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

University of Pittsburgh

Status: Completed

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

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

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01868334

CDC-1U01IP000662-01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 70,549 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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70,549 participants in 2 patient groups

Intervention with the Toolkit

Experimental group

Description:

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.

Treatment:

Behavioral: Pillar 2: Patient notification

Behavioral: Pillar 1: Convenient Vaccination Services

Behavioral: Pillar 4: Motivation

Behavioral: Pillar 3: Enhanced Office Systems

12 clinical practices (control sites)

No Intervention group

Description:

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