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Quality Improvement Strategies to Increase Human Papillomavirus (HPV) Vaccination in Integrated Healthcare Delivery Systems

Primary Purpose

Human Papillomavirus Infection

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VACs
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Human Papillomavirus Infection focused on measuring quality improvement, HPV vaccine, integrated healthcare delivery systems

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Integrated healthcare delivery systems headquartered in New York State or Wisconsin with at least 4 pediatric or internal medicine practices within the system.
  • All clinics within the integrated healthcare delivery system must participate in the state immunization registry.

Exclusion Criteria:

  • Integrated healthcare delivery systems headquartered outside of New York State or Wisconsin.

Sites / Locations

  • New York State Department of Health
  • Wisconsin Department of Health Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

VACs intervention

Wait list control

Arm Description

Integrated healthcare delivery systems randomly assigned to this arm will participate in the Vaccinate Adolescents against Cancers (VACs) model for HPV vaccine QI. Specific QI activities will be chosen by healthcare system leadership and healthcare providers on the systems' QI teams.

Integrated healthcare delivery systems randomly assigned to this arm will be placed on a waiting list to receive the intervention after the conclusion of the study period.

Outcomes

Primary Outcome Measures

HPV vaccination (≥1 dose), 11-12 year olds at 6 months
Coverage change from baseline to 6 months in HPV vaccine initiation (≥1 dose), among 11- to 12- year old patients, as measured by states' immunization information system (IIS) records

Secondary Outcome Measures

HPV vaccination (≥1 dose), 11-12 year olds at 6 months by state
Coverage change from baseline to 6 months in HPV vaccine initiation (≥1 dose), among 11- to 12- year-old patients, as measured by states' IIS records, stratifying by state (NY or WI)
HPV vaccination (completion according to the Advisory Committee on Immunization Practices (ACIP) guidelines), 11-12 year olds at six months
Coverage change from baseline to six months in HPV vaccine completion, among 11- to 12- year-old patients, as measured by states' IIS records
HPV vaccination (completion according to the Advisory Committee on Immunization Practices (ACIP) guidelines), 11-12 year olds at six months by state
Coverage change from baseline to six months in HPV vaccine completion, among 11- to 12- year-old patients by state (NY or WI), as measured by states' IIS records
HPV vaccination (≥1 dose), 13-17 year olds at six months
Coverage change from baseline to six months in HPV vaccine initiation (≥1 dose), among 13- to 17- year-old patients, as measured by states' IIS records
HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at six months
Coverage change from baseline to six months in HPV vaccine completion, among 13- to 17- year-old patients, as measured by states' IIS records

Full Information

First Posted
February 26, 2019
Last Updated
February 24, 2020
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Centers for Disease Control and Prevention, American Cancer Society, Inc., Wisconsin Department of Health and Family Services, New York State Department of Health, Association of Immunization Managers
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1. Study Identification

Unique Protocol Identification Number
NCT03887793
Brief Title
Quality Improvement Strategies to Increase Human Papillomavirus (HPV) Vaccination in Integrated Healthcare Delivery Systems
Official Title
Quality Improvement Strategies to Increase Human Papillomavirus (HPV) Vaccination in Integrated Healthcare Delivery Systems
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Inadequate recruitment of study clinics
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
July 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Centers for Disease Control and Prevention, American Cancer Society, Inc., Wisconsin Department of Health and Family Services, New York State Department of Health, Association of Immunization Managers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
HPV vaccination coverage is at lower levels than the national goal. This study will evaluate the effectiveness of quality improvement strategies for increasing HPV vaccination coverage among adolescent within the context of large integrated health care delivery systems.
Detailed Description
The University of North Carolina (UNC) will evaluate the impact of a quality improvement (QI) model for increasing HPV vaccination coverage among adolescents in primary care settings. UNC will partner with the American Cancer Society (ACS) to evaluate the effectiveness of their Vaccinate Adolescents against Cancer (VACs) model for HPV vaccine QI within the context of integrated healthcare delivery systems (IDSs). The VACs model includes the development of a QI action plan and a QI team. The QI team is made up of health care providers from participating clinics within the IDSs. The team then helps implement specific QI activities in participating primary care clinics. The model also includes vaccination coverage assessments in participating clinics at multiple time points to assess the impact of QI activities. Specific QI activities that will be offered to participating clinics will be chosen from a menu of options that will include the Center for Disease Control and Prevention's AFIX model and physician-to-physician engagement. AFIX (Assessment, Feedback, Incentives and eXchange) consists of brief quality improvement consultations that immunization specialists from state health departments deliver to vaccine providers in primary care settings. Using immunization registry data, the specialist evaluates the clinic's vaccination coverage and delivers education on best practices to improve coverage. Physician-to-physician (P2P) engagement consists of an in-depth training about how to make strong and effective HPV vaccination recommendations to primary care providers. The investigators will compare changes in HPV vaccination coverage between the quality improvement arm or wait list control arm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papillomavirus Infection
Keywords
quality improvement, HPV vaccine, integrated healthcare delivery systems

