<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/NCT01731405</url>
  </required_header>
  <id_info>
    <org_study_id>ABT-5599</org_study_id>
    <secondary_id>Abbott Laboratories</secondary_id>
    <nct_id>NCT01731405</nct_id>
  </id_info>
  <brief_title>Consumer Understanding and Use of Medication Guides</brief_title>
  <official_title>Consumer Understanding and Use of Medication Guides</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abbott</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the potential efficacy of three revised Medication&#xD;
      Guide layouts to increase consumers' comprehension&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      'Medication Guides' (Med Guides) are industry-developed documents that have been required by&#xD;
      the Food and Drug Administration (FDA) to be issued to consumers for prescription medications&#xD;
      that have been viewed to possess &quot;serious and significant public health concerns&quot; since&#xD;
      1998.1,2 These materials for consumers are intended to 1) provide specific dosing&#xD;
      administration instructions that could prevent serious adverse effects associated with taking&#xD;
      the medication, 2) warn individuals about significant health risks that could affect one's&#xD;
      decision to take the medication, or 3) underscore the importance of taking the prescribed&#xD;
      medication to the patient's health, and the need for proper adherence.&#xD;
&#xD;
      Despite their potential value in communicating safe and appropriate medication use, problems&#xD;
      are clearly evident with the current template for Med Guides. Research conducted by this team&#xD;
      in 2006 showed that the majority, if not all Med Guides dispensed with prescribed medicines&#xD;
      are too complex and written at a reading grade level not suitable for the majority of&#xD;
      patients to comprehend. As a result, these materials are usually ignored by consumers.3&#xD;
      Further research by this team investigating consumers' ability to process and correctly&#xD;
      understand content contained in existing Med Guides found that, across all literacy levels,&#xD;
      current Med Guides are poorly understood and ineffective in conveying safety information.&#xD;
      Patients with low literacy comprehended significantly less, proving yet again that industry&#xD;
      standards must be applied to improve these documents.&#xD;
&#xD;
      It is clear that the current guidance for Medication Guide development is insufficient, and&#xD;
      the FDA is working to change that. Both the FDA and this research team have proposed multiple&#xD;
      new Medication Guide formats, most of which are one-page cover sheets that highlight the most&#xD;
      important information of the medication. To examine these new prototypes, this research team&#xD;
      conducted six focus groups to obtain consumer-based feedback, and then evaluated three of the&#xD;
      prototypes in an eye tracking study. Using the collective data from these two consumer-based&#xD;
      studies, the investigators have further developed patient-centered and evidence-based Med&#xD;
      Guide prototypes that will be more user-friendly, clear, usable, and low literacy&#xD;
      appropriate.&#xD;
&#xD;
      In a cross-sectional, controlled trial, the investigators will investigate consumers' ability&#xD;
      to process and correctly understand content contained in each of these top three new,&#xD;
      redesigned prototypes.&#xD;
&#xD;
      The purpose of this research is to better understand how well people with varying levels of&#xD;
      literacy understand information contained in three newly designed Med Guides. Through an&#xD;
      in-person interview, the investigators aim to test consumers' ability to comprehend&#xD;
      information contained in the guides by asking them retrieval and inference questions over the&#xD;
      guides' content. This will allow us to compare the three formats against each other to see&#xD;
      which prototype is most efficient in conveying the important information it is intended to&#xD;
      convey. The investigators will recruit a total of 600 participants from general internal&#xD;
      medicine clinics here in Chicago (Northwestern clinic = 300 participants and University of&#xD;
      Illinois Chicago = 300 participants. A UIC RA will be responsible for this recruitment and&#xD;
      will submit their own IRB for review).&#xD;
&#xD;
      This trial will field test our enhanced prototypes and allow us to compare them to each&#xD;
      other, showing which format is best understood, especially in participants with low literacy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Functional Understanding and Comprehension</measure>
    <time_frame>30 minute interview</time_frame>
    <description>The primary outcome is to measure which of the three different formats of Medication Guides has the best participant comprehension, which we will assess based on total correct points out of total possible points.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health Literacy (REALM)</measure>
    <time_frame>30 minutes</time_frame>
