Human Papillomavirus (HPV) Vaccines
Conditions
Keywords
Health Information Technology (HIT)
Brief summary
Human papillomavirus (HPV) vaccines have potential to prevent an average of 26,900 cancer cases each year in the United States, but vaccine coverage rates remain low. The study team has developed an electronic application (app), Protect Me 4, to help parents and providers assess and have more productive conversations about needed vaccines. The specific aims of this study are to: (1) evaluate the feasibility of implementing Protect Me 4, and (2) estimate preliminary efficacy of Protect Me 4 to increase HPV vaccine initiation (receipt of first dose).
Detailed description
Human papillomavirus (HPV) vaccines have potential to prevent an average of 26,900 cancer cases each year in the United States, but vaccine coverage rates remain low. The study team has developed a health information technology (HIT) electronic application (app), Protect Me 4, to help parents and providers assess and have more productive conversations about needed vaccines. In past studies, Protect Me 4 users have demonstrated three times higher chances of initiating the HPV vaccine. Despite this promise, Protect Me 4 system implementation suffered from very low reach within clinics. In this phase of the project, the investigators will assess the feasibility of implementing Protect Me 4 in community clinics, as well as test vaccination rate data collection strategies and estimate the preliminary efficacy of Protect Me 4 to increase HPV vaccine initiation. Seven clinics will participate in the study, and three will be randomly assigned the use of Protect Me 4. Three of the clinics will act as controls and will not receive Protect Me 4. The final clinic will receive the intervention (but has not participated in any of the intervention development. This clinic will s as a demonstration clinic for the subsequent R01. For evaluation, vaccination records will be grouped in three-month periods \[initial (months 1-3), implementation (months 4-6) and maintenance (months 7-9)\] from Medicaid and CHIP (Children's Health Insurance Program) claims and Florida Immunization Registry data. During the implementation period (months 4-6), intervention clinics will receive the Protect Me 4 app and External Quality Improvement Support (practice facilitation and external and internal provider peer opinion leaders and provider incentives). During the maintenance period (months 7-9), intervention clinics will receive Protect Me 4 without external support (practice facilitation and external provider peer opinion leaders). To evaluate effectiveness at the individual-level, the study team will compare vaccination rates between eligible adolescents who visited intervention and control clinics across the three time periods.
Interventions
BEHAVIORALProtect Me 4 Application + External Quality Improvement Support
Participants will be asked to interact with the Protect Me 4 application, using an iPad tablet. During the implementation period (months 4-6), intervention clinics will receive the Protect Me 4 app and External Quality Improvement Support (practice facilitation and external and internal provider peer opinion leaders and provider incentives). Providers from intervention clinics will complete audit and feedback reports to assess HPV vaccination rates with the assistance of the practice facilitator. Providers at the intervention clinic will complete a pre-intervention survey to obtain background information (demographics, approximate HPV vaccination rates, comfort with the use of technology etc.)
BEHAVIORALProtect Me 4 Application Alone
During the maintenance period (months 7-9), intervention clinics will receive Protect Me 4 without external support (practice facilitation and external provider peer opinion leaders). Providers from intervention clinics will complete audit and feedback reports to assess HPV vaccination rates without the assistance of the practice facilitator. Providers at the intervention clinic will complete a post-intervention survey to gain provider feedback regarding the feasibility of Protect Me 4 and changes in perceptions regarding the use of technology.
Sponsors
University of Florida
National Cancer Institute (NCI)
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
The statistical team is blinded to the clinic assignment.
Intervention model description
Clinics are randomly assigned to use the intervention app or not. A 5th clinic, will use the app, but has not been involved in the app development.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Must be parent of an adolescent aged 11-12 years old. * Providers working with age appropriate for study adolescents at the intervention clinics * Adolescents/Parents/Providers willing to consent to participation * Adolescents/Parents that can read and speak English
Exclusion criteria
* Adolescents out of the age range for participation * Adolescents/Parents/Providers unwilling to consent to participation * Adolescents/Parents that can NOT read and speak English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reach - Feasibility | After month 9 | Goal will be to have 80% of the parents of 11-12 year olds offered the Protect Me 4 app. |
| Adoption - Feasibility | After month 9 | Goal will be to have 70% of parents complete the Protect Me 4 app for each provider. App will be considered feasible of 80% or more of providers use the app during the study. |
| Provider-level Implementation - Feasibility | After month 9 | Goal will be to have providers report using the discussion tips approximately half the time they are provided and offering HPV vaccine 75% of the time it is due. App will be considered feasible if providers view shot lists for 60% of their patients with screens indicating that shots are due. Will aim for providers to look at specific hesitations reported by parents 60% of the time they login to the app and hesitations are reported. |
| Parent-level Implementation - Feasibility | After month 9 | Goal will be to have 95% of people who start the app successfully enter the app and 80% agree to participate (consent and assent.) |
| Maintenance - Feasibility | Months 7-9 | During months 7-9, the study team will assess clinic and provider maintenance of use of the Protect Me 4 app |
| Acceptability - Feasibility | Month 6, Month 9 | At both the end of the implementation and the maintenance period, providers will complete the Post Intervention Survey. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Data Collection Strategy | After month 9 | Analysis of de-identified participant datasets linked to clinic records, HIT participation date, and vaccinations from the Florida Medicaid and CHIP claims or the Florida Immunization Registry data. |
| Efficacy Measurements | After month 9 | Determination of HPV vaccine initiation using Current Procedural Terminology (CPT) and Current Vaccine Administered (CVX) codes |
Countries
United States
Contacts
CONTACTStephanie Staras, PhD
CONTACTMarta Hansen
PRINCIPAL_INVESTIGATORStephanie Staras, PhD
University of Florida
Outcome results
None listed