efforts for their state. To reduce burden on participating clinics, we recruited clinics to each trial arm following randomization in a manner similar to Zelen’s design.10,11 We selected this pragmatic randomization strategy to streamline enrollment procedures for busy clinical staff who often had limited time for preparing for the possibility of multiple trial conditions. Within each state, health department staff invited clinics to participate by phone and email, making up to five contact attempts. The point of contact was typically the clinic’s designated vaccine coordinator who worked with health department staff on vaccine ordering, storage, and handling. Working simultaneously across all three trial arms, staff continued recruitment using randomly ordered lists until reaching at least 30 clinics per arm per state or until the recruitment period was over. Due to the interactive nature of the intervention, neither QI coaches nor participating clinics were blinded to trial arm.
The trial enrolled 224 clinics (Figure 1). Reasons clinics did not enroll included that they had closed or could not be reached (60 clinics), declined to participate (46 clinics), or were not contacted because the trial arm was already at quota (553 clinics). The University of North Carolina Institutional Review Board reviewed the trial protocol and determined that it did not constitute human subjects research.
Figure 1.
Flow diagram.
The flow diagram shows the process of clinic randomization and enrollment in the control, in-person coaching, and virtual coaching trial arms.
Procedures
Each enrolled clinic received no intervention (control) or an in-person or virtual HPV vaccine-specific QI coaching consultation. QI coaches from each health department delivered consultations to participating clinics in their states on a rolling basis, concurrently with recruitment. The study team trained coaches in intervention delivery prior to the trial through a series of meetings that culminated in a full-day in-person workshop. Training sessions included didactic presentations on HPV vaccine-related topics such as effectiveness, safety, and communication, as well as role play activities designed to build coaches’ skills and confidence in delivering in-person and virtual consultations. Coaches piloted intervention protocols by delivering one in-person and one virtual consultation to clinics that were not part of the study. We also evaluated a subsample of coaches’ initial consultations for the trial using a fidelity checklist and provided one-on-one feedback through debriefing sessions to help coaches improve.
In-person QI coaching.
QI coaches traveled to each clinic in the in-person coaching arm to deliver a single QI coaching consultation focused on HPV vaccination. Coaches delivered the consultation to a representative from the clinic, who was most often the clinic’s vaccine coordinator. Coaches also encouraged physicians, other vaccine providers, and other clinic staff to attend whenever possible. To encourage provider attendance, we offered eligible providers up to one hour of continuing medical education (CME) credit for their participation.
Our 4-part QI coaching consultations typically lasted 45–60 minutes and featured HPV vaccine-specific training, assessment and feedback, and goal setting that constituted enhancements of states’ traditional QI coaching approach (Figure 2). First, the coach used standardized slides and talking points to deliver a didactic presentation on the public health burden of HPV cancers, the safety and effectiveness of HPV vaccination, and tips for improving provider communication about HPV vaccination. Second, the coach provided assessment and feedback on the clinic’s HPV vaccination coverage, using an immunization “report card” completed with data from the state IIS. We designed the report card to display the proportion of the clinic’s 11- to 17-year-old patients who had received one or more doses of HPV vaccine, in comparison to the proportions who had received two other vaccines administered to this age group: Tdap and meningococcal conjugate vaccines. Third, the coach encouraged the clinic to set a goal of improving their HPV vaccination coverage by 10 percentage points in the next 6 months. Finally, the coach worked with clinic staff to develop a brief action plan for improving coverage by selecting evidence-based strategies from a pre-specified list. This list included strategies such as increasing the frequency and quality of provider recommendations and establishing standing orders to allow nurses to administer HPV vaccination without provider oversight. Coaches also discussed opportunities for sharing the report card and QI goal with others in the clinic.
Figure 2.
Traditional versus enhanced QI coaching.
This figure compares key components of the traditional and enhanced QI coaching interventions.
Coaches followed up with clinics, by email or phone, at 3 and 6 months after the in-person consultation. Follow-up was typically directed to clinic representatives, such as vaccine coordinators, who participated in the initial consultations. During these follow-up contacts, coaches shared updated report cards that showed coverage for each adolescent vaccine, as well as progress toward the HPV vaccination QI goal. Coaches also offered to answer questions and reflect on strengths, challenges, and possible course corrections related to the clinic’s action plan.
Virtual QI coaching.
QI coaches delivered virtual coaching consultations remotely using an interactive video conferencing platform. We designed virtual consultations to include the same content, material, and structure as in-person consultations. As with in-person coaching, clinics received follow up at 3 and 6 months after the virtual consultation.
