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

Not Applicable

Completed

• Conditions: Adult PPSV Vaccinations; Adult Tdap/Td Vaccinations; Adult Influenza Vaccinations

• Registration Number: NCT01868334
• Lead Sponsor: 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).

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.

Study Timeline

• Study First Submitted: 2013-03-20
• Study Start: 2013-04
• Study First Submitted QC: 2013-05-29
• Study First Posted: 2013-06-04
• Primary Completion: 2015-05
• Study Completion: 2015-12
• Results First Submitted: 2017-01-04
• Results First Submitted QC: 2017-05-02
• Results First Posted: 2017-10-02
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70549

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1	% 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

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

Trial Locations

Locations (2)

Baylor Colllege of Medicine; 🇺🇸 Houston, Texas, United States

University of Pittsburgh, School of Medicine, Department of Family Medicine; 🇺🇸 Pittsburgh, Pennsylvania, United States