<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/NCT04452331</url>
  </required_header>
  <id_info>
    <org_study_id>IIR 19-068</org_study_id>
    <nct_id>NCT04452331</nct_id>
  </id_info>
  <brief_title>Assessing Open Access Audio</brief_title>
  <acronym>OAA</acronym>
  <official_title>An Assessment of Open Access Audio of the Clinical Encounter on Veterans and Their Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The medical encounter can be overwhelming in term of the amount of information discussed, its&#xD;
      technical nature, and the anxiety it can generate. Easy access to a secure audio recording&#xD;
      from any internet enabled device is an available low cost technology that allows patients to&#xD;
      &quot;revisit the visit&quot; either alone or sharing with caretakers and family. It has been&#xD;
      introduced and tested outside the VA with evidence that it increases patient recall and&#xD;
      understanding and may even improve physician performance. Little is known, however, about&#xD;
      whether and to what extent these effects lead to better outcomes, such as improved treatment&#xD;
      plan adherence and chronic disease self-management. This study is a randomized controlled&#xD;
      trial designed ascertain whether easy access to audio recordings of the medical visit&#xD;
      improves patients perception that they understand and can manage their own care, and leads to&#xD;
      a variety of improved outcomes, such as better blood pressure and diabetes control, and fewer&#xD;
      emergency department visits and hospitalizations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study aims to assess (1) the impact of an open access audio (OAA) program on two&#xD;
      behaviors (patient activation, treatment plan adherence), and two chronic condition measures&#xD;
      (glycosylated hemoglobin, blood pressure); (2) the impact of open access audio on provider&#xD;
      communication and on their attention to patient contextual factors (i.e. individual Veteran's&#xD;
      needs and circumstances relevant to planning effective care); and (3) patient, provider, and&#xD;
      leadership perceptions of the extent to which the program is safe, not burdensome, and&#xD;
      worthwhile at both the start and at two years into the program. A secondary analysis will&#xD;
      descriptively measure the effect size of OAA on ED visits and hospital admissions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 5, 2021</start_date>
  <completion_date type="Anticipated">July 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2024</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>The setting will be primary care and diabetes clinics, at two facilities for generalizability. To achieve aims 1 and 2, the investigators plan a randomized controlled three arm design: (1) the encounter is recorded, with provider and patient aware, and uploaded to a server the Veteran, provider, and research team can access post visit; (2) the encounter is recorded, with both parties aware, and uploaded to a server only the research team can access; and (3) the encounter is recorded, with only the patient aware, and uploaded to a server only the research team can access. Resource utilization and disease measures indicated in aims 1 and 2 will be collected in all arms.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>Arm 1 is the intervention, with both provider and patient aware of the recording. It is designed to represent how OAA would be utilized in actual practice. In Arm 2 all parties are also aware of the audio recording, but this time neither gets access to the audio after the visit (although the research team does). Arm 2 is a control for isolating the effect of patient access after the visit to the audio in Arm 1. Both patient and physician are blind to whether they are in Arm 1 or 2 until after the visit. Arm 3 is a second kind of control, as the audio is again not shared with the patient. In this arm, however, the patient conceals the audio recorder, so that the provider is unaware they are being audio recorded until after the visit.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>6 months</time_frame>
    <description>This outcome tests the hypothesis that blood pressure control improves in patients with blood pressure &gt; 140/90 when they have access to an audio recording of their visit with their provider regarding blood pressure management compared to those who do not. An improvement in blood pressure is defined as a reduction of 10 or more mmHg in either the systolic or diastolic blood pressure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glycosylated Hemoglobin (HgB A1c)</measure>
    <time_frame>4-6 months</time_frame>
    <description>This outcome tests the hypothesis that HgB A1c improves in patients with Hgb A1c &gt; 7 when they have access to an audio recording of their discussion with their provider regarding diabetes management compared to when they do no. An improvement is defined as a decrease of 1% or more.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Return Visit Adherence (RVA)</measure>
    <time_frame>6 months</time_frame>
    <description>This outcome tests the hypothesis that return visit adherence (RVA) improves in patients with non-adherence when they have access to an audio recording of their discussion with their provider. RVA is the percentage of all scheduled visits to any clinics at the facility that the patient attends. Non-adherence is defined as an RVA &lt; 80% during the 6 months prior to the audio recorded visit. A reduction in the RVA of 10% or more is an improved outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prescription Refill Rate (PDC -- Proportion of Days Covered)</measure>
