Clinical trial NCT05744960: Impact of Financial Incentives
Official title: The Impact of Clinic-level Financial Incentives on HPV Vaccine Communication and Uptake
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Human Papilloma Virus
Keywords: financial incentives
pediatric medicine
vaccination
pay-for-performance
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-02-27
Enrollment: 34
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized design in which clinics will be randomized within healthcare systems
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: HPV vaccination (≥1 dose), 9-12 year olds
timeFrame: from baseline to 12 months
Secondary outcomes:
measure: HPV vaccination (≥1 dose), 9-12 year olds
timeFrame: from 13 months to 24 months
measure: HPV vaccination (≥2 doses), 9-12 year olds
timeFrame: from baseline to 12 months
measure: HPV vaccination (≥2 doses), 9-12 year olds
timeFrame: from 13 months to 24 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Justin G Trogdon, PhD
role: PRINCIPAL_INVESTIGATOR
References: