Papillomavirus Vaccines
Conditions
Keywords
Papillomavirus vaccines, Vaccination, Patient acceptance of health care, Child, Parents, Primary health care, Health personnel, Primary prevention, Neoplasms
Brief summary
Each year the human papillomavirus (HPV) causes 30,000 cancers in the United States despite the availability of very effective and safe vaccines. Uptake of the HPV vaccine has been disappointingly low and lags behind other adolescent vaccines. This study seeks to test interventions targeting health care system, provider, and patient factors to improve the population uptake of the HPV vaccine.
Detailed description
The broad, long-term objective is to substantially increase human papillomavirus (HPV) vaccination rates by deploying effective population-health interventions in clinical practices across the United States. As part of this effort, the investigators intend to evaluate two evidence-based interventions with innovative enhancements at six Mayo Clinic primary care practices (PCP) to evaluate their individual and combined impact on rates of HPV vaccination among female and male patients. Aim 1, Less Pain, Less Fuss, Right Now!, will test the hypothesis that, as compared to no intervention (current practice), a practice-level intervention utilizing reminder-recalls featuring the availability of non-medication and medication anesthetics, the convenience of nurse-only visits, and the use of persuasive language for early, on-time vaccinations will improve HPV vaccine delivery rates. Aim 2, Make It Count!, will test the hypothesis that, as compared to no intervention, a provider level intervention utilizing a missed-opportunities assessment and feedback intervention applying social pressure (specific peer-performance comparisons) and equipping providers with a strong-recommendation toolkit will improve HPV vaccine delivery rates. Aim 3 will test the hypothesis that simultaneous implementation of interventions targeting individual, interpersonal, and organizational factors will have a synergistic effect on HPV vaccine delivery rates. To accomplish Aims 1-3, the investigators will use a stepped-wedge cluster randomized trial with an integrated process evaluation. The cluster approach prevents cross-contamination between patients or providers as we allocate two separate interventions (Aims 1 and 2) in the six PCPs. The stepped-wedge design, which ensures all practices eventually receive the same set of interventions, permits the single institutional review board overseeing all six PCPs to approve the study without requiring recruitment and consent of individual patients or providers. The stepped-wedge approach also permits the investigators to test the presence of each of the interventions in each PCP, making trial participation more attractive, while also allowing each practice to serve as its own control, reducing the bias due to imbalanced risk factors across practices. The factorial design allows the investigators to use a single trial to test two interventions and assess each individually and in combination. The design also conserves sample size while maintaining power. The investigators will measure the impact separately in females and males, 11-12 years of age for the rates of receipt of HPV vaccine doses due. Rigorously tested, highly effective, population-level interventions are essential if the US is to reach the Healthy People 2020 goal for HPV vaccination. The rigor, design, and high likelihood of success of this study will provide key evidence regarding practice- and provider-level interventions to improve HPV vaccination rates. Mayo Clinic's best practices inform not only its own 70 practices across five states but its Mayo Clinic Care Network, which consists of nearly 40 health-care organizations across 26 states and Puerto Rico.
Interventions
BEHAVIORALCurrent care
The current care arm consists of the contemporary efforts now in practice to support provider recommendation including a shared, standard immunization schedule, a shared rooming process, a shared well child visit schedule, a shared electronic prompt at point-of-care of vaccines due.
BEHAVIORALReminder-recall
The communication will use expectant (announcement-style or presumptive) language noting the child's HPV vaccination status and stating that the child's provider strongly recommends the child receive the HPV vaccination now. The communication will also describe availability of topical anesthetics (less pain), indicate the availability and convenience of nurse visits for HPV vaccination (less fuss), and describe the immunological and logistical benefits of early vaccination (right now).
BEHAVIORALAudit-and-feedback
The intervention includes two components. The first is a missed opportunities audit-and-feedback. The second is a provision of a strong recommendation provider-toolkit, along with a broad education of the practice staff-nurses, medical secretaries, receptionists, and clinical assistants-regarding the nature of the intervention, its goals, and its likely impact on the practice. The broad education will be conducted through supervisory communications only to practice staff in practices allocated to the intervention at the beginning of the step.