    <time_frame>6 months</time_frame>
    <description>This outcome tests the hypothesis that PDC improves in patients with non-adherence when they have access to an audio recording of their discussion with their provider compared to when they do not. PDC is the total number of days covered by refills in a measurement period divided by the number of days between the first fill and the end of the measurement period. Non-adherence is defined as a PDC&lt;80% during the 6 months prior to the audio recorded visit. An improved outcome is defined as a 10% or greater improvement post visit in any patient classified as non-adherent pre-visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Activation Measure (PAM)</measure>
    <time_frame>2 weeks</time_frame>
    <description>This outcome tests the hypothesis that patient activation is higher in patients when they have access to an audio recording of their visit with their provider compared to when they do not. Patients are called by phone post visit to answer PAM 10, a 10 item questionnaire with a 5 point Likert response that scores their perceived knowledge, skills, and confident in their capacity to follow their treatment plan with scores from 0-100. A higher score indicates higher patient activation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SEGUE Framework for evaluating and scoring communication behavior.</measure>
    <time_frame>2 weeks</time_frame>
    <description>This outcome tests the hypothesis that physicians communicate more effectively when they are aware the visit is being recorded for the patient to when they are not. Communication behavior will be rated off the audio recording by a research assistant utilizing the SEGUE checklist. Outcome measure is total score on 32 item SEGUE instrument with a higher score indicating more effective communication.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Contextualization of Care</measure>
    <time_frame>2 weeks</time_frame>
    <description>This outcome tests the hypothesis that physicians are more likely to contextualize the care plan when they are aware the visit is being recorded for the patient to when they are not. Contextualization of care will be rated off of the audio recording by a research assistant trained in Content Coding for Contextualization of Care (4C Coding). Outcome measure is the percentage of encounters in which the care plan was coded as contextualized.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Emergency department utilization</measure>
    <time_frame>6 months</time_frame>
    <description>This outcome tests the hypothesis that emergency department visit rates are lower following encounters in which patients have access to an audio recording of their visit with their provider compared to when they do not. Outcome measure is the average number of ED visits during the designated (6 month) time period following the audio recorded visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hospital admission rate</measure>
    <time_frame>6 months</time_frame>
    <description>This outcome tests the hypothesis that inpatient admission rates are lower following encounters in which patients have access to an audio recording of their visit with their provider compared to when they do not. Outcome measure is the average number of inpatient admissions during the designated (6 month) time period following the audio recorded visit.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">2308</enrollment>
  <condition>Hypertension</condition>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>OAA Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OAA Physician Aware Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OAA Physician Unaware Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Visit recorded, patient aware but provider unaware, neither patient nor provider have access to audio post-visit</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Open Access Audio</intervention_name>
    <description>Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device.</description>
    <arm_group_label>OAA Intervention</arm_group_label>
    <other_name>OAA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Access, Patient and Provider Aware of Recording</intervention_name>
    <description>Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.</description>
    <arm_group_label>OAA Physician Aware Control</arm_group_label>
    <other_name>OAA All Aware</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Access, Provider Unaware of Recording</intervention_name>
    <description>Patient does not obtain access to audio recording and provider is unaware visit is being recorded.</description>
    <arm_group_label>OAA Physician Unaware Control</arm_group_label>
    <other_name>OAA Provider Unaware</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with scheduled appointments at the participating sites: primary care and&#xD;
             diabetes clinics at Jesse Brown VA Medical Center and the Louis Stokes Cleveland VA&#xD;
             Medical Center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>Saul J. Weiner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jesse Brown VA Medical Center, Chicago, IL</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Saul J Weiner, MD</last_name>
    <phone>(312) 413-2799</phone>
    <email>saul.weiner@va.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gunjan S Sharma, PhD</last_name>
    <phone>(312) 569-6486</phone>
    <email>Gunjan.Sharma2@va.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Jesse Brown VA Medical Center, Chicago, IL</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karen M Lenehan</last_name>
      <phone>312-569-6343</phone>
      <email>Karen.Lenehan@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Valencia E Burton, BA AAS</last_name>
      <phone>(312) 569-7473</phone>
      <email>valencia.burton@va.gov</email>
    </contact_backup>
    <investigator>
      <last_name>Saul J. Weiner, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Louis Stokes VA Medical Center, Cleveland, OH</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Corinna D Falck-Ytter, MD</last_name>
      <email>Corinna.Falck-Ytter@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Sherry L Ball, PhD</last_name>
      <phone>(216) 791-2300</phone>
      <phone_ext>5830</phone_ext>
      <email>sherry.ball@va.gov</email>
    </contact_backup>
    <investigator>
      <last_name>Corinna D. Falck-Ytter, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>October 7, 2022</last_update_submitted>
  <last_update_submitted_qc>October 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</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/NCT04452331
org study id: IIR 19-068
nct id: NCT04452331
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The medical encounter can be overwhelming in term of the amount of information discussed, its
      technical nature, and the anxiety it can generate. Easy access to a secure audio recording
      from any internet enabled device is an available low cost technology that allows patients to
      "revisit the visit" either alone or sharing with caretakers and family. It has been
      introduced and tested outside the VA with evidence that it increases patient recall and
      understanding and may even improve physician performance. Little is known, however, about
      whether and to what extent these effects lead to better outcomes, such as improved treatment
      plan adherence and chronic disease self-management. This study is a randomized controlled
      trial designed ascertain whether easy access to audio recordings of the medical visit
      improves patients perception that they understand and can manage their own care, and leads to
      a variety of improved outcomes, such as better blood pressure and diabetes control, and fewer
      emergency department visits and hospitalizations.
The study aims to assess (1) the impact of an open access audio (OAA) program on two
      behaviors (patient activation, treatment plan adherence), and two chronic condition measures
      (glycosylated hemoglobin, blood pressure); (2) the impact of open access audio on provider
      communication and on their attention to patient contextual factors (i.e. individual Veteran's
      needs and circumstances relevant to planning effective care); and (3) patient, provider, and
      leadership perceptions of the extent to which the program is safe, not burdensome, and
      worthwhile at both the start and at two years into the program. A secondary analysis will
      descriptively measure the effect size of OAA on ED visits and hospital admissions.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The setting will be primary care and diabetes clinics, at two facilities for generalizability. To achieve aims 1 and 2, the investigators plan a randomized controlled three arm design: (1) the encounter is recorded, with provider and patient aware, and uploaded to a server the Veteran, provider, and research team can access post visit; (2) the encounter is recorded, with both parties aware, and uploaded to a server only the research team can access; and (3) the encounter is recorded, with only the patient aware, and uploaded to a server only the research team can access. Resource utilization and disease measures indicated in aims 1 and 2 will be collected in all arms.
primary purpose: Health Services Research
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: Arm 1 is the intervention, with both provider and patient aware of the recording. It is designed to represent how OAA would be utilized in actual practice. In Arm 2 all parties are also aware of the audio recording, but this time neither gets access to the audio after the visit (although the research team does). Arm 2 is a control for isolating the effect of patient access after the visit to the audio in Arm 1. Both patient and physician are blind to whether they are in Arm 1 or 2 until after the visit. Arm 3 is a second kind of control, as the audio is again not shared with the patient. In this arm, however, the patient conceals the audio recorder, so that the provider is unaware they are being audio recorded until after the visit.
measure: Blood pressure
time frame: 6 months
description: This outcome tests the hypothesis that blood pressure control improves in patients with blood pressure > 140/90 when they have access to an audio recording of their visit with their provider regarding blood pressure management compared to those who do not. An improvement in blood pressure is defined as a reduction of 10 or more mmHg in either the systolic or diastolic blood pressure.
measure: Glycosylated Hemoglobin (HgB A1c)
time frame: 4-6 months
description: This outcome tests the hypothesis that HgB A1c improves in patients with Hgb A1c > 7 when they have access to an audio recording of their discussion with their provider regarding diabetes management compared to when they do no. An improvement is defined as a decrease of 1% or more.
