Adolescent Health Services, Human Papillomavirus Vaccines
Conditions
Brief summary
The safe, highly-effective human papillomavirus (HPV) vaccine remains underused in the US; only 51% of 13- to 17-year-old girls and boys were up-to-date by 2018. The Announcement Approach Training is effective in increasing HPV vaccine uptake during the clinic visit by training providers to make strong vaccine recommendations and answer parents' common questions. Systems communication like recall notifications also improve vaccination by reducing missed clinical opportunities. Although never tested to support HPV vaccination, the ECHO (Extension for Community Healthcare Outcomes) Model is a proven implementation strategy to promote capacity exchange between health care experts at academic centers and primary care providers at the front line of rural community health care. The trial will test the effectiveness of two ECHO-delivered HPV vaccination communication interventions versus control: HPV ECHO will provide Announcement Approach training, and HPV ECHO+ will provide training plus recall notices to communicate with parents who initially decline vaccination.
Detailed description
The investigators will recruit 36 primary care clinics (family medicine and pediatric) in Pennsylvania. Eligible clinics will have at least 100 active patients, ages 11-14, in their electronic health record systems. Recruitment will target clinics in Central Pennsylvania, where most counties are designated as rural. Clinics will be randomized to one of three arms: ECHO-delivered HPV vaccine communication training using the Announcement Approach (HPV ECHO); HPV ECHO plus systems follow-up communication for parents who initially decline vaccination (HPV ECHO+); or control. Covariate-constrained randomization will be used to ensure balance among the three arms with respect to clinic size (adolescent patient population), clinic type (academic vs. non-academic), rurality, and historic adolescent HPV vaccination rates.
Interventions
OTHERProject ECHO
Using proven adult learning techniques and interactive video technology, the ECHO Model promotes knowledge exchange between experts or specialists at centers of excellence ("the hub") and primary care providers (the "spokes), typically located in rural settings. Through regular real-time collaborative sessions, the spokes connect with the hub and with other spokes to discuss 1) best practices in care and 2) complex cases managed within their practice.
OTHERAnnouncement Approach Training
Train physicians and their clinic staff to make strong HPV vaccine recommendations by using presumptive announcements. If parents show vaccine hesitancy, the Training train physicians a 3-step approach (Connect, Clarify, Counsel) to share effective, evidence-based messages about HPV vaccine.
OTHERRecall notices
Notify parents that their child is behind for HPV vaccination. Recall notices will include research-tested messages to specifically address parent concerns. Recall notices will be sent to parents via patient portal or email communication.
Sponsors
Milton S. Hershey Medical Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Cluster randomized design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Clinics in cluster RCT (main study) Inclusion Criteria: * Family medicine or pediatric clinic in Pennsylvania * Having at least 100 active patients, ages 11-14.
Exclusion criteria
* Primary care clinic outside Pennsylvania * Participated in HPV vaccine communication or quality improvement research either through Penn State or another institution in the last 12 months. Parents in nested study survey Inclusion criteria: * Parent or guardian of an adolescent ages 11-17 * Adolescent has not yet started HPV vaccination * Adolescent receive primary care at participating clinic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HPV Vaccination (≥1 Dose), 11-14 Year Olds at 12 Months | Twelve months | Coverage change from baseline to 12 months in HPV vaccine initiation (≥1 dose), among 11- to 14- year old patients, as measured by clinics' records |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HPV Vaccination (≥1 Dose), 11-14 Year Olds at 3 Months | Three months | Coverage change from baseline to 3 months in HPV vaccine initiation (≥1 dose), among 11- to 14- year old patients, as measured by clinics' records |
| HPV Vaccination (≥1 Dose), 11-14 Year Olds at 6 Months | Six months | Coverage change from baseline to 6 months in HPV vaccine initiation (≥1 dose), among 11- to 14- year old patients, as measured by clinics' records |
