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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05105711
Other study ID # 20-0810
Secondary ID 1R21CA241518-01
Status Completed
Phase N/A
First received
Last updated
Start date June 21, 2021
Est. completion date January 14, 2022

Study information

Verified date July 2022
Source UNC Lineberger Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date January 14, 2022
Est. primary completion date January 14, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
QI coaching intervention
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.

Locations

Country Name City State
United States Kaiser Permanente Washington Health Research Institute Seattle Washington

Sponsors (4)

Lead Sponsor Collaborator
UNC Lineberger Comprehensive Cancer Center Kaiser Permanente, National Cancer Institute (NCI), University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in HPV Vaccine Recommendation Quality Score 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
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