Immunization Status Among Obstetrics and Gynecology PatientsNCT01565135
Immunization Delivery in Obstetrics and Gynecology Settings
A study testing Multimodal Vaccine Program in people with Immunization Status Among Obstetrics and Gynecology Patients, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to determine if a multimodal immunization program carried out in obstetrics and gynecology (ob/gyn) practices would be more effective in improving ob/gyn patients' immunization rates, specifically for Tdap (Tetanus, Diphtheria, Pertussis), HPV (Human papilloma virus), and influenza… Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Immunization Status Among Obstetrics and Gynecology Patients
- What is being tested?
- Multimodal Vaccine Program
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97,087 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Oct 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 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 15 years of age or older when presenting for care
- Patients who present for care one year prior to the start of the intervention and up to 21 months after the start of the intervention
Who cannot join
- less than 15 years of age when presenting for care
- patient is not eligible for any immunizations
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
The purpose of this study is to determine if a multimodal immunization program carried out in obstetrics and gynecology (ob/gyn) practices would be more effective in improving ob/gyn patients' immunization rates, specifically for Tdap (Tetanus, Diphtheria, Pertussis), HPV (Human papilloma virus), and influenza vaccines, than the usual care provided to patients in ob/gyn practices.
- Being tested
- Multimodal Vaccine Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Vaccine ProgramBehavioural
Efforts will be made to collaborate with private ob/gyn offices to develop a multimodal intervention to improve patients'immunization rates. As part of the overall intervention, intervention practices will agree to 1) purchase, stock, and administer influenza, HPV, and Tdap vaccines, if not already doing so and 2) track patients' vaccination status. In addition, intervention strategies adopted by intervention settings to improve immunization rates may include:
- Patient education regarding the importance of vaccination, including encouragement of vaccination for family members
- Practice-based reminder/recall
- Seek to decrease missed opportunities for immunization by using either or both of the following: provider prompts and/or provider education and feedback
| Study group | Role | What they receive |
|---|---|---|
| Intervention Practices | Experimental | Intervention offices will adopt a multimodal vaccine program to increase their patients' vaccine rates. Receives: Behavioral: Multimodal Vaccine Program |
| Control Practices | No intervention | Control offices will offer usual health care related to immunizations throughout the duration of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the percent of women vaccinated with one or more Tdap vaccines (among eligible patients) in intervention settings compared to control settings.
The percent of eligible patients presenting for care who receive Tdap vaccine will be assessed one year prior to the intervention and 12 and 21 months after the intervention. This assessment will occur in both intervention and control settings using two data sources 1) administrative data and 2) patient self-report of vaccine history.
Measured: 1 year (administrative data) & 2 months (survey data) prior to intervention & 12 and 21 months after intervention (administrative and survey data)
Change in the percent of women vaccinated with influenza vaccine (among eligible patients) in intervention settings compared to control settings.
The percent of eligible patients presenting for care who receive influenza vaccine will be assessed one year prior to the intervention and at 12 and 21 months after the intervention. This will be assessed in both intervention and control settings using two data sources 1) administrative data and 2) patient self-report of vaccine history.
Measured: 1 year (administrative data) & 2 months (survey data) prior to intervention & 12 and 21 months after intervention (administrative and survey data)
Change in the percent of women who have initiated the HPV vaccine series (among eligible patients) in intervention settings compared to control settings.
The percent of eligible patients presenting for care who have received one or more HPV vaccines will be assessed one year prior to the intervention and at 12 and 21 months after the intervention. This number will be assess in both intervention and control settings using two data sources 1) administrative data and 2) patient self-report of vaccine history.
Measured: 1 year (administrative data) & 2 months (survey data) prior to intervention & 12 and 21 months after intervention (administrative and survey data)
Change in the percent of women who have received one or more needed vaccines (eligible patients who receive HPV, influenza, and/or Tdap vaccines) in intervention settings compared to control settings.
The percent of eligible patients presenting for care who have received one or more needed vaccines (HPV, Tdap, and/or influenza vaccines) will be assessed one year prior to the intervention and at 12 and 21 months after the intervention. This number will be assess in both intervention and control settings using two data sources 1) administrative data and 2) patient self-report of vaccine history.
