Increasing HPV Vaccination in Community-Based Pediatric Practices
NCT ID: NCT03399396
Last Updated: 2023-12-05
Study Results
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Basic Information
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COMPLETED
NA
420 participants
INTERVENTIONAL
2018-02-21
2021-02-28
Brief Summary
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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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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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).
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Web-Based Coaching
Web-based delivery of practice facilitation for HPV vaccine
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.
In-Person Coaching
In-person delivery of practice facilitation for HPV vaccine
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Pamela Hull
OTHER
Responsible Party
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Pamela Hull
Assistant Professor
Principal Investigators
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Pamela C Hull, PhD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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References
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Chang RS, Shing JZ, Erves JC, Du L, Koyama T, Deppen S, Rentuza AB, McAfee C, Stroebel C, Cates J, Harnack L, Andrews D, Bramblett R, Hull PC. Measurement of provider fidelity to immunization guidelines: a mixed-methods study on the feasibility of documenting patient refusals of the human papillomavirus vaccine. BMC Med Inform Decis Mak. 2022 Dec 22;22(1):339. doi: 10.1186/s12911-022-02083-2.
Other Identifiers
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171793
Identifier Type: -
Identifier Source: org_study_id