Trial record 6 of 71 for:    pillar

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

This study is ongoing, but not recruiting participants.
Baylor College of Medicine
Information provided by (Responsible Party):
Richard Zimmerman, University of Pittsburgh Identifier:
First received: March 20, 2013
Last updated: December 1, 2014
Last verified: December 2014

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).

Condition Intervention
Adult Influenza Vaccinations
Adult PPSV Vaccinations
Adult Tdap/Td Vaccinations
Behavioral: Pillar 1: Convenient Vaccination Services
Behavioral: Pillar 2: Patient notification
Behavioral: Pillar 3: Enhanced Office Systems
Behavioral: Pillar 4: Motivation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Vaccination SOP Toolkit in Diverse Practices Implemented & Tested With RE-AIM

Resource links provided by NLM:

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Age-based criteria will be used: 18 years and older for influenza and Tdap; 65 years and older for PPSV. Vaccination rates before and after the intervention will be calculated both at the clinic level and overall for intervention and control arms.

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    The lead nurse/office manager, lead physician, and immunization champion will be surveyed, based upon the RE-AIM framework components and 4 pillars

Estimated Enrollment: 596
Study Start Date: April 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention with the Toolkit
Pillar 1: Convenient Vaccination Services Pillar 2: Patient notification Pillar 3: Enhanced Office Systems Pillar 4: Motivation
Behavioral: 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.

Behavioral: 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
Behavioral: 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
Behavioral: 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 clinical practices (control sites)
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

Detailed 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01868334

United States, Pennsylvania
University of Pittsburgh, School of Medicine, Department of Family Medicine
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Baylor Colllege of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
University of Pittsburgh
Baylor College of Medicine
Study Director: Mary Patricia Nowalk, PhD, RD University of Pittsburgh, School of Medicine, Department of Family Medicine
Study Director: Anthony E Brown, MD MPH Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Richard Zimmerman, Principal Investigator, Professor, University of Pittsburgh Identifier: NCT01868334     History of Changes
Other Study ID Numbers: CDC-1U01IP000662-01
Study First Received: March 20, 2013
Last Updated: December 1, 2014
Health Authority: United States: University of Pittsburgh Institutional Review Board
United States: Federal Government

Keywords provided by University of Pittsburgh:
influenza vaccine
adult processed this record on May 21, 2015