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Multilevel Interventions to Enhance Provider Recommendations for HPV Vaccination

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ClinicalTrials.gov Identifier: NCT03501992
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : April 23, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Robert M. Jacobson, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Papillomavirus Vaccines Behavioral: Current care Behavioral: Reminder-recall Behavioral: Audit-and-feedback Behavioral: Combined reminder-recall and audit-and-feedback Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: A factorial, stepped-wedge cluster randomized trial with process evaluation
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).
Primary Purpose: Prevention
Official Title: "Less Pain, Less Fuss, Right Now!" and "Make It Count!"--Multilevel Interventions for Patient, Parent, and Practice to Enhance Provider Recommendations for HPV Vaccination
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
Practice A
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
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.
Other Name: Active control, active comparator, current practice

Behavioral: Reminder-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).
Other Name: "Less Pain, Less Fuss, Right Now!" reminder-recall

Behavioral: Combined 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.
Other Name: "Less Pain, Less Fuss, Right Now!" and "Make It Count!"

Practice B
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
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.
Other Name: Active control, active comparator, current practice

Behavioral: Reminder-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).
Other Name: "Less Pain, Less Fuss, Right Now!" reminder-recall

Behavioral: Combined 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.
Other Name: "Less Pain, Less Fuss, Right Now!" and "Make It Count!"

Practice C
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
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.
Other Name: Active control, active comparator, current practice

Behavioral: Audit-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.
Other Name: "Make It Count!" audit-and-feedback & provider toolkit

Behavioral: Combined 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.
Other Name: "Less Pain, Less Fuss, Right Now!" and "Make It Count!"

Practice D
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
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.
Other Name: Active control, active comparator, current practice

Behavioral: Audit-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.
Other Name: "Make It Count!" audit-and-feedback & provider toolkit

Behavioral: Combined 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.
Other Name: "Less Pain, Less Fuss, Right Now!" and "Make It Count!"

Practice E
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
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.
Other Name: Active control, active comparator, current practice

Behavioral: Reminder-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).
Other Name: "Less Pain, Less Fuss, Right Now!" reminder-recall

Behavioral: Combined 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.
Other Name: "Less Pain, Less Fuss, Right Now!" and "Make It Count!"

Practice F
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
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.
Other Name: Active control, active comparator, current practice

Behavioral: Audit-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.
Other Name: "Make It Count!" audit-and-feedback & provider toolkit

Behavioral: Combined 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.
Other Name: "Less Pain, Less Fuss, Right Now!" and "Make It Count!"




Primary Outcome Measures :
  1. Rates of HPV-vaccine receipt [ Time Frame: 12 months, 24 months, 36 months, and 48 months ]
    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.


Secondary Outcome Measures :
  1. Rates of HPV vaccine-initiation [ Time Frame: 12 months, 24 months, 36 months, and 48 months ]
    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.

  2. Rates of HPV vaccine-completion [ Time Frame: 12 months, 24 months, 36 months, and 48 months ]
    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.


Other Outcome Measures:
  1. Rates of HPV-vaccine receipt in females [ Time Frame: 12 months, 24 months, 36 months, and 48 months ]
    Rates of at least one dose of HPV-vaccine for empaneled, vaccine-eligible females at each practice, measured each month for the 12 months of each step.

  2. Rates of HPV-vaccine receipt in males [ Time Frame: 12 months, 24 months, 36 months, and 48 months ]
    Rates of at least one dose of HPV-vaccine for empaneled, vaccine-eligible males at each practice, measured each month for the 12 months of each step.

  3. Rates of HPV-vaccine receipt at 11 years of age [ Time Frame: 12 months, 24 months, 36 months, and 48 months ]
    Rates of at least one dose of HPV-vaccine for empaneled, vaccine-eligible 11-year-old males and females at each practice, measured each month for the 12 months of each step.

  4. Rates of HPV-vaccine receipt at 12 years of age [ Time Frame: 12 months, 24 months, 36 months, and 48 months ]
    Rates of at least one dose of HPV-vaccine for empaneled, vaccine-eligible 12-year-old males and females at each practice, measured each month for the 12 months of each step.

  5. Rates of HPV-vaccine receipt of dose 1 [ Time Frame: 12 months, 24 months, 36 months, and 48 months ]
    Rates of receipt of the first dose of HPV-vaccine for empaneled, vaccine-eligible females at each practice, measured each month for the 12 months of each step.

