Multilevel Interventions to Enhance Provider Recommendations for HPV Vaccination

Study Overview
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Brief Summary
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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
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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.

Official Title
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Less Pain, Less Fuss, Right Now! and Make It Count!--Multilevel Interventions for Patient, Parent, and Practice to Enhance Provider Recommendations for HPV Vaccination

Conditions
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Papillomavirus Vaccines

Intervention / Treatment
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* Behavioral: Current care
* Behavioral: Reminder-recall
* Behavioral: Audit-and-feedback
* Behavioral: Combined reminder-recall and audit-and-feedback


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: A factorial, stepped-wedge cluster randomized trial with process evaluation
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Practice A<br>Practice A will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice A will be assigned to receive the current care intervention. in the second step, Practice A will be assigned to receive the current care intervention. In the third step, Practice A will receive the reminder-recall intervention. In the fourth step, Practice A will receive the combined reminder-recall and audit-and-feedback intervention. | Behavioral: Current care<br>* 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.<br>* Other names: Active control, active comparator, current practice;Behavioral: Reminder-recall<br>* 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).<br>* Other names: Less Pain, Less Fuss, Right Now! reminder-recall;Behavioral: Combined reminder-recall and audit-and-feedback<br>* 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.<br>* Other names: Less Pain, Less Fuss, Right Now! and Make It Count!;|
| Other: Practice B<br>Practice B will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice B will be assigned to receive the current care intervention. In the second step, Practice B will be assigned to receive the reminder-recall intervention. In the third step, Practice B will receive the combined reminder-recall and audit-and-feedback intervention. In the fourth step, Practice A will receive the combined reminder-recall and audit-and-feedback intervention. | Behavioral: Current care<br>* 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.<br>* Other names: Active control, active comparator, current practice;Behavioral: Reminder-recall<br>* 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).<br>* Other names: Less Pain, Less Fuss, Right Now! reminder-recall;Behavioral: Combined reminder-recall and audit-and-feedback<br>* 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.<br>* Other names: Less Pain, Less Fuss, Right Now! and Make It Count!;|
| Other: Practice C<br>Practice C will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice C will be assigned to receive the current care intervention. In the second step, Practice C will be assigned to receive the audit-and-feedback intervention. In the third step, Practice C will receive the audit-and-feedback intervention. In the fourth step, Practice C will receive the combined reminder-recall and audit-and-feedback intervention. | Behavioral: Current care<br>* 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.<br>* Other names: Active control, active comparator, current practice;Behavioral: Audit-and-feedback<br>* 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.<br>* Other names: Make It Count! audit-and-feedback & provider toolkit;Behavioral: Combined reminder-recall and audit-and-feedback<br>* 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.<br>* Other names: Less Pain, Less Fuss, Right Now! and Make It Count!;|
| Other: Practice D<br>Practice D will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice D will be assigned to receive the current care intervention. In the second step, Practice D will be assigned to receive the current care intervention. In the third step, Practice D will receive the audit-and-feedback intervention. In the fourth step, Practice D will receive the combined reminder-recall and audit-and-feedback intervention. | Behavioral: Current care<br>* 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.<br>* Other names: Active control, active comparator, current practice;Behavioral: Audit-and-feedback<br>* 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.<br>* Other names: Make It Count! audit-and-feedback & provider toolkit;Behavioral: Combined reminder-recall and audit-and-feedback<br>* 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.<br>* Other names: Less Pain, Less Fuss, Right Now! and Make It Count!;|
| Other: Practice E<br>Practice E will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice E will be assigned to receive the current care intervention. In the second step, Practice E will be assigned to receive the reminder-recall intervention. In the third step, Practice E will receive the reminder-recall intervention. In the fourth step, Practice E will receive the combined reminder-recall and audit-and-feedback intervention. | Behavioral: Current care<br>* 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.<br>* Other names: Active control, active comparator, current practice;Behavioral: Reminder-recall<br>* 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).<br>* Other names: Less Pain, Less Fuss, Right Now! reminder-recall;Behavioral: Combined reminder-recall and audit-and-feedback<br>* 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.<br>* Other names: Less Pain, Less Fuss, Right Now! and Make It Count!;|
| Other: Practice F<br>Practice F will consist of the eligible patients empaneled to one of the six participating practices. In the first step, Practice F will be assigned to receive the current care intervention. In the second step, Practice F will be assigned to receive the audit-and-feedback intervention. In the third step, Practice F will receive the combined reminder-recall and audit-and-feedback intervention. In the fourth step, Practice F will receive the combined reminder-recall and audit-and-feedback intervention. | Behavioral: Current care<br>* 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.<br>* Other names: Active control, active comparator, current practice;Behavioral: Audit-and-feedback<br>* 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.<br>* Other names: Make It Count! audit-and-feedback & provider toolkit;Behavioral: Combined reminder-recall and audit-and-feedback<br>* 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.<br>* Other names: Less Pain, Less Fuss, Right Now! and Make It Count!;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of HPV-vaccine receipt | Rates of at least one dose of HPV-vaccine for empaneled, vaccine-eligible males and females at each practice, measured each month for the 12 months of each step. | 12 months, 24 months, 36 months, and 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of HPV vaccine-initiation | Rates of receipt of the first valid dose for the initiation of the HPV vaccine series for empaneled, vaccine-eligible males and females at each practice, measured each month for the 12 months of each step. | 12 months, 24 months, 36 months, and 48 months | 
| Rates of HPV vaccine-completion | Rates of receipt of the last valid dose for the completion of the HPV vaccine series for empaneled, vaccine-eligible males and females at each practice, measured each month for the 12 months of each step. | 12 months, 24 months, 36 months, and 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Papillomavirus vaccines, Vaccination, Patient acceptance of health care, Child, Parents, Primary health care, Health personnel, Primary prevention, Neoplasms