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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Adult Influenza Vaccinations, Adult PPSV Vaccinations, Adult Tdap/Td Vaccinations

Intervention / Treatment
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* Behavioral: Pillar 1: Convenient Vaccination Services
* Behavioral: Pillar 2: Patient notification
* Behavioral: Pillar 3: Enhanced Office Systems
* Behavioral: Pillar 4: Motivation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention with the Toolkit<br>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<br>* 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.<br>Behavioral: Pillar 2: Patient notification<br>* 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<br>Behavioral: Pillar 3: Enhanced Office Systems<br>* 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<br>Behavioral: Pillar 4: Motivation<br>* 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.<br>|
| No Intervention: 12 clinical practices (control sites)<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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influenza vaccine, PPSV, Tdap, vaccination, adult