Human Papillomavirus Clinical Trial
— HPVVOfficial title:
Effectiveness and Mechanisms of Multilevel Implementation Strategies to Improve Provider Recommendation and Advance HPV Vaccination: a Cluster Randomized Trial
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.
Status | Recruiting |
Enrollment | 90000 |
Est. completion date | May 31, 2025 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 70 Years |
Eligibility | Inclusion Criteria: - 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). Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Kaiser Permanente Southern California | Pasadena | California |
Lead Sponsor | Collaborator |
---|---|
Kaiser Permanente | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | HPV vaccine series completion - EMR | 9-12 year old who received 2 doses of the HPV vaccine during data collection period | Year 1 through Year 4 | |
Other | Time taken to recommend the HPV vaccine - survey | Time taken by provider to recommend the HPV vaccine at pre-intervention. | Year 1 | |
Other | Time taken to recommend the HPV vaccine - survey | Time taken by provider to recommend the HPV vaccine at post-intervention. | Year 4 | |
Other | Perceived comfort/distress in discussing HPV vaccination with parents - survey | Provider perception on comfort/distress in discussing the vaccine at pre-intervention. | Year 1 | |
Other | Perceived comfort/distress in discussing HPV vaccination with parents - survey | Provider perception on comfort/distress in discussing the vaccine at post-intervention. | Year 4 | |
Other | Parent satisfaction with HPV vaccine communication - survey | Satisfaction with provider communication regarding the HPV vaccine at pre-intervention. | Year 1 | |
Other | Parent satisfaction with HPV vaccine communication - survey | Satisfaction with provider communication regarding the HPV vaccine at post-intervention. | Year 4 | |
Other | Sustainment of study interventions - survey | Provider perception regarding the sustainment of the local-tailored or prescribed strategy after study ends. This question will be asked at post-intervention only. | Year 4 | |
Other | Fidelity - survey | The fidelity to the interventions will be obtained through the post-intervention provider surveys. An overall fidelity score will be obtained. | 12 month after intervention period | |
Primary | 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 | |
Primary | 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 | Provider Recommendation - survey | Questions to assess time spent on recommending the HPV vaccine, frequency of recommending the vaccine and content of discussion. In the baseline parent survey, we will ask questions regarding what the physician mentioned regarding the HPV vaccine and perception on how the information was discussed. We will derive a recommendation quality score. | Year 1 | |
Secondary | Provider Recommendation - survey | At post-intervention, surveys will include questions to assess time spent on recommending the HPV vaccine, frequency of recommending the vaccine and content of discussion. We will derive a recommendation quality score. | Year 4 |
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