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

Adult Influenza Vaccinations Clinical Trial

— SOP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868334
• Other study ID #: CDC-1U01IP000662-01
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: December 2015

Study information

• Verified date: October 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70549
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adult Influenza Vaccinations
• Adult PPSV Vaccinations
• Adult Tdap/Td Vaccinations
• Influenza, Human

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Baylor Colllege of Medicine	Houston	Texas
United States	University of Pittsburgh, School of Medicine, Department of Family Medicine	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	Baylor College of Medicine, Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (3)

Lin CJ, Nowalk MP, Pavlik VN, Brown AE, Zhang S, Raviotta JM, Moehling KK, Hawk M, Ricci EM, Middleton DB, Patel S, South-Paul JE, Zimmerman RK. Using the 4 pillars practice transformation program to increase adult influenza vaccination and reduce missed — View Citation

Nowalk MP, Lin CJ, Pavlik VN, Brown AE, Zhang S, Moehling KK, Raviotta JM, South-Paul JE, Hawk M, Ricci EM, Middleton DB, Patel SA, Ahmed F, Zimmerman RK. Using the 4 Pillars Practice Transformation Program to increase adult Tdap immunization in a randomi — View Citation

Zimmerman RK, Brown AE, Pavlik VN, Moehling KK, Raviotta JM, Lin CJ, Zhang S, Hawk M, Kyle S, Patel S, Ahmed F, Nowalk MP. Using the 4 Pillars Practice Transformation Program to Increase Pneumococcal Immunizations for Older Adults: A Cluster-Randomized Tr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1	Outcome listed is total percentage point difference in vaccination rates from baseline to end of year 1	% vaccinated by 5/31/2014 (Tdap, Pneumococcal); % vaccinated by 1/31/2014 (Influenza)
Secondary	Year 2 Pre-post Study: Change From Year 1 in the Percentage of Participants Who Were Vaccinated at the End of Year 2	Outcome listed is total percentage point difference in vaccination rates from end of year 1 to end of year 2	% vaccinated by 1/31/2015