Provider Recommendation and HPV Vaccination

NCT05365048 | Recruiting

• 1 other identifier: R01CA255872
• Study Type: interventional
• Target: 301,201
• Locations: 1 country
• Sites: 1

Brief Summary

In the United State, there are millions of US teens who are not vaccinated against the human papillomavirus (HPV) putting them at risk of getting HPV-related cancers. Although there are clinical guidelines recommending the HPV vaccine and interventions encouraging parents to vaccinate their children to prevent HPV-related cancers, the vaccination rate for teens remains low according to a 2018 national survey. Survey data shows that HPV vaccine complete series coverage for teens aged 13-15 years was 50%, far below the 80% target of Healthy People 2020. Receiving a strong provider recommendation is the most powerful strategy for improving HPV vaccine rates. Yet, little is known about how to include provider recommendations and other important factors into an intervention to improve the HPV vaccination rates. Studies show there are provider, patient and system-level barriers in the initiation and completion of HPV vaccine series among 9-12 years old children. Barriers to the HPV vaccine also differ across demographic subgroups, communities, and clinics. Interventions that address only one component are not responsive to site barriers and as effective as one that addresses multiple components and site-specific barriers. This study uses a 3-arm cluster randomized controlled trial (RCT) to compare three implementation strategies to improve provider recommendations on the HPV vaccine. Two of the implementation strategies (local-tailored and prescribed strategy) utilize a multilevel approach. The three implementation strategies of interest are (1) a "local-tailored" implementation strategy, co-designed with local care teams to address local barriers and contexts (2) A "prescribed" strategy, most commonly used by health systems, that involves pre-specified interventions addressing pre-selected vaccination barriers and (3) usual standard of care where there are no research-led activities. We will use surveys, interviews, and electronic health records to evaluate the three implementation strategies and their impact on improving HPV vaccination rates. The study surveys and interviews will include pediatric providers, nurses, administrators, staff members, and parents of HPV vaccine-eligible children (9-12 years old). Successful implementation will be defined as improvement in HPV vaccination rates (primary outcome), strengthening provider recommendation (secondary outcome), and the cost-effectiveness of the implementation strategy.

Conditions

Human Papillomavirus

Keywords

Human Papillomavirus; Vaccine; Local Tailoring; 4 Pillars; Prescribed Strategy; Implementation Strategy; Provider Recommendation

Outcome Measures

Primary Outcomes (2)

• Proportion of children 9-12 years old who received the first dose of the HPV vaccine -EMR

  9-12 years old who received the first dose of the HPV vaccine at pre-intervention. Data obtained from electronic medical record (EMR)

  Year 1

• Proportion of children 9-12 years old who received the first dose of the HPV vaccine - EMR

  9-12 years old who received the first dose of the HPV vaccine at post-intervention

  Year 4

Secondary Outcomes (2)

• Provider Recommendation - survey

  Year 1

• Provider Recommendation - survey

  Year 4

Other Outcomes (9)

• HPV vaccine series completion - EMR

  Year 1 through Year 4

• Time taken to recommend the HPV vaccine - survey

  Year 1

• Time taken to recommend the HPV vaccine - survey

  Year 4

Study Arms (3)

Local Tailoring

EXPERIMENTAL

The intervention arm will include 20 clinics randomly assigned to the intervention arm. All physicians, nurses, department administrator and other staff members from the pediatric departments randomized to this arm will be included in the study, as well as parents of HPV vaccine eligible children (9-12 years old) who had one or more visits with their pediatric provider during the data collection period.

Other: Local Tailoring implementation strategy

Prescribed Strategy

EXPERIMENTAL

The intervention arm will include 20 clinics randomly assigned to the intervention arm.. All physicians, nurses, department administrator,s and other staff members from the pediatric departments randomized to this arm will be included in the study, as well as parents of HPV vaccine eligible children (9-12 years old) who had one or more visits with their pediatric provider during the data collection period.

Other: Prescribed Strategy

Usual Care

NO INTERVENTION

The intervention arm will include 20 clinics randomly assigned to the usual care arm. All physicians, nurses, department administrators,s and other staff members from the pediatric departments randomized to this arm will be included in the study, as well as parents of HPV vaccine eligible children (9-12 years old) who had one or more visits with their pediatric provider during the data collection period.

Interventions

Local Tailoring implementation strategy OTHER

The "local-tailored" approach will be guided by a structured process involving the following: (1) convening a local HPV vaccine project team, (2) conducting a local diagnostic process to identify top barriers, (3) selecting from a menu of intervention options that will be offered in this study, categorized by core function (i.e., the forms and functions menu) that address top local barriers, and (4) deploying the selected interventions. The barrier assessment and intervention customization are key processes for the local-tailored strategy, which allow clinics to devote resources to respond to unique local barriers in addition to common barriers.

Local Tailoring

Prescribed Strategy OTHER

The prescribed strategy is the standard implementation approach used by most health systems. Our prescribed approach will be guided by the evidence-based, award-winning 4 Pillars™ Practice Transformation Program for improving vaccination rates in the outpatient setting. The 4 Pillars™ address 4 main "functions", i.e., convenience, communication, office systems, and motivation to guide the selection of interventions. For adolescent HPV vaccination, the 4 Pillars has demonstrated moderate effectiveness.

Prescribed Strategy

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All KPSC pediatric clinics.
• All providers (physicians, nurses, and medical assistants) and department administrators from the pediatric department.
• Parents of HPV vaccine-eligible children (9-12 years old).

You may not qualify if:

• Providers and administrators who do not work for the pediatric department
• Parents of children older than 12 years and/or who did not have a clinic visit in the study period.

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Kaiser Permanente Southern California

Pasadena, California, 91101, United States

RECRUITING

Study Officials

• Erin Hahn, PhD

  KPSC Department of Research and Evaluation

  PRINCIPAL INVESTIGATOR

• Chun R Chao, PhD

  KPSC Department of Research and Evaluation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy Takahashi Cannnizzaro, PhD

CONTACT

626-564-7663; Nancy.Takahashi@kp.org

Chunyi Hsu, MPH

CONTACT

626-564-3508; Chunyi.Hsu@kp.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: This prospective study will utilize a cluster randomization design to compare three implementation strategies with outcome measures at the patient, provider and system level. Prior to randomization, clinics will be matched in triads on key attributes that may be associated with implementation success (e.g. geographic location, CFIR constructs, membership, race/ethnicity and baseline HPV vaccine converge) using a SAS algorithm. The 3 clinics matched in a triad will be most like each other in these attributes. The matched triads will be first randomized to determine the timing of their implementation (phase 1 will include 10 triads of 30 clinics) or phase 2 (10 triads of 30 clinics). Within each triad, the 3 clinics will then be randomized to determine which receives the local-tailored strategy ( 20 clinics) vs prescribed ( 20 clinics) vs usual care (20 clinics).

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 9, 2022
• Study Start: March 21, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)