Clinical trial NCT01868334: SOP Toolkit in Diverse Practices Implemented & Tested With RE-AIM
Official title: A Vaccination SOP Toolkit in Diverse Practices Implemented & Tested With RE-AIM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Influenza Vaccinations
Adult PPSV Vaccinations
Adult Tdap/Td Vaccinations
Keywords: influenza vaccine
PPSV
Tdap
vaccination
adult
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Baylor College of Medicine
First posted: 2013-06-04
Enrollment: 70549
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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.

Primary outcomes:
measure: Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1
timeFrame: % vaccinated by 5/31/2014 (Tdap, Pneumococcal); % vaccinated by 1/31/2014 (Influenza)
Secondary outcomes:
measure: Year 2 Pre-post Study: Change From Year 1 in the Percentage of Participants Who Were Vaccinated at the End of Year 2
timeFrame: % vaccinated by 1/31/2015
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh, School of Medicine, Department of Family Medicine
state: Pennsylvania
city: Houston
country: United States
facility: Baylor Colllege of Medicine
state: Texas
Study officials:
affiliation: University of Pittsburgh, School of Medicine, Department of Family Medicine
name: Mary Patricia Nowalk, PhD, RD
role: STUDY_DIRECTOR
affiliation: Baylor College of Medicine
name: Anthony E Brown, MD MPH
role: STUDY_DIRECTOR
References:
citation: 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 opportunities in a randomized cluster trial. BMC Infect Dis. 2016 Nov 3;16(1):623. doi: 10.1186/s12879-016-1940-1.
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 Trial. J Am Geriatr Soc. 2017 Jan;65(1):114-122. doi: 10.1111/jgs.14451. Epub 2016 Oct 18.
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 randomized controlled cluster trial. Vaccine. 2016 Sep 22;34(41):5026-5033. doi: 10.1016/j.vaccine.2016.07.053. Epub 2016 Aug 26.