- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05105711
Mobile Coaching to Improve HPV Vaccine Delivery
July 20, 2022 updated by: UNC Lineberger Comprehensive Cancer Center
Evaluating the Feasibility of a Mobile Coaching Intervention to Improve HPV Vaccine Delivery
The purpose of this study is to examine the feasibility of using Checkup Coach, a mobile coaching intervention, to improve the way that primary care providers recommend HPV vaccination to adolescent patients and their parents.
To conduct this feasibility study, the investigators will deliver the Checkup Coach intervention to 20 Kaiser Permanente Washington primary care providers who routinely recommend HPV vaccine to adolescent patients.
The investigators will use a single-arm, pre-post design.
Participating primary care providers will attend a 1-hour virtual communication workshop and then use a mobile phone app to receive additional coaching for 12 weeks.
Providers will complete surveys at three time points: before the communication workshop, immediately after the workshop, and at 12-week follow-up.
Surveys will assess changes in providers' self-reported HPV vaccine recommendation practices and beliefs about HPV vaccine and also acceptability of the intervention.
The investigators hypothesizes that providers' HPV vaccine communication will improve between baseline and 12-week follow-up.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98101
- Kaiser Permanente Washington Health Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Primary care providers who treat 11-12 year old adolescent patients in participating Kaiser Permanente Washington pediatric and family medicine practices
Exclusion Criteria:
- Primary care providers who do not treat adolescent patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Primary care providers
Providers who treat 11-12 year old adolescent patients in participating Kaiser Permanente Washington pediatric and family medicine practices.
|
The intervention consists of two main components: a webinar communication workshop and use of the Checkup Coach mobile app.
The Checkup Coach intervention begins with a brief (<1 hour), communication training workshop that reviews evidence on HPV vaccination, models guideline-consistent recommendations, trains providers to address parent concerns, and facilitates discussion of shared goals for improving.
Next, providers are invited to download and use the Checkup coach mobile app at their discretion for the 12-week study period.
Providers complete in-app self-assessments and receive tailored feedback about their HPV vaccine recommendation quality, progress toward improving recommendation practices, a dashboard of aggregate HPV vaccination coverage for patients in their clinic, and tips for addressing parents' concerns about HPV vaccination every time they use the app.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in HPV Vaccine Recommendation Quality Score
Time Frame: Baseline, 12 weeks
|
The change in providers' mean composite score on a 5-item index of self-reported use of HPV vaccine communication practices with scores ranging from 5-25 (5 indicating the lowest quality score to 25 indicating the highest quality score).
|
Baseline, 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Melissa B Gilkey, PhD, University of North Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 21, 2021
Primary Completion (Actual)
January 14, 2022
Study Completion (Actual)
January 14, 2022
Study Registration Dates
First Submitted
October 21, 2021
First Submitted That Met QC Criteria
October 21, 2021
First Posted (Actual)
November 3, 2021
Study Record Updates
Last Update Posted (Actual)
July 25, 2022
Last Update Submitted That Met QC Criteria
July 20, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 20-0810
- 1R21CA241518-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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