Back to resultsImpact of Standing Orders Optimization
Primary Purpose
Human Papilloma Virus
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Communication training
Communication training enhanced with standing orders optimization
Sponsored by
About this trial
This is an interventional health services research trial for Human Papilloma Virus focused on measuring Human Papilloma Virus, Pediatric medicine, Primary care, Standing orders, Vaccination
Eligibility Criteria
This trial will enroll clinics and intervene with clinical staff. We will use vaccination data from children and survey data from clinical staff to evaluate intervention effectiveness. We will not enroll children or interact with them directly. Inclusion Criteria Clinics are eligible if they: provide HPV vaccine to children ages 9-12 have standing orders for HPV vaccination approved but not routinely used or be willing to adopt them prior to the start of the trial have rates of HPV vaccination (≥1 dose) below 72%, boys and girls combined 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 are attributed to a participating clinic at 12- or 24-month follow-up Clinical staff's survey data will be eligible to be included in the dataset if clinical staff complete the follow-up survey. Exclusion Criteria Clinics are excluded if they: do not provide HPV vaccine to children ages 9-12 do not have standing orders for HPV vaccination or are not willing to adopt them prior to the start of the trial have rates of HPV vaccination (≥1 dose) above 72%, boys and girls combined have hosted an AAT workshop in the previous 3 years or are part of current HPV vaccine communication trainings have quality improvement efforts to change HPV vaccine standing orders during the trial 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 are receiving hospice/palliative care, are pregnant, or have a history of HPV vaccine contraindications Clinical staff's survey data will be not eligible to be included in the dataset if clinical staff do not complete the follow-up survey.
Sites / Locations
- The 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 standing orders optimization
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 AAT and conduct a set of activities to optimize use of HPV vaccine standing orders.
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.
Standing orders attitude rating
Positive attitude toward using HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating more positive attitudes.
Standing orders norms rating
Norms in favor of using HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating more supportive norms.
Standing orders self-efficacy rating
Confidence about using HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating higher confidence.
Standing orders adoption rating
Adoption of HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating greater adoption.
Standing orders acceptability rating
Acceptability of HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating higher acceptability.
Standing orders appropriateness rating
Appropriateness of HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating greater appropriateness.
Standing orders role rating
Understanding of role under HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating better understanding of role.
Standing orders feasibility rating
Feasibility of HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating greater feasibility.
Standing orders sustainability rating
Sustainability of HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating greater sustainability.
Estimated time spent on recommendations
Time spent on HPV vaccine recommendations will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 0-99 minutes, with higher values indicating more time spent.
Estimated recommendation frequency, 9-10 year olds
Frequency of recommending HPV vaccine for children ages 9 or 10 will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating more frequent recommendations.
Estimated recommendation frequency, 11-12 year olds
Frequency of recommending HPV vaccine for children ages 11 or 12 will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating more frequent recommendations.
Recommendation attitudes rating
Positive attitudes toward recommending HPV vaccine for ages children ages 9 or 10 years will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating more positive recommendation attitudes.
Recommendation self-efficacy rating
Confidence in recommending HPV vaccine for children ages 9 or 10 will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating higher recommendation confidence.
Recommendation norms rating
Norms in favor of recommending HPV vaccine for children ages 9 or 10 will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating more supportive norms.
Recommendation intentions rating
Intentions to recommend HPV vaccine for children ages 9 or 10 will be measured by one item on the survey, taken by clinical staff two months after attending the AAT The range for this measure will be 1 to 5, with higher values indicating higher recommendation intentions.
Full Information
NCT ID
NCT05742386
First Posted
February 13, 2023
Last Updated
February 27, 2023
Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05742386
Brief Title
Impact of Standing Orders Optimization
Official Title
Evaluating the Impact of Optimizing the Use of HPV Vaccine Standing Orders in Primary Care Clinics
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
July 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 optimizing human papillomavirus (HPV) vaccine standing orders. The research team will work with primary care clinics. Some clinics will receive communication training. Other clinics will receive the same training and tools for increasing the use of their standing orders.
Detailed Description
The researchers will conduct a cluster randomized clinical trial. The trial will look at the impact of optimizing HPV vaccine standing orders. 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 a communication training. Other clinics will receive a communication training and tools for optimizing the use of their standing orders. 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 researchers will also use survey data to compare HPV vaccine communication and implementation of standing orders among clinical staff. 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
Human Papilloma Virus, Pediatric medicine, Primary care, Standing orders, Vaccination
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomized design in which clinics will be randomized
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 standing orders optimization
Arm Type
Experimental
Arm Description
Staff in clinics randomized to this arm will receive the AAT and conduct a set of activities to optimize use of HPV vaccine standing orders.
