Comparative Effectiveness of System Interventions to Increase HPV Vaccine Receipt in FQHCs
NCT ID: NCT03726151
Last Updated: 2023-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
17000 participants
INTERVENTIONAL
2018-05-01
2023-10-31
Brief Summary
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Detailed Description
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Additional aims include:
* Explore the relationship between child age (12-14 years versus 15-17 years) and intervention effectiveness, due to the difference in dosing schedules for the two age groups.
* Examine parent (e.g., language preference) and provider (e.g., specialty) characteristics that may act as moderators of intervention effectiveness.
* Assess parent perspectives and experiences related to the different interventions.
* Examine the implementation process (including adaptations) for each of the interventions.
* Disseminate study findings widely to a local and national audience of relevant stakeholders.
The multicomponent clinic system strategies include workflow modifications to minimize missed opportunities for vaccination, provider- and clinic-level audit and feedback, establishment of clinic-level policies and protocols, and will also include provider and staff training regarding workflow modifications and patient communication strategies.
The study will be implemented across six study periods of 12 months each. The seven NEVHC clinics will be randomized into three groups (A, B, C). Following a 12-month start-up and observation period (Period 1), as part of a stepped wedge design, Group A will implement the parent reminders beginning in Period 2, Group B will implement the clinic-based intervention beginning in Period 3, and Group C will implement the combined condition beginning in period 4. In Period 5, Group A will crossover to the combined condition. This change from the original protocol was approved by the study funder as of Fall 2021.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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Usual Care
No interventions assigned to this group
Parent Reminders
Parent Reminders
Automated, system-generated mailed or text message reminders
Multicomponent clinic-system strategies
Multicomponent clinic-system strategies
1. Workflow modifications to reduce missed opportunities for vaccination
2. Provider- and clinic-level audit and feedback
3. Provider \& staff training on workflow modifications and communication strategies
Combined Condition
Combined Condition
Parent reminders and multicomponent clinic-system strategies
Interventions
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Parent Reminders
Automated, system-generated mailed or text message reminders
Multicomponent clinic-system strategies
1. Workflow modifications to reduce missed opportunities for vaccination
2. Provider- and clinic-level audit and feedback
3. Provider \& staff training on workflow modifications and communication strategies
Combined Condition
Parent reminders and multicomponent clinic-system strategies
Eligibility Criteria
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Inclusion Criteria
* Has had at least one appointment at NEVHC in the last 2 years
* Must be aged 11-17
Exclusion Criteria
* Has not had an appointment at NEVHC in the last 2 years
* Is not aged 11-17
11 Years
17 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of California, Los Angeles
OTHER
Responsible Party
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Roshan Bastani
Professor, Health Policy and Management, UCLA Fielding School of Public Health
Principal Investigators
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Roshan Bastani, PhD
Role: PRINCIPAL_INVESTIGATOR
Professor, Health Policy and Management, UCLA Fielding School of Public Health
Beth Glenn, PhD
Role: PRINCIPAL_INVESTIGATOR
Professor, Health Policy and Management, UCLA Fielding School of Public Health
Locations
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Northeast Valley Health Corporation- Canoga Park
Canoga Park, California, United States
Northeast Valley Health Corporation- Pacoima
Pacoima, California, United States
Northeast Valley Health Corporation- San Fernando
San Fernando, California, United States
Northeast Valley Health Corporation- Santa Clarita
Santa Clarita, California, United States
Northeast Valley Health Corporation- Sun Valley
Sun Valley, California, United States
Northeast Valley Health Corporation- Valencia
Valencia, California, United States
Northeast Valley Health Corporation- Van Nuys
Van Nuys, California, United States
Countries
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Other Identifiers
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PCS-2017C1-6482
Identifier Type: -
Identifier Source: org_study_id
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