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VACs intervention
Arm Type
Experimental
Arm Description
Integrated healthcare delivery systems randomly assigned to this arm will participate in the Vaccinate Adolescents against Cancers (VACs) model for HPV vaccine QI. Specific QI activities will be chosen by healthcare system leadership and healthcare providers on the systems' QI teams.
Arm Title
Wait list control
Arm Type
No Intervention
Arm Description
Integrated healthcare delivery systems randomly assigned to this arm will be placed on a waiting list to receive the intervention after the conclusion of the study period.
Intervention Type
Other
Intervention Name(s)
VACs
Intervention Description
The VACs (Vaccinate Adolescents against Cancer) model for HPV vaccine quality improvement is a strategy developed by the American Cancer Society to improve HPV vaccination coverage in large integrated health care delivery systems. It includes the development of a quality improvement (QI) action plan, the formation of a QI team of health care providers, education for the QI team about HPV-related disease burden and vaccine efficacy, HPV vaccine coverage assessments at several time points that are shared with individual clinics within the health are system, and the adoption of specific QI strategies by participating clinics in the health care system.
Primary Outcome Measure Information:
Title
HPV vaccination (≥1 dose), 11-12 year olds at 6 months
Description
Coverage change from baseline to 6 months in HPV vaccine initiation (≥1 dose), among 11- to 12- year old patients, as measured by states' immunization information system (IIS) records
Time Frame
Six months
Secondary Outcome Measure Information:
Title
HPV vaccination (≥1 dose), 11-12 year olds at 6 months by state
Description
Coverage change from baseline to 6 months in HPV vaccine initiation (≥1 dose), among 11- to 12- year-old patients, as measured by states' IIS records, stratifying by state (NY or WI)
Time Frame
Six months
Title
HPV vaccination (completion according to the Advisory Committee on Immunization Practices (ACIP) guidelines), 11-12 year olds at six months
Description
Coverage change from baseline to six months in HPV vaccine completion, among 11- to 12- year-old patients, as measured by states' IIS records
Time Frame
Six months
Title
HPV vaccination (completion according to the Advisory Committee on Immunization Practices (ACIP) guidelines), 11-12 year olds at six months by state
Description
Coverage change from baseline to six months in HPV vaccine completion, among 11- to 12- year-old patients by state (NY or WI), as measured by states' IIS records
Time Frame
Six months
Title
HPV vaccination (≥1 dose), 13-17 year olds at six months
Description
Coverage change from baseline to six months in HPV vaccine initiation (≥1 dose), among 13- to 17- year-old patients, as measured by states' IIS records
Time Frame
Six months
Title
HPV vaccination (completion according to ACIP guidelines), 13-17 year olds at six months
Description
Coverage change from baseline to six months in HPV vaccine completion, among 13- to 17- year-old patients, as measured by states' IIS records
Time Frame
Six months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Integrated healthcare delivery systems headquartered in New York State or Wisconsin with at least 4 pediatric or internal medicine practices within the system. All clinics within the integrated healthcare delivery system must participate in the state immunization registry. Exclusion Criteria: Integrated healthcare delivery systems headquartered outside of New York State or Wisconsin.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noel T Brewer, PhD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Melissa B Gilkey, PhD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Department of Health
City
Albany
State/Province
New York
ZIP/Postal Code
12237
Country
United States
Facility Name
Wisconsin Department of Health Services
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53703
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Quality Improvement Strategies to Increase Human Papillomavirus (HPV) Vaccination in Integrated Healthcare Delivery Systems

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