<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/NCT03241589</url>
  </required_header>
  <id_info>
    <org_study_id>SDR 16-192</org_study_id>
    <nct_id>NCT03241589</nct_id>
  </id_info>
  <brief_title>Teledermatology Mobile App: Patient Facing</brief_title>
  <official_title>Teledermatology Mobile Apps: Implementation and Impact on Veterans' Access to Dermatology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>US Department of Veterans Affairs Center for Healthcare Organization &amp; Implementation Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Durham VA Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>VA Office of Research and Development</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was designed to measure the impact of two teledermatology apps to provide direct&#xD;
      to patient teledermatology follow up care, Patient Viewer and My VA Images, with a trial on&#xD;
      access to dermatology care. The overall hypothesis was that sites implementing Department of&#xD;
      Veterans Affairs' (VA) teledermatology mobile apps would significantly augment the use of&#xD;
      teledermatology and improve Veterans' access to skin care relative to control sites.&#xD;
      Specifically, the investigators hypothesized that these apps would improve established&#xD;
      patients' ability to follow-up with dermatology care remotely, reducing patient travel to&#xD;
      dermatology clinics while opening up dermatology clinic space for other patients. Due to a&#xD;
      lack of participation by sites during the study which was conducted during the novel&#xD;
      coronavirus (COVID-19) pandemic, the groups examined are Veterans who live in rural areas&#xD;
      compared to those in urban areas.&#xD;
&#xD;
      Previously the study included a parallel trial to evaluate another teledermatology mobile&#xD;
      app, VA Telederm. This trial was no longer feasible within this study's funding timeline due&#xD;
      to limitations imposed on the mobile app by Office of Information &amp; Technology that were not&#xD;
      under the control of the PI or the operational partner, Office of Connected Care (OCC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Access to healthcare is a key priority for the Department of Veterans Affairs (VA). The&#xD;
      current practice of teledermatology in VA is effective but has not been uniformly&#xD;
      implemented. Once patients establish care in a dermatology clinic, they often need follow-up&#xD;
      visits to evaluate responses to treatment and to adjust management, neither of which&#xD;
      necessarily requires a face-to-face visit. To improve clinic access to in-person dermatology&#xD;
      clinics, VA Office of Connected Care developed a patient-facing mobile app, My VA Images, to&#xD;
      be used in conjunction with the clinician-facing Patient Viewer app, to allow established&#xD;
      dermatology clinic patients to follow-up remotely by submitting digital skin images and&#xD;
      interval history. The mobile apps were planned for wide-spread implementation in the VA. The&#xD;
      investigators conducted a trial of database review to understand how these two apps affected&#xD;
      features of dermatology care, specifically related to access to care.&#xD;
&#xD;
      The apps were made available over a 1 year and 4 month period in a cluster randomized,&#xD;
      stepped-wedge design to Veterans Health Administration (VHA) facilities. The&#xD;
      direct-to-patient facing apps were distributed to 31 facilities with dermatology clinics that&#xD;
      had recent relatively high teledermatology activity and thus already had relatively mature&#xD;
      teledermatology programs ready for advanced operations.&#xD;
&#xD;
      By using a stop code unique to this process, the investigators planned to use the VA&#xD;
      Corporate Data Warehouse (CDW) to measure effectiveness of the apps on all outcomes&#xD;
      reflecting dermatology access. Due to an unexpectedly small sample size resulting from poor&#xD;
      adoption of the intervention, in part during the COVID-19 pandemic, analysis using the&#xD;
      cluster-randomized stepped wedge design evaluation was not warranted. Instead, we focused on&#xD;
      understanding factors associated with successful completion of consults with the mobile apps,&#xD;
      examining differences between rural and urban Veteran users. The results are of significance&#xD;
      to VA as it develops and implements other mobile telehealth programs, and more generally to&#xD;
      other healthcare organizations planning for large-scale telehealth interventions.&#xD;
&#xD;
      The planned study originally also included a parallel trial to evaluate another&#xD;
      teledermatology mobile app, VA Telederm, designed to facilitate adoption of consultative&#xD;
      teledermatology and enhance overall access to dermatology opinion in VA. Unforeseen changes&#xD;
      in the app hosting environment imposed by VA Office of Information and Technology early in&#xD;
      the study and not under the control of the PI or the operational partner, Office of Connected&#xD;
      Care (OCC), rendered the app non-functional, and the trial was no longer feasible within this&#xD;
      study's funding timeline were not under the control of the PI or the operational partner,&#xD;
      Office of Connected Care (OCC). Organizational readiness for change for the VA Telederm app&#xD;
