4 Pillars Toolkit for Adolescent Vaccination

NCT ID: NCT02165722

Last Updated: 2018-08-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-12-31

Brief Summary

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The purpose of this study is to test whether or not the 4 Pillars Immunization Toolkit increases adolescent vaccination rates, particularly influenza and human papillomavirus (HPV) but also tetanus, diphtheria and pertussis (Tdap), and meningococcal conjugate (MCV) vaccination rates. The vaccines are all FDA licensed vaccines and to be used according to national guidelines. The investigators will conduct a randomized cluster trial of this toolkit in diverse primary care practices with electronic medical records (EMRs).

Detailed Description

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This intervention is a stratified randomized cluster trial in about 22 diverse primary care practices. These practices will be randomly assigned to be intervention or control sites to test this 4 Pillars Immunization Toolkit intervention package of evidence-based techniques tailored to their practice structure and culture; the specialties are split between pediatric and family medicine practices.

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Conditions

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Adolescent HPV Vaccine Adolescent Influenza Vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention: Toolkit

4 Pillars Toolkit

Group Type EXPERIMENTAL

4 Pillars Toolkit

Intervention Type BEHAVIORAL

Behavioral: Pillar 1: Convenient Vaccination Services (e.g. use every visit \[chronic and acute\] as an opportunity to vaccinate; use express vaccination clinics and dedicated vaccination stations; use influenza vaccination as an opportunity to vaccinate for other vaccines).

Behavioral: Pillar 2: Patient Notification (e.g. use electronic reminders and social media for vaccination reminders; use physician recommendations).

Behavioral: Pillar 3: Enhanced Office Systems (e.g. implement Standing Order Programs; use EMR prompts; add vaccination status as a vital sign when rooming).

Behavioral: Pillar 4: Motivation (e.g. establish an office Immunization Champion to track goal progress, aided by research team feedback).

No Intervention: Standard practice

11 Clinical Practices \[control sites\]

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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4 Pillars Toolkit

Behavioral: Pillar 1: Convenient Vaccination Services (e.g. use every visit \[chronic and acute\] as an opportunity to vaccinate; use express vaccination clinics and dedicated vaccination stations; use influenza vaccination as an opportunity to vaccinate for other vaccines).

Behavioral: Pillar 2: Patient Notification (e.g. use electronic reminders and social media for vaccination reminders; use physician recommendations).

Behavioral: Pillar 3: Enhanced Office Systems (e.g. implement Standing Order Programs; use EMR prompts; add vaccination status as a vital sign when rooming).

Behavioral: Pillar 4: Motivation (e.g. establish an office Immunization Champion to track goal progress, aided by research team feedback).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* For clinical sites: inclusion criterion includes

1. an appropriate adolescent population: e.g., adolescents aged 11 to 17 years
2. currently using an EMR
3. having and keeping immunization data within a EMR or registry.
Minimum Eligible Age

11 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Richard Zimmerman

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard K Zimmerman, MD, MPH, MA

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh, School of Medicine, Department of Family Medicine

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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Zimmerman RK, Moehling KK, Lin CJ, Zhang S, Raviotta JM, Reis EC, Humiston SG, Nowalk MP. Improving adolescent HPV vaccination in a randomized controlled cluster trial using the 4 Pillars practice Transformation Program. Vaccine. 2017 Jan 3;35(1):109-117. doi: 10.1016/j.vaccine.2016.11.018. Epub 2016 Nov 18.

Reference Type RESULT
PMID: 27876200 (View on PubMed)

Zimmerman RK, Raviotta JM, Nowalk MP, Moehling KK, Reis EC, Humiston SG, Lin CJ. Using the 4 Pillars Practice Transformation Program to increase adolescent human papillomavirus, meningococcal, tetanus-diphtheria-pertussis and influenza vaccination. Vaccine. 2017 Oct 27;35(45):6180-6186. doi: 10.1016/j.vaccine.2017.09.039. Epub 2017 Sep 22.

Reference Type DERIVED
PMID: 28947346 (View on PubMed)

Other Identifiers

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PRO13070205

Identifier Type: -

Identifier Source: org_study_id

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