Back to resultsImpact of Financial Incentives
Primary Purpose
Human Papilloma Virus
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Communication training
financial Incentive
Sponsored by
About this trial
This is an interventional health services research trial for Human Papilloma Virus focused on measuring financial incentives, pediatric medicine, vaccination, pay-for-performance
Eligibility Criteria
This trial will enroll clinics and intervene with clinical staff. We will use vaccination data from children to evaluate intervention effectiveness. We will not enroll children or interact with them directly. Inclusion Criteria: Clinics are eligible if they are a pediatric or family medicine clinic in North Carolina that in the past year had: less than 72% HPV vaccine initiation rate, greater than or equal to 50 patients ages 9-12 greater than or equal to 2 HPV vaccine providers no clinic or provider-level financial incentive programs to increase system, clinic, or provider HPV vaccination rates among patients aged 9-12 in the past two years, and no HPV vaccine provider communication trainings in the past six months. Children's medical records will be eligible to be included in the dataset if children: are between the ages of 9-12 years at baseline and are attributed to a participating clinic at 12- or 24-month follow-up. Exclusion Criteria: Clinics are excluded if they: do not provide HPV vaccine to children ages 9-12 have a specialty other than pediatrics or family medicine had an HPV vaccine-specific financial incentive program in the past two years had a formal HPV vaccine communication training in the past 6 months had an HPV initiation rate greater than 72$ had fewer than 49 patients aged 9-12 had 1 or fewer HPV vaccine providers Children's medical records will not be eligible to be included in the dataset if children: are not between the ages of 9-12 years at baseline are not attributed to a participating clinic at 12- or 24-month follow-up
Sites / Locations
- University of North Carolina at Chapel HillRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
HPV vaccine communication training.
HPV vaccine communication training and clinic-level financial incentive program
Arm Description
Staff in clinics randomized to this arm will receive an intervention called Announcement Approach Training (AAT). This training is designed to improve communication about HPV vaccination.
Staff in clinics randomized to this arm will receive the Announcement Approach Training and a clinic-level financial incentive program with a monthly data feedback report to increase HPV vaccine uptake.
Outcomes
Primary Outcome Measures
HPV vaccination (≥1 dose), 9-12 year olds
Proportion of unvaccinated children who initiate the HPV vaccine series between baseline and 12-month follow-up, among those who were ages 9-12 at baseline.
Secondary Outcome Measures
HPV vaccination (≥1 dose), 9-12 year olds
Proportion of unvaccinated children who initiate the HPV vaccine series between 13- and 24-month follow-up, among those who were ages 9-12 at 13 months.
HPV vaccination (≥2 doses), 9-12 year olds
Proportion of unvaccinated children who complete the HPV vaccine series between baseline and 12-month follow-up, among those who were ages 9-12 at baseline.
HPV vaccination (≥2 doses), 9-12 year olds
Proportion of unvaccinated children who complete the HPV vaccine series between 13- and 24-month follow-up, among those who were ages 9-12 at 13 months.
Full Information
NCT ID
NCT05744960
First Posted
February 15, 2023
Last Updated
March 15, 2023
Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05744960
Brief Title
Impact of Financial Incentives
Official Title
The Impact of Clinic-level Financial Incentives on HPV Vaccine Communication and Uptake
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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
This trial will look at the impact of clinic-level financial incentives to improve provider communication and increase HPV vaccine uptake. Some clinics will receive communication training. Other clinics will receive the same training and a clinic-level financial incentive program with a monthly data feedback report to increase HPV vaccine uptake.
Detailed Description
The researchers will conduct a cluster randomized control trial. This trial will look at the impact of clinic-level financial incentives to improve provider communication and increase HPV vaccine uptake. The recruitment goal for the trial is 34 clinics in healthcare systems, including 9 rural-serving clinics. The researchers will randomize clinics using simple randomization (1:1). Some clinics will receive communication training. Other clinics will receive the same training and a clinic-level financial incentive program with a monthly data feedback report to increase HPV vaccine uptake. The researchers will use medical record data to compare changes in HPV vaccination among children ages 9-12. Clinics will be followed for 24 months. The study will engage clinical staff. Researchers will not have direct contact with children or their families.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus
Keywords
financial incentives, pediatric medicine, vaccination, pay-for-performance
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 ratio control and intervention arm randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HPV vaccine communication training.