BEHAVIORALCombined reminder-recall and audit-and-feedback
The combination reminder-and-audit arm consists of a simultaneous application of the intervention tested in the reminder-recall arm and the intervention tested in the audit-and-feedback arm.
Sponsors
National Cancer Institute (NCI)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The data analyst will conduct the measurement of the patients eligible and vaccinated and the calculations of the outcomes. The investigators will blind the data analyst to which intervention(s) each practice was assigned to receive. However that only masks the practices' interventions for Step 2 and Step 3 as all practices receive the same interventions in Step 1 (current care) and Step 4 (combined reminder-audit).
Intervention model description
A factorial, stepped-wedge cluster randomized trial with process evaluation
Eligibility
Sex/Gender
ALL
Age
11 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Empaneled in one of the six participating primary care practices * 11 to 12 years of age at the first day of each of the 12-month-long steps * Due during that 12-month-long step for at least one dose of the HPV vaccine
Exclusion criteria
* Not empaneled in one of the six participating practices * Empaneled in one of the six participating practices but less than 11 years of age or more than 12 years of age on the first day of each 12 month long step * Not due during that 12-month-long step for a dose of HPV vaccine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Human Papillomavirus or HPV-vaccine-dose Receipt | The dose had to have been received during the 12-month-long study step. | The outcome measure was the proportion of empaneled, HPV-vaccine-dose eligible males and females in the study step who received the dose of HPV vaccine dose due by the end of the study step. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Initiation | The initiating dose had to have been received during the 12-month-long study step. | The outcome measure was the proportion of empaneled, HPV-vaccine-dose eligible males and females due for their first doses of the HPV vaccine series in the study step who received the first dose of HPV vaccine dose due by the end of the study step, thus initiating the HPV vaccine series. |
| Completion | The final dose had to have been received during the 12-month-long study step. | The outcome measure was the proportion of empaneled, HPV-vaccine-dose eligible males and females due for their final doses of the HPV vaccine series in the study step who received the final dose of HPV vaccine dose due by the end of the study step, thus completing the HPV vaccine series. |
Other
| Measure | Time frame | Description |
|---|---|---|
| HPV-vaccine-dose Receipt in Females | The dose had to have been received during the 12-month-long study step. | The outcome measure was the proportion of empaneled, HPV-vaccine-dose eligible females in the study step who received the dose of HPV vaccine dose due by the end of the study step. |
| HPV-vaccine-dose Receipt in Males | The dose had to have been received during the 12-month-long study step. | The outcome measure was the proportion of empaneled, HPV-vaccine-dose eligible males in the study step who received the dose of HPV vaccine dose due by the end of the study step. |
Countries
United States
Participant flow
Recruitment details
During each trial month for each practice, we identified patients both age- and dose-eligible. To become age eligible for a particular trial month and for the rest of the step, the patient must turn 11 or 12 years of age during the calendar month that preceded the calendar month before the given trial month. To be dose eligible for the same period, the patient must be due for an HPV vaccine dose in the month following their 11th or 12th birthday (ie, the month prior to the relevant trial month).
