Immunization, Vaccination
Conditions
Keywords
HPV, Vaccination, Practice based intervention
Brief summary
Most adolescents who receive human papillomavirus (HPV) vaccine are vaccinated in pediatric practices, yet missed opportunities (MOs) for HPV vaccination occur often and lead to low HPV vaccination rates. This cluster randomized clinical trial (RCT) will test the effectiveness (and cost-effectiveness) of training providers on HPV vaccine communication to reduce MOs and increase HPV vaccination rates.
Detailed description
As highlighted by NCI, low HPV vaccination rates represent a major lost opportunity for population-wide cancer prevention. Pediatric primary care office visits are the main site for HPV vaccination, yet many missed opportunities (MOs) for vaccination occur in primary care and contribute to low vaccination rates. MOs are office visits during which a patient is eligible for a vaccine, but does not receive it. Many factors cause MOs - provider factors (e.g., time-constrained visits, lack of communication skills, and giving vaccinations only at preventive visits) and parent factors (e.g., vaccine hesitancy). This cluster randomized clinical trial will test the effectiveness (and cost-effectiveness) of training providers in HPV vaccine communication to reduce MOs and increase HPV vaccination rates. This training will be done through online educational modules (sent via text or email), weekly mini lessons and live office practice sessions.
Interventions
BEHAVIORALSTOP-HPV communication intervention
This intervention will be communication skills training.
Sponsors
Children's Hospital of Philadelphia
American Academy of Pediatrics
University of Pennsylvania
National Institutes of Health (NIH)
National Cancer Institute (NCI)
University of Rochester
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
This study will use a cluster RCT study design to test the impact of the communication intervention to reduce missed opportunities (MOs) and raise HPV vaccine rates
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
Practice Inclusion Criteria: * The practice provides HPV vaccination services to adolescents. * The practice is part of Physician's Computer Company (PCC), Office Practicum (OP) or (a) yet-to-be selected health system(s). * The practice has had the same EHR system in place for a year or more (with special consideration on a case by case basis if they are close to but not do not reach a year). * The practice agrees to not participate in other HPV-related QI projects or research interventions during the study period (with special consideration on a case by case basis). Practice
Exclusion criteria
* The practice plans to change EHR systems in the next three years. * The practice participated in the last year, is currently engaged in, or plans to participate in an office-based HPV-related quality improvement (QI) project or research intervention during the study period (with special consideration on a case by case basis). * Estimated 20% or more of adolescents at the practice receive HPV vaccinations at schools or health department clinics (given standard practice and published data, the investigators expect that few to no practices will need to be excluded based on this restriction). Patient inclusion criteria: -All patients of participating practices (intervention and comparison) aged 11-17 years who have at least 1 visit to the practice within the past two years. Patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Rate of Missed Vaccination Opportunities Among All Clinicians | Assessment of rates from 2 time periods- baseline period (assessed outcomes retrospectively from minus 12 months to Time 0), followed by 6 month intervention period (excluding a 4 week ramp-up period). | The difference in the missed opportunity rate for HPV vaccination between the baseline period (12 months long) and the feedback period (6 months long) among all the clinicians in the participating practices, regardless of whether they received the training intervention. A missed opportunity is a visit-based measure, with the denominator representing all the visits where an HPV vaccine is due at the time of the visit and the numerator representing the number of visits where an HPV vaccine was not given. |
| Change in the Rate of Missed Vaccination Opportunities Among Consenting Clinicians | Assessment of rates from 2 time periods- baseline period (assessed outcomes retrospectively from minus 12 months to Time 0), followed by 6 month intervention period (excluding a 4 week ramp-up period). | The difference in the missed opportunity rate for HPV vaccination between the baseline period (12 months long) and the feedback period (6 months long) among all the clinicians in the participating practices who received the training intervention. A missed opportunity is a visit-based measure, with the denominator representing all the visits where an HPV vaccine is due at the time of the visit and the numerator representing the number of visits where an HPV vaccine was not given. |
Countries
United States
Participant flow
Recruitment details
Practices were recruited through the American Academy of Pediatrics' PROS (Pediatric Research in Office Settings) Network. Practices were the unit of randomization (48 practices total- 24 randomized into each arm).
Pre-assignment details
The unit of randomization in this cluster randomized design is the practice. Eligible patients of the practices had at least one visit in the baseline and/or communication period in this cluster-randomized design (overlap between periods is possible).
