Vaccine ComplianceNCT03039725
Vaccination Compliance
An observational study of Vaccine Compliance, run by Jaye Shyken, MD at 1 site in United States.
Trial summary
Retrospective study to assess a single Clinic on Immunization Practices (ACIP) recommendations for hepatitis A, hepatitis B, influenza, tetanus/diphtheria/pertussis, HPV and pneumococcal disease Read more about this study
- Who is it for?
- Ages 14 to 55 years, women only
- Conditions the study is for
- Vaccine Compliance
- What is being tested?
- Observational
- Type of treatment
- Vaccines
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 28 Aug 2017
- Phase
- Observational
- 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 14 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: * Female * All ethnic backgrounds
Who may be able to join
- Patients addicted to opioids during pregnancy
Who cannot join
- must meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaccination Rates in Obstetric Opioid-Addicted Patients
Retrospective study to assess a single Clinic on Immunization Practices (ACIP) recommendations for hepatitis A, hepatitis B, influenza, tetanus/diphtheria/pertussis, HPV and pneumococcal disease
Read the detailed description
Vaccines are known as one of the greatest public health achievements of the twentieth century. Due to the successful implementation of childhood immunization programs in the United States (US), once common disease states such as polio, smallpox, and measles are no longer a natural part of childhood. Unfortunately, these successes have not been replicated in the adult population despite the availability of vaccines and published recommendations guiding appropriate screening for and administration of vaccines. On average, 42,000 adults compared to 300 children die in the US of vaccine-preventable infections every year. In fact, results of the National Health Interview Survey from 2012 demonstrated low immunization rates for adults 19 years of age and older leaving a significant portion of eligible patients susceptible to disease.
Vaccine administration rates are often lower in the obstetric population likely due to fear of administration during pregnancy and lack of recommendations and education to patients about vaccines. The influenza and Tdap vaccines are recommended for every pregnant patient. However, in 2015-16 influenza season only 49.9% of pregnant patients received the influenza vaccine. Additionally, only 30-53.% have receive the Tdap vaccine. Besides these needed vaccines, patients are often indicated for additional vaccines including hepatitis A, hepatitis B, pneumococcal-23, and human papillomavirus. Additionally, patients who have unequivocal or negative rubella titers during pregnancy should receive the measles, mumps, and rubella vaccine when post-partum. Because of the lack of vaccination, the American College of Obstetricians and Gynecologists (ACOG) has recommended that vaccines become part of the routine obstetric care.
According to American Society of Healthcare Pharmacists (ASHP) Guidelines on the pharmacist's role in immunizations, all pharmacists can contribute to the effort by promoting proper immunizations in various ways. One way is by helping to identify patients in need of immunizations by gathering immunization histories, identifying patient specific indication, issuing immunization records to patients, and educating patients on their specific indications, and the risk of the immunizations.
The investigator's team includes a maternal fetal medicine specialist, nurse practitioners, clinical pharmacist, social workers, and registered nurses. The pharmacist meets with all patients to perform medication reconciliation, vaccine history, social history, allergy history, disease specific review of systems, pregnancy related review of systems, and preventative health review; assess medical and preventative health problems; recommend appropriate management of medical problems and preventative health; and provide extensive education including information on all indicated vaccines. The indicated vaccines are recommended to either the physician or nurse practitioner provider for that visit as well as documented in the medical record. Additionally, prior to each office visit, the pharmacist reviews each patient's chart to determine what vaccines are indicated for this visit. This list of indicated vaccines is provided to the nurse who asks the patients about receiving the vaccine at that day's visit. If the patient is willing to receive the vaccine, the nurse has the provider order the indicated vaccines. All the vaccines are kept as floor stock in the clinic to minimize wait time for the patient.
Although there have been recent efforts to increase immunization rates throughout the health care system, there is little evidence about the impact of pharmacists' involvement on immunization rates in outpatient obstetric clinic setting. The goal of this study is to evaluate immunization administration compliance with the Centers for Disease Control (CDC) 2016 immunization recommendations for influenza, pneumococcal 23 polyvalent, hepatitis A, hepatitis B, tetanus, diphtheria, and acellular pertussis (Tdap), human papillomavirus (HPV), and measles-mumps-rubella (MMR).
