<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/NCT03004937</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00082363</org_study_id>
    <nct_id>NCT03004937</nct_id>
  </id_info>
  <brief_title>Early Auditory Referral in Primary Care</brief_title>
  <acronym>EAR-PC</acronym>
  <official_title>Early Auditory Referral in Primary Care (EAR-PC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Busy Primary Care providers (PCPs) have complex practices with many competing demands, making&#xD;
      it difficult to improve their HL identification rates. Little research has been conducted to&#xD;
      identify effective approaches to address the poor PCP knowledge and provide tools for them to&#xD;
      better identify/refer patients with HL for appropriate intervention. Current data suggests&#xD;
      there is a critical need to redesign how PCPs deliver hearing health care (HHC) by developing&#xD;
      focused educational programs and simple clinical management tools to help them integrate HHC&#xD;
      into their practices. To address this need, this study will educate providers on hearing loss&#xD;
      (HL) screening/treatment as well as create a Best Practice Alert (BPA), or clinical prompt,&#xD;
      that is configured for maximal effectiveness in reminding PCPs to ask their patients if they&#xD;
      think they have a HL. This combination of education for providers and clinical reminder could&#xD;
      help increase HL screening rates but how much is not clear. This 5 year R21/R33 study funded&#xD;
      by National Institute of Deafness and Communicative Disorders seeks to provide detailed&#xD;
      understanding of both how educating providers on HL and the use of an effective BPA affects&#xD;
      HL screening rates and identification for people with mild to moderate hearing loss.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Best Practice Alert (BPA) was developed via an iterative process during a two year pilot&#xD;
      phase at one site at each health system. First, a &quot;standard&quot; BPA was developed to be launched&#xD;
      at each site during the pilot phase. Similarly, a pilot 10-minute education system was&#xD;
      developed to be presented just before the above BPA was launched. Pre and post surveys of&#xD;
      clinicians were conducted to evaluate the effectiveness of the education program. After&#xD;
      clinicians had experience with the BPA, Cognitive Task Analyses (CTAs) with clinicians were&#xD;
      conducted to identify ways to make the BPA more effective, and then the BPA was iteratively&#xD;
      improved. Similarly, the CTAs helped the investigators understand why clinicians do or do not&#xD;
      use BPAs in general. Using this process, a highly rated, easy to use BPA was created and will&#xD;
      be utilized in the actual study. The investigators also revamped the education program to a&#xD;
      10 minute video that focused on clinicians mental models of HL, to be used in the actual&#xD;
      study. The bigger study, i.e., the R33 phase, will launch at several Family Medicine&#xD;
      practices within each of the two different health systems. One of these systems is a&#xD;
      traditional academic institution with only academic faculty (physicians and audiologists),&#xD;
      midlevels and residents, and the other is a newer academic system, based within a private&#xD;
      health system, that includes non-academic physicians and private audiologists. Patients who&#xD;
      trigger the BPA will be 55 years or older, do not have an open referral in their chart to&#xD;
      audiology, and do not have a known hearing loss already on their problem summary list (PSL).&#xD;
      These patients are asked to complete a Hearing Handicap Inventory (HHI) at check-in, a common&#xD;
      hearing loss screening tool (score of 10+ indicates probable hearing loss); the results of&#xD;
      this will not be shared with clinicians. If the physician chooses to address the prompt&#xD;
      during the patient encounter, the BPA design allows them to, 1) Indicate that the patient&#xD;
      declines hearing screening (BPA is dismissed for 1 year), 2) Indicate that the patient&#xD;
      already has a known hearing loss (HL) and add HL to the PSL (The BPA will be permanently&#xD;
      dismissed), 3) Indicate that the patient does not have any HL at this time (The BPA is&#xD;
      dismissed for one year), or 4) refer the patient to audiology for hearing screening. The data&#xD;
      generated by the BPA is extracted from the electronic health record (EHR) and analyzed to&#xD;
      determine if HL screening rates improve when compared to baseline data, whether or not&#xD;
      providers are interacting with the BPA, and whether HL is being added to the PSL. The HHI&#xD;
      results are used as the &quot;gold standard,&quot; i.e., when compared to the data generated by the&#xD;
      BPA, indicate whether or not patients with probable HL are getting appropriate care. When an&#xD;
      enrolled patient shows up in Audiology the audiologist is asked to complete a three question&#xD;
      survey to verify that 1) the referral was appropriate, 2) what is the severity of hearing&#xD;
      loss if any, and 3) were hearing aids recommended. This step is to study whether the BPA is&#xD;
      generating appropriate referrals. 20% of patients that score 10 or above on their HHI and/or&#xD;
      were referred to audiology are contacted by phone and researchers ask them questions about&#xD;
      any conversation they may recall related to HL at their appointment as well as their&#xD;
      experience in audiology. Iterative improvements will be made to the BPA based on Cognitive&#xD;
      Task Analysis (CTA) interviews with randomly selected providers (mostly family physicians).&#xD;
      Finally, the implementation of the BPA into clinical practice is observed using the&#xD;
      principles of Normalization Process Theory (NPT) to study whether there are other potential&#xD;
      issues that may impact whether patients at risk for HL are being screened and referred. The&#xD;
      revamped educational video will be shown a week prior to the BPA going live at each site, and&#xD;
      repeating the pre and post evaluations. The investigators will be studying whether the&#xD;
