<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03039725</url>
  </required_header>
  <id_info>
    <org_study_id>27919</org_study_id>
    <nct_id>NCT03039725</nct_id>
  </id_info>
  <brief_title>Vaccination Compliance</brief_title>
  <official_title>Vaccination Rates in Obstetric Opioid-Addicted Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jaye Shyken, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Retrospective study to assess a single Clinic on Immunization Practices (ACIP)&#xD;
      recommendations for hepatitis A, hepatitis B, influenza, tetanus/diphtheria/pertussis, HPV&#xD;
      and pneumococcal disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vaccines are known as one of the greatest public health achievements of the twentieth&#xD;
      century. Due to the successful implementation of childhood immunization programs in the&#xD;
      United States (US), once common disease states such as polio, smallpox, and measles are no&#xD;
      longer a natural part of childhood. Unfortunately, these successes have not been replicated&#xD;
      in the adult population despite the availability of vaccines and published recommendations&#xD;
      guiding appropriate screening for and administration of vaccines. On average, 42,000 adults&#xD;
      compared to 300 children die in the US of vaccine-preventable infections every year. In fact,&#xD;
      results of the National Health Interview Survey from 2012 demonstrated low immunization rates&#xD;
      for adults 19 years of age and older leaving a significant portion of eligible patients&#xD;
      susceptible to disease.&#xD;
&#xD;
      Vaccine administration rates are often lower in the obstetric population likely due to fear&#xD;
      of administration during pregnancy and lack of recommendations and education to patients&#xD;
      about vaccines. The influenza and Tdap vaccines are recommended for every pregnant patient.&#xD;
      However, in 2015-16 influenza season only 49.9% of pregnant patients received the influenza&#xD;
      vaccine. Additionally, only 30-53.% have receive the Tdap vaccine. Besides these needed&#xD;
      vaccines, patients are often indicated for additional vaccines including hepatitis A,&#xD;
      hepatitis B, pneumococcal-23, and human papillomavirus. Additionally, patients who have&#xD;
      unequivocal or negative rubella titers during pregnancy should receive the measles, mumps,&#xD;
      and rubella vaccine when post-partum. Because of the lack of vaccination, the American&#xD;
      College of Obstetricians and Gynecologists (ACOG) has recommended that vaccines become part&#xD;
      of the routine obstetric care.&#xD;
&#xD;
      According to American Society of Healthcare Pharmacists (ASHP) Guidelines on the pharmacist's&#xD;
      role in immunizations, all pharmacists can contribute to the effort by promoting proper&#xD;
      immunizations in various ways. One way is by helping to identify patients in need of&#xD;
      immunizations by gathering immunization histories, identifying patient specific indication,&#xD;
      issuing immunization records to patients, and educating patients on their specific&#xD;
      indications, and the risk of the immunizations.&#xD;
&#xD;
      The investigator's team includes a maternal fetal medicine specialist, nurse practitioners,&#xD;
      clinical pharmacist, social workers, and registered nurses. The pharmacist meets with all&#xD;
      patients to perform medication reconciliation, vaccine history, social history, allergy&#xD;
      history, disease specific review of systems, pregnancy related review of systems, and&#xD;
      preventative health review; assess medical and preventative health problems; recommend&#xD;
      appropriate management of medical problems and preventative health; and provide extensive&#xD;
      education including information on all indicated vaccines. The indicated vaccines are&#xD;
      recommended to either the physician or nurse practitioner provider for that visit as well as&#xD;
      documented in the medical record. Additionally, prior to each office visit, the pharmacist&#xD;
      reviews each patient's chart to determine what vaccines are indicated for this visit. This&#xD;
      list of indicated vaccines is provided to the nurse who asks the patients about receiving the&#xD;
      vaccine at that day's visit. If the patient is willing to receive the vaccine, the nurse has&#xD;
      the provider order the indicated vaccines. All the vaccines are kept as floor stock in the&#xD;
      clinic to minimize wait time for the patient.&#xD;
&#xD;
      Although there have been recent efforts to increase immunization rates throughout the health&#xD;
      care system, there is little evidence about the impact of pharmacists' involvement on&#xD;
      immunization rates in outpatient obstetric clinic setting. The goal of this study is to&#xD;
      evaluate immunization administration compliance with the Centers for Disease Control (CDC)&#xD;
      2016 immunization recommendations for influenza, pneumococcal 23 polyvalent, hepatitis A,&#xD;
      hepatitis B, tetanus, diphtheria, and acellular pertussis (Tdap), human papillomavirus (HPV),&#xD;
      and measles-mumps-rubella (MMR).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">August 28, 2017</completion_date>
  <primary_completion_date type="Actual">August 28, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>compliance with the 2016 ACIP recommendations</measure>
    <time_frame>6 months</time_frame>
    <description>Chart review</description>
  </primary_outcome>
  <enrollment type="Actual">99</enrollment>
  <condition>Vaccine Compliance</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational</intervention_name>
    <description>Retrospective chart review on vaccine compliance</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        -  Female&#xD;
&#xD;
          -  All ethnic backgrounds&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients addicted to opioids during pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  must meet inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jaye Shyken, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Mary's Health Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>November 17, 2017</last_update_submitted>
  <last_update_submitted_qc>November 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Jaye Shyken, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03039725
org study id: 27919
nct id: NCT03039725
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
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).
observational model: Cohort
time perspective: Retrospective
measure: compliance with the 2016 ACIP recommendations
time frame: 6 months
description: Chart review
intervention type: Other
intervention name: Observational
description: Retrospective chart review on vaccine compliance
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 14 Years
maximum age: 55 Years
healthy volunteers: No
last name: Jaye Shyken, MD
role: Principal Investigator
affiliation: St. Louis University
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: St. Louis University
investigator full name: Jaye Shyken, MD
investigator title: Principal Investigator
sharing ipd: No