Measures
We assessed vaccination outcomes using data from each state’s IIS and defined our patient population at follow-up to include patients who joined the clinic during the trial period. The primary trial outcome was change in the proportion of patients ages 11–12 who had initiated HPV vaccination (1 or more doses) between baseline and 12-month follow-up (Clinicaltrials.gov: NCT02370459). We chose to focus on patients who were ages 11–12 at baseline because this age range is the target for routine HPV vaccination.12 We prioritized HPV vaccine initiation because it is more sensitive to intervention effects; furthermore, most children who begin the HPV vaccine series go on to complete the series, making initiation an especially important goal.1 We selected 12-month follow-up as our primary outcome to best account for the high degree of seasonality in HPV vaccine delivery.13 The secondary trial outcome was HPV vaccination coverage change for older patients, ages 13–17.
In addition to vaccination coverage, we assessed clinics on several characteristics at baseline. These characteristics included clinic location (Illinois, Michigan, or Washington) and type (pediatrics or family medicine). We also assessed clinics’ patient loads in terms of the number of patients, ages 11–17, with IIS records (≤1000, 1001–1500, or >1500 patients).
Statistical analyses
Analyses used a mixed-level Poisson regression for each vaccination outcome, modeling the change in vaccination coverage between baseline and follow-up separately for each age group. Models included a random intercept to account for clustering by clinic, as well as an offset variable equal to the log of the number of patients at each clinic. Analyses compared each of the two intervention arms to the control arm. A sensitivity analysis examined variation in intervention impact on the primary outcome separately for each state.
We report vaccination coverage at follow-up as unadjusted proportions. We report vaccination coverage changes as differences in proportions, adjusted for clinic size and accounting for clustering of data according to clinic. We analyzed data using SAS 9.4 (SAS Institute, Inc, Cary, NC); regression analyses used the NLMIXED procedure. All statistical tests were 2-tailed with a critical α of 0.05.
Data Availability
The data analyzed in this study are available from state health departments. Restrictions apply to the availability of these data.
RESULTS
Clinic and patient characteristics
The 224 clinics enrolled in our trial were located in Illinois (41%), Michigan (19%), and Washington state (40%, Table 1). Over half (60%) were pediatric clinics. IIS records indicated that clinics served 312,227 patients who were ages 11–17 at baseline. Baseline coverage for HPV vaccine initiation was 34% among patients ages 11–12 and 53% among patients ages 13–17. All participating clinics received the intervention to which they were assigned (Figure 1).
Table 1.
Clinic and patient characteristics at baseline
| Control | In-person coaching | Virtual coaching | ||||
|---|---|---|---|---|---|---|
| (76 clinics) | (76 clinics) | (72 clinics) | ||||
| n | (%) | n | (%) | n | (%) | |
| Clinic characteristics | ||||||
| Location | ||||||
| Illinois | 32 | (42.1) | 30 | (39.5) | 30 | (41.7) |
| Michigan | 14 | (18.4) | 16 | (21.1) | 13 | (18.1) |
| Washington | 30 | (39.5) | 30 | (39.5) | 29 | (40.3) |
| Type | ||||||
| Pediatric | 44 | (57.9) | 47 | (61.8) | 43 | (59.7) |
| Family medicine | 32 | (42.1) | 29 | (38.2) | 29 | (40.3) |
| Patient load, ages 11–17 | ||||||
| ≤1000 patients | 32 | (42.1) | 31 | (40.8) | 31 | (43.1) |
| 1001–1500 patients | 22 | (29.0) | 22 | (29.0) | 14 | (19.4) |
| >1500 patients | 22 | (29.0) | 23 | (30.3) | 27 | (37.5) |
| Patient characteristics | ||||||
| Age | ||||||
| 11–12 years | 30,620 | (30.9) | 33,821 | (30.5) | 31,343 | (30.6) |
| 13–17 years | 68,601 | (69.1) | 76,921 | (69.5) | 70,921 | (69.4) |
| HPV vaccination status, among ages 11–12 | ||||||
| 0 doses | 20,525 | (67.0) | 22,105 | (65.4) | 20,697 | (66.0) |
| ≥1 dose | 10,095 | (33.0) | 11,716 | (34.6) | 10,646 | (34.0) |
| HPV vaccination status, among ages 13–17 | ||||||
| 0 doses | 32,779 | (47.8) | 34,761 | (45.2) | 33,697 | (47.5) |
| ≥1 dose | 35,822 | (52.2) | 42,160 | (54.8) | 37,224 | (52.5) |
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Vaccination coverage change
Primary outcome.
