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AzTrials

Adult Influenza VaccinationsSOPNCT01868334

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

A study testing Pillar 1: Convenient Vaccination Services, Pillar 2: Patient notification and Pillar 3: Enhanced Office Systems in people with Adult Influenza Vaccinations and Adult PPSV Vaccinations, run by University of Pittsburgh at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Pillar 1: Convenient Vaccination Services, Pillar 2: Patient notification and Pillar 3: Enhanced Office Systems
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70,549 participants
Where
2 sitesUnited States
Study dates
Apr 2013to Dec 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

United States2 sites
  • Baylor Colllege of Medicine

    Houston, Texas, 77030

  • University of Pittsburgh, School of Medicine, Department of Family Medicine

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

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

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).

Read the 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.

Being tested
Pillar 1: Convenient Vaccination Services, Pillar 2: Patient notification, Pillar 3: Enhanced Office Systems, Pillar 4: Motivation
Keywords
influenza vaccine, PPSV, Tdap, vaccination, adult
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pillar 1: Convenient Vaccination ServicesBehavioural

    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 notificationBehavioural

    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 SystemsBehavioural

    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: MotivationBehavioural

    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.

Study groups in NCT01868334
Study groupRoleWhat they receive
Intervention with the ToolkitExperimentalPillar 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.
Receives: Behavioral: Pillar 1: Convenient Vaccination Services; Behavioral: Pillar 2: Patient notification; Behavioral: Pillar 3: Enhanced Office Systems; Behavioral: Pillar 4: Motivation
12 clinical practices (control sites)No intervention12 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: % vaccinated by 5/31/2014 (Tdap, Pneumococcal); % vaccinated by 1/31/2014 (Influenza)

Secondary outcomes (1)
  1. 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

    Measured: % vaccinated by 1/31/2015

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionMay 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
70,549 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01868334
Sponsor's protocol ID
CDC-1U01IP000662-01
Acronym
SOP
Status last verified
Oct 2023
First submitted
20 Mar 2013
Last updated
6 Oct 2023
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27809793
  • 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.

    PubMed 27755655
  • 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.

    PubMed 27576073

Questions about this trial

What is this clinical trial studying?

A study testing Pillar 1: Convenient Vaccination Services, Pillar 2: Patient notification and Pillar 3: Enhanced Office Systems in people with Adult Influenza Vaccinations and Adult PPSV Vaccinations, run by University of Pittsburgh at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1 (time frame: % vaccinated by 5/31/2014 (Tdap, Pneumococcal); % vaccinated by 1/31/2014 (Influenza)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01868334, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.

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