      was measured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 13, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Total Number of Participants That Successfully Completed Remote Follow up</measure>
    <time_frame>1 year 4 months</time_frame>
    <description>Whether patient had a successful completion of a remote follow-up visit during the study period, which included 1 year and 4 months. The time frame of the follow up varied as clinically appropriate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Number of Participants Who Ever Completed Remote Follow-up Requests</measure>
    <time_frame>1 year 4 months</time_frame>
    <description>Ever completed is defined as those who at first experienced an expired request or no show but eventually completed the request, after subsequent requests were submitted for the same problem. The time frame for the follow-up of each patient was clinically appropriate determined by the dermatologist and thus varied. The collection of whether or not the follow up of patients were ever completed took place over the study period of 1 year and 4 months.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">466</enrollment>
  <condition>Introduction of Teledermatology Mobile Apps</condition>
  <arm_group>
    <arm_group_label>Rural Veterans</arm_group_label>
    <description>Originally the aim was to include VA sites who received the direct to patient facing app from OCC. Due to a lack of enrollment, the first arm or group has been redefined as Veterans living in rural areas receiving a request to use the patient facing app.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nonrural Veterans</arm_group_label>
    <description>Originally the comparison group consisted of VA sites to eventually receive the direct to patient facing apps. Since our enrollment at the facility level was low, this arm now consists of Veterans receiving a request to use the patient facing app, living in nonrural areas.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Direct to patient facing mobile apps introduction</intervention_name>
    <description>VA employees and Veterans begin use of OCC's direct to patient facing mobile app.</description>
    <arm_group_label>Nonrural Veterans</arm_group_label>
    <arm_group_label>Rural Veterans</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients at sites in study who received consultative teledermatology requests via My VA&#xD;
        Images.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The inclusion criterion for the trial with direct to patient facing apps was that a&#xD;
             site had greater than or equal to 9% of all Fiscal Year (FY) 2018 dermatology&#xD;
             encounters under secondary stop codes 695/696.&#xD;
&#xD;
          -  This indicated considerable pre-existing experience with consultative teledermatology&#xD;
             and the likely presence of dermatology reader and support personnel needed to&#xD;
             implement direct to patient facing apps.&#xD;
&#xD;
          -  The investigators identified 31 sites eligible for direct to patient facing apps.&#xD;
&#xD;
          -  We followed above criteria but due to low enrollment, an additional criteria was added&#xD;
             that patients were included if they received a request to use the patient-facing&#xD;
             mobile app.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  VA medical centers with no 695/696 stop code activity in FY2018 or with zero full-time&#xD;
             equivalent dermatologists were excluded since these sites likely lacked the expertise,&#xD;
             support, and infrastructure to feasibly adopt teledermatology during the study period.&#xD;
&#xD;
          -  The investigators also excluded sites outside the continental U.S., and sites without&#xD;
             a dermatology clinic.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dennis H. Oh, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Francisco VA Medical Center, San Francisco, CA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>San Francisco VA Medical Center, San Francisco, CA</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94121-1563</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Durham VA Medical Center, Durham, NC</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705-3875</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence VA Medical Center, Providence, RI</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02908-4734</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Peracca SB, Jackson GL, Jackson MA, Oh DH. Implementation of Teledermatology: Theory and Practice. Current Dermatology Reports. 2019 Jun 1; 8(2):35-45.</citation>
  </reference>
  <results_reference>
    <citation>Done N, Oh DH, Weinstock MA, Whited JD, Jackson GL, King HA, Peracca SB, Elwy AR, Prentice JC. VA Telederm study: protocol for a stepped-wedge cluster randomised trial to compare access to care for a mobile app versus a workstation-based store-and-forward teledermatology process. BMJ Open. 2018 Dec 14;8(12):e022218. doi: 10.1136/bmjopen-2018-022218.</citation>
    <PMID>30552249</PMID>
  </results_reference>
  <results_reference>
    <citation>Fonseca A, Peracca SB, Lachica O, Morris I, King H, Jackson G, Whited J, Oh DH, Weinstock MA. 379 Implementing a teledermatology patient-facing mobile application in the VA. [Abstract]. The Journal of Investigative Dermatology. 2020 Jul 1; 140(7):S48.</citation>
  </results_reference>
  <results_reference>