- Conditions
- Vaccine Compliance
- Being tested
- Observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Retrospective chart review on vaccine compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
compliance with the 2016 ACIP recommendations
Chart review
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start1 May 2017
- Primary completion28 Aug 2017
- Study completion28 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine ComplianceStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaye Shyken, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jaye Shyken, MD, St. Louis University
- Investigators
- Jaye Shyken, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039725
- Sponsor's protocol ID
- 27919
- Status last verified
- Nov 2017
- First submitted
- 31 Jan 2017
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination Rates in Obstetric Opioid-Addicted Patients
- ClinicalTrials.gov ID
- NCT03039725
- Acronym / sponsor ID
- 27919
- Conditions
- Vaccine Compliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Jaye Shyken, MDUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 28 Aug 2017 (actual)
- Study completion
- 28 Aug 2017 (actual)
- First posted
- 1 Feb 2017 (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.
Retrospective study to assess a single Clinic on Immunization Practices (ACIP) recommendations for hepatitis A, hepatitis B, influenza, tetanus/diphtheria/pertussis, HPV and pneumococcal disease
Detailed description
Vaccines are known as one of the greatest public health achievements of the twentieth century. Due to the successful implementation of childhood immunization programs in the United States (US), once common disease states such as polio, smallpox, and measles are no longer a natural part of childhood. Unfortunately, these successes have not been replicated in the adult population despite the availability of vaccines and published recommendations guiding appropriate screening for and administration of vaccines. On average, 42,000 adults compared to 300 children die in the US of vaccine-preventable infections every year. In fact, results of the National Health Interview Survey from 2012 demonstrated low immunization rates for adults 19 years of age and older leaving a significant portion of eligible patients susceptible to disease.
Vaccine administration rates are often lower in the obstetric population likely due to fear of administration during pregnancy and lack of recommendations and education to patients about vaccines. The influenza and Tdap vaccines are recommended for every pregnant patient. However, in 2015-16 influenza season only 49.9% of pregnant patients received the influenza vaccine. Additionally, only 30-53.% have receive the Tdap vaccine. Besides these needed vaccines, patients are often indicated for additional vaccines including hepatitis A, hepatitis B, pneumococcal-23, and human papillomavirus. Additionally, patients who have unequivocal or negative rubella titers during pregnancy should receive the measles, mumps, and rubella vaccine when post-partum. Because of the lack of vaccination, the American College of Obstetricians and Gynecologists (ACOG) has recommended that vaccines become part of the routine obstetric care.
According to American Society of Healthcare Pharmacists (ASHP) Guidelines on the pharmacist's role in immunizations, all pharmacists can contribute to the effort by promoting proper immunizations in various ways. One way is by helping to identify patients in need of immunizations by gathering immunization histories, identifying patient specific indication, issuing immunization records to patients, and educating patients on their specific indications, and the risk of the immunizations.
The investigator's team includes a maternal fetal medicine specialist, nurse practitioners, clinical pharmacist, social workers, and registered nurses. The pharmacist meets with all patients to perform medication reconciliation, vaccine history, social history, allergy history, disease specific review of systems, pregnancy related review of systems, and preventative health review; assess medical and preventative health problems; recommend appropriate management of medical problems and preventative health; and provide extensive education including information on all indicated vaccines. The indicated vaccines are recommended to either the physician or nurse practitioner provider for that visit as well as documented in the medical record. Additionally, prior to each office visit, the pharmacist reviews each patient's chart to determine what vaccines are indicated for this visit. This list of indicated vaccines is provided to the nurse who asks the patients about receiving the vaccine at that day's visit. If the patient is willing to receive the vaccine, the nurse has the provider order the indicated vaccines. All the vaccines are kept as floor stock in the clinic to minimize wait time for the patient.
Although there have been recent efforts to increase immunization rates throughout the health care system, there is little evidence about the impact of pharmacists' involvement on immunization rates in outpatient obstetric clinic setting. The goal of this study is to evaluate immunization administration compliance with the Centers for Disease Control (CDC) 2016 immunization recommendations for influenza, pneumococcal 23 polyvalent, hepatitis A, hepatitis B, tetanus, diphtheria, and acellular pertussis (Tdap), human papillomavirus (HPV), and measles-mumps-rubella (MMR).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- * Female * All ethnic backgrounds
Key inclusion criteria (1 listed)
- Patients addicted to opioids during pregnancy
Key exclusion criteria (1 listed)
- must meet inclusion criteria
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 |
|---|---|---|
| ObservationalRetrospective chart review on vaccine compliance | Other | – |
Primary outcome
compliance with the 2016 ACIP recommendations
Time frame: 6 months
Chart review
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 21 Nov 2017.
- Individual participant dataSharing planned: No
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.
Jaye Shyken, MD principal investigator
St. Louis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccine Compliance, run by Jaye Shyken, MD 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 1 inclusion and 1 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 21 Nov 2017. 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?
compliance with the 2016 ACIP recommendations (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2017; AzTrials last refreshed its copy on 28 Oct 2026.