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm 1 will receive the STOP-HPV communication intervention
STOP-HPV communication intervention: This intervention will be communication skills training. | 79,775 |
| Control Arm 2 will receive standard of care | 87,783 |
| Total | 167,558 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Customized Adolescents ages 11-17 years Baseline Period | 50569 Participants | 53869 Participants | 104438 Participants |
| Age, Customized Adolescents ages 11-17 years Communication Intervention | 29206 Participants | 33914 Participants | 63120 Participants |
| Race/Ethnicity, Customized Baseline Period African American | 4962 Participants | 5080 Participants | 10042 Participants |
| Race/Ethnicity, Customized Baseline Period American Indiana/Alaskan Native | 229 Participants | 448 Participants | 677 Participants |
| Race/Ethnicity, Customized Baseline Period Asian or Pacific Islander | 2734 Participants | 1901 Participants | 4635 Participants |
| Race/Ethnicity, Customized Baseline Period Missing data | 6064 Participants | 14807 Participants | 20871 Participants |
| Race/Ethnicity, Customized Baseline Period Multiracial group | 348 Participants | 352 Participants | 700 Participants |
| Race/Ethnicity, Customized Baseline Period Other | 178 Participants | 223 Participants | 401 Participants |
| Race/Ethnicity, Customized Baseline Period White | 36054 Participants | 31058 Participants | 67112 Participants |
| Race/Ethnicity, Customized Communication Intervention African American | 2705 Participants | 3042 Participants | 5747 Participants |
| Race/Ethnicity, Customized Communication Intervention American Indiana/Alaskan Native | 138 Participants | 281 Participants | 419 Participants |
| Race/Ethnicity, Customized Communication Intervention Asian or Pacific Islander | 1583 Participants | 1148 Participants | 2731 Participants |
| Race/Ethnicity, Customized Communication Intervention Missing data | 3640 Participants | 9612 Participants | 13252 Participants |
| Race/Ethnicity, Customized Communication Intervention Multiracial group | 215 Participants | 223 Participants | 438 Participants |
| Race/Ethnicity, Customized Communication Intervention Other | 101 Participants | 128 Participants | 229 Participants |
| Race/Ethnicity, Customized Communication Intervention White | 20824 Participants | 19480 Participants | 40304 Participants |
| Sex/Gender, Customized Baseline Period Female | 25093 Participants | 26762 Participants | 51855 Participants |
| Sex/Gender, Customized Baseline Period Male | 25472 Participants | 27106 Participants | 52578 Participants |
| Sex/Gender, Customized Baseline Period Missing | 4 Participants | 1 Participants | 5 Participants |
| Sex/Gender, Customized Communication Intervention Female | 14664 Participants | 17068 Participants | 31732 Participants |
| Sex/Gender, Customized Communication Intervention Male | 14542 Participants | 16845 Participants | 31387 Participants |
| Sex/Gender, Customized Communication Intervention Missing | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change in the Rate of Missed Vaccination Opportunities Among All Clinicians
The difference in the missed opportunity rate for HPV vaccination between the baseline period (12 months long) and the feedback period (6 months long) among all the clinicians in the participating practices, regardless of whether they received the training intervention. A missed opportunity is a visit-based measure, with the denominator representing all the visits where an HPV vaccine is due at the time of the visit and the numerator representing the number of visits where an HPV vaccine was not given.
Time frame: Assessment of rates from 2 time periods- baseline period (assessed outcomes retrospectively from minus 12 months to Time 0), followed by 6 month intervention period (excluding a 4 week ramp-up period).
Population: The Overall Number Participants analyzed is the number of unique patients with one or more visits to their practice (regardless of whether HPV vaccine was due) a study period - the Baseline Period (12 months) and the Communication Intervention Period (6 months). The number of units analyzed, serving as the denominator, is the number of eligible visits (visits where a child is due for HPV vaccine). The number of these visits where the vaccine was not given at the eligible visit is the numerator.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Intervention | Change in the Rate of Missed Vaccination Opportunities Among All Clinicians | Baseline Period Missed Opportunity Rate | 37063 Eligible visits (due for vaccine) |
| Intervention | Change in the Rate of Missed Vaccination Opportunities Among All Clinicians | Communication Intervention Missed Opportunity Rate | 14932 Eligible visits (due for vaccine) |
| Control | Change in the Rate of Missed Vaccination Opportunities Among All Clinicians | Baseline Period Missed Opportunity Rate | 40764 Eligible visits (due for vaccine) |
| Control | Change in the Rate of Missed Vaccination Opportunities Among All Clinicians | Communication Intervention Missed Opportunity Rate | 18343 Eligible visits (due for vaccine) |
Primary
Change in the Rate of Missed Vaccination Opportunities Among Consenting Clinicians
The difference in the missed opportunity rate for HPV vaccination between the baseline period (12 months long) and the feedback period (6 months long) among all the clinicians in the participating practices who received the training intervention. A missed opportunity is a visit-based measure, with the denominator representing all the visits where an HPV vaccine is due at the time of the visit and the numerator representing the number of visits where an HPV vaccine was not given.
Time frame: Assessment of rates from 2 time periods- baseline period (assessed outcomes retrospectively from minus 12 months to Time 0), followed by 6 month intervention period (excluding a 4 week ramp-up period).
Population: The unique children who made a visit (not just an HPV eligible visit) in either the baseline period (12 month) and/or the communication intervention period (6 month) to a clinician who consented to receive online training. Because the missed opportunity rate is a visit-based outcome, the overall number of units analyzed is the number of HPV eligible visits made in the two time periods and the count of units below is the number of visits where an HPV vaccination was not given in each period
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Intervention | Change in the Rate of Missed Vaccination Opportunities Among Consenting Clinicians | Baseline Period | 25117 Eligible visits (HPV due) |
| Intervention | Change in the Rate of Missed Vaccination Opportunities Among Consenting Clinicians | Communication Intervention Period | 11152 Eligible visits (HPV due) |
| Control | Change in the Rate of Missed Vaccination Opportunities Among Consenting Clinicians | Baseline Period | 27817 Eligible visits (HPV due) |
| Control | Change in the Rate of Missed Vaccination Opportunities Among Consenting Clinicians | Communication Intervention Period | 13193 Eligible visits (HPV due) |