<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/NCT02265120</url>
  </required_header>
  <id_info>
    <org_study_id>UP-14-00447</org_study_id>
    <nct_id>NCT02265120</nct_id>
  </id_info>
  <brief_title>Primary Care Providers' Views and Understanding of Current Recommended Guidelines for Cervical Cancer Screening</brief_title>
  <official_title>Primary Care Providers' Views and Understanding of Current Recommended Guidelines for Cervical Cancer Screening</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Significant developments have led to a dramatic change in recommendations for cervical cancer&#xD;
      screening. The understanding that the Human Papilloma Virus (HPV) is the cause of nearly 100%&#xD;
      of cervical cancer cases and the development of new technologies for detection of HPV DNA at&#xD;
      time of cervical cancer screening, has produced changes in preventive healthcare policy for&#xD;
      this condition. In an unprecedented event, the American College of Obstetrics and Gynecology,&#xD;
      the American Cancer Society and the U.S. Preventive Services Task Force recommended dramatic&#xD;
      and unified changes in screening utilizing this new framework. No studies of significance&#xD;
      have evaluated (since guideline change in 2013), whether primary care providers find the new&#xD;
      recommendations authoritative and believe in them, or whether providers understand&#xD;
      implementation of these new guidelines given the many decades of contradictory and differing&#xD;
      recommendations. For this study, the opinions of primary care providers who care for patients&#xD;
      in the 194 federally designated regions of Primary Care provider shortage within California&#xD;
      will be studied. Using the California Medical Board database of licensed providers, a&#xD;
      questionnaire will be mailed to a random subset. It is anticipated that the analysis will&#xD;
      show varying contempt, confusion and compliance with new guidelines exists. Understanding&#xD;
      these factors will have beneficial health policy implications in terms of overcoming barriers&#xD;
      to these cost-effective, less intrusive, and more accurate health policy guidelines in the&#xD;
      prevention and early detection of cervical cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cervical cancer remains a common cause of death and disability among women both within the&#xD;
      United States and world-wide. Potential exists for significant prevention and early detection&#xD;
      if cervical cancer screening is performed at the correct frequencies, with correct methods,&#xD;
      on the appropriate women. Since the development of the Papanicolaou smear (Pap smear),&#xD;
      cervical cancer screening has been recommended as a component of preventative healthcare for&#xD;
      women. The tradition of an annual pap smear remains a common component of American medicine.&#xD;
      For over four decades, controversy has existed as to the optimal method and timing of&#xD;
      cervical cancer screening. The result has been great confusion amongst providers.&#xD;
&#xD;
      Significant developments have led to a dramatic change in recommendations for cervical cancer&#xD;
      screening. The understanding that the Human Papilloma Virus (HPV) is the cause of nearly 100%&#xD;
      of cervical cancer cases and the development of new technologies for detection of HPV DNA at&#xD;
      time of cervical cancer screening, has produced changes in preventive healthcare policy for&#xD;
      this condition. In an unprecedented event, the American College of Obstetrics and Gynecology,&#xD;
      the American Cancer Society and the U.S. Preventive Services Task Force recommended dramatic&#xD;
      and unified changes in screening utilizing this new technology: In healthy women, A: do not&#xD;
      start screening prior to age 21, B: screen every 3 years between ages 21-29, C: screen only&#xD;
      every 5 years between ages 30-65, and D: stop any further screening for cervical cancer after&#xD;
      65. This significant reduction in the number of cervical cancer screenings is the result of&#xD;
      these new technologies for the detection of the HPV virus, as well as evidence-based findings&#xD;
      on the lack of risk for cancer in women who test negative for HPV. From a public health&#xD;
      policy standpoint, the new recommendations are revolutionary. Whereas a women previously&#xD;
      might have received 62 &quot;Pap Smears&quot; between the ages of 18-79, with new recommendations, only&#xD;
      6 cervical cancer screenings would be required over her lifetime.&#xD;
&#xD;
      Understanding these new recommendations and complying with these new unified recommendations&#xD;
      would have a dramatic effect on health policy. The current multi-billion dollar cost of&#xD;
      annual cervical cancer screening would be dramatically reduced. The time and physical&#xD;
      inconvenience of this examination would be lessened. At a time when there is a great shortage&#xD;
      of primary care providers (MD's, PA's and NP's) in many parts of the U.S., these dramatically&#xD;
      reduced needs for cervical cancer screening might allow primary care providers greater time&#xD;
      for more important health policy. No studies of significance have evaluated (since guideline&#xD;
      change in 2013), whether primary care providers find the new recommendations authoritative&#xD;
      and believe in them, or whether providers understand implementation of these new guidelines&#xD;
      given the many decades of contradictory and differing recommendations.&#xD;
&#xD;
      The implications for health policy are significant:&#xD;
&#xD;
        1. To the extent that primary care providers don't believe in the new guidelines, then&#xD;
           providers should be educated on the evidence-based rationale from which they were&#xD;
           constructed. In other words: to overcome whatever misgivings providers might harbor as&#xD;
           to the new recommendations.&#xD;
&#xD;
        2. To the extent that primary care providers believe in the new guidelines, but can't&#xD;
           correctly apply them, then health policy would suggest an educational campaign to&#xD;