    <description>The REALM (Rapid Estimate of Adult Health Literacy in Medicine) is a word recognition test designed to provide a valid and quick assessment of participant health literacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant Characteristics</measure>
    <time_frame>30 minutes</time_frame>
    <description>Basic demographic characteristics (age, sex, race/ethnicity), socioeconomic information (education, household income), health status information (self-reported overall health), and recent medication use will be collected by self report.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">600</enrollment>
  <condition>Revised Medication Guide Formats</condition>
  <arm_group>
    <arm_group_label>Formats A,B,C; medicines Ritalin, Morphine Sulfate, Aranesp</arm_group_label>
    <description>All patients will see all 3 different formats of the Medication Guide prototypes. They will also see information for the same drugs, in the same order - Ritalin, Morphine Sulfate, and Aranesp. All participants see all the formats, the only thing that changes by participant is which format is in each medication. There will be 6 different randomized orders - A,B,C; A,C,B; B,C,A; B,A,C; C,A,B; C,B,A. So for example, A,B,C participants would see Ritalin in format A, Morphine Sulfate in format B, and Aranesp in format C.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>There is not another group</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        We are recruiting from 2 primary care clinics.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Physically in the primary care clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years old&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  An uncorrectable hearing or a visual impairment which would hinder participants'&#xD;
             ability to view the materials&#xD;
&#xD;
          -  Too ill to participate&#xD;
&#xD;
          -  Moderate to severe cognitive impairments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael S Wolf, PhD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern Medical Faculty Foundation</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primary Care Plus</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60636</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://edocket.access.gpo.gov/2010/2010-31388.htm</url>
    <description>Federal Register (FDA-2010-N-0184). Experimental Study of Patient Information Prototypes.</description>
  </link>
  <reference>
    <citation>Tsfasman IM, Starovoitov II, Ziakun AM, Skriabin GK. [Study of the initial reaction of enzymatic oxidation of 1,8-dimethylnaphthalene]. Biokhimiia. 1976 May;41(5):864-8. Russian.</citation>
    <PMID>15641</PMID>
  </reference>
  <results_reference>
    <citation>Wolf MS, King J, Wilson EA, Curtis LM, Bailey SC, Duhig J, Russell A, Bergeron A, Daly A, Parker RM, Davis TC, Shrank WH, Lambert B. Usability of FDA-approved medication guides. J Gen Intern Med. 2012 Dec;27(12):1714-20. doi: 10.1007/s11606-012-2068-7. Epub 2012 May 8.</citation>
    <PMID>22566170</PMID>
  </results_reference>
  <results_reference>
    <citation>Wallace LS, Roskos SE, Weiss BD. Readability characteristics of consumer medication information for asthma inhalation devices. J Asthma. 2006 Jun-Jul;43(5):375-8. doi: 10.1080/02770900600709856.</citation>
    <PMID>16801142</PMID>
  </results_reference>
  <results_reference>
    <citation>Safonova TIa, Shelkovskii VI. [Nicotinamide coenzyme level in erythrocytes in children with cerebral paralysis]. Pediatriia. 1977 May;(5):71-3. No abstract available. Russian.</citation>
    <PMID>17846</PMID>
  </results_reference>
  <results_reference>
    <citation>Bull C, Goncher G, Deutschman CS, Hoffman BM. Source of residual Bohr effect in hemoglobin oxidation. J Biol Chem. 1977 May 25;252(10):3128-30.</citation>
    <PMID>16881</PMID>
  </results_reference>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>November 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>April 8, 2014</last_update_submitted>
  <last_update_submitted_qc>April 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Michael S. Wolf</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Medication Guides</keyword>
  <keyword>FDA</keyword>
  <keyword>Prototype</keyword>
  <keyword>Format</keyword>
  <!-- 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/NCT01731405
org study id: ABT-5599
secondary id: Abbott Laboratories
nct id: NCT01731405
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine the potential efficacy of three revised Medication
      Guide layouts to increase consumers' comprehension
'Medication Guides' (Med Guides) are industry-developed documents that have been required by
      the Food and Drug Administration (FDA) to be issued to consumers for prescription medications
      that have been viewed to possess "serious and significant public health concerns" since
      1998.1,2 These materials for consumers are intended to 1) provide specific dosing
      administration instructions that could prevent serious adverse effects associated with taking
      the medication, 2) warn individuals about significant health risks that could affect one's
      decision to take the medication, or 3) underscore the importance of taking the prescribed
      medication to the patient's health, and the need for proper adherence.

