RECRUITING

Provider Recommendation and HPV Vaccination

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effectiveness and Mechanisms of Multilevel Implementation Strategies to Improve Provider Recommendation and Advance HPV Vaccination: a Cluster Randomized Trial

Quick Facts

Study Start:2022-03-21
Study Completion:2025-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05365048

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All KPSC pediatric clinics.
  2. * All providers (physicians, nurses, and medical assistants) and department administrators from the pediatric department.
  3. * Parents of HPV vaccine-eligible children (9-12 years old).
  1. * Providers and administrators who do not work for the pediatric department
  2. * Parents of children older than 12 years and/or who did not have a clinic visit in the study period.

Contacts and Locations

Study Contact

Nancy Takahashi Cannnizzaro, PhD
CONTACT
626-564-7663
Nancy.Takahashi@kp.org
Chunyi Hsu, MPH
CONTACT
626-564-3508
Chunyi.Hsu@kp.org

Principal Investigator

Erin Hahn, PhD
PRINCIPAL_INVESTIGATOR
KPSC Department of Research and Evaluation
Chun R Chao, PhD
PRINCIPAL_INVESTIGATOR
KPSC Department of Research and Evaluation

Study Locations (Sites)

Kaiser Permanente Southern California
Pasadena, California, 91101
United States

Collaborators and Investigators

Sponsor: Kaiser Permanente

  • Erin Hahn, PhD, PRINCIPAL_INVESTIGATOR, KPSC Department of Research and Evaluation
  • Chun R Chao, PhD, PRINCIPAL_INVESTIGATOR, KPSC Department of Research and Evaluation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-21
Study Completion Date2025-05-31

Study Record Updates

Study Start Date2022-03-21
Study Completion Date2025-05-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Human Papillomavirus