Multilevel Interventions to Enhance Provider Recommendations for HPV Vaccination

NCT03501992 | Completed Results

• 2 other identifiers: 17-010661R01CA217889
• Study Type: interventional
• Target: 9,242
• Locations: 1 country
• Sites: 1

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.

Conditions

Papillomavirus Vaccines

Keywords

Papillomavirus vaccines; Vaccination; Patient acceptance of health care; Child; Parents; Primary health care; Health personnel; Primary prevention; Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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.

  The dose had to have been received during the 12-month-long study step.

Secondary Outcomes (2)

• Initiation

  The initiating dose had to have been received during the 12-month-long study step.

• Completion

  The final dose had to have been received during the 12-month-long study step.

Other Outcomes (2)

• HPV-vaccine-dose Receipt in Females

  The dose had to have been received during the 12-month-long study step.

• HPV-vaccine-dose Receipt in Males

  The dose had to have been received during the 12-month-long study step.

Study Arms (6)

Practice A

OTHER

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

Practice B

OTHER

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

Practice C

OTHER

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

Practice D

OTHER

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

Practice E

OTHER

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

Practice F

OTHER

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

Interventions

Current care BEHAVIORAL

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.

Also known as: Active control, active comparator, current practice

Practice A; Practice B; Practice C; Practice D; Practice E; Practice F

Reminder-recall BEHAVIORAL

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).

Also known as: "Less Pain, Less Fuss, Right Now!" reminder-recall

Practice A; Practice B; Practice E

Audit-and-feedback BEHAVIORAL

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.

Also known as: "Make It Count!" audit-and-feedback & provider toolkit

Practice C; Practice D; Practice F

Combined reminder-recall and audit-and-feedback BEHAVIORAL

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.

Also known as: "Less Pain, Less Fuss, Right Now!" and "Make It Count!"

Practice A; Practice B; Practice C; Practice D; Practice E; Practice F

Eligibility Criteria

• Age: 11 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Empaneled in one of the six participating primary care practices
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (3)

• Finney Rutten LJ, Griffin JM, St Sauver JL, MacLaughlin K, Austin JD, Jenkins G, Herrin J, Jacobson RM. Multilevel Implementation Strategies for Adolescent Human Papillomavirus Vaccine Uptake: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2024 Jan 1;178(1):29-36. doi: 10.1001/jamapediatrics.2023.4932.

  PMID: 37983062 RESULT

• Kong WY, Finney Rutten LJ, Herrin J, St Sauver JL, Jenkins GD, Griffin JM, Jacobson RM. Multilevel Intervention and Human Papillomavirus Vaccination Disparities: A Secondary Analysis of a Cluster Randomized Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2518895. doi: 10.1001/jamanetworkopen.2025.18895.

  PMID: 40622715 DERIVED

• Finney Rutten LJ, Radecki Breitkopf C, St Sauver JL, Croghan IT, Jacobson DJ, Wilson PM, Herrin J, Jacobson RM. Evaluating the impact of multilevel evidence-based implementation strategies to enhance provider recommendation on human papillomavirus vaccination rates among an empaneled primary care patient population: a study protocol for a stepped-wedge cluster randomized trial. Implement Sci. 2018 Jul 13;13(1):96. doi: 10.1186/s13012-018-0778-x.

  PMID: 30001723 DERIVED

MeSH Terms

Conditions

Patient Acceptance of Health Care; Neoplasms

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

As a result of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or COVID-19 pandemic, routine clinical care for the 6 practices was interrupted from the end of March 2020 through August 31, 2020. For that reason, we did not begin Step 3 until September 1, 2020. Because Human Papillomavirus vaccination is highly seasonal among adolescents, Step 3 and Step 4 remained 12 months in duration. Step 3 ended August 31, 2021, and Step 4 began September 1, 2021, and ended August 31, 2022.

Results Point of Contact

• Title: Robert M Jacobson, MD
• Organization: Mayo Clinic

jacobson.robert@mayo.edu

507-250-4576

Study Officials

• Robert M Jacobson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Joan M Griffin, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: A factorial, stepped-wedge cluster randomized trial with process evaluation

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: April 18, 2018
• Study Start: April 1, 2018
• Primary Completion: August 31, 2022
• Study Completion: September 1, 2023
• Last Updated: October 24, 2024
• Results First Posted: October 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)