  6. Rates of HPV-vaccine receipt of dose 2 [ Time Frame: 12 months, 24 months, 36 months, and 48 months ]
    Rates of receipt of a second valid dose of HPV-vaccine for empaneled, vaccine-eligible females at each practice, measured each month for the 12 months of each step.

  7. Rates of HPV-vaccine receipt of dose 3 [ Time Frame: 12 months, 24 months, 36 months, and 48 months ]
    Rates of receipt of a third valid dose of HPV-vaccine for empaneled, vaccine-eligible females at each practice, measured each month for the 12 months of each step.

  8. Rates of HPV-vaccine receipt in patients empaneled to family physicians [ Time Frame: 12 months, 24 months, 36 months, and 48 months ]
    Rates of at least one dose of HPV-vaccine for empaneled, vaccine-eligible females at each practice who are empaneled to family physicians, measured each month for the 12 months of each step.

  9. Rates of HPV-vaccine receipt in patients empaneled to pediatricians [ Time Frame: 12 months, 24 months, 36 months, and 48 months ]
    Rates of at least one dose of HPV-vaccine for empaneled, vaccine-eligible females at each practice who are empaneled to pediatricians, measured each month for the 12 months of each step.

  10. Rates of HPV-vaccine receipt in patients empaneled to family medicine nurse practitioners [ Time Frame: 12 months, 24 months, 36 months, and 48 months ]
    Rates of at least one dose of HPV-vaccine for empaneled, vaccine-eligible females at each practice who are empaneled to family medicine nurse practitioners, measured each month for the 12 months of each step.

  11. Rates of HPV-vaccine receipt in patients empaneled to pediatric nurse practitioners [ Time Frame: 12 months, 24 months, 36 months, and 48 months ]
    Rates of at least one dose of HPV-vaccine for empaneled, vaccine-eligible females at each practice who are empaneled to pediatric nurse practitioners, measured each month for the 12 months of each step.

  12. Rates of HPV-vaccine receipt in patients empaneled to family medicine residents [ Time Frame: 12 months, 24 months, 36 months, and 48 months ]
    Rates of at least one dose of HPV-vaccine for empaneled, vaccine-eligible females at each practice who are empaneled to family medicine residents, measured each month for the 12 months of each step.

  13. Rates of HPV-vaccine receipt in patients empaneled to pediatric residents [ Time Frame: 12 months, 24 months, 36 months, and 48 months ]
    Rates of at least one dose of HPV-vaccine for empaneled, vaccine-eligible females at each practice who are empaneled to pediatric residents, measured each month for the 12 months of each step.

  14. Rates of missed opportunities for HPV-vaccine receipt [ Time Frame: 11 months (m), 12 m, 13 m, 14 m, 15 m, 16 m, 17 m, 18 m, 19 m, 20 m, 21 m, 22 m, 23 m, 24 m, 25 m, 26 m, 27 m, 28 m, 29 m, 30 m, 31 m, 32 m, 33 m, 34 m, 35 m, 36 m, 37 m, 38 m, 39 m, 40 m, 41 m, 42 m, 43 m, 44 m, 45 m, 46 m, and 47 m ]
    By provider, rates of encounters of patients seen in the preceding month who were 9 to 26 years of age and due for a dose of HPV vaccine and received an HPV vaccine the day of that encounter.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   11 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03501992


Contacts
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Contact: Ivana T Croghan, PhD 507-266-1944 croghan.Ivana@mayo.edu
Contact: Stephanie M Pagel, MA 507-538-7490 pagel.stephanie@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Ashley E Baker    507-293-0364    baker.ashley2@mayo.edu   
Contact: Christine M Prissel    507-284-8465    Prissel.Christine@mayo.edu   
Principal Investigator: Robert M Jacobson, MD         
Principal Investigator: Lila J Rutten, PhD         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Robert M Jacobson, MD Mayo Clinic
Principal Investigator: Lila J Rutten, PhD Mayo Clinic

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Robert M. Jacobson, Professor of Pediatrics, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03501992     History of Changes
Other Study ID Numbers: 17-010661
1R01CA217889-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Robert M. Jacobson, Mayo Clinic:
Papillomavirus vaccines
Vaccination
Patient acceptance of health care
Child
Parents
Primary health care
Health personnel
Primary prevention
Neoplasms

Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs