Increasing HPV Vaccination in Community-Based Pediatric Practices

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.

Study Overview

• Status: Completed
• Conditions: HPV Vaccines
• Intervention / Treatment: Behavioral: Practice facilitation for HPV vaccine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 420
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All providers and staff at each practice

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Documented recommendation rate (well visits)	Percentage of well visits with documentation of HPV vaccine either administered, deferred or refused, among all well visits for active vaccine-eligible patients ages 11-17	Monthly, up to 36 months post baseline
Documented recommendation rate (all visits)	Percentage of visits with documentation of HPV vaccine either administered, deferred or refused, among all visits for active vaccine-eligible patients ages 11-17	Monthly, up to 36 months post baseline
Bundling adolescent vaccines rate	Percentage of visits in which HPV, meningococcal, and Tdap vaccines were administered, among all visits for active patients ages 11-12 in which Tdap was administered and patient was eligible for both HPV and meningococcal vaccines	Monthly, up to 36 months post baseline
Missed opportunities rate	Percentage of non-well visits in which HPV vaccine was not administered, among all visits for active vaccine-eligible patients ages 11-17	Monthly, up to 36 months post baseline

Collaborators and Investigators

• Sponsor: Pamela Hull
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Pamela C Hull, PhD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2018
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: January 8, 2018
• First Posted (Actual): January 16, 2018

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 3, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 171793; 1R01CA207401-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data collected from providers and staff (surveys and interviews) will be made available to other researchers upon request. All individual identifiers will be stripped to ensure confidentiality and privacy of study participants.
• IPD Sharing Time Frame: Upon request
• IPD Sharing Access Criteria: Qualified researcher with IRB approval
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No