<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/NCT04426331</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00054137</org_study_id>
    <nct_id>NCT04426331</nct_id>
  </id_info>
  <brief_title>Vouchers to Increase Uptake of Already Free Eye Care</brief_title>
  <official_title>Providing Vouchers Redeemable for Already Free Eye Exams To Increase Uptake Among a Low-Income Minority Population: A Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins 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>
      This study was intended to test if reframing an offer for a free follow-up eye examination&#xD;
      could increase uptake within ongoing community-based screening program for low-income and&#xD;
      minority populations in Baltimore City. This study evaluated the effect of offering&#xD;
      participants a physical voucher they were told was redeemable for free follow-up, relative to&#xD;
      simply telling participants that the follow-up appointment would be free of charge. The&#xD;
      investigators assessed two forms of vouchers, one with estimated value information, and one&#xD;
      without. The underlying hypothesis was that reframing these already free offers would&#xD;
      increase uptake by increasing perceived offer value and increasing a sense of regret from not&#xD;
      taking advantage of a &quot;good deal.&quot;&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 5, 2017</start_date>
  <completion_date type="Actual">January 1, 2019</completion_date>
  <primary_completion_date type="Actual">January 1, 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>
    <intervention_model_description>Cluster randomized study: screening events (clusters) randomized to one of three interventions, outcomes from individuals within clusters tracked.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Uptake of follow-up appointment</measure>
    <time_frame>Within 90 days of the date of screening</time_frame>
    <description>The primary endpoint was attending a follow-up appointment, either on the initially scheduled or on a rescheduled date within 90 days of the date of screening. Individuals who did not meet this endpoint either stated that they were not interested in follow-up at the screening event itself, cancelled or did not show for their appointments on 3 occasions, stated that they were not interested in follow-up when study staff attempted to reschedule, or did not show for an appointment and could not be reached for rescheduling after 3 attempts.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Uptake of initial appointment</measure>
    <time_frame>Within 90 days of the date of screening</time_frame>
    <description>Binary indicator for completion of the initially scheduled appointment.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">739</enrollment>
  <condition>Glaucoma</condition>
  <condition>Eye Diseases</condition>
  <arm_group>
    <arm_group_label>No Voucher</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Individuals being referred from screening events randomized to &quot;no intervention&quot; received the standard approach to offering free follow-up examinations (patient education, standard counseling, appointment information packet, reminder phone calls).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Voucher Without Value Information</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to receiving the standard approach above, individuals being referred from screening events randomized to &quot;Voucher Without Value Information&quot; received a personal voucher.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Voucher With Value Information</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to receiving the standard approach above, individuals being referred from screening events randomized to &quot;Voucher With Value Information&quot; received a personal voucher, which differed from the voucher in the second arm since it included a statement of value.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Voucher Without Value Information</intervention_name>
    <description>Patients being referred for follow-up received standard materials, counseling, and reminders as in the 'no information' group and were provided with a physical voucher they were told is redeemable for free follow-up appointment at Johns Hopkins Hospital. The voucher included the patient's name, the screener's name, and an expiration date 90 days from the date of screening.&#xD;
These participants were told: &quot;I am going to give you this voucher for a completely free appointment and a free pair of glasses if you need them. So, with this voucher, both the exam and the glasses will be completely free.&quot;</description>
    <arm_group_label>Voucher Without Value Information</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Voucher With Value Information</intervention_name>
    <description>Patients being referred for follow-up received standard materials, counseling, and reminders as in the 'no information' group and were provided with a physical voucher they were told is redeemable for free follow-up appointment at Johns Hopkins Hospital, which would normally cost $250. The voucher included the patient's name, the screener's name, an expiration date 90 days from the date of screening, and a statement about the $250 voucher value.&#xD;
These participants were told: &quot;I am going to give you this voucher for a completely free appointment and a free pair of glasses if you need them. These services normally cost about $250, but with this voucher, both the exam and the glasses will be completely free.&quot;</description>
    <arm_group_label>Voucher With Value Information</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Referred for follow-up at a Screening to Prevent Glaucoma (SToP) study screening event&#xD;
             (overarching observational study from which trial sample was drawn). SToP participants&#xD;
             were referred for follow-up for any of the following conditions: (1) VA worse than&#xD;
             20/40 in at least 1 eye despite autorefraction; (2) signs of retinal abnormalities on&#xD;
             fundus photography; (3) uninterpretable fundus photography; (4) cup-to-disc ratio&#xD;
             (CDR) greater than or equal to 0.9, and/or CDR between 0.7 and 0.9 with visual field&#xD;
             defects or history of glaucoma; and (5) IOP of 23 mm Hg or greater.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  SToP participants who were not referred at the time of screening but later contacted&#xD;
             after review of fundus photography&#xD;
&#xD;
          -  SToP participants who were referred for follow-up but stated at the time of counseling&#xD;
             that they were already under the care of an eye doctor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seema Kacker, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David S Friedman, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts Eye and Ear Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Hospital - Wilmer Eye Institute</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.stopglaucomajhu.org/</url>
    <description>Website dedicated to overarching study from which trial participants were drawn</description>
  </link>
  <reference>
    <citation>Zhao D, Guallar E, Gajwani P, Swenor B, Crews J, Saaddine J, Mudie L, Varadaraj V, Friedman DS; SToP Glaucoma Study Group. Optimizing Glaucoma Screening in High-Risk Population: Design and 1-Year Findings of the Screening to Prevent (SToP) Glaucoma Study. Am J Ophthalmol. 2017 Aug;180:18-28. doi: 10.1016/j.ajo.2017.05.017. Epub 2017 May 24.</citation>
    <PMID>28549849</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>voucher</keyword>
  <keyword>information</keyword>
  <keyword>health behavior</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Eye Diseases</mesh_term>
  </condition_browse>
  <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/NCT04426331
org study id: IRB00054137
nct id: NCT04426331
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study was intended to test if reframing an offer for a free follow-up eye examination
      could increase uptake within ongoing community-based screening program for low-income and
      minority populations in Baltimore City. This study evaluated the effect of offering
      participants a physical voucher they were told was redeemable for free follow-up, relative to
      simply telling participants that the follow-up appointment would be free of charge. The
      investigators assessed two forms of vouchers, one with estimated value information, and one
      without. The underlying hypothesis was that reframing these already free offers would
      increase uptake by increasing perceived offer value and increasing a sense of regret from not
      taking advantage of a "good deal."
