InfluenzaNCT01761799
Protecting Pregnant Women From Infectious Diseases
A study testing P3 Vaccine Promotion Package. in people with Influenza and Pertussis, run by Emory University at 11 sites in United States.
Trial summary
The primary research aim of this project is to test the effectiveness of a comprehensive, evidence-based vaccine promotion package implemented in the obstetric setting on increasing the likelihood that a pregnant woman in Georgia will receive an influenza and/or pertussis vaccine. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- What is being tested?
- P3 Vaccine Promotion Package.
- Type of treatment
- Vaccines, Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 11 sitesUnited States
- Study dates
- Dec 2012to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18 - 50
- Currently pregnant
- Unvaccinated with 2012 - 2013 seasonal influenza vaccine
- Unvaccinated with Tdap vaccine during current pregnancy
Who cannot join
- Under 18 years of age or over 50
- Not currently pregnant
- Previous receipt of 2012 - 2013 seasonal influenza vaccine
- Previous receipt of Tdap vaccine during current pregnancy
- Does not speak English
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Athens OBGYN
Athens, Georgia, 30606
Women's Healthcare Associates
Athens, Georgia, 30606
Emory Clinic A, Clifton Road Clinic
Atlanta, Georgia, 30322
Women's Center of Athens
Bogart, Georgia, 30622
North Pointe OB/GYN
Cumming, Georgia, 30041
Southern Crescent Women's Health Care
Fayetteville, Georgia, 30214
W.T. Anderson Health Center - MCCG
Macon, Georgia, 31201
My OB/GYN
Riverdale, Georgia, 30274
New Millennium OB/GYN
Riverdale, Georgia, 30274
Statesboro OB/GYN Specialists
Statesboro, Georgia, 30458
Shaw Center for Women's Health
Thomasville, Georgia, 31792
About this study
Official title: Protecting Pregnant Women From Infectious Diseases: a Cluster Randomized Evaluation of the Comprehensive "P3" Intervention Package Within Obstetric Practices in Georgia
The primary research aim of this project is to test the effectiveness of a comprehensive, evidence-based vaccine promotion package implemented in the obstetric setting on increasing the likelihood that a pregnant woman in Georgia will receive an influenza and/or pertussis vaccine.
Read the detailed description
The primary research aim of this project is to test the effectiveness of a comprehensive, evidence-based vaccine promotion package implemented in the obstetric setting on increasing the likelihood that a pregnant woman in Georgia will receive an influenza vaccine and/or Tdap vaccine before delivery. A secondary research aim assesses whether the comprehensive package improves maternal knowledge, attitudes, and beliefs regarding maternal and infant vaccination. The intervention package will include evidence-based components aimed at the practice-level, provider-level, and patient level and will be tested through a cluster-randomized trial design. The primary outcome measure is influenza vaccine receipt during pregnancy. The secondary outcomes include 1) receipt of pertussis (Tdap) vaccination during pregnancy, and 2) changes in maternal knowledge, attitudes and beliefs regarding maternal and infant vaccination. The primary hypothesis is that implementation of a comprehensive vaccine promotion package in the obstetric setting will increase the likelihood that a pregnant woman receives an influenza and/or pertussis vaccination.
- Being tested
- P3 Vaccine Promotion Package.
- Keywords
- Influenza, Pertussis, Vaccination
- Medical subject headings
- Influenza, Human, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P3 Vaccine Promotion Package.Behavioural
"P3" stands for Practice, Provider, and Patient level vaccine promotion package. The 5 obstetric practices randomized to the intervention arm will receive this comprehensive influenza and Tdap vaccine promotion package at the beginning of the study. Physicians and staff will be familiarized with each component, and practices will be instructed to implement each component to the best of their ability. The components include: posters, educational brochures, lapel buttons, provider-to-patient talking points, lists of nearby locations offering flu and/or Tdap vaccines (if not offered by the practice), identification of a "vaccine champion" within the practice, provider and staff training on vaccination during pregnancy, and use of an interactive, tablet-based educational tutorial for patients.
