Impact of Financial Incentives

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of Clinic-level Financial Incentives on HPV Vaccine Communication and Uptake

Conditions
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Human Papilloma Virus

Intervention / Treatment
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* Behavioral: Communication training
* Behavioral: financial Incentive


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 ratio control and intervention arm randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPV vaccine communication training.<br>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. | Behavioral: Communication training<br>* 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.<br>|
| Experimental: HPV vaccine communication training and clinic-level financial incentive program<br>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. | Behavioral: Communication training<br>* 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.<br>Behavioral: financial Incentive<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | from baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | from 13 months to 24 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. | from baseline to 12 months | 
| 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. | from 13 months to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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financial incentives, pediatric medicine, vaccination, pay-for-performance