Pre-assignment details
A patient empaneled to a practice who was both age and dose eligible for one 12-month step may become age and dose eligible in the following 12-month step. We included patients in a step who were age and dose eligible for a preceding step who remained empaneled to a practice and became age and dose eligible in the next step. The dose eligibility may result from either still being due for the first, initial HPV vaccine dose or now being due for the second, final HPV vaccine dose. Others aged out.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of either step 1 or 2 to usual care. | 3,572 |
| Parent Reminder-Recall Letter Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of steps 2 or 3 to the parent reminder-recall letter intervention. | 1,670 |
| Provider Audit-Feedback Intervention. Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of steps 2 or 3 to the provider audit-feedback intervention. | 1,340 |
| Combination of Parent Reminder-Recall Letter and Provider Audit-Feedback Interventions Adolescents who turned 11 or 12 years of age, due for a dose of the human papillomavirus vaccine, empaneled in one of the six participating practices that were allocated for the duration of steps 3 and 4 to the combination of parent reminder-recall letter and provider audit-feedback interventions. | 2,660 |
| Total | 9,242 |
Baseline characteristics
| Characteristic | Total | Parent Reminder-Recall Letter | Provider Audit-Feedback Intervention. | Combination of Parent Reminder-Recall Letter and Provider Audit-Feedback Interventions | Usual Care |
|---|---|---|---|---|---|
| Age, Customized 11 years old | 5165 Participants | 943 Participants | 741 Participants | 1497 Participants | 1984 Participants |
| Age, Customized 12 years old | 4077 Participants | 727 Participants | 599 Participants | 1163 Participants | 1588 Participants |
| Human Papillomavirus (HPV) Vaccine Status Completing the HPV vaccine series | 2686 Participants | 503 Participants | 394 Participants | 955 Participants | 834 Participants |
| Human Papillomavirus (HPV) Vaccine Status Initiating the HPV vaccine series | 6556 Participants | 1167 Participants | 946 Participants | 1705 Participants | 2738 Participants |
| Race/Ethnicity, Customized Asian | 430 Participants | 75 Participants | 51 Participants | 107 Participants | 197 Participants |
| Race/Ethnicity, Customized Black | 832 Participants | 179 Participants | 92 Participants | 232 Participants | 329 Participants |
| Race/Ethnicity, Customized Hispanic | 215 Participants | 51 Participants | 18 Participants | 75 Participants | 71 Participants |
| Race/Ethnicity, Customized Other | 1067 Participants | 204 Participants | 143 Participants | 262 Participants | 458 Participants |
| Race/Ethnicity, Customized White | 6698 Participants | 1161 Participants | 1036 Participants | 1984 Participants | 2517 Participants |
| Region of Enrollment United States | 9242 participants | 1670 participants | 1340 participants | 2660 participants | 3572 participants |
| Sex: Female, Male Female | 4394 Participants | 799 Participants | 648 Participants | 1280 Participants | 1667 Participants |
| Sex: Female, Male Male | 4848 Participants | 871 Participants | 692 Participants | 1380 Participants | 1905 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Human Papillomavirus or HPV-vaccine-dose Receipt
The outcome measure was the proportion of empaneled, HPV-vaccine-dose eligible males and females in the study step who received the dose of HPV vaccine dose due by the end of the study step.
Time frame: The dose had to have been received during the 12-month-long study step.
Population: The overall number of participants analyzed summed the numbers of the empaneled, HPV-vaccine-eligible males and females in each of the study steps in each of the practices assigned to the intervention (arm/group). For example, we allocated all six practices to Usual Care in Step 1 and two practices to Usual Care in Step 2. The numbers from those eight practices add up to the overall number of participants analyzed for the Usual Care Arm/Group, which is 3572.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Human Papillomavirus or HPV-vaccine-dose Receipt | 782 Participants |
| Parent Reminder-Recall Letter | Human Papillomavirus or HPV-vaccine-dose Receipt | 578 Participants |
| Provider Audit-Feedback Intervention. | Human Papillomavirus or HPV-vaccine-dose Receipt | 408 Participants |
| Combination of Parent Reminder-Recall Letter and Provider Audit-Feedback Interventions | Human Papillomavirus or HPV-vaccine-dose Receipt | 1056 Participants |
Secondary
Completion
The outcome measure was the proportion of empaneled, HPV-vaccine-dose eligible males and females due for their final doses of the HPV vaccine series in the study step who received the final dose of HPV vaccine dose due by the end of the study step, thus completing the HPV vaccine series.
Time frame: The final dose had to have been received during the 12-month-long study step.
