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HPV Vaccine Communication ECHO for Primary Care Clinics

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ClinicalTrials.gov Identifier: NCT04587167
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : July 27, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
William Calo, Milton S. Hershey Medical Center

Brief Summary:
The safe, highly-effective human papillomavirus (HPV) vaccine remains underused in the US; only 51% of 13- to 17-year-old girls and boys were up-to-date by 2018. The Announcement Approach Training is effective in increasing HPV vaccine uptake during the clinic visit by training providers to make strong vaccine recommendations and answer parents' common questions. Systems communication like recall notifications also improve vaccination by reducing missed clinical opportunities. Although never tested to support HPV vaccination, the ECHO (Extension for Community Healthcare Outcomes) Model is a proven implementation strategy to promote capacity exchange between health care experts at academic centers and primary care providers at the front line of rural community health care. The trial will test the effectiveness of two ECHO-delivered HPV vaccination communication interventions versus control: HPV ECHO will provide Announcement Approach training, and HPV ECHO+ will provide training plus recall notices to communicate with parents who initially decline vaccination.

Condition or disease Intervention/treatment Phase
Human Papillomavirus Vaccines Adolescent Health Services Other: Project ECHO Other: Announcement Approach Training Other: Recall notices Not Applicable

Detailed Description:
The investigators will recruit 36 primary care clinics (family medicine and pediatric) in Pennsylvania. Eligible clinics will have at least 100 active patients, ages 11-14, in their electronic health record systems. Recruitment will target clinics in Central Pennsylvania, where most counties are designated as rural. Clinics will be randomized to one of three arms: ECHO-delivered HPV vaccine communication training using the Announcement Approach (HPV ECHO); HPV ECHO plus systems follow-up communication for parents who initially decline vaccination (HPV ECHO+); or control. Covariate-constrained randomization will be used to ensure balance among the three arms with respect to clinic size (adolescent patient population), clinic type (academic vs. non-academic), rurality, and historic adolescent HPV vaccination rates.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomized design
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: HPV ECHO: Increasing the Adoption of Evidence-based Communication Strategies for HPV Vaccination in Rural Primary Care Practices
Actual Study Start Date : May 1, 2021
Estimated Primary Completion Date : November 15, 2024
Estimated Study Completion Date : November 15, 2024

Arm Intervention/treatment
Experimental: HPV ECHO
Clinics randomly assigned to this arm will receive the intervention via real-time, interactive videoconferencing using Zoom at no cost to participants. The intervention has a curriculum of 10 sessions focused on the evidence-based Announcement Approach. Sessions will be 60 minutes in duration and held every other weekly for 4 months at regularly scheduled times.
Other: Project ECHO
Using proven adult learning techniques and interactive video technology, the ECHO Model promotes knowledge exchange between experts or specialists at centers of excellence ("the hub") and primary care providers (the "spokes), typically located in rural settings. Through regular real-time collaborative sessions, the spokes connect with the hub and with other spokes to discuss 1) best practices in care and 2) complex cases managed within their practice.
Other Name: ECHO Model

Other: Announcement Approach Training
Train physicians and their clinic staff to make strong HPV vaccine recommendations by using presumptive announcements. If parents show vaccine hesitancy, the Training train physicians a 3-step approach (Connect, Clarify, Counsel) to share effective, evidence-based messages about HPV vaccine.

Experimental: HPV ECHO+
Clinics randomly assigned to this arm will receive the HPV ECHO intervention plus a systems communication strategy to deliver recall notices to parents who initially decline HPV vaccination. This arm includes 12 primary care clinics in Pennsylvania.
Other: Project ECHO
Using proven adult learning techniques and interactive video technology, the ECHO Model promotes knowledge exchange between experts or specialists at centers of excellence ("the hub") and primary care providers (the "spokes), typically located in rural settings. Through regular real-time collaborative sessions, the spokes connect with the hub and with other spokes to discuss 1) best practices in care and 2) complex cases managed within their practice.
Other Name: ECHO Model

Other: Announcement Approach Training
Train physicians and their clinic staff to make strong HPV vaccine recommendations by using presumptive announcements. If parents show vaccine hesitancy, the Training train physicians a 3-step approach (Connect, Clarify, Counsel) to share effective, evidence-based messages about HPV vaccine.

Other: Recall notices
Notify parents that their child is behind for HPV vaccination. Recall notices will include research-tested messages to specifically address parent concerns. Recall notices will be sent to parents via patient portal or email communication.

No Intervention: Control
Clinics randomly assigned to this arm will receive no ECHO interventions. This arm includes 12 primary care clinics in Pennsylvania.