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Cluster randomized study: screening events (clusters) randomized to one of three interventions, outcomes from individuals within clusters tracked.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Uptake of follow-up appointment
time frame: Within 90 days of the date of screening
description: The primary endpoint was attending a follow-up appointment, either on the initially scheduled or on a rescheduled date within 90 days of the date of screening. Individuals who did not meet this endpoint either stated that they were not interested in follow-up at the screening event itself, cancelled or did not show for their appointments on 3 occasions, stated that they were not interested in follow-up when study staff attempted to reschedule, or did not show for an appointment and could not be reached for rescheduling after 3 attempts.
measure: Uptake of initial appointment
time frame: Within 90 days of the date of screening
description: Binary indicator for completion of the initially scheduled appointment.
arm group label: No Voucher
arm group type: No Intervention
description: Individuals being referred from screening events randomized to "no intervention" received the standard approach to offering free follow-up examinations (patient education, standard counseling, appointment information packet, reminder phone calls).
arm group label: Voucher Without Value Information
arm group type: Experimental
description: In addition to receiving the standard approach above, individuals being referred from screening events randomized to "Voucher Without Value Information" received a personal voucher.
arm group label: Voucher With Value Information
arm group type: Experimental
description: In addition to receiving the standard approach above, individuals being referred from screening events randomized to "Voucher With Value Information" received a personal voucher, which differed from the voucher in the second arm since it included a statement of value.
intervention type: Behavioral
intervention name: Voucher Without Value Information
description: Patients being referred for follow-up received standard materials, counseling, and reminders as in the 'no information' group and were provided with a physical voucher they were told is redeemable for free follow-up appointment at Johns Hopkins Hospital. The voucher included the patient's name, the screener's name, and an expiration date 90 days from the date of screening.
These participants were told: "I am going to give you this voucher for a completely free appointment and a free pair of glasses if you need them. So, with this voucher, both the exam and the glasses will be completely free."
arm group label: Voucher Without Value Information
intervention type: Behavioral
intervention name: Voucher With Value Information
description: Patients being referred for follow-up received standard materials, counseling, and reminders as in the 'no information' group and were provided with a physical voucher they were told is redeemable for free follow-up appointment at Johns Hopkins Hospital, which would normally cost $250. The voucher included the patient's name, the screener's name, an expiration date 90 days from the date of screening, and a statement about the $250 voucher value.
These participants were told: "I am going to give you this voucher for a completely free appointment and a free pair of glasses if you need them. These services normally cost about $250, but with this voucher, both the exam and the glasses will be completely free."
arm group label: Voucher With Value Information
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Seema Kacker, PhD
role: Principal Investigator
affiliation: Johns Hopkins School of Medicine
last name: David S Friedman, MD PhD
role: Principal Investigator
affiliation: Massachusetts Eye and Ear Hospital
facility: 
country: United States
url: https://www.stopglaucomajhu.org/
description: Website dedicated to overarching study from which trial participants were drawn
citation: Zhao D, Guallar E, Gajwani P, Swenor B, Crews J, Saaddine J, Mudie L, Varadaraj V, Friedman DS; SToP Glaucoma Study Group. Optimizing Glaucoma Screening in High-Risk Population: Design and 1-Year Findings of the Screening to Prevent (SToP) Glaucoma Study. Am J Ophthalmol. 2017 Aug;180:18-28. doi: 10.1016/j.ajo.2017.05.017. Epub 2017 May 24.
PMID: 28549849
responsible party type: Sponsor
mesh term: Eye Diseases
sharing ipd: No