Population: The overall number of participants analyzed summed the numbers of the empaneled, HPV-vaccine-eligible males and females due for their final doses in each of the study steps in each of the practices assigned to the intervention (arm/group). For example, we allocated all six practices to Usual Care in Step 1 and two practices to Usual Care in Step 2. The numbers from those eight practices add up to the overall number of participants analyzed for the Usual Care Arm/Group, which is 834.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Completion | 300 Participants |
| Parent Reminder-Recall Letter | Completion | 249 Participants |
| Provider Audit-Feedback Intervention. | Completion | 157 Participants |
| Combination of Parent Reminder-Recall Letter and Provider Audit-Feedback Interventions | Completion | 566 Participants |
Secondary
Initiation
The outcome measure was the proportion of empaneled, HPV-vaccine-dose eligible males and females due for their first doses of the HPV vaccine series in the study step who received the first dose of HPV vaccine dose due by the end of the study step, thus initiating the HPV vaccine series.
Time frame: The initiating dose had to have been received during the 12-month-long study step.
Population: The overall number of participants analyzed summed the numbers of the empaneled, HPV-vaccine-eligible males and females due for their first doses in each of the study steps in each of the practices assigned to the intervention (arm/group). For example, we allocated all six practices to Usual Care in Step 1 and two practices to Usual Care in Step 2. The numbers from those eight practices add up to the overall number of participants analyzed for the Usual Care Arm/Group, which is 2738.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Initiation | 482 Participants |
| Parent Reminder-Recall Letter | Initiation | 329 Participants |
| Provider Audit-Feedback Intervention. | Initiation | 251 Participants |
| Combination of Parent Reminder-Recall Letter and Provider Audit-Feedback Interventions | Initiation | 490 Participants |
Other Pre-specified
HPV-vaccine-dose Receipt in Females
The outcome measure was the proportion of empaneled, HPV-vaccine-dose eligible females in the study step who received the dose of HPV vaccine dose due by the end of the study step.
Time frame: The dose had to have been received during the 12-month-long study step.
Population: The overall number of participants analyzed summed the numbers of the empaneled, HPV-vaccine-eligible females in each of the study steps in each of the practices assigned to the intervention (arm/group). For example, we allocated all six practices to Usual Care in Step 1 and two practices to Usual Care in Step 2. The numbers from those eight practices add up to the overall number of female participants analyzed for the Usual Care Arm/Group, which is 1667.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | HPV-vaccine-dose Receipt in Females | 385 Participants |
| Parent Reminder-Recall Letter | HPV-vaccine-dose Receipt in Females | 296 Participants |
| Provider Audit-Feedback Intervention. | HPV-vaccine-dose Receipt in Females | 188 Participants |
| Combination of Parent Reminder-Recall Letter and Provider Audit-Feedback Interventions | HPV-vaccine-dose Receipt in Females | 517 Participants |
Other Pre-specified
HPV-vaccine-dose Receipt in Males
The outcome measure was the proportion of empaneled, HPV-vaccine-dose eligible males in the study step who received the dose of HPV vaccine dose due by the end of the study step.
Time frame: The dose had to have been received during the 12-month-long study step.
Population: The overall number of participants analyzed summed the numbers of the empaneled, HPV-vaccine-eligible males in each of the study steps in each of the practices assigned to the intervention (arm/group). For example, we allocated all six practices to Usual Care in Step 1 and two practices to Usual Care in Step 2. The numbers from those eight practices add up to the overall number of male participants analyzed for the Usual Care Arm/Group, which is 1905.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | HPV-vaccine-dose Receipt in Males | 397 Participants |
| Parent Reminder-Recall Letter | HPV-vaccine-dose Receipt in Males | 282 Participants |
| Provider Audit-Feedback Intervention. | HPV-vaccine-dose Receipt in Males | 220 Participants |
| Combination of Parent Reminder-Recall Letter and Provider Audit-Feedback Interventions | HPV-vaccine-dose Receipt in Males | 539 Participants |