<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/NCT03796585</url>
  </required_header>
  <id_info>
    <org_study_id>1R36HS026093-01A1</org_study_id>
    <nct_id>NCT03796585</nct_id>
  </id_info>
  <brief_title>Assessing Barriers and Increasing Use of Immunization Registries in Pharmacies</brief_title>
  <official_title>Assessing Barriers and Increasing Use of Immunization Registries in Pharmacies: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Auburn University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agency for Healthcare Research and Quality (AHRQ)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Auburn 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>
      The purpose of this study is to identify barriers to utilization of immunization registries&#xD;
      within a pharmacy context and tailor the information into a novel immunization registry&#xD;
      training program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to identify barriers to utilization of immunization registries&#xD;
      within a pharmacy context and tailor the information learned about barriers into a novel&#xD;
      immunization registry training program with strategies specific to individual subsets of&#xD;
      pharmacies, independent pharmacies in rural areas. Doing so will help achieve the long-term&#xD;
      goal which is to increase the use of immunization registries in community pharmacies in&#xD;
      Alabama.&#xD;
&#xD;
      The specific aims are to&#xD;
&#xD;
        1. identify barriers and best practices of immunization registry implementation,&#xD;
&#xD;
        2. use a participatory design approach to develop an immunization registry training&#xD;
           program, and&#xD;
&#xD;
        3. disseminate and assess the impact of the immunization registry training program among&#xD;
           community pharmacies' registry participation rates.&#xD;
&#xD;
      The impact of the training program on registry participation rates will be assessed using a&#xD;
      randomized controlled trial design comparing Alabama community pharmacies' registry data as&#xD;
      well as intention to participate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Actual">September 15, 2019</completion_date>
  <primary_completion_date type="Actual">September 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of pharmacies enrolled in the Alabama Immunization Registry</measure>
    <time_frame>3 months</time_frame>
    <description>The change in the number of participant pharmacies enrolled in the Alabama immunization registry from baseline to 3 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Level of Immunization Registry Participation</measure>
    <time_frame>3 months</time_frame>
    <description>Proportion of self-reported doses administered that are verified in the immunization registry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in awareness</measure>
    <time_frame>1 month and 3 months</time_frame>
    <description>The change in participant awareness of immunization registries from baseline to 3 months assessed by online questionnaire at baseline, one month, and three months. Awareness will be measured using three true or false items. Each item will be scored, 0 for an incorrect answer and 1 for a correct answer. Awareness index is the sum of the 3 items and could range from 0-3 with higher values representing greater awareness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in knowledge</measure>
    <time_frame>1 month and 3 months</time_frame>
    <description>The extent to which participant is familiar with and understands immunization registries will be assessed via online questionnaire at baseline, one month, and three months. Eight true or false and multiple answer items will be used to measure knowledge. Each item will be scored, 0 for an incorrect answer and 1 for a correct answer. Knowledge is the sum of the 8 items and could range from 0-8 with higher values representing greater knowledge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in attitudes</measure>
    <time_frame>1 month and 3 months</time_frame>
    <description>Participant's perceptions toward attributes of the immunization registry assessed via online questionnaire at baseline, one month, and three months. A scale including 25 Likert-type items will be used to measure attitudes. Each Likert-type item will be scored, ranging from 0 for strongly disagree to 6 for strongly agree. Mean scores will be calculated for the 25 items in the scale so that attitudes score range from 0 to 6 with higher values indicating greater positive attitudes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in intention to enroll in immunization registry</measure>
    <time_frame>1 month and 3 months</time_frame>
    <description>Participant's likelihood to enroll their pharmacy in the immunization registry assessed via online questionnaire at baseline and one month. A scale including 3 Likert-type items will be used to measure intention. Each Likert-type item will be scored, ranging from 0 for strongly disagree to 6 for strongly agree. Mean scores will be calculated for the three items in the scale so that intention score ranges from 0 to 6 with higher values indicating greater intention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Implementation Factors</measure>
    <time_frame>3 months</time_frame>
    <description>Implementation factors informed by the Consolidated Framework for Implementation Research (CFIR) including innovation characteristics, characteristics of individuals, inner setting, outer setting, and process will be assessed via online questionnaire at baseline and three months. A scale including 42 Likert-type items will be used to measure Implementation Factors. Each Likert-type item will be scored, ranging from 0 for strongly disagree to 6 for strongly agree. Mean scores will be calculated so that the implementation factors score ranges from 0 to 6 with higher values indicating greater positive influence of CFIR implementation factors.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Immunization</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pharmacists assigned to this group will receive an immunization registry training program and informational flyer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pharmacists assigned to this group will receive an informational flyer. They will not receive training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Immunization Registry Training</intervention_name>
    <description>Education highlighting practical strategies to improve pharmacies' willingness to adopt the immunization registry and improve their ability to integrate the immunization registry into their pharmacy workflow.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Informational flyer</intervention_name>
    <description>Informational flyer with ImmPRINT contact information</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  not currently enrolled in ImmPRINT&#xD;
&#xD;
          -  currently provide at least one type of vaccination in addition to influenza&#xD;
&#xD;
          -  independently owned&#xD;
&#xD;
          -  agree to provide requested data for assessment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Auburn University</name>
      <address>
        <city>Auburn</city>
        <state>Alabama</state>
        <zip>36849</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>October 28, 2019</last_update_submitted>
  <last_update_submitted_qc>October 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Auburn University</investigator_affiliation>
    <investigator_full_name>Tessa Hastings</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/NCT03796585
org study id: 1R36HS026093-01A1
nct id: NCT03796585
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to identify barriers to utilization of immunization registries
      within a pharmacy context and tailor the information into a novel immunization registry
      training program.
The purpose of this study is to identify barriers to utilization of immunization registries
      within a pharmacy context and tailor the information learned about barriers into a novel
      immunization registry training program with strategies specific to individual subsets of
      pharmacies, independent pharmacies in rural areas. Doing so will help achieve the long-term
      goal which is to increase the use of immunization registries in community pharmacies in
      Alabama.

