Increasing HPV Vaccination in Community-Based Pediatric Practices

HPV Vaccines Clinical Trial

Official title:

Increasing HPV Vaccination in Community-Based Pediatric Practices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03399396
• Other study ID #: 171793
• Secondary ID: 1R01CA207401-01A
• Status: Completed
• Phase: N/A
• Start date: February 21, 2018
• Est. completion date: February 28, 2021

Study information

• Verified date: December 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All providers and staff at each practice

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• HPV Vaccines

Intervention

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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Pamela Hull	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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