           indicate correct application.&#xD;
&#xD;
        3. To the extent that primary care providers harbor biases, further research to understand&#xD;
           and develop strategies to overcome these biases would be indicated.&#xD;
&#xD;
      For this study, the opinions of primary care providers who care for patients in the 194&#xD;
      federally designated regions of Primary Care provider shortage within California will be&#xD;
      studied. Using the California Medical Board database of licensed providers, a questionnaire&#xD;
      will be mailed to a random subset. The sample will be randomized to include providers in both&#xD;
      urban and rural areas of provider shortages, with a spectrum of patients of differing ethnic&#xD;
      and economic status. It is anticipated that approximately 5,000 questionnaires will be mailed&#xD;
      out with the goal of 1,000 responses.&#xD;
&#xD;
      The study will investigate the following issues: 1) Do primary care providers in these&#xD;
      regions believe in these new and dramatically different guidelines? 2) Are the providers able&#xD;
      to correctly apply these guidelines in four different clinical vignettes? 3) Do the providers&#xD;
      hold a bias which may influence their willingness to follow these new guidelines? It is&#xD;
      anticipated that the analysis will show varying contempt, confusion and compliance with new&#xD;
      guidelines exists. Understanding these factors will have beneficial health policy&#xD;
      implications in terms of overcoming barriers to these cost-effective, less intrusive, and&#xD;
      more accurate health policy guidelines in the prevention and early detection of cervical&#xD;
      cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Health Care Providers Beliefs Regarding Current Cervical Cancer Screening Guidelines</measure>
    <time_frame>5 months</time_frame>
    <description>Questionnaire responses to clinical scenarios and assessments of current published clinical guidelines by ACOG, ACS or USPSTF</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>primary care providers by region</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A questionnaire will be given to a randomized sample of primary care providers who care for patients in the 194 federally designated regions of Primary Care provider shortage within California will be studied.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>The Questionnaire aims to evaluate based on the responses if providers don't uniformly agree with the new guidelines, if they can't interpret them correctly, and or if they have personal biases towards the older guidelines based upon prior training, personal experience, financial incentives, etc.</description>
    <arm_group_label>primary care providers by region</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary care providers who care for patients within the 194 federally designated&#xD;
             regions of Primary Care provider shortage within California&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Outside of federally designated region of Primary Care provider shortage within&#xD;
             California&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emily J Boone</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USC Sol Price School of Public Policy</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>November 30, 2015</last_update_submitted>
  <last_update_submitted_qc>November 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Lavona Lewis</investigator_full_name>
    <investigator_title>Teaching Professor of Public Policy and Director of Undergraduate Programs</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02265120
org study id: UP-14-00447
nct id: NCT02265120
lead sponsor: 
has dmc: No
Significant developments have led to a dramatic change in recommendations for cervical cancer
      screening. The understanding that the Human Papilloma Virus (HPV) is the cause of nearly 100%
      of cervical cancer cases and the development of new technologies for detection of HPV DNA at
      time of cervical cancer screening, has produced changes in preventive healthcare policy for
      this condition. In an unprecedented event, the American College of Obstetrics and Gynecology,
      the American Cancer Society and the U.S. Preventive Services Task Force recommended dramatic
      and unified changes in screening utilizing this new framework. No studies of significance
      have evaluated (since guideline change in 2013), whether primary care providers find the new
      recommendations authoritative and believe in them, or whether providers understand
      implementation of these new guidelines given the many decades of contradictory and differing
      recommendations. For this study, the opinions of primary care providers who care for patients
      in the 194 federally designated regions of Primary Care provider shortage within California
      will be studied. Using the California Medical Board database of licensed providers, a
      questionnaire will be mailed to a random subset. It is anticipated that the analysis will
      show varying contempt, confusion and compliance with new guidelines exists. Understanding
      these factors will have beneficial health policy implications in terms of overcoming barriers
      to these cost-effective, less intrusive, and more accurate health policy guidelines in the
      prevention and early detection of cervical cancer.
Cervical cancer remains a common cause of death and disability among women both within the
      United States and world-wide. Potential exists for significant prevention and early detection
      if cervical cancer screening is performed at the correct frequencies, with correct methods,
      on the appropriate women. Since the development of the Papanicolaou smear (Pap smear),
      cervical cancer screening has been recommended as a component of preventative healthcare for
      women. The tradition of an annual pap smear remains a common component of American medicine.
      For over four decades, controversy has existed as to the optimal method and timing of
      cervical cancer screening. The result has been great confusion amongst providers.

