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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01868334
Recruitment Status : Completed
First Posted : June 4, 2013
Results First Posted : October 2, 2017
Last Update Posted : November 30, 2017
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Baylor College of Medicine
Information provided by (Responsible Party):
Richard Zimmerman, University of Pittsburgh

Brief Summary:
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 or disease Intervention/treatment Phase
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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70549 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Vaccination SOP Toolkit in Diverse Practices Implemented & Tested With RE-AIM
Study Start Date : April 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arm Intervention/treatment
Experimental: Intervention with the Toolkit

Pillar 1: Convenient Vaccination Services Pillar 2: Patient notification Pillar 3: Enhanced Office Systems Pillar 4: Motivation

13 clinical practices (intervention sites) will receive the Toolkit in Year 1 to increase their adult influenza, PPSV, Tdap/Td vaccination rates. In Year 2, those who choose to continue will "maintain" use of the Toolkit and online resources available but will receive no active intervention from study staff.

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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868334


Locations
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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
Centers for Disease Control and Prevention
Baylor College of Medicine
Investigators
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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
Publications of Results:
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Responsible Party: Richard Zimmerman, Principal Investigator, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01868334    
Other Study ID Numbers: CDC-1U01IP000662-01
First Posted: June 4, 2013    Key Record Dates
Results First Posted: October 2, 2017
Last Update Posted: November 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Richard Zimmerman, University of Pittsburgh:
influenza vaccine
PPSV
Tdap
vaccination
adult
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs