Increasing HPV Vaccination in Community-Based Pediatric Practices

Study Overview
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Brief Summary
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The central goal of this study is to identify the optimal approach to implementing an evidence-based practice facilitation (PF) intervention for the uptake and completion of HPV vaccine among adolescents receiving care in the community, guided by implementation science theory. AIM 1: Determine the clinical effectiveness and cost-effectiveness of two modalities for delivering a multi-component PF intervention to increase HPV vaccination initiation and completion in community-based pediatric practices. The investigators will compare the traditional In-person Coaching PF modality to a lower-resource Web-Based Coaching PF modality. The primary patient outcome is HPV vaccination. The investigators will also examine and compare the sustainability of practice changes on vaccination rates and the effects over time for each intervention modality. AIM 2. Understand mechanisms of why the PF intervention may work better for some pediatric practices than others for HPV vaccination. The investigators will examine theory-based determinants at the organizational, provider, and patient levels that may mediate (explain) or moderate (change) the effects of the PF intervention on vaccination outcomes.

Detailed Description
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Background: The human papillomavirus (HPV) vaccine offers the unprecedented opportunity to prevent nearly all cervical and anal cancers and a high proportion of vaginal, oropharyngeal, vulvar and penile cancers, where HPV is the etiologic agent. HPV vaccination is recommended for all children ages 11-12, with catch up for females to age 26 and males to age 21. However, despite clear and indisputable value in cancer prevention, uptake and completion of the HPV vaccine series has lagged far behind the goal of 80%. Provider recommendation is the strongest determinant of HPV vaccination, but slow translation of guidelines for preventive services, such as immunizations, into practice is a known challenge. Practice Facilitation (PF), also called quality improvement coaching, is a multicomponent quality improvement intervention approach that has well-established efficacy, in which external support and resources are provided to build the internal capacity of practices to improve quality of care and patient outcomes. Objectives: The central goal of the study is to identify the optimal approach to implementing an evidence-based intervention for the uptake and completion of HPV vaccine among adolescents receiving care in the community, guided by implementation science theory. AIM 1: Determine the clinical effectiveness and cost-effectiveness of two modalities for delivering a multi-component PF intervention to increase HPV vaccination initiation and completion in community-based pediatric practices. The investigators will compare the traditional In-person Coaching modality to a lower-resource Web-Based Coaching modality. The primary patient outcome is HPV vaccination. The investigators will also examine and compare the sustainability of practice changes on vaccination rates and the effects over time for each intervention modality. H1: Both interventions will result in significant increases in HPV vaccination from baseline over time. H2: Increases in the rate of HPV vaccination will be higher and sustained for a longer period of time in the In-person Coaching PF Arm as compared with the Web-Based Coaching Arm. H3: The Web-Based Coaching Arm will be more cost-effective than the In-person Coaching Arm. AIM 2. Understand mechanisms of why the PF intervention may work better for some pediatric practices than others for HPV vaccination. The investigators will examine theory-based determinants at the organizational, provider, and patient levels that may mediate (explain) or moderate (change) the effects of the PF intervention on vaccination outcomes. H4: Adoption of changes (process variables) and patient factors will mediate effects of the intervention on HPV vaccination outcomes. H5: Organizational factors, provider attitudes, and intervention characteristics will moderate intervention effects on HPV vaccination outcomes. Implications: The findings will inform organizations about which PF modality to use among their constituent practices to improve HPV vaccination rates, with potential for future national dissemination.

Official Title
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Increasing HPV Vaccination in Community-Based Pediatric Practices

Conditions
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HPV Vaccines

Intervention / Treatment
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* Behavioral: Practice facilitation for HPV vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All providers and staff at each practice Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Using a two-group, cluster randomized control trial (RCT) design, with the clusters being pediatric practices, practices will be randomized to two study arms representing two delivery modalities of the intervention: In-Person Coaching Arm and Web-Based Coaching Arm. The intervention targets the providers and staff in the pediatric practices to make changes aimed to improve their quality of care, and the study participants are the providers and staff (not patients). Individual patients will not be recruited or enrolled in the study, since the intervention is focused on QI and all patient vaccination outcome data will be collected via aggregated reports from the EHR or other clinical data systems (no individual patient-level private health information (PHI)). The study practices include approximately 190 providers (physicians, nurse practitioners, physician assistants) and 275 other staff (nurses, clinical support staff, administrative staff).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-Based Coaching<br>Web-based delivery of practice facilitation for HPV vaccine | Behavioral: Practice facilitation for HPV vaccine<br>* The practice facilitation intervention provides coaching support to pediatric practices to guide them through quality improvement projects to increase HPV vaccination rates.<br>|
| Experimental: In-Person Coaching<br>In-person delivery of practice facilitation for HPV vaccine | Behavioral: Practice facilitation for HPV vaccine<br>* The practice facilitation intervention provides coaching support to pediatric practices to guide them through quality improvement projects to increase HPV vaccination rates.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age-appropriate completion rate (ages 13-17) | Percentage of active patients ages 13-17 who completed the HPV vaccine series before 13th birthday | Annually, up to 3 years post baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age-appropriate initiation rate (ages 13-17) | Percentage of active patients ages 13-17 who received at least one dose of HPV vaccine before 13th birthday | Monthly, up to 36 months post baseline | 
| Age-appropriate completion rate (at age 13) | Percentage of active patients who turned age 13 who completed the HPV vaccine series before 13th birthday | Monthly, up to 36 months post baseline | 
| Age-appropriate initiation rate (at age 13) | Percentage of active patients who turned age 13 who received at least one dose of HPV vaccine before 13th birthday | Monthly, up to 36 months post baseline | 
| Overall completion rate (ages 13-17) | Percentage of active patients ages 13-17 who completed the HPV vaccine series at any age | Monthly, up to 36 months post baseline | 
| Overall initiation rate (ages 13-17) | Percentage of active patients ages 13-17 who received at least one dose of HPV vaccine at any age | Monthly, up to 36 months post baseline | 
| Dose received rate (well visits) | Percentage of well visits in which a dose of HPV vaccine was administered (1st, 2nd, or 3rd dose), among all well visits for active vaccine-eligible patients ages 11-17 | Monthly, up to 36 months post baseline | 
| Dose received rate (all visits) | Percentage of visits in which a dose of HPV vaccine was administered (1st, 2nd, or 3rd dose), among all visits for active vaccine-eligible patients ages 11-17 | Monthly, up to 36 months post baseline | 
| Age at vaccination | Average age at receipt of first HPV vaccine dose, among active patients ages 13-17 who received 1st dose | Monthly, up to 36 months post baseline | 
| Time to series completion | Average number of months from 1st dose to last dose of HPV vaccine, among active patients ages 13-17 who completed the series | Monthly, up to 36 months post baseline |