Increasing HPV Vaccination in Community-Based Pediatric Practices

Sponsor

Pamela Hull (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03399396

Collaborator

National Cancer Institute (NCI) (NIH)

465

Enrollment

Location

Arms

57.3

Anticipated Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HPV Vaccines	Behavioral: Practice facilitation for HPV vaccine	N/A

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.

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 Design

Study Type:

Interventional

Anticipated Enrollment :

465 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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).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).

Masking:

None (Open Label)

Masking Description:

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.

Primary Purpose:

Health Services Research

Official Title:

Increasing HPV Vaccination in Community-Based Pediatric Practices

Actual Study Start Date :

Feb 21, 2018

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Nov 30, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Age-appropriate completion rate (ages 13-17) [Annually, up to 3 years post baseline]
Percentage of active patients ages 13-17 who completed the HPV vaccine series before 13th birthday

Secondary Outcome Measures

Age-appropriate initiation rate (ages 13-17) [Monthly, up to 36 months post baseline]
Percentage of active patients ages 13-17 who received at least one dose of HPV vaccine before 13th birthday
Age-appropriate completion rate (at age 13) [Monthly, up to 36 months post baseline]
Percentage of active patients who turned age 13 who completed the HPV vaccine series before 13th birthday
Age-appropriate initiation rate (at age 13) [Monthly, up to 36 months post baseline]
Percentage of active patients who turned age 13 who received at least one dose of HPV vaccine before 13th birthday
Overall completion rate (ages 13-17) [Monthly, up to 36 months post baseline]
Percentage of active patients ages 13-17 who completed the HPV vaccine series at any age
Overall initiation rate (ages 13-17) [Monthly, up to 36 months post baseline]
Percentage of active patients ages 13-17 who received at least one dose of HPV vaccine at any age
Dose received rate (well visits) [Monthly, up to 36 months post baseline]
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
Dose received rate (all visits) [Monthly, up to 36 months post baseline]
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
Age at vaccination [Monthly, up to 36 months post baseline]
Average age at receipt of first HPV vaccine dose, among active patients ages 13-17 who received 1st dose
Time to series completion [Monthly, up to 36 months post baseline]
Average number of months from 1st dose to last dose of HPV vaccine, among active patients ages 13-17 who completed the series

Other Outcome Measures

Documented recommendation rate (well visits) [Monthly, up to 36 months post baseline]
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
Documented recommendation rate (all visits) [Monthly, up to 36 months post baseline]
Percentage of visits with documentation of HPV vaccine either administered, deferred or refused, among all visits for active vaccine-eligible patients ages 11-17
Bundling adolescent vaccines rate [Monthly, up to 36 months post baseline]
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
Missed opportunities rate [Monthly, up to 36 months post baseline]
Percentage of non-well visits in which HPV vaccine was not administered, among all visits for active vaccine-eligible patients ages 11-17

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

All providers and staff at each practice

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37203

Sponsors and Collaborators

Pamela Hull
National Cancer Institute (NCI)

Investigators

Principal Investigator: Pamela C Hull, PhD, Vanderbilt University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pamela Hull, Assistant Professor, University of Kentucky

ClinicalTrials.gov Identifier:

NCT03399396

Other Study ID Numbers:

171793
1R01CA207401-01A1

First Posted:

Jan 16, 2018

Last Update Posted:

Mar 8, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 8, 2022