      The specific aims are to

        1. identify barriers and best practices of immunization registry implementation,

        2. use a participatory design approach to develop an immunization registry training
           program, and

        3. disseminate and assess the impact of the immunization registry training program among
           community pharmacies' registry participation rates.

      The impact of the training program on registry participation rates will be assessed using a
      randomized controlled trial design comparing Alabama community pharmacies' registry data as
      well as intention to participate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Number of pharmacies enrolled in the Alabama Immunization Registry
time frame: 3 months
description: The change in the number of participant pharmacies enrolled in the Alabama immunization registry from baseline to 3 months.
measure: Level of Immunization Registry Participation
time frame: 3 months
description: Proportion of self-reported doses administered that are verified in the immunization registry.
measure: Change in awareness
time frame: 1 month and 3 months
description: The change in participant awareness of immunization registries from baseline to 3 months assessed by online questionnaire at baseline, one month, and three months. Awareness will be measured using three true or false items. Each item will be scored, 0 for an incorrect answer and 1 for a correct answer. Awareness index is the sum of the 3 items and could range from 0-3 with higher values representing greater awareness.
measure: Change in knowledge
time frame: 1 month and 3 months
description: The extent to which participant is familiar with and understands immunization registries will be assessed via online questionnaire at baseline, one month, and three months. Eight true or false and multiple answer items will be used to measure knowledge. Each item will be scored, 0 for an incorrect answer and 1 for a correct answer. Knowledge is the sum of the 8 items and could range from 0-8 with higher values representing greater knowledge.
measure: Change in attitudes
time frame: 1 month and 3 months
description: Participant's perceptions toward attributes of the immunization registry assessed via online questionnaire at baseline, one month, and three months. A scale including 25 Likert-type items will be used to measure attitudes. Each Likert-type item will be scored, ranging from 0 for strongly disagree to 6 for strongly agree. Mean scores will be calculated for the 25 items in the scale so that attitudes score range from 0 to 6 with higher values indicating greater positive attitudes.
measure: Change in intention to enroll in immunization registry
time frame: 1 month and 3 months
description: Participant's likelihood to enroll their pharmacy in the immunization registry assessed via online questionnaire at baseline and one month. A scale including 3 Likert-type items will be used to measure intention. Each Likert-type item will be scored, ranging from 0 for strongly disagree to 6 for strongly agree. Mean scores will be calculated for the three items in the scale so that intention score ranges from 0 to 6 with higher values indicating greater intention.
measure: Change in Implementation Factors
time frame: 3 months
description: Implementation factors informed by the Consolidated Framework for Implementation Research (CFIR) including innovation characteristics, characteristics of individuals, inner setting, outer setting, and process will be assessed via online questionnaire at baseline and three months. A scale including 42 Likert-type items will be used to measure Implementation Factors. Each Likert-type item will be scored, ranging from 0 for strongly disagree to 6 for strongly agree. Mean scores will be calculated so that the implementation factors score ranges from 0 to 6 with higher values indicating greater positive influence of CFIR implementation factors.
arm group label: Intervention
arm group type: Experimental
description: Pharmacists assigned to this group will receive an immunization registry training program and informational flyer.
arm group label: Control
arm group type: Active Comparator
description: Pharmacists assigned to this group will receive an informational flyer. They will not receive training.
intervention type: Behavioral
intervention name: Immunization Registry Training
description: Education highlighting practical strategies to improve pharmacies' willingness to adopt the immunization registry and improve their ability to integrate the immunization registry into their pharmacy workflow.
arm group label: Intervention
intervention type: Behavioral
intervention name: Informational flyer
description: Informational flyer with ImmPRINT contact information
arm group label: Control
arm group label: Intervention
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Auburn University
investigator full name: Tessa Hastings
investigator title: Principal Investigator
sharing ipd: No