      Significant developments have led to a dramatic change in recommendations for cervical cancer
      screening. The understanding that the Human Papilloma Virus (HPV) is the cause of nearly 100%
      of cervical cancer cases and the development of new technologies for detection of HPV DNA at
      time of cervical cancer screening, has produced changes in preventive healthcare policy for
      this condition. In an unprecedented event, the American College of Obstetrics and Gynecology,
      the American Cancer Society and the U.S. Preventive Services Task Force recommended dramatic
      and unified changes in screening utilizing this new technology: In healthy women, A: do not
      start screening prior to age 21, B: screen every 3 years between ages 21-29, C: screen only
      every 5 years between ages 30-65, and D: stop any further screening for cervical cancer after
      65. This significant reduction in the number of cervical cancer screenings is the result of
      these new technologies for the detection of the HPV virus, as well as evidence-based findings
      on the lack of risk for cancer in women who test negative for HPV. From a public health
      policy standpoint, the new recommendations are revolutionary. Whereas a women previously
      might have received 62 "Pap Smears" between the ages of 18-79, with new recommendations, only
      6 cervical cancer screenings would be required over her lifetime.

      Understanding these new recommendations and complying with these new unified recommendations
      would have a dramatic effect on health policy. The current multi-billion dollar cost of
      annual cervical cancer screening would be dramatically reduced. The time and physical
      inconvenience of this examination would be lessened. At a time when there is a great shortage
      of primary care providers (MD's, PA's and NP's) in many parts of the U.S., these dramatically
      reduced needs for cervical cancer screening might allow primary care providers greater time
      for more important health policy. No studies of significance have evaluated (since guideline
      change in 2013), whether primary care providers find the new recommendations authoritative
      and believe in them, or whether providers understand implementation of these new guidelines
      given the many decades of contradictory and differing recommendations.

      The implications for health policy are significant:

        1. To the extent that primary care providers don't believe in the new guidelines, then
           providers should be educated on the evidence-based rationale from which they were
           constructed. In other words: to overcome whatever misgivings providers might harbor as
           to the new recommendations.

        2. To the extent that primary care providers believe in the new guidelines, but can't
           correctly apply them, then health policy would suggest an educational campaign to
           indicate correct application.

        3. To the extent that primary care providers harbor biases, further research to understand
           and develop strategies to overcome these biases would be indicated.

      For this study, the opinions of primary care providers who care for patients in the 194
      federally designated regions of Primary Care provider shortage within California will be
      studied. Using the California Medical Board database of licensed providers, a questionnaire
      will be mailed to a random subset. The sample will be randomized to include providers in both
      urban and rural areas of provider shortages, with a spectrum of patients of differing ethnic
      and economic status. It is anticipated that approximately 5,000 questionnaires will be mailed
      out with the goal of 1,000 responses.

      The study will investigate the following issues: 1) Do primary care providers in these
      regions believe in these new and dramatically different guidelines? 2) Are the providers able
      to correctly apply these guidelines in four different clinical vignettes? 3) Do the providers
      hold a bias which may influence their willingness to follow these new guidelines? It is
      anticipated that the analysis will show varying contempt, confusion and compliance with new
      guidelines exists. Understanding these factors will have beneficial health policy
      implications in terms of overcoming barriers to these cost-effective, less intrusive, and
      more accurate health policy guidelines in the prevention and early detection of cervical
      cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Primary Health Care Providers Beliefs Regarding Current Cervical Cancer Screening Guidelines
time frame: 5 months
description: Questionnaire responses to clinical scenarios and assessments of current published clinical guidelines by ACOG, ACS or USPSTF
arm group label: primary care providers by region
arm group type: Experimental
description: A questionnaire will be given to a randomized sample of primary care providers who care for patients in the 194 federally designated regions of Primary Care provider shortage within California will be studied.
intervention type: Behavioral
intervention name: Questionnaire
description: The Questionnaire aims to evaluate based on the responses if providers don't uniformly agree with the new guidelines, if they can't interpret them correctly, and or if they have personal biases towards the older guidelines based upon prior training, personal experience, financial incentives, etc.
arm group label: primary care providers by region
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Emily J Boone
role: Principal Investigator
affiliation: University of Southern California
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: Lavona Lewis
investigator title: Teaching Professor of Public Policy and Director of Undergraduate Programs
mesh term: Uterine Cervical Neoplasms