Intervention Type
Behavioral
Intervention Name(s)
Communication training
Intervention Description
Clinics will host an 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)
Communication training enhanced with standing orders optimization
Intervention Description
Clinics will host an AAT workshop, as in the other trial arm.
Clinic representatives will attend working meetings on putting HPV vaccine standing orders into clinic workflow. Clinics will then orient their staff to the standing orders. Finally, clinic representatives will discuss their use of standing orders in a learning collaborative.
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
Title
Standing orders attitude rating
Description
Positive attitude toward using HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating more positive attitudes.
Time Frame
up to 6 months
Title
Standing orders norms rating
Description
Norms in favor of using HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating more supportive norms.
Time Frame
up to 6 months
Title
Standing orders self-efficacy rating
Description
Confidence about using HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating higher confidence.
Time Frame
up to 6 months
Title
Standing orders adoption rating
Description
Adoption of HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating greater adoption.
Time Frame
up to 6 months
Title
Standing orders acceptability rating
Description
Acceptability of HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating higher acceptability.
Time Frame
up to 6 months
Title
Standing orders appropriateness rating
Description
Appropriateness of HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating greater appropriateness.
Time Frame
up to 6 months
Title
Standing orders role rating
Description
Understanding of role under HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating better understanding of role.
Time Frame
up to 6 months
Title
Standing orders feasibility rating
Description
Feasibility of HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating greater feasibility.
Time Frame
up to 6 months
Title
Standing orders sustainability rating
Description
Sustainability of HPV vaccine standing orders will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating greater sustainability.
Time Frame
up to 6 months
Title
Estimated time spent on recommendations
Description
Time spent on HPV vaccine recommendations will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 0-99 minutes, with higher values indicating more time spent.
Time Frame
up to 6 months
Title
Estimated recommendation frequency, 9-10 year olds
Description
Frequency of recommending HPV vaccine for children ages 9 or 10 will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating more frequent recommendations.
Time Frame
up to 6 months
Title
Estimated recommendation frequency, 11-12 year olds
Description
Frequency of recommending HPV vaccine for children ages 11 or 12 will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating more frequent recommendations.
Time Frame
up to 6 months
Title
Recommendation attitudes rating
Description
Positive attitudes toward recommending HPV vaccine for ages children ages 9 or 10 years will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating more positive recommendation attitudes.
Time Frame
up to 6 months
Title
Recommendation self-efficacy rating
Description
Confidence in recommending HPV vaccine for children ages 9 or 10 will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating higher recommendation confidence.
Time Frame
up to 6 months
Title
Recommendation norms rating
Description
Norms in favor of recommending HPV vaccine for children ages 9 or 10 will be measured by one item on the survey, taken by clinical staff two months after attending the AAT. The range for this measure will be 1 to 5, with higher values indicating more supportive norms.
Time Frame
up to 6 months
Title
Recommendation intentions rating
Description
Intentions to recommend HPV vaccine for children ages 9 or 10 will be measured by one item on the survey, taken by clinical staff two months after attending the AAT The range for this measure will be 1 to 5, with higher values indicating higher recommendation intentions.
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
This trial will enroll clinics and intervene with clinical staff. We will use vaccination data from children and survey data from clinical staff to evaluate intervention effectiveness. We will not enroll children or interact with them directly.
Inclusion Criteria
Clinics are eligible if they:
provide HPV vaccine to children ages 9-12
have standing orders for HPV vaccination approved but not routinely used or be willing to adopt them prior to the start of the trial
have rates of HPV vaccination (≥1 dose) below 72%, boys and girls combined
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
are attributed to a participating clinic at 12- or 24-month follow-up
Clinical staff's survey data will be eligible to be included in the dataset if clinical staff complete the follow-up survey.
Exclusion Criteria
Clinics are excluded if they:
do not provide HPV vaccine to children ages 9-12
do not have standing orders for HPV vaccination or are not willing to adopt them prior to the start of the trial
have rates of HPV vaccination (≥1 dose) above 72%, boys and girls combined
have hosted an AAT workshop in the previous 3 years or are part of current HPV vaccine communication trainings
have quality improvement efforts to change HPV vaccine standing orders during the trial
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
are receiving hospice/palliative care, are pregnant, or have a history of HPV vaccine contraindications
Clinical staff's survey data will be not eligible to be included in the dataset if clinical staff do not complete the follow-up survey.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Kritikos
Phone
+1 (919) 962-6327
Email
kkritikos@unc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Bernstein
Email
elizabeth_bernstein@unc.edu
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
Facility Information:
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Kritikos
Phone
919-962-6327
Email
kkritikos@unc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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