For HPV vaccine initiation among patients ages 11–12, coverage changes were higher for the in-person coaching and virtual coaching arms than for the control arm at 12-month follow-up (1.2 and 0.7% point difference, respectively, both p<0.05, Table 2). Sensitivity analyses by state found that, compared to control, in-person coaching led to higher coverage change in Michigan (p<.001), but not Illinois or Washington. Virtual coaching led to higher coverage change in Michigan and Washington (both p<.05), but not Illinois.
Table 2.
Impact of QI coaching on HPV vaccine initiation (≥1 dose) at 12-month follow-up
| Ages 11–12 (n=95,784 patients) | Ages 13–17 (n=216,443 patients) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Coverage at 12 months % | Coverage change over prior 12 months % points | Difference from control % points (95% CI) | p | Coverage at 12 months % | Coverage change over prior 12 months % points | Difference from control % points (95% CI) | p | |||
| Full sample | ||||||||||
| Control | 49.2 | 15.4 | (ref) | 62.3 | 7.2 | (ref) | ||||
| In-person | 52.6 | 16.6 | 1.2 | (0.6, 1.8) | <.001 | 63.6 | 7.3 | 0.1 | (−0.2, 0.4) | .42 |
| Virtual | 50.1 | 16.1 | 0.7 | (0.1, 1.3) | .03 | 61.2 | 8.6 | 1.4 | (1.1, 1.7) | <.001 |
| Illinois | ||||||||||
| Control | 47.3 | 14.7 | (ref) | 60.7 | 8.6 | (ref) | ||||
| In-person | 52.0 | 15.5 | 0.8 | (−0.1, 1.7) | .08 | 63.5 | 8.2 | −0.4 | (−0.8, 0.1) | .08 |
| Virtual | 50.1 | 14.7 | 0.0 | (−0.9, 0.8) | .98 | 63.0 | 10.1 | 1.5 | (1.0, 2.0) | <.001 |
| Michigan | ||||||||||
| Control | 44.1 | 14.8 | (ref) | 61.5 | 6.5 | (ref) | ||||
| In-person | 50.0 | 18.4 | 3.7 | (2.1, 5.1) | <.001 | 60.1 | 7.4 | 0.9 | (0.02, 1.5) | .01 |
| Virtual | 40.5 | 16.5 | 1.7 | (0.1, 3.3) | .04 | 50.1 | 7.2 | 0.7 | (0.02, 1.4) | .04 |
| Washington | ||||||||||
| Control | 53.7 | 16.8 | (ref) | 64.3 | 5.6 | (ref) | ||||
| In-person | 54.5 | 17.2 | 0.4 | (−0.8, 1.5) | .53 | 65.5 | 5.9 | 0.3 | (−0.1, 0.7) | .14 |
| Virtual | 54.4 | 18.5 | 1.7 | (0.5, 2.9) | .01 | 64.3 | 6.8 | 1.2 | (0.8, 1.7) | <.001 |
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Note. Vaccination coverage proportions are unadjusted. Vaccination coverage change and difference from control are estimated proportions adjusted for clinic size and accounting for clustering of data according to clinic. CI: confidence interval.
Secondary outcome.
For HPV vaccine initiation among patients ages 13–17, coverage change was higher for the virtual coaching arm than for the control arm at 12-month follow-up (1.4% point difference, p<0.001, Table 2). The sensitivity analysis indicated an intervention effect for virtual coaching in all three states (all p<.05). In contrast, in-person coaching did not outperform the control in the overall sample, although the sensitivity analysis indicated an intervention effect in Michigan (p<.05).
DISCUSSION
Our pragmatic cluster randomized trial with primary care clinics in three U.S. states found that HPV vaccine-focused QI coaching had a small but long-lasting impact on HPV vaccination coverage. In contrast to our prior evaluation of traditional QI coaching that focused on multiple vaccine types,4 coverage changes produced by HPV vaccine-specific QI coaching persisted at 12-month follow-up among patients ages 11–12 for both in-person and virtual delivery modes. Additionally, virtual QI coaching led to higher HPV vaccination for older adolescents, ages 13–17. These improvements were smaller than those that have been reported in trials of more intensive clinic-based approaches such as provider communication training.14–16 However, compared to communication training, QI coaching benefits from comparable acceptability to providers, lower delivery cost, and the availability of an existing national network of QI coaches that enhance the intervention’s scalability.17,18 For these reasons, our findings suggest that vaccine-specific QI coaching is a promising approach for state and regional health departments seeking to improve HPV vaccination coverage in primary care settings.