| Study group | Role | What they receive |
|---|---|---|
| P3 Vaccine Promotion Package | Experimental | The 5 obstetric practices randomized to the intervention arm will receive and implement all components of the evidence-based P3 vaccine promotion package at the beginning of the study. Receives: Behavioral: P3 Vaccine Promotion Package. |
| No P3 vaccine promotion package intervention | No intervention | The 5 obstetric practices randomized to the control arm will not receive the comprehensive vaccine promotion package at the beginning of the study and will instead be instructed to continue their standard of care regarding influenza and Tdap vaccination of pregnant patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of influenza vaccine during pregnancy
Our primary outcome is receipt of a 2012 - 2013 seasonal influenza vaccine during a participant's current pregnancy, before she delivers her child(ren).
Measured: Participants will be followed for the remaining duration of their pregnancy, which will range from approximately 2 weeks to 7 months depending upon their gestation at enrollment.
Secondary outcomes (1)
Receipt of Tdap vaccine during pregnancy
A secondary outcome is receipt of a Tdap vaccine during a participant's current pregnancy, before she delivers her child(ren).
Measured: Participants will be followed for the remaining duration of their pregnancy, which will range from approximately 2 weeks to 7 months depending upon their gestation at enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionFeb 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Saad B. Omer, PhD, Emory University
- Investigators
- Saad B Omer, MBBS,MPH,PhD, Principal investigator, Emory Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761799
- Sponsor's protocol ID
- IRB00060292
- Other IDs
- 5P01TP000300-05
- Status last verified
- Oct 2015
- First submitted
- 18 Dec 2012
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Chamberlain AT, Seib K, Ault KA, Rosenberg ES, Frew PM, Cortes M, Whitney EA, Berkelman RL, Orenstein WA, Omer SB. Improving influenza and Tdap vaccination during pregnancy: A cluster-randomized trial of a multi-component antenatal vaccine promotion package in late influenza season. Vaccine. 2015 Jul 9;33(30):3571-9. doi: 10.1016/j.vaccine.2015.05.048. Epub 2015 Jun 1.
PubMed 26044495Chamberlain AT, Seib K, Ault KA, Rosenberg ES, Frew PM, Cortes M, Whitney EA, Berkelman RL, Orenstein WA, Omer SB. Impact of a multi-component antenatal vaccine promotion package on improving knowledge, attitudes and beliefs about influenza and Tdap vaccination during pregnancy. Hum Vaccin Immunother. 2016 Aug 2;12(8):2017-2024. doi: 10.1080/21645515.2015.1127489. Epub 2016 Apr 15.
PubMed 27082036
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protecting Pregnant Women From Infectious Diseases: a Cluster Randomized Evaluation of the Comprehensive "P3" Intervention Package Within Obstetric Practices in Georgia
- ClinicalTrials.gov ID
- NCT01761799
- Acronym / sponsor ID
- IRB00060292
- Keywords
- Influenza, Pertussis, Vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Dec 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 7 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary research aim of this project is to test the effectiveness of a comprehensive, evidence-based vaccine promotion package implemented in the obstetric setting on increasing the likelihood that a pregnant woman in Georgia will receive an influenza and/or pertussis vaccine.