| HPV Vaccination (≥1 Dose), 11-14 Year Olds at 9 Months | Nine months | Coverage change from baseline to 9 months in HPV vaccine initiation (≥1 dose), among 11- to 14- year old patients, as measured by clinics' records |
| HPV Vaccination (Completion), 11-14 Year Olds at 3 Months | Three months | Coverage change from baseline to 3 months in HPV vaccine completion (according to the Advisory Committee on Immunization Practices (ACIP) guidelines), among 11- to 14- year-old patients, as measured by clinics' records |
| HPV Vaccination (Completion), 11-14 Year Olds at 6 Months | Six months | Coverage change from baseline to 6 months in HPV vaccine completion (according to the Advisory Committee on Immunization Practices (ACIP) guidelines), among 11- to 14- year-old patients, as measured by clinics' records |
| HPV Vaccination (Completion), 11-14 Year Olds at 9 Months | Nine months | Coverage change from baseline to 9 months in HPV vaccine completion (according to the Advisory Committee on Immunization Practices (ACIP) guidelines), among 11- to 14- year-old patients, as measured by clinics' records |
| HPV Vaccination (Completion), 11-14 Year Olds at 12 Months | Twelve months | Coverage change from baseline to 12 months in HPV vaccine completion (according to the Advisory Committee on Immunization Practices (ACIP) guidelines), among 11- to 14- year-old patients, as measured by clinics' records |
| HPV Vaccination (≥1 Dose), 15-17 Year Olds at 3 Months | Three months | Coverage change from baseline to 3 months in HPV vaccine initiation (≥1 dose), among 15- to 17- year old patients, as measured by clinics' records |
| HPV Vaccination (≥1 Dose), 15-17 Year Olds at 6 Months | Six months | Coverage change from baseline to 6 months in HPV vaccine initiation (≥1 dose), among 15- to 17- year old patients, as measured by clinics' records |
| HPV Vaccination (≥1 Dose), 15-17 Year Olds at 12 Months | Twelve months | Coverage change from baseline to 12 months in HPV vaccine initiation (≥1 dose), among 15- to 17- year old patients, as measured by clinics' records |
| HPV Vaccination (≥1 Dose), 11-14 Year Olds at 12 Months by Sex | Twelve months | Coverage change from baseline to 12 months in HPV vaccine initiation (≥1 dose), among 11- to 14- year old patients by sex, as measured by clinics' records |
| HPV Vaccination (≥1 Dose), 15-17 Year Olds at 9 Months | Nine months | Coverage change from baseline to 9 months in HPV vaccine initiation (≥1 dose), among 15- to 17- year old patients, as measured by clinics' records |
| HPV Vaccination (≥1 Dose), 15-17 Year Olds at 12 Months by Sex | Twelve months | Coverage change from baseline to 12 months in HPV vaccine initiation (≥1 dose), among 15- to 17- year old patients by sex, as measured by clinics' records |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWilliam A Calo, PhD, JD, MPH
Penn State College of Medicine
Participant flow
Recruitment details
Clinics were recruited using existing professional contacts, purchasing of professional listservs, and participation as an exhibitor at state-wide conferences. The study team employed multiple outreach methods, including personalized mailings, individualized electronic messages, and mass email communications.
Pre-assignment details
Clinics were randomized using covariate-constrained randomization to ensure balance among the 3 arms with respect to clinic size, clinic type (academic vs non-academic), rurality (defined using RUCC), and initial HPV vaccination rates. Our outcomes were evaluated on the clinic-level. Each clinic reported aggregate immunization data on patients 11-17 years of age. Patients reported in the aggregate data are from the clinics, parents and patients were not enrolled. Only clinic staff were enrolled.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Aggregate Patient Immunization Data 11-14 year olds | 17812 Participants |
| Age, Customized Aggregate Patient Immunization Data 15-17 year olds | 13318 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 11426 patients |
| Sex: Female, Male 11-14 year olds Female | 3211 Participants |
| Sex: Female, Male 11-14 year olds Male | 9105 Participants |
| Sex: Female, Male 15-17 year olds Female | 2417 Participants |
| Sex: Female, Male 15-17 year olds Male | 2471 Participants |
| Sex/Gender, Customized Gender Female | 45 Participants |
| Sex/Gender, Customized Gender Male | 4 Participants |
| Sex/Gender, Customized Gender Not reported | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
None listed