Multilevel Interventions to Enhance Provider Recommendations for HPV Vaccination

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StatusRecruiting

Keywords

Abstract

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.

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.

Dates

Last Verified:	02/29/2020
First Submitted:	01/24/2018
Estimated Enrollment Submitted:	04/09/2018
First Posted:	04/17/2018
Last Update Submitted:	03/03/2020
Last Update Posted:	03/04/2020
Actual Study Start Date:	03/31/2018
Estimated Primary Completion Date:	12/30/2023
Estimated Study Completion Date:	12/30/2023

Condition or disease

Papillomavirus Vaccines

Intervention/treatment

Behavioral: Current care

Behavioral: Reminder-recall

Behavioral: Audit-and-feedback

Behavioral: Combined reminder-recall and audit-and-feedback

Phase

Arm Groups

Arm	Intervention/treatment
Other: 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.
Other: 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.
Other: 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.
Other: 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.
Other: 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.
Other: 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.

Eligibility Criteria

Ages Eligible for Study	11 Years To 11 Years
Sexes Eligible for Study	All
Accepts Healthy Volunteers	Yes
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.

Outcome

Primary Outcome Measures

1. Rates of HPV-vaccine receipt [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.