Detailed description
The primary research aim of this project is to test the effectiveness of a comprehensive, evidence-based vaccine promotion package implemented in the obstetric setting on increasing the likelihood that a pregnant woman in Georgia will receive an influenza vaccine and/or Tdap vaccine before delivery. A secondary research aim assesses whether the comprehensive package improves maternal knowledge, attitudes, and beliefs regarding maternal and infant vaccination. The intervention package will include evidence-based components aimed at the practice-level, provider-level, and patient level and will be tested through a cluster-randomized trial design. The primary outcome measure is influenza vaccine receipt during pregnancy. The secondary outcomes include 1) receipt of pertussis (Tdap) vaccination during pregnancy, and 2) changes in maternal knowledge, attitudes and beliefs regarding maternal and infant vaccination. The primary hypothesis is that implementation of a comprehensive vaccine promotion package in the obstetric setting will increase the likelihood that a pregnant woman receives an influenza and/or pertussis vaccination.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P3 Vaccine Promotion Package | Experimental | Behavioral: P3 Vaccine Promotion Package.The 5 obstetric practices randomized to the intervention arm will receive and implement all components of the evidence-based P3 vaccine promotion package at the beginning of the study. |
| No P3 vaccine promotion package intervention | No intervention | –The 5 obstetric practices randomized to the control arm will not receive the comprehensive vaccine promotion package at the beginning of the study and will instead be instructed to continue their standard of care regarding influenza and Tdap vaccination of pregnant patients. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between the ages of 18 - 50
- Currently pregnant
- Unvaccinated with 2012 - 2013 seasonal influenza vaccine
- Unvaccinated with Tdap vaccine during current pregnancy
Key exclusion criteria (5 listed)
- Under 18 years of age or over 50
- Not currently pregnant
- Previous receipt of 2012 - 2013 seasonal influenza vaccine
- Previous receipt of Tdap vaccine during current pregnancy
- Does not speak English
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 |
|---|---|---|
| P3 Vaccine Promotion Package."P3" stands for Practice, Provider, and Patient level vaccine promotion package. The 5 obstetric practices randomized to the intervention arm will receive this comprehensive influenza and Tdap vaccine promotion package at the beginning of the study. Physicians and staff will be familiarized with each component, and practices will be instructed to implement each component to the best of their ability. The components include: posters, educational brochures, lapel buttons, provider-to-patient talking points, lists of nearby locations offering flu and/or Tdap vaccines (if not offered by the practice), identification of a "vaccine champion" within the practice, provider and staff training on vaccination during pregnancy, and use of an interactive, tablet-based educational tutorial for patients. | Behavioural | P3 Vaccine Promotion Package |
Primary outcome
Receipt of influenza vaccine during pregnancy
Time frame: Participants will be followed for the remaining duration of their pregnancy, which will range from approximately 2 weeks to 7 months depending upon their gestation at enrollment.
Our primary outcome is receipt of a 2012 - 2013 seasonal influenza vaccine during a participant's current pregnancy, before she delivers her child(ren).
1 secondary outcome
Receipt of Tdap vaccine during pregnancy
Time frame: Participants will be followed for the remaining duration of their pregnancy, which will range from approximately 2 weeks to 7 months depending upon their gestation at enrollment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
- Results publication: PubMed 26044495Chamberlain AT, Seib K, Ault KA, Rosenberg ES, Frew PM, Cortes M, Whitney EA, Berkelman RL, Orenstein WA, Omer SB. Improving influenza and Tdap vaccination during pregnancy: A cluster-randomized trial of a multi-component antenatal vaccine promotion package in late influenza season. Vaccine. 2015 Jul 9;33(30):3571-9. doi: 10.1016/j.vaccine.2015.05.048. Epub 2015 Jun 1.
- Derived from this study: PubMed 27082036Chamberlain AT, Seib K, Ault KA, Rosenberg ES, Frew PM, Cortes M, Whitney EA, Berkelman RL, Orenstein WA, Omer SB. Impact of a multi-component antenatal vaccine promotion package on improving knowledge, attitudes and beliefs about influenza and Tdap vaccination during pregnancy. Hum Vaccin Immunother. 2016 Aug 2;12(8):2017-2024. doi: 10.1080/21645515.2015.1127489. Epub 2016 Apr 15.
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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.
Saad B Omer, MBBS,MPH,PhD principal investigator
Emory Unversity
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P3 Vaccine Promotion Package. in people with Influenza and Pertussis, run by Emory University at 11 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 4 inclusion and 5 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 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Receipt of influenza vaccine during pregnancy (time frame: Participants will be followed for the remaining duration of their pregnancy, which will range from approximately 2 weeks to 7 months depending upon their gestation at enrollment.). 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 NCT01761799, which also lists 2 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 2 Nov 2015.