      education video increases identification and referral of patients at high risk for HL.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2014</start_date>
  <completion_date type="Actual">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Increase in Screening Referrals for Hearing Testing of Patients at High Risk for Hearing Loss</measure>
    <time_frame>Analysis will be done 3 months after data collection completion to allow time for patients to follow up with audiology.</time_frame>
    <description>Baseline data on providers and the clinics will be compared to post-intervention data to determine if hearing loss screening referrals improved; Investigators will also do a step-wedged analysis to look at differences between clinics that have gone live with the BPA and those who have not yet gone live.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Increase in identification of patients with hearing loss</measure>
    <time_frame>Analysis will be done 3 months after data collection completion to allow time for patients to follow up with audiology.</time_frame>
    <description>Baseline data on providers will be compared to post-intervention data to determine if the percentage of patients with hearing loss on the problem lists is approaching accepted population rates for this age group</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Hearing Loss</condition>
  <arm_group>
    <arm_group_label>Single-Arm, Non-Randomized, Stepped Wedge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients who meet the inclusion criteria will receive the same intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Family Medicine Hearing Loss Best Practice Alert</intervention_name>
    <description>A Best Practice Alert, or BPA, was created in the electronic medical record system, which fires when patients meet the inclusion criteria. It reminds providers to ask their patients if they think have a hearing loss and allows them to respond as needed (refer to audiology, add hearing loss to the problem summary list, or dismiss for one year).</description>
    <arm_group_label>Single-Arm, Non-Randomized, Stepped Wedge</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -55 years or older, doesn't have a known hearing loss on their problem summary list (found&#xD;
        in the electronic health record), doesn't already have an open referral to audiology in&#xD;
        their chart, and has an encounter with a provider at a participating Family Medicine&#xD;
        clinic.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philip Zazove, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dominos Farms Family Medicine</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chelsea Family Medicine</name>
      <address>
        <city>Chelsea</city>
        <state>Michigan</state>
        <zip>48118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dexter Health Center</name>
      <address>
        <city>Dexter</city>
        <state>Michigan</state>
        <zip>48130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Livonia Health Center</name>
      <address>
        <city>Livonia</city>
        <state>Michigan</state>
        <zip>48152</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beaumont Rochester Hills Family Physicians</name>
      <address>
        <city>Rochester Hills</city>
        <state>Michigan</state>
        <zip>48307</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beaumont East Area Family Practice</name>
      <address>
        <city>Roseville</city>
        <state>Michigan</state>
        <zip>48066</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beaumont Shorepointe Family Physicians</name>
      <address>
        <city>Saint Clair Shores</city>
        <state>Michigan</state>
        <zip>48080</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beaumont Family Practice</name>
      <address>
        <city>Saint Clair Shores</city>
        <state>Michigan</state>
        <zip>48081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clearwater Family Medicine</name>
      <address>
        <city>Washington</city>
        <state>Michigan</state>
        <zip>48095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ypsilanti Health Center</name>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <zip>48198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>August 1, 2019</last_update_submitted>
  <last_update_submitted_qc>August 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Philip Zazove</investigator_full_name>
    <investigator_title>Chair of the Department of Family Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>In process of data collection. Data will be analyzed, papers written, and results posted in clinicaltrials.gov.</ipd_description>
  </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/NCT03004937
org study id: HUM00082363
nct id: NCT03004937
lead sponsor: 
has dmc: Yes
Busy Primary Care providers (PCPs) have complex practices with many competing demands, making
      it difficult to improve their HL identification rates. Little research has been conducted to
      identify effective approaches to address the poor PCP knowledge and provide tools for them to
      better identify/refer patients with HL for appropriate intervention. Current data suggests
      there is a critical need to redesign how PCPs deliver hearing health care (HHC) by developing
      focused educational programs and simple clinical management tools to help them integrate HHC
      into their practices. To address this need, this study will educate providers on hearing loss
      (HL) screening/treatment as well as create a Best Practice Alert (BPA), or clinical prompt,
      that is configured for maximal effectiveness in reminding PCPs to ask their patients if they
      think they have a HL. This combination of education for providers and clinical reminder could
      help increase HL screening rates but how much is not clear. This 5 year R21/R33 study funded
      by National Institute of Deafness and Communicative Disorders seeks to provide detailed
      understanding of both how educating providers on HL and the use of an effective BPA affects
      HL screening rates and identification for people with mild to moderate hearing loss.
