Skip to main content
OpenTrials
Completed

NCT Number: NCT01868334

SOP Toolkit in Diverse Practices Implemented & Tested With RE-AIM

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh, School of Medicine, Department of Family Medicine, Pittsburgh, Pennsylvania, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pillar 1: Convenient Vaccination Services

Behavioral

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

Behavioral

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

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1

    Time frame: % vaccinated by 5/31/2014 (Tdap, Pneumococcal); % vaccinated by 1/31/2014 (Influenza)

    Outcome listed is total percentage point difference in vaccination rates from baseline to end of year 1

Secondary outcomes

  1. Year 2 Pre-post Study: Change From Year 1 in the Percentage of Participants Who Were Vaccinated at the End of Year 2

    Time frame: % vaccinated by 1/31/2015

    Outcome listed is total percentage point difference in vaccination rates from end of year 1 to end of year 2

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Baylor College of Medicine
  • Centers for Disease Control and Prevention

Registry information

Official study title

A Vaccination SOP Toolkit in Diverse Practices Implemented & Tested With RE-AIM

Acronym: SOP

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 4, 2013
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.