      Despite their potential value in communicating safe and appropriate medication use, problems
      are clearly evident with the current template for Med Guides. Research conducted by this team
      in 2006 showed that the majority, if not all Med Guides dispensed with prescribed medicines
      are too complex and written at a reading grade level not suitable for the majority of
      patients to comprehend. As a result, these materials are usually ignored by consumers.3
      Further research by this team investigating consumers' ability to process and correctly
      understand content contained in existing Med Guides found that, across all literacy levels,
      current Med Guides are poorly understood and ineffective in conveying safety information.
      Patients with low literacy comprehended significantly less, proving yet again that industry
      standards must be applied to improve these documents.

      It is clear that the current guidance for Medication Guide development is insufficient, and
      the FDA is working to change that. Both the FDA and this research team have proposed multiple
      new Medication Guide formats, most of which are one-page cover sheets that highlight the most
      important information of the medication. To examine these new prototypes, this research team
      conducted six focus groups to obtain consumer-based feedback, and then evaluated three of the
      prototypes in an eye tracking study. Using the collective data from these two consumer-based
      studies, the investigators have further developed patient-centered and evidence-based Med
      Guide prototypes that will be more user-friendly, clear, usable, and low literacy
      appropriate.

      In a cross-sectional, controlled trial, the investigators will investigate consumers' ability
      to process and correctly understand content contained in each of these top three new,
      redesigned prototypes.

      The purpose of this research is to better understand how well people with varying levels of
      literacy understand information contained in three newly designed Med Guides. Through an
      in-person interview, the investigators aim to test consumers' ability to comprehend
      information contained in the guides by asking them retrieval and inference questions over the
      guides' content. This will allow us to compare the three formats against each other to see
      which prototype is most efficient in conveying the important information it is intended to
      convey. The investigators will recruit a total of 600 participants from general internal
      medicine clinics here in Chicago (Northwestern clinic = 300 participants and University of
      Illinois Chicago = 300 participants. A UIC RA will be responsible for this recruitment and
      will submit their own IRB for review).

      This trial will field test our enhanced prototypes and allow us to compare them to each
      other, showing which format is best understood, especially in participants with low literacy.
measure: Functional Understanding and Comprehension
time frame: 30 minute interview
description: The primary outcome is to measure which of the three different formats of Medication Guides has the best participant comprehension, which we will assess based on total correct points out of total possible points.
measure: Health Literacy (REALM)
time frame: 30 minutes
description: The REALM (Rapid Estimate of Adult Health Literacy in Medicine) is a word recognition test designed to provide a valid and quick assessment of participant health literacy.
measure: Participant Characteristics
time frame: 30 minutes
description: Basic demographic characteristics (age, sex, race/ethnicity), socioeconomic information (education, household income), health status information (self-reported overall health), and recent medication use will be collected by self report.
arm group label: Formats A,B,C; medicines Ritalin, Morphine Sulfate, Aranesp
description: All patients will see all 3 different formats of the Medication Guide prototypes. They will also see information for the same drugs, in the same order - Ritalin, Morphine Sulfate, and Aranesp. All participants see all the formats, the only thing that changes by participant is which format is in each medication. There will be 6 different randomized orders - A,B,C; A,C,B; B,C,A; B,A,C; C,A,B; C,B,A. So for example, A,B,C participants would see Ritalin in format A, Morphine Sulfate in format B, and Aranesp in format C.
arm group label: There is not another group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael S Wolf, PhD MPH
role: Principal Investigator
affiliation: Northwestern University
facility: 
facility: 
country: United States
url: http://edocket.access.gpo.gov/2010/2010-31388.htm
description: Federal Register (FDA-2010-N-0184). Experimental Study of Patient Information Prototypes.
citation: Tsfasman IM, Starovoitov II, Ziakun AM, Skriabin GK. [Study of the initial reaction of enzymatic oxidation of 1,8-dimethylnaphthalene]. Biokhimiia. 1976 May;41(5):864-8. Russian.
PMID: 15641
citation: Wolf MS, King J, Wilson EA, Curtis LM, Bailey SC, Duhig J, Russell A, Bergeron A, Daly A, Parker RM, Davis TC, Shrank WH, Lambert B. Usability of FDA-approved medication guides. J Gen Intern Med. 2012 Dec;27(12):1714-20. doi: 10.1007/s11606-012-2068-7. Epub 2012 May 8.
PMID: 22566170
citation: Wallace LS, Roskos SE, Weiss BD. Readability characteristics of consumer medication information for asthma inhalation devices. J Asthma. 2006 Jun-Jul;43(5):375-8. doi: 10.1080/02770900600709856.
PMID: 16801142
citation: Safonova TIa, Shelkovskii VI. [Nicotinamide coenzyme level in erythrocytes in children with cerebral paralysis]. Pediatriia. 1977 May;(5):71-3. No abstract available. Russian.
PMID: 17846
citation: Bull C, Goncher G, Deutschman CS, Hoffman BM. Source of residual Bohr effect in hemoglobin oxidation. J Biol Chem. 1977 May 25;252(10):3128-30.
PMID: 16881
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Michael S. Wolf
investigator title: Associate Professor