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.
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
- Conditions the study is for
- Adult Influenza Vaccinations, Adult PPSV Vaccinations, Adult Tdap/Td Vaccinations
- What is being tested?
- Pillar 1: Convenient Vaccination Services, Pillar 2: Patient notification and Pillar 3: Enhanced Office Systems
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Intervention with the Toolkit | Experimental | 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. 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 intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted4 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adult Influenza VaccinationsStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Baylor College of Medicine
- Responsible party
- Principal investigator, Richard Zimmerman MD, University of Pittsburgh
- Investigators
- Mary Patricia Nowalk, PhD, RD, Study director, University of Pittsburgh, School of Medicine, Department of Family MedicineAnthony E Brown, MD MPH, Study director, Baylor College of Medicine
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 27809793Zimmerman 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 27755655Nowalk 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Vaccination SOP Toolkit in Diverse Practices Implemented & Tested With RE-AIM
- ClinicalTrials.gov ID
- NCT01868334
- Acronym / sponsor ID
- SOP / CDC-1U01IP000662-01
- Keywords
- influenza vaccine, PPSV, Tdap, vaccination, adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70,549 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Baylor College of Medicine
- Study start
- Apr 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Posted 2 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention with the Toolkit | Experimental | Behavioral: Pillar 1: Convenient Vaccination Services, Behavioral: Pillar 2: Patient notification, Behavioral: Pillar 3: Enhanced Office Systems, Behavioral: Pillar 4: MotivationPillar 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. |
| 12 clinical practices (control sites) | No intervention | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- 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.
Key exclusion criteria (4 listed)
- 1) consistent SOP use for the 3 vaccines being studied or high vaccination rates (e.g., 80%)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pillar 1: Convenient Vaccination ServicesExtend 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. | Behavioural | Intervention with the Toolkit |
| Pillar 2: Patient notificationPatient 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 | Behavioural | Intervention with the Toolkit |
| Pillar 3: Enhanced Office SystemsRoutine 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 | Behavioural | Intervention with the Toolkit |
| Pillar 4: MotivationUtilization 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. | Behavioural | Intervention with the Toolkit |
Primary outcome
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)
Outcome listed is total percentage point difference in vaccination rates from baseline to end of year 1
1 secondary outcome
Year 2 Pre-post Study: Change From Year 1 in the Percentage of Participants Who Were Vaccinated at the End of Year 2
Time frame: % vaccinated by 1/31/2015
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27809793Lin 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.
- Results publication: PubMed 27755655Zimmerman 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.
- Results publication: PubMed 27576073Nowalk 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Patricia Nowalk, PhD, RD study director
University of Pittsburgh, School of Medicine, Department of Family Medicine
Anthony E Brown, MD MPH study director
Baylor College of Medicine
2 sites in 1 country: see every site and its status.
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.