The Best Practice Alert (BPA) was developed via an iterative process during a two year pilot
      phase at one site at each health system. First, a "standard" BPA was developed to be launched
      at each site during the pilot phase. Similarly, a pilot 10-minute education system was
      developed to be presented just before the above BPA was launched. Pre and post surveys of
      clinicians were conducted to evaluate the effectiveness of the education program. After
      clinicians had experience with the BPA, Cognitive Task Analyses (CTAs) with clinicians were
      conducted to identify ways to make the BPA more effective, and then the BPA was iteratively
      improved. Similarly, the CTAs helped the investigators understand why clinicians do or do not
      use BPAs in general. Using this process, a highly rated, easy to use BPA was created and will
      be utilized in the actual study. The investigators also revamped the education program to a
      10 minute video that focused on clinicians mental models of HL, to be used in the actual
      study. The bigger study, i.e., the R33 phase, will launch at several Family Medicine
      practices within each of the two different health systems. One of these systems is a
      traditional academic institution with only academic faculty (physicians and audiologists),
      midlevels and residents, and the other is a newer academic system, based within a private
      health system, that includes non-academic physicians and private audiologists. Patients who
      trigger the BPA will be 55 years or older, do not have an open referral in their chart to
      audiology, and do not have a known hearing loss already on their problem summary list (PSL).
      These patients are asked to complete a Hearing Handicap Inventory (HHI) at check-in, a common
      hearing loss screening tool (score of 10+ indicates probable hearing loss); the results of
      this will not be shared with clinicians. If the physician chooses to address the prompt
      during the patient encounter, the BPA design allows them to, 1) Indicate that the patient
      declines hearing screening (BPA is dismissed for 1 year), 2) Indicate that the patient
      already has a known hearing loss (HL) and add HL to the PSL (The BPA will be permanently
      dismissed), 3) Indicate that the patient does not have any HL at this time (The BPA is
      dismissed for one year), or 4) refer the patient to audiology for hearing screening. The data
      generated by the BPA is extracted from the electronic health record (EHR) and analyzed to
      determine if HL screening rates improve when compared to baseline data, whether or not
      providers are interacting with the BPA, and whether HL is being added to the PSL. The HHI
      results are used as the "gold standard," i.e., when compared to the data generated by the
      BPA, indicate whether or not patients with probable HL are getting appropriate care. When an
      enrolled patient shows up in Audiology the audiologist is asked to complete a three question
      survey to verify that 1) the referral was appropriate, 2) what is the severity of hearing
      loss if any, and 3) were hearing aids recommended. This step is to study whether the BPA is
      generating appropriate referrals. 20% of patients that score 10 or above on their HHI and/or
      were referred to audiology are contacted by phone and researchers ask them questions about
      any conversation they may recall related to HL at their appointment as well as their
      experience in audiology. Iterative improvements will be made to the BPA based on Cognitive
      Task Analysis (CTA) interviews with randomly selected providers (mostly family physicians).
      Finally, the implementation of the BPA into clinical practice is observed using the
      principles of Normalization Process Theory (NPT) to study whether there are other potential
      issues that may impact whether patients at risk for HL are being screened and referred. The
      revamped educational video will be shown a week prior to the BPA going live at each site, and
      repeating the pre and post evaluations. The investigators will be studying whether the
      education video increases identification and referral of patients at high risk for HL.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Increase in Screening Referrals for Hearing Testing of Patients at High Risk for Hearing Loss
time frame: Analysis will be done 3 months after data collection completion to allow time for patients to follow up with audiology.
description: Baseline data on providers and the clinics will be compared to post-intervention data to determine if hearing loss screening referrals improved; Investigators will also do a step-wedged analysis to look at differences between clinics that have gone live with the BPA and those who have not yet gone live.
measure: Increase in identification of patients with hearing loss
time frame: Analysis will be done 3 months after data collection completion to allow time for patients to follow up with audiology.
description: Baseline data on providers will be compared to post-intervention data to determine if the percentage of patients with hearing loss on the problem lists is approaching accepted population rates for this age group
arm group label: Single-Arm, Non-Randomized, Stepped Wedge
arm group type: Experimental
description: All patients who meet the inclusion criteria will receive the same intervention.
intervention type: Other
intervention name: Family Medicine Hearing Loss Best Practice Alert
description: A Best Practice Alert, or BPA, was created in the electronic medical record system, which fires when patients meet the inclusion criteria. It reminds providers to ask their patients if they think have a hearing loss and allows them to respond as needed (refer to audiology, add hearing loss to the problem summary list, or dismiss for one year).
arm group label: Single-Arm, Non-Randomized, Stepped Wedge
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Philip Zazove, MD
role: Principal Investigator
affiliation: University of Michigan
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Philip Zazove
investigator title: Chair of the Department of Family Medicine
mesh term: Hearing Loss
sharing ipd: Yes
ipd description: In process of data collection. Data will be analyzed, papers written, and results posted in clinicaltrials.gov.