Measured: 1 year (administrative data) & 2 months (survey data) prior to intervention & at 12 and 21 months after intervention (administrative and survey data)
Secondary outcomes (3)
Change in the percent of women who have completed the HPV vaccine series (among eligible patients) in intervention settings compared to control settings.
The percent of eligible patients presenting for care who have completed the HPV vaccine series will be assessed one year prior to the intervention and at 12 and 21 months after the intervention. This number will be assess for both intervention and control settings using two data sources 1) administrative data and 2) patient self-report of vaccine history.
Measured: 1 year (administrative data) & 2 months (survey data) prior to intervention & at 12 and 21 months after intervention (administrative and survey data)
Change in the percent of women who report Tdap vaccine uptake among individuals in frequent contact with their infant in intervention offices compared to control offices
The percent of patients who report one or more individuals who are/will be in frequent contact with their infant having received Tdap vaccine will be assessed during Feb/March 2013 and Feb/March 2014. These data will be collected in patients of both intervention and control settings via on-line survey and be administered to patients who volunteer to take the survey.
Measured: Feb/March 2013 & Feb/March 2014
Change in the percent of women who report influenza vaccine uptake among individuals in frequent contact with their infant in intervention offices. compared to control offices
The percent of patients who report one or more individuals who are/will be in frequent contact with their infant having received influenza vaccine will be assessed during Feb/March 2013 and Feb/March 2014. These data will be collected in patients of both intervention and control settings via on-line survey and be administered to patients who volunteer to take the survey.
Measured: Feb/March 2013 & Feb/March 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immunization Status Among Obstetrics and Gynecology PatientsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 97,087 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Sean O'Leary, MD, MPH, Principal investigator, University of Colorado Denver, Children's Hospital ColoradoAmanda Dempsey, MD, PhD, MPH, Principal investigator, University of Colorado, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565135
- Sponsor's protocol ID
- 11-1149
- Other IDs
- U01IP000501
- Status last verified
- Jun 2019
- First submitted
- 26 Mar 2012
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Leary ST, Pyrzanowski J, Brewer SE, Sevick C, Miriam Dickinson L, Dempsey AF. Effectiveness of a multimodal intervention to increase vaccination in obstetrics/gynecology settings. Vaccine. 2019 Jun 6;37(26):3409-3418. doi: 10.1016/j.vaccine.2019.05.034. Epub 2019 May 15.
PubMed 31103367
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunization Delivery in Obstetrics and Gynecology Settings
- ClinicalTrials.gov ID
- NCT01565135
- Acronym / sponsor ID
- 11-1149
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97,087 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Sep 2012 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 28 Mar 2012 (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 purpose of this study is to determine if a multimodal immunization program carried out in obstetrics and gynecology (ob/gyn) practices would be more effective in improving ob/gyn patients' immunization rates, specifically for Tdap (Tetanus, Diphtheria, Pertussis), HPV (Human papilloma virus), and influenza vaccines, than the usual care provided to patients in ob/gyn practices.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Practices | Experimental | Behavioral: Multimodal Vaccine ProgramIntervention offices will adopt a multimodal vaccine program to increase their patients' vaccine rates. |
| Control Practices | No intervention | –Control offices will offer usual health care related to immunizations throughout the duration of the study. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 15 years of age or older when presenting for care
- Patients who present for care one year prior to the start of the intervention and up to 21 months after the start of the intervention
Key exclusion criteria (2 listed)
- less than 15 years of age when presenting for care
- patient is not eligible for any immunizations
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 |
|---|---|---|
| Multimodal Vaccine ProgramEfforts will be made to collaborate with private ob/gyn offices to develop a multimodal intervention to improve patients'immunization rates. As part of the overall intervention, intervention practices will agree to 1) purchase, stock, and administer influenza, HPV, and Tdap vaccines, if not already doing so and 2) track patients' vaccination status. In addition, intervention strategies adopted by intervention settings to improve immunization rates may include: * Patient education regarding the importance of vaccination, including encouragement of vaccination for family members * Practice-based reminder/recall * Seek to decrease missed opportunities for immunization by using either or both of the following: provider prompts and/or provider education and feedback | Behavioural | Intervention Practices |
Primary outcome
Change in the percent of women vaccinated with one or more Tdap vaccines (among eligible patients) in intervention settings compared to control settings.
