Clinical trial NCT03399396: Increasing HPV Vaccination in Community-Based Pediatric Practices
Official title: Increasing HPV Vaccination in Community-Based Pediatric Practices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HPV Vaccines
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-01-16
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* All providers and staff at each practice

Exclusion Criteria:

* None

Primary outcomes:
measure: Age-appropriate completion rate (ages 13-17)
timeFrame: Annually, up to 3 years post baseline
Secondary outcomes:
measure: Age-appropriate initiation rate (ages 13-17)
timeFrame: Monthly, up to 36 months post baseline
measure: Age-appropriate completion rate (at age 13)
timeFrame: Monthly, up to 36 months post baseline
measure: Age-appropriate initiation rate (at age 13)
timeFrame: Monthly, up to 36 months post baseline
measure: Overall completion rate (ages 13-17)
timeFrame: Monthly, up to 36 months post baseline
measure: Overall initiation rate (ages 13-17)
timeFrame: Monthly, up to 36 months post baseline
measure: Dose received rate (well visits)
timeFrame: Monthly, up to 36 months post baseline
measure: Dose received rate (all visits)
timeFrame: Monthly, up to 36 months post baseline
measure: Age at vaccination
timeFrame: Monthly, up to 36 months post baseline
measure: Time to series completion
timeFrame: Monthly, up to 36 months post baseline
Other outcomes:
measure: Documented recommendation rate (well visits)
timeFrame: Monthly, up to 36 months post baseline
measure: Documented recommendation rate (all visits)
timeFrame: Monthly, up to 36 months post baseline
measure: Bundling adolescent vaccines rate
timeFrame: Monthly, up to 36 months post baseline
measure: Missed opportunities rate
timeFrame: Monthly, up to 36 months post baseline
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Pamela C Hull, PhD
role: PRINCIPAL_INVESTIGATOR
References: