Impact of a Clinical Interventions Bundle on Uptake of HPV Vaccine at an Urban, Hospital-based OB/GYN Clinic

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Impact of a Clinical Interventions Bundle on Uptake of HPV Vaccine at an Urban, Hospital-based OB/GYN Clinic Uma Deshmukh MD, MUP OB/GYN Resident Yale School of Medicine Department of Obstetrics, Gynecology, & Reproductive Medicine New Haven, CT, USA

Disclosures No financial relationships or conflict of interest to disclose.

Background HPV vaccination rates remain low in the United States. Estimated vaccine coverage for American girls 13-17 yo (CDC, 2015): 62.8% 1 dose 41.9% 3 doses Estimated vaccination coverage with selected vaccines and doses* among adolescents aged 13 17 years, by survey year National Immunization Survey-Teen, United States, 2006 2015 (CDC, 2015)

Barriers to Vaccination Several barriers to vaccination exist, including: Lack of knowledge/awareness by patients/providers Failure of providers to identify eligible patients and recommend the vaccine Tendency by providers to minimize its importance Lack of systems support

Evidence-Based Intervention Strategies Team-based approach and staff engagement Chart reviews and reminders for providers in patient charts Reminders and prompts in the EMR Elimination of unnecessary pre-vaccination requirements Removal of cost barriers for uninsured patients

Quality Improvement Initiative for HPV Immunization Single-site hospital-based ob/gyn clinic within a primary care center in an urban setting Serving a diverse, low-income patient population: 37% black, 13% white, 1% Asian; 45% Hispanic 73% Medicaid (2015), 13% uninsured Interdisciplinary provider team: Patient-care associates (PCAs) RNs Nurse-midwives, APRNs, PAs, Attending & resident MDs

Clinic-Based Intervention Bundle Designated physician and nurse champions Care Coordinator reviews charts and annotates EMR Added prompts to clinic note templates 2014 Nurses empowered to offer vaccine 2015 Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Jan Feb Mar Apr May Jun Nurses pre-screen charts for patients coming for depo Introduced Merck s Financial Assistance Program Eliminated pregnancy test requirement

Objective and Hypothesis The aim of our study is to evaluate the impact of a clinical intervention bundle on uptake of HPV vaccine. Hypothesis: The intervention bundle will be associated with a decrease in missed opportunities to administer the HPV vaccine, and an increase in vaccine initiation and series completion rates among eligible clinic patients.

Study Design Chart review of patients seen from Feb 1, 2013 through Sept 30, 2016: STUDY PERIOD DATES DESCRIPTION Pre-implementation Feb 1, 2013 Jan 31, 2014 12-month period prior to interventions During implementation Feb 1, 2014 June 30, 2015 Post-implementation July 1, 2015 Sept 30, 2016 17-month period during implementation of interventions 15-month period after implementation of last intervention

Inclusion/Exclusion Criteria Inclusion Criteria: Patients eligible to receive the HPV vaccine (have had fewer than 3 doses) Patients 18-26-years-old at the time of their clinic visit. Exclusion Criteria: Pregnancy (including any patient with ongoing management of abnormal pregnancies such as ectopic or spontaneous abortions) Documented completion of 3-dose vaccine series

Data Analysis Descriptive analysis and comparison of the pre- and postimplementation patient populations using Chi-square and Mann- Whitney U tests. Interrupted time series models to analyze trends in missed opportunities, as well as initiation and series completion rates. Counterfactual predictions to assess the trends that would have been expected had the bundled interventions not been introduced.

Definitions Missed Opportunity: A vaccine-eligible encounter when a patient was due for an HPV vaccine dose but none was administered. Vaccine-Eligible Encounter: An encounter where the patient was between 18-26 years of age, not pregnant, was under-immunized (had previously received < 3 doses of the HPV vaccine), and was due for the vaccine.

Results Total 4,035 women with 6,451 vaccine-eligible encounters Demographics: Median age 23 yo 47% Black, 40% Hispanic 14% Spanish-speaking 84% Unmarried 80% Public Insurance Significantly more women were white (15% vs 10%) and had public insurance (85% vs 75%) in the post- compared with preimplementation group

Results 98.5% -0.23%/month (p<0.01) -1.1%/month 5 times faster (p<0.01) -0.56%/month 2 times faster (p<0.01) 88.1% 69.2%

Results 0.9%/month (p<0.01) 0.21%/month 8 times faster (p<0.01) 18.4% 0.02%/month (p=0.74) 1.9%

Results 2.4%/month (p<0.01) -0.11%/month (p<0.01) 41.6% 0.68%/month (p=0.05) 1.5%

Study Limitations Lack of control group and use of a pre- and post-design Retrospective study with possibly incomplete immunization records Dynamic nature of data inputs in EMR

Summary Implementation of our intervention bundle was feasible and was associated with a reduction in missed opportunities to administer the HPV vaccine. improvement in vaccine series initiation and completion. While the proportion of women who completed the series was higher at the end of the study period, the rate of series completion slowed. Despite improvements, the overall proportion of under-vaccinated patients in our clinic remains high.

Future Directions Compare our vaccination rates during the study period with those seen in similar OB/GYN clinics in our region. Evaluate impact of individual bundle elements. Develop/improve specific, targeted interventions that were most effective or have potential to have largest impact. Introduce new interventions (standing orders, provider audit/feedback). Consider adaptation of these interventions for application in other similar urban, hospital-based clinics.

Acknowledgements Co-Authors: Carlos R. Oliveira MD Susan Griggs BSN, MS Emily Coleman Lital Avni-Singer Shefali Pathy MD, MPH Eugene D. Shapiro MD Sangini S. Sheth MD, MPH (Principal Investigator) Clinic patients and providers Staff at the Yale Women s Center Clinic Joint Data Analytics Team (JDAT)

References Kharbanda E, Stockwell M, Fox H, Andres R, Lara M, Rickert V. Text message reminders to promote human papillomavirus vaccination. Vaccine 2011; 29:2537-41; PMID:21300094; http://dx.doi.org/10.1016/j.vaccine.2011.01.065 Niccolai LM, Hansen CE. Practice- and Community-Based Interventions to Increase Human Papillomavirus Vaccine Coverage: A Systematic Review. JAMA Pediatr 2015;169:686-92. Nowalk MP, Zimmerman RK, Lin CJ, et al. Raising adult vaccination rates over 4 years among racially diverse patients at inner-city health centers. J Am Geriatr Soc 2008;56:1177-82. Ruffin MT, Plegue MA, Rockwell PG, Young AP, Patel DA, Yeazel MW. Impact of an electronic health record (EHR) reminder on human papillomavirus (HPV) vaccine initiation and timely completion. J Am Board Fam Med 2015; 28(3):324-33; PMID:25957365; http://dx.doi.org/10.3122/jabfm.2015.03.140082: Smulian EA, Mitchell KR, Stokley S. Interventions to increase HPV vaccination coverage: A systematic review. Hum Vaccin Immunother 2016;12:1566-88.

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Definitions Proportion of Missed Opportunities: Missed opportunities/total # of vaccine-eligible encounters per month. Initiation Rate: Women who received 1 st dose/ Total # of women who never received a dose per 100 women per month. Completion Rate: Women who received 3 rd dose/total # women who had previously received 2 doses per 100 women per month.

Merck Financial Assistance Program Complete online form: -No additional documentation needed; -Must provide annual household income; Form is faxed: -Response in 15-30 min -Vaccine order placed in EMR -Vaccine is administered. Repeat process for each dose.