Arm Type
Experimental
Arm Description
Staff in clinics randomized to this arm will receive an intervention called Announcement Approach Training (AAT). This training is designed to improve communication about HPV vaccination.
Arm Title
HPV vaccine communication training and clinic-level financial incentive program
Arm Type
Experimental
Arm Description
Staff in clinics randomized to this arm will receive the Announcement Approach Training and a clinic-level financial incentive program with a monthly data feedback report to increase HPV vaccine uptake.
Intervention Type
Behavioral
Intervention Name(s)
Communication training
Intervention Description
Clinics will host an Announcement Approach Training (AAT) workshop. A trained facilitator will use a standard script and slides to deliver workshop in-person or over Zoom; clinical staff who are unavailable will take the workshop later on their own.
Intervention Type
Behavioral
Intervention Name(s)
financial Incentive
Intervention Description
Clinics will host an AAT workshop, as in the other trial arm. Clinics in the intervention arm will then receive a 12-month clinic-level financial incentive program with predetermined targets for HPV vaccine initiation rates (5%, 10%, and 30% increases from baseline). Clinics will be notified of their HPV vaccination rates though a monthly, automated report. Clinic achievement will be assessed and incentives will be paid out to clinics monthly. Incentives will be tiered based on target and sized based on the number of clinic providers. For reaching the highest tier of 30%, clinics will receive an aggregate of $1000 per provider.
Primary Outcome Measure Information:
Title
HPV vaccination (≥1 dose), 9-12 year olds
Description
Proportion of unvaccinated children who initiate the HPV vaccine series between baseline and 12-month follow-up, among those who were ages 9-12 at baseline.
Time Frame
from baseline to 12 months
Secondary Outcome Measure Information:
Title
HPV vaccination (≥1 dose), 9-12 year olds
Description
Proportion of unvaccinated children who initiate the HPV vaccine series between 13- and 24-month follow-up, among those who were ages 9-12 at 13 months.
Time Frame
from 13 months to 24 months
Title
HPV vaccination (≥2 doses), 9-12 year olds
Description
Proportion of unvaccinated children who complete the HPV vaccine series between baseline and 12-month follow-up, among those who were ages 9-12 at baseline.
Time Frame
from baseline to 12 months
Title
HPV vaccination (≥2 doses), 9-12 year olds
Description
Proportion of unvaccinated children who complete the HPV vaccine series between 13- and 24-month follow-up, among those who were ages 9-12 at 13 months.
Time Frame
from 13 months to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
This trial will enroll clinics and intervene with clinical staff. We will use vaccination data from children to evaluate intervention effectiveness. We will not enroll children or interact with them directly.
Inclusion Criteria:
Clinics are eligible if they are a pediatric or family medicine clinic in North Carolina that in the past year had:
less than 72% HPV vaccine initiation rate,
greater than or equal to 50 patients ages 9-12
greater than or equal to 2 HPV vaccine providers
no clinic or provider-level financial incentive programs to increase system, clinic, or provider HPV vaccination rates among patients aged 9-12 in the past two years, and
no HPV vaccine provider communication trainings in the past six months.
Children's medical records will be eligible to be included in the dataset if children:
are between the ages of 9-12 years at baseline and
are attributed to a participating clinic at 12- or 24-month follow-up.
Exclusion Criteria:
Clinics are excluded if they:
do not provide HPV vaccine to children ages 9-12
have a specialty other than pediatrics or family medicine
had an HPV vaccine-specific financial incentive program in the past two years
had a formal HPV vaccine communication training in the past 6 months
had an HPV initiation rate greater than 72$
had fewer than 49 patients aged 9-12
had 1 or fewer HPV vaccine providers
Children's medical records will not be eligible to be included in the dataset if children:
are not between the ages of 9-12 years at baseline
are not attributed to a participating clinic at 12- or 24-month follow-up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathryn R Brignole, MSc
Phone
4846617752
Email
brignolk@ad.unc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Justin G Trogdon, PhD
Email
trogdonj@ad.unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin G Trogdon, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7590
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn R Brignole, MSc
Phone
484-661-7752
Email
brignolk@ad.unc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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