Time frame: 1 year (administrative data) & 2 months (survey data) prior to intervention & 12 and 21 months after intervention (administrative and survey data)
The percent of eligible patients presenting for care who receive Tdap vaccine will be assessed one year prior to the intervention and 12 and 21 months after the intervention. This assessment will occur in both intervention and control settings using two data sources 1) administrative data and 2) patient self-report of vaccine history.
Change in the percent of women vaccinated with influenza vaccine (among eligible patients) in intervention settings compared to control settings.
Time frame: 1 year (administrative data) & 2 months (survey data) prior to intervention & 12 and 21 months after intervention (administrative and survey data)
The percent of eligible patients presenting for care who receive influenza vaccine will be assessed one year prior to the intervention and at 12 and 21 months after the intervention. This will be assessed in both intervention and control settings using two data sources 1) administrative data and 2) patient self-report of vaccine history.
Change in the percent of women who have initiated the HPV vaccine series (among eligible patients) in intervention settings compared to control settings.
Time frame: 1 year (administrative data) & 2 months (survey data) prior to intervention & 12 and 21 months after intervention (administrative and survey data)
The percent of eligible patients presenting for care who have received one or more HPV vaccines will be assessed one year prior to the intervention and at 12 and 21 months after the intervention. This number will be assess in both intervention and control settings using two data sources 1) administrative data and 2) patient self-report of vaccine history.
Change in the percent of women who have received one or more needed vaccines (eligible patients who receive HPV, influenza, and/or Tdap vaccines) in intervention settings compared to control settings.
Time frame: 1 year (administrative data) & 2 months (survey data) prior to intervention & at 12 and 21 months after intervention (administrative and survey data)
The percent of eligible patients presenting for care who have received one or more needed vaccines (HPV, Tdap, and/or influenza vaccines) will be assessed one year prior to the intervention and at 12 and 21 months after the intervention. This number will be assess in both intervention and control settings using two data sources 1) administrative data and 2) patient self-report of vaccine history.
3 secondary outcomes
Change in the percent of women who have completed the HPV vaccine series (among eligible patients) in intervention settings compared to control settings.
Time frame: 1 year (administrative data) & 2 months (survey data) prior to intervention & at 12 and 21 months after intervention (administrative and survey data)
Change in the percent of women who report Tdap vaccine uptake among individuals in frequent contact with their infant in intervention offices compared to control offices
Time frame: Feb/March 2013 & Feb/March 2014
Change in the percent of women who report influenza vaccine uptake among individuals in frequent contact with their infant in intervention offices. compared to control offices
Time frame: Feb/March 2013 & Feb/March 2014
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 24 Jun 2019.
- Derived from this study: PubMed 31103367O'Leary ST, Pyrzanowski J, Brewer SE, Sevick C, Miriam Dickinson L, Dempsey AF. Effectiveness of a multimodal intervention to increase vaccination in obstetrics/gynecology settings. Vaccine. 2019 Jun 6;37(26):3409-3418. doi: 10.1016/j.vaccine.2019.05.034. Epub 2019 May 15.
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.
Sean O'Leary, MD, MPH principal investigator
University of Colorado Denver, Children's Hospital Colorado
Amanda Dempsey, MD, PhD, MPH principal investigator
University of Colorado, Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Vaccine Program in people with Immunization Status Among Obstetrics and Gynecology Patients, run by University of Colorado, Denver at 1 site 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 2 inclusion and 2 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 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in the percent of women vaccinated with one or more Tdap vaccines (among eligible patients) in intervention settings compared to control settings. (time frame: 1 year (administrative data) & 2 months (survey data) prior to intervention & 12 and 21 months after intervention (administrative and survey data)). The study lists 4 primary outcomes in all. 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 NCT01565135, which also lists 1 linked publication.
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 24 Jun 2019.