NCT05105711

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2022

Completed
6 months until next milestone

Results Posted

Study results publicly available

July 25, 2022

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

October 21, 2021

Results QC Date

May 31, 2022

Last Update Submit

July 20, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Primary care providers

EXPERIMENTAL

Providers who treat 11-12 year old adolescent patients in participating Kaiser Permanente Washington pediatric and family medicine practices.

Behavioral: QI coaching intervention

Interventions

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.

Primary care providers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary care providers who treat 11-12 year old adolescent patients in participating Kaiser Permanente Washington pediatric and family medicine practices

You may not qualify if:

  • Primary care providers who do not treat adolescent patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101, United States

Location

Results Point of Contact

Title
Melissa Gilkey, PhD
Organization
University of North Carolina at Chapel Hill

Study Officials

  • Melissa B Gilkey, PhD

    University of North Carolina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2021

First Posted

November 3, 2021

Study Start

June 21, 2021

Primary Completion

January 14, 2022

Study Completion

January 14, 2022

Last Updated

July 25, 2022

Results First Posted

July 25, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations