<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/NCT04496713</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00257994</org_study_id>
    <nct_id>NCT04496713</nct_id>
  </id_info>
  <brief_title>Pilot Study of Video and Telephone Primary Care Visits</brief_title>
  <official_title>Pilot Study - Randomized Controlled Trial of Video and Telephone Primary Care Visits</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      The inability to access and use smartphones or camera-outfitted internet-connected devices&#xD;
      during the COVID-19 pandemic relegates certain patients to receive audio-only telemedicine&#xD;
      instead of audio/video-based telemedicine. The investigators are conducting a randomized&#xD;
      controlled trial in order to characterize patient and provider attitudes towards these two&#xD;
      modalities of care and to test the feasibility of a new model to make tablets for video-based&#xD;
      care accessible to those who need that. The investigators hypothesize that patient and&#xD;
      provider satisfaction will be higher with video-based telehealth when compared to phone-based&#xD;
      telehealth.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 24, 2021</start_date>
  <completion_date type="Actual">December 30, 2021</completion_date>
  <primary_completion_date type="Actual">November 24, 2021</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>Provider rating as assessed by the Consumer Assessment of Healthcare Providers and Systems question on provider rating</measure>
    <time_frame>Within 2 weeks of the study visit</time_frame>
    <description>Provider rating will be assessed with the Consumer Assessment of Healthcare Providers and Systems question on provider rating of 0-10; 0 being worst provider possible and 10 being best provider possible.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with telemedicine visit for patient as assessed by a Likert scale</measure>
    <time_frame>Within 2 weeks of the study visit</time_frame>
    <description>Satisfaction with telemedicine visit for patient will be assessed with Likert-scale questions related to satisfaction.&#xD;
Satisfaction (1=strongly disagree to 5=strongly agree).&#xD;
In general, I was satisfied with using a video or phone call for this visit&#xD;
I could explain my medical problems well enough&#xD;
Talking to the doctor was as satisfying as talking in person&#xD;
Overall score 3 to 15 with higher scores signifying better satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with telemedicine visit for provider as assessed by a Likert scale</measure>
    <time_frame>Within 2 weeks of the study visit</time_frame>
    <description>Satisfaction with telemedicine visit for provider will be assessed with Likert-scale questions related to satisfaction.&#xD;
[1=Strongly Disagree. 5=Strongly Agree].&#xD;
In general, I was satisfied with using telemedicine for this visit&#xD;
Talking to the patient was as satisfying as talking in person.&#xD;
Overall score 2 to 10 with higher scores signifying better satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of telemedicine visit for provider as assessed by a Likert scale</measure>
    <time_frame>Within 2 weeks of the study visit</time_frame>
    <description>Efficacy of telemedicine visit for provider will be assessed with Likert-scale questions related to efficacy.&#xD;
[1=Strongly Disagree. 5=Strongly Agree]. b. I was able to understand the patient's explanation of their medical problems well enough.&#xD;
c. In general, this telemedicine visit was effective in improving this patient's medical care d. An in-person visit would likely have provided additional clinically-relevant information e. An in-person visit would likely have led to a change in management</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Provider communication as assessed by yes/no question</measure>
    <time_frame>Within 2 weeks of the study visit</time_frame>
    <description>The ability of a provider to communicate will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire related to communication.&#xD;
Did this provider explain things in a way that was easy to understand? Yes/No</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Provider listening as assessed by yes/no question</measure>
    <time_frame>Within 2 weeks of the study visit</time_frame>
    <description>Provider listening will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire related to listening.&#xD;
Did this provider listen carefully to you? Yes/No</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Provider respect as assessed by yes/no question</measure>
    <time_frame>Within 2 weeks of the study visit</time_frame>
    <description>Provider respect will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire relating to respect.&#xD;
Did this provider show respect for what you had to say? Yes/No</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Provider time spent as assessed by yes/no question</measure>
    <time_frame>Within 2 weeks of the study visit</time_frame>
    <description>Provider time spent will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire relating to time spent during the clinical encounter.&#xD;
Did this provider spend enough time with you? Yes/No</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient health rating as assessed by a likert scale</measure>
    <time_frame>Within 2 weeks of the study visit</time_frame>
    <description>Patient health will be assessed with Likert-scale questions related to patient health.&#xD;
In general, how would you rate your overall health?&#xD;
Excellent&#xD;
Very good&#xD;
Good&#xD;
Fair&#xD;
Poor&#xD;
In general, how would you rate your overall mental or emotional health?&#xD;
Excellent&#xD;
Very good&#xD;
Good&#xD;
Fair&#xD;
Poor&#xD;
Overall score 2 to 10 with lower scores signifying better health.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Telemedicine</condition>
  <arm_group>
    <arm_group_label>Telemedicine - Phone</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will continue with their telephone-based telemedicine visit as scheduled. There will be no change to their care. Patients will receive a survey by mail about the visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telemedicine - Audio/Video</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be given an internet-connected tablet to have their upcoming visit with their physician by audio/video. A survey can be completed on the tablet. The devices will be sent back to the research time after their single use.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Internet-connected computer tablet</intervention_name>
    <description>An internet-connected tablet provided to patient for upcoming visit with physician by audio/video which can also be used to complete a survey.</description>
    <arm_group_label>Telemedicine - Audio/Video</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients scheduled for telephone-based visits who are doing so because of a lack&#xD;
             of ability to conduct a video visit (i.e. no tablet/laptop; no access to internet) who&#xD;
             live in Baltimore City&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with significant visual or hearing impairment&#xD;
&#xD;
          -  Patients that have legal guardians or who are marked as lacking healthcare&#xD;
             decision-making capacity&#xD;
&#xD;
          -  Patients that have not selected English as their preferred language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeremy A Epstein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Casey Overby Taylor, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Outpatient Center</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>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>February 8, 2022</last_update_submitted>
  <last_update_submitted_qc>February 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>telemedicine</keyword>
  <keyword>audio/video</keyword>
  <keyword>telephone</keyword>
  <keyword>primary care</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Protocol and analysis plan, without any protected health information (PHI), can be shared on request via email.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
  </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/NCT04496713
org study id: IRB00257994
nct id: NCT04496713
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The inability to access and use smartphones or camera-outfitted internet-connected devices
      during the COVID-19 pandemic relegates certain patients to receive audio-only telemedicine
      instead of audio/video-based telemedicine. The investigators are conducting a randomized
      controlled trial in order to characterize patient and provider attitudes towards these two
      modalities of care and to test the feasibility of a new model to make tablets for video-based
      care accessible to those who need that. The investigators hypothesize that patient and
      provider satisfaction will be higher with video-based telehealth when compared to phone-based
      telehealth.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Provider rating as assessed by the Consumer Assessment of Healthcare Providers and Systems question on provider rating
time frame: Within 2 weeks of the study visit
description: Provider rating will be assessed with the Consumer Assessment of Healthcare Providers and Systems question on provider rating of 0-10; 0 being worst provider possible and 10 being best provider possible.
measure: Satisfaction with telemedicine visit for patient as assessed by a Likert scale
time frame: Within 2 weeks of the study visit
description: Satisfaction with telemedicine visit for patient will be assessed with Likert-scale questions related to satisfaction.
Satisfaction (1=strongly disagree to 5=strongly agree).
In general, I was satisfied with using a video or phone call for this visit
I could explain my medical problems well enough
Talking to the doctor was as satisfying as talking in person
Overall score 3 to 15 with higher scores signifying better satisfaction.
measure: Satisfaction with telemedicine visit for provider as assessed by a Likert scale
time frame: Within 2 weeks of the study visit
description: Satisfaction with telemedicine visit for provider will be assessed with Likert-scale questions related to satisfaction.
[1=Strongly Disagree. 5=Strongly Agree].
In general, I was satisfied with using telemedicine for this visit
Talking to the patient was as satisfying as talking in person.
Overall score 2 to 10 with higher scores signifying better satisfaction.
measure: Efficacy of telemedicine visit for provider as assessed by a Likert scale
time frame: Within 2 weeks of the study visit
description: Efficacy of telemedicine visit for provider will be assessed with Likert-scale questions related to efficacy.
[1=Strongly Disagree. 5=Strongly Agree]. b. I was able to understand the patient's explanation of their medical problems well enough.
c. In general, this telemedicine visit was effective in improving this patient's medical care d. An in-person visit would likely have provided additional clinically-relevant information e. An in-person visit would likely have led to a change in management
measure: Provider communication as assessed by yes/no question
time frame: Within 2 weeks of the study visit
description: The ability of a provider to communicate will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire related to communication.
Did this provider explain things in a way that was easy to understand? Yes/No
measure: Provider listening as assessed by yes/no question
time frame: Within 2 weeks of the study visit
description: Provider listening will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire related to listening.
Did this provider listen carefully to you? Yes/No
measure: Provider respect as assessed by yes/no question
time frame: Within 2 weeks of the study visit
description: Provider respect will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire relating to respect.
Did this provider show respect for what you had to say? Yes/No
measure: Provider time spent as assessed by yes/no question
time frame: Within 2 weeks of the study visit
description: Provider time spent will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire relating to time spent during the clinical encounter.
Did this provider spend enough time with you? Yes/No
measure: Patient health rating as assessed by a likert scale
time frame: Within 2 weeks of the study visit
description: Patient health will be assessed with Likert-scale questions related to patient health.
In general, how would you rate your overall health?
Excellent
Very good
Good
Fair
Poor
In general, how would you rate your overall mental or emotional health?
Excellent
Very good
Good
Fair
Poor
Overall score 2 to 10 with lower scores signifying better health.
arm group label: Telemedicine - Phone
arm group type: No Intervention
description: Patients will continue with their telephone-based telemedicine visit as scheduled. There will be no change to their care. Patients will receive a survey by mail about the visit.
arm group label: Telemedicine - Audio/Video
arm group type: Experimental
description: Patients will be given an internet-connected tablet to have their upcoming visit with their physician by audio/video. A survey can be completed on the tablet. The devices will be sent back to the research time after their single use.
intervention type: Other
intervention name: Internet-connected computer tablet
description: An internet-connected tablet provided to patient for upcoming visit with physician by audio/video which can also be used to complete a survey.
arm group label: Telemedicine - Audio/Video
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeremy A Epstein, MD
role: Principal Investigator
affiliation: Johns Hopkins University
last name: Casey Overby Taylor, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Protocol and analysis plan, without any protected health information (PHI), can be shared on request via email.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)