Our trial provides novel evidence that virtual delivery of QI coaching compares favorably to in-person delivery. Indeed, our finding that virtual coaching improved HPV vaccination coverage for both age groups of patients suggests that virtual coaching might be even more effective than in-person coaching. In a previously published process evaluation of this trial, we found that virtual and in-person delivery modes performed similarly on intermediate outcomes.18 For example, they achieved comparable improvements in providers’ cognitions, including their self-efficacy to improve their clinic’s HPV vaccination coverage.18 Not surprisingly, we found that virtual coaching cost less to deliver per clinic than in-person coaching ($461 vs. $733, respectively) due to the elimination of travel costs.18 On the other hand, virtual coaching also attracted fewer providers to consultations and so cost more per participating provider ($92 vs $81).18 Given the relative advantages of each delivery mode, our findings suggest that both in-person and virtual coaching should be considered viable options for health departments seeking to maximize the reach of their immunization programs.
One notable aspect of our trial is the variation in the effectiveness of QI coaching by state. For example, in Michigan, we observed an intervention effect for both delivery modes and age groups, while in Illinois, we observed an intervention effect only for virtual QI coaching for older patients. The reasons for these differences are unclear, but could be due to coaches’ experience; in Michigan, a highly experienced coach delivered consultations for our trial, while in Illinois, the coach was a recent hire. Experienced coaches stand to have greater content expertise, as well as more established relationships with clinics’ vaccine coordinators and other staff, which could translate into greater trust, engagement, and effectiveness. Alternatively, variation in effectiveness may have been due to the smaller sample sizes by state, which resulted in more limited power for our sensitivity analysis. Whatever the case, additional implementation research is needed to understand organizational determinants of QI coaching effectiveness and to assess the potential for combining QI coaching with additional intervention components to yield a larger and more consistent intervention effect. Understanding how effectiveness varies by factors such as clinic type, adolescent patient load, baseline HPV vaccination coverage, and level of provider and staff participation could also meaningfully advance the science on QI coaching.
Our trial offers multiple strengths, including a large, multi-state sample of primary care clinics and a pragmatic design in which practicing QI coaches delivered consultations as they would in real-world clinical practice. Clinics participating in our trial were similar to the national average in terms of coverage for HPV vaccine initiation at baseline (53% versus 56% for ages 13–17), which lends support for the generalizability of our findings.8 To evaluate vaccination outcomes, we used IIS data which are derived from medical records and can capture vaccinations delivered at a wide variety of clinical sites.
Our trial’s limitations include that IISs offer limited data on patient demographics and visit characteristics. For this reason, we were not able to conduct subgroup analyses by race/ethnicity, insurance type, or whether the patient had a clinical visit during the study period. Other limitations include that our data were collected before the COVID-19 pandemic which dramatically increased the use of virtual conferencing platforms in clinical settings. The effectiveness of virtual QI coaching may be higher now that providers are more familiar with the technology or lower now that online training for providers is no longer novel. Future iterations of our intervention will require updating to reflect the most recent data on HPV vaccine effectiveness and safety, as well as new communication strategies for increasing HPV vaccine uptake such as beginning provider recommendations at age 9. Finally, although our trial arms appear to have been similar in terms of recruitment rates and baseline clinical characteristics, they may have varied on other, unmeasured variables such as clinics’ capacity and readiness to engage in HPV vaccine-related QI; these differences may have introduced selection effects despite our use of a randomized trial design.
Conclusion
HPV vaccine-specific QI coaching achieved small improvements in HPV vaccination coverage when delivered either in-person or virtually. State and regional health departments can use trial findings to determine whether virtual delivery can expand the reach of their QI coaching programs to more clinics. Immunization program leaders can also consider opportunities to target their QI coaching programs to vaccines, like HPV vaccine, that most need improvement. Health departments’ existing infrastructure for QI coaching, along with CDC’s ongoing programmatic support, offer a unique opportunity for scaling up light-touch interventions to help primary care providers improve their vaccine-related communication and delivery systems.
Financial Support:
This study was funded by a grant from the Robert Wood Johnson Foundation (ID# 71272). Dr. Calo’s time was supported by a training grant from the National Cancer Institute (R25CA116339). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the Robert Wood Johnson Foundation.
Footnotes
Conflict of Interest Disclosures: N.T. Brewer has served as a paid advisor for Merck, CDC and WHO. The remaining authors declare no potential conflicts of interest.
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