measure: Return Visit Adherence (RVA)
time frame: 6 months
description: This outcome tests the hypothesis that return visit adherence (RVA) improves in patients with non-adherence when they have access to an audio recording of their discussion with their provider. RVA is the percentage of all scheduled visits to any clinics at the facility that the patient attends. Non-adherence is defined as an RVA < 80% during the 6 months prior to the audio recorded visit. A reduction in the RVA of 10% or more is an improved outcome.
measure: Prescription Refill Rate (PDC -- Proportion of Days Covered)
time frame: 6 months
description: This outcome tests the hypothesis that PDC improves in patients with non-adherence when they have access to an audio recording of their discussion with their provider compared to when they do not. PDC is the total number of days covered by refills in a measurement period divided by the number of days between the first fill and the end of the measurement period. Non-adherence is defined as a PDC<80% during the 6 months prior to the audio recorded visit. An improved outcome is defined as a 10% or greater improvement post visit in any patient classified as non-adherent pre-visit.
measure: Patient Activation Measure (PAM)
time frame: 2 weeks
description: This outcome tests the hypothesis that patient activation is higher in patients when they have access to an audio recording of their visit with their provider compared to when they do not. Patients are called by phone post visit to answer PAM 10, a 10 item questionnaire with a 5 point Likert response that scores their perceived knowledge, skills, and confident in their capacity to follow their treatment plan with scores from 0-100. A higher score indicates higher patient activation.
measure: SEGUE Framework for evaluating and scoring communication behavior.
time frame: 2 weeks
description: This outcome tests the hypothesis that physicians communicate more effectively when they are aware the visit is being recorded for the patient to when they are not. Communication behavior will be rated off the audio recording by a research assistant utilizing the SEGUE checklist. Outcome measure is total score on 32 item SEGUE instrument with a higher score indicating more effective communication.
measure: Contextualization of Care
time frame: 2 weeks
description: This outcome tests the hypothesis that physicians are more likely to contextualize the care plan when they are aware the visit is being recorded for the patient to when they are not. Contextualization of care will be rated off of the audio recording by a research assistant trained in Content Coding for Contextualization of Care (4C Coding). Outcome measure is the percentage of encounters in which the care plan was coded as contextualized.
measure: Emergency department utilization
time frame: 6 months
description: This outcome tests the hypothesis that emergency department visit rates are lower following encounters in which patients have access to an audio recording of their visit with their provider compared to when they do not. Outcome measure is the average number of ED visits during the designated (6 month) time period following the audio recorded visit.
measure: hospital admission rate
time frame: 6 months
description: This outcome tests the hypothesis that inpatient admission rates are lower following encounters in which patients have access to an audio recording of their visit with their provider compared to when they do not. Outcome measure is the average number of inpatient admissions during the designated (6 month) time period following the audio recorded visit.
arm group label: OAA Intervention
arm group type: Experimental
description: Visit recorded, both patient and provider aware, both patient and provider have access to audio post-visit
arm group label: OAA Physician Aware Control
arm group type: Sham Comparator
description: Visit recorded, both patient and provider aware, neither patient nor provider have access to audio post-visit
arm group label: OAA Physician Unaware Control
arm group type: Placebo Comparator
description: Visit recorded, patient aware but provider unaware, neither patient nor provider have access to audio post-visit
intervention type: Other
intervention name: Open Access Audio
description: Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device.
arm group label: OAA Intervention
other name: OAA
intervention type: Other
intervention name: No Access, Patient and Provider Aware of Recording
description: Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.
arm group label: OAA Physician Aware Control
other name: OAA All Aware
intervention type: Other
intervention name: No Access, Provider Unaware of Recording
description: Patient does not obtain access to audio recording and provider is unaware visit is being recorded.
arm group label: OAA Physician Unaware Control
other name: OAA Provider Unaware
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Saul J. Weiner, MD
role: Principal Investigator
affiliation: Jesse Brown VA Medical Center, Chicago, IL
last name: Saul J Weiner, MD
phone: (312) 413-2799
email: saul.weiner@va.gov
last name: Gunjan S Sharma, PhD
phone: (312) 569-6486
email: Gunjan.Sharma2@va.gov
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Hypertension
sharing ipd: No