Increasing HPV Vaccination in Community-Based Pediatric Practices

NCT03399396 | Completed

• 2 other identifiers: 1717931R01CA207401-01A1
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

HPV Vaccines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Age-appropriate initiation rate (ages 13-17)

  Monthly, up to 36 months post baseline

• Age-appropriate completion rate (at age 13)

  Monthly, up to 36 months post baseline

• Age-appropriate initiation rate (at age 13)

  Monthly, up to 36 months post baseline

• Overall completion rate (ages 13-17)

  Monthly, up to 36 months post baseline

• Overall initiation rate (ages 13-17)

  Monthly, up to 36 months post baseline

Other Outcomes (4)

• Documented recommendation rate (well visits)

  Monthly, up to 36 months post baseline

• Documented recommendation rate (all visits)

  Monthly, up to 36 months post baseline

• Bundling adolescent vaccines rate

  Monthly, up to 36 months post baseline

Study Arms (2)

Web-Based Coaching

EXPERIMENTAL

Web-based delivery of practice facilitation for HPV vaccine

Behavioral: Practice facilitation for HPV vaccine

In-Person Coaching

EXPERIMENTAL

In-person delivery of practice facilitation for HPV vaccine

Behavioral: Practice facilitation for HPV vaccine

Interventions

Practice facilitation for HPV vaccine BEHAVIORAL

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; Web-Based Coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All providers and staff at each practice

You may not qualify if:

• None

Sponsors & Collaborators

• Pamela Hull: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• 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.

  PMID: 36550466 DERIVED

MeSH Terms

Interventions

Papillomavirus Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Pamela C Hull, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention, it is not possible to blind the practices or study staff to study arm allocation. To minimize bias, allocation will be masked until after baseline data collection of outcome measures, when it is time for each practice to initiate the intervention.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: January 16, 2018
• Study Start: February 21, 2018
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon request
• Access Criteria: Qualified researcher with IRB approval

Locations

US (1)