This trial is active, not recruiting.

Conditions adult influenza vaccinations, adult ppsv vaccinations, adult tdap/td vaccinations
Treatments pillar 1: convenient vaccination services, pillar 2: patient notification, pillar 3: enhanced office systems, pillar 4: motivation
Sponsor University of Pittsburgh
Collaborator Centers for Disease Control and Prevention
Start date April 2013
End date May 2015
Trial size 596 participants
Trial identifier NCT01868334, CDC-1U01IP000662-01


The purpose of this study is to test whether or not the 4 Pillars Toolkit increases adult Influenza, pneumococcal polysaccharide vaccine (PPSV), tetanus, adult diphtheria and acellular pertussis vaccine (Tdap/Td) 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 practice with electronic medical records (EMRs).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose health services research
Pillar 1: Convenient Vaccination Services Pillar 2: Patient notification Pillar 3: Enhanced Office Systems Pillar 4: Motivation
pillar 1: convenient vaccination services
Extend Vaccination Season: Begin vaccinating for influenza as soon as vaccine arrives; use every visit as opportunity to vaccinate; extend the season for influenza by vaccinating in January and beyond. Use Express Vaccination services such as influenza vaccination clinics, Open access vaccine scheduling (for all vaccines), or dedicated vaccination station. When giving influenza vaccination, screen for need for PPSV/Tdap.
pillar 2: patient notification
Patient Education: notifying patients of doctor recommendations for vaccination; providing information on express vaccination services via email, autodialer, "on-hold" messages, clinic websites, and/or social media
pillar 3: enhanced office systems
Routine assessment for office systems flow to ensure staff consistently promoting vaccination: utilization of EMR prompts, review of Immunization tabs within EMR, and/or checking vaccination status as part of vital signs when rooming. Empower staff to vaccinate by use of a standing orders program (SOP). Order a sufficient supply of vaccination to cover increased rates
pillar 4: motivation
Utilization of an Office Immunization Champion who will track overall progress towards their goal - setting a goal of increased rates of 20 to 25% for influenza vaccine; monitoring and sharing progress with staff regularly; and changing office systems flow as needed to increased vaccination rates.
(No Intervention)
12 diverse clinical practices will receive no additional assistance in Year 1 to increase their adult influenza, PPSV, Tdap/Td vaccination rates, they will follow guidelines for usual care. In Year 2 however they will become intervention sites and receive the 4 Pillars Toolkit for use in increasing vaccination rates

Primary Outcomes

Assessment of adult vaccination rates for influenza, PPSV, Tdap
time frame: Baseline year (for background data): January 1, 2012 to April 30, 2013; Year 1: May 1, 2013 to January 31, 2014; Year 2: February 1, 2014 to January 31, 2015. All reports from baseline year thru year 2 will be via EMR data pulls.

Secondary Outcomes

Utilization of the 4 Pillars intervention via the RE-AIM framework - assessment via questionnaires
time frame: Intervention arm: April/May 2013 (pre-survey); December 2013 (mid-season survey); May 2014 (post-survey). Control arm: April/May 2014 (pre-survey); December 2014 (mid-season survey); May 2015 (post-survey)

Eligibility Criteria

Male or female participants at least 18 years old.

Practice staff and adults in enrolled clinical sites Inclusion Criteria: Site inclusion criteria: - 1) an appropriate adult population: e.g., adults aged 50 years and older; - 2) currently using an EMR that has prompt ability, such as EpicCare; - 3) having and keeping immunization data within this EMR Patient-level inclusion criteria: - 1) Adults (18 years and above) who are active patients of the enrolled practices (e.g., active patients are those with a visit within the last 12 months) - 2) All unvaccinated adults without a contraindication are eligible to receive Td/Tdap and influenza, regardless of age and at age 65 years or older are eligible for PPSV. Exclusion Criteria: Site exclusion criteria: - 1) consistent SOP use for the 3 vaccines being studied or high vaccination rates (e.g., 80%) Patient-level exclusion criteria: - 1) those with a true contraindication, following the CDC's Guide to Contraindications (attached with the US Recommended Adult Immunization Schedule), such as prior vaccine anaphylaxis.

Additional Information

Official title A Vaccination SOP Toolkit in Diverse Practices Implemented & Tested With RE-AIM
Description This intervention is a two-region, two-year, stratified randomized cluster trial in 24 primary care practices with EMRs. These practices will be randomly assigned to be intervention or control sites to test this 4 Pillars Toolkit intervention package of evidence-based techniques tailored to their practice structure and culture; one set of practices randomized to intervention in year 1 and the other to control. In year 2, the other set of practices will receive the intervention and community controls may be sought. These diverse practices consist of: 18 diverse practices from UPMC in western Pennsylvania and 6 diverse practices from large community health centers in a PBRN in Texas.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Pittsburgh.