Primary Outcome Measures :
  1. HPV vaccination (≥1 dose), 11-14 year olds at 12 months [ Time Frame: Twelve months ]
    Coverage change from baseline to 12 months in HPV vaccine initiation (≥1 dose), among 11- to 14- year old patients, as measured by clinics' records


Secondary Outcome Measures :
  1. HPV vaccination (≥1 dose), 11-14 year olds at 3 months [ Time Frame: Three months ]
    Coverage change from baseline to 3 months in HPV vaccine initiation (≥1 dose), among 11- to 14- year old patients, as measured by clinics' records

  2. HPV vaccination (≥1 dose), 11-14 year olds at 6 months [ Time Frame: Six months ]
    Coverage change from baseline to 6 months in HPV vaccine initiation (≥1 dose), among 11- to 14- year old patients, as measured by clinics' records

  3. HPV vaccination (≥1 dose), 11-14 year olds at 9 months [ Time Frame: Nine months ]
    Coverage change from baseline to 9 months in HPV vaccine initiation (≥1 dose), among 11- to 14- year old patients, as measured by clinics' records

  4. HPV vaccination (completion), 11-14 year olds at 3 months [ Time Frame: Three months ]
    Coverage change from baseline to 3 months in HPV vaccine completion (according to the Advisory Committee on Immunization Practices (ACIP) guidelines), among 11- to 14- year-old patients, as measured by clinics' records

  5. HPV vaccination (completion), 11-14 year olds at 6 months [ Time Frame: Six months ]
    Coverage change from baseline to 6 months in HPV vaccine completion (according to the Advisory Committee on Immunization Practices (ACIP) guidelines), among 11- to 14- year-old patients, as measured by clinics' records

  6. HPV vaccination (completion), 11-14 year olds at 9 months [ Time Frame: Nine months ]
    Coverage change from baseline to 9 months in HPV vaccine completion (according to the Advisory Committee on Immunization Practices (ACIP) guidelines), among 11- to 14- year-old patients, as measured by clinics' records

  7. HPV vaccination (completion), 11-14 year olds at 12 months [ Time Frame: Twelve months ]
    Coverage change from baseline to 12 months in HPV vaccine completion (according to the Advisory Committee on Immunization Practices (ACIP) guidelines), among 11- to 14- year-old patients, as measured by clinics' records

  8. HPV vaccination (≥1 dose), 15-17 year olds at 3 months [ Time Frame: Three months ]
    Coverage change from baseline to 3 months in HPV vaccine initiation (≥1 dose), among 15- to 17- year old patients, as measured by clinics' records

  9. HPV vaccination (≥1 dose), 15-17 year olds at 6 months [ Time Frame: Six months ]
    Coverage change from baseline to 6 months in HPV vaccine initiation (≥1 dose), among 15- to 17- year old patients, as measured by clinics' records

  10. HPV vaccination (≥1 dose), 15-17 year olds at 9 months [ Time Frame: Nine months ]
    Coverage change from baseline to 9 months in HPV vaccine initiation (≥1 dose), among 15- to 17- year old patients, as measured by clinics' records

  11. HPV vaccination (≥1 dose), 15-17 year olds at 12 months [ Time Frame: Twelve months ]
    Coverage change from baseline to 12 months in HPV vaccine initiation (≥1 dose), among 15- to 17- year old patients, as measured by clinics' records

  12. HPV vaccination (≥1 dose), 11-14 year olds at 12 months by sex [ Time Frame: Twelve months ]
    Coverage change from baseline to 12 months in HPV vaccine initiation (≥1 dose), among 11- to 14- year old patients by sex, as measured by clinics' records

  13. HPV vaccination (≥1 dose), 15-17 year olds at 12 months by sex [ Time Frame: Twelve months ]
    Coverage change from baseline to 12 months in HPV vaccine initiation (≥1 dose), among 15- to 17- year old patients by sex, as measured by clinics' records


Other Outcome Measures:
  1. Tetanus, diphtheria, and acellular pertussis (Tdap) vaccination, 11-14 year olds [ Time Frame: Twelve months ]
    Coverage change from baseline to 12 months in Tdap vaccination among 11- to 14-year-old patients, as measured by clinics' records

  2. Meningococcal vaccination (≥1 dose), 11-14 year olds [ Time Frame: Twelve months ]
    Coverage change from baseline to 12 months in meningococcal vaccination (≥1 dose), among 11- to 14-year-old patients, as measured by clinics' records



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Family medicine or pediatric clinic in Pennsylvania
  • Having at least 100 active patients, ages 11-14.

Exclusion Criteria:

  • Primary care clinic outside Pennsylvania
  • Participated in HPV vaccine communication or quality improvement research either through Penn State or another institution in the last 12 months.

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): NCT04587167


Contacts
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Contact: William A Calo, PhD, JD, MPH 7175313535 wcalo@phs.psu.edu
Contact: Erica Francis, MS 7175310003 ext 289862 efrancis@pennstatehealth.psu.edu

Locations
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United States, Pennsylvania
Penn State College of Medicine Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: William A Calo, PhD, JD, MPH    717-531-3535    wcalo@pennstatehealth.psu.edu   
Principal Investigator: William A Calo, PhD, JD, MPH         
Sponsors and Collaborators
Milton S. Hershey Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: William A Calo, PhD, JD, MPH Penn State College of Medicine
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Responsible Party: William Calo, Assistant Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT04587167    
Other Study ID Numbers: STUDY00015734
R37CA253279 ( U.S. NIH Grant/Contract )
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No raw data will be shared with the general public or other researchers.

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