    <citation>Peracca S, Fonseca A, Grenga A, Jackson G, King H, Chapman J, Whited J, Weinstock M, Oh DH. 411 Implementation of a consultative teledermatology mobile application in Veterans Affairs. [Abstract]. The Journal of Investigative Dermatology. 2020 Jul 1; 140(7):S53.</citation>
  </results_reference>
  <results_reference>
    <citation>Peracca SB, Fonseca A, Hines A, King HA, Grenga AM, Jackson GL, Whited JD, Chapman JG, Lamkin R, Mohr DC, Gifford A, Weinstock MA, Oh DH. Implementation of Mobile Teledermatology: Challenges and Opportunities. Telemed J E Health. 2021 Dec;27(12):1416-1422. doi: 10.1089/tmj.2020.0500. Epub 2021 Mar 1.</citation>
    <PMID>33691074</PMID>
  </results_reference>
  <results_reference>
    <citation>Lewinski AA, Crowley MJ, Miller C, Bosworth HB, Jackson GL, Steinhauser K, White-Clark C, McCant F, Zullig LL. Applied Rapid Qualitative Analysis to Develop a Contextually Appropriate Intervention and Increase the Likelihood of Uptake. Med Care. 2021 Jun 1;59(Suppl 3):S242-S251. doi: 10.1097/MLR.0000000000001553.</citation>
    <PMID>33976073</PMID>
  </results_reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <results_first_submitted>October 14, 2021</results_first_submitted>
  <results_first_submitted_qc>December 6, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 18, 2022</results_first_posted>
  <last_update_submitted>July 19, 2023</last_update_submitted>
  <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Teledermatology</keyword>
  <keyword>Telehealth</keyword>
  <keyword>Dermatology</keyword>
  <keyword>Telemedicine</keyword>
  <keyword>Mobile Application</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 12, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT03241589/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Rural Veterans</title>
          <description>Originally the aim was to include VA sites who received the direct to patient facing app from Office of Connected Care (OCC). Due to a lack of enrollment, the first arm or group has been redefined as Veterans living in rural areas.&#xD;
Direct to patient facing mobile apps introduction: VA employees and Veterans begin use of OCC's direct to patient facing mobile app. The two arms occur simultaneously.</description>
        </group>
        <group group_id="P2">
          <title>Nonrural Veterans</title>
          <description>Originally VA sites to eventually receive the direct to patient facing apps but at present had not were in the second arm or control group. Since our enrollment at the facility level was low, this arm now consists of Veterans living in nonrural areas.&#xD;
Direct to patient facing mobile apps introduction: VA employees and Veterans begin use of OCC's direct to patient facing mobile app. The two arms occur simultaneously.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="109"/>
                <participants group_id="P2" count="357"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="109"/>
                <participants group_id="P2" count="357"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline population is all Veteran patients who were given the opportunity to use the My VA Images app.</population>
      <group_list>
        <group group_id="B1">
          <title>Rural Veterans</title>
          <description>Originally the aim was to include VA sites who received the direct to patient facing app from OCC. Due to a lack of enrollment, the first arm or group has been redefined as Veterans living in rural areas.&#xD;
Direct to patient facing mobile apps introduction: VA employees and Veterans begin use of OCC's direct to patient facing mobile app. The two arms occur simultaneously.</description>
        </group>
        <group group_id="B2">
          <title>Nonrural Veterans</title>
          <description>Originally VA sites to eventually receive the direct to patient facing apps but at present had not were in the second arm or control group. Since our enrollment at the facility level was low, this arm now consists of Veterans living in nonrural areas.&#xD;
Direct to patient facing mobile apps introduction: VA employees and Veterans begin use of OCC's direct to patient facing mobile app. The two arms occur simultaneously.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="109"/>
            <count group_id="B2" value="357"/>
            <count group_id="B3" value="466"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="189"/>
                    <measurement group_id="B3" value="222"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="168"/>
                    <measurement group_id="B3" value="244"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.31" spread="12.10"/>
                    <measurement group_id="B2" value="61.54" spread="14.83"/>
                    <measurement group_id="B3" value="62.89" spread="14.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="99"/>
                    <measurement group_id="B2" value="296"/>
                    <measurement group_id="B3" value="395"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="103"/>
                    <measurement group_id="B2" value="332"/>
                    <measurement group_id="B3" value="435"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="109"/>
                    <measurement group_id="B2" value="357"/>
                    <measurement group_id="B3" value="466"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Number of Participants That Successfully Completed Remote Follow up</title>
        <description>Whether patient had a successful completion of a remote follow-up visit during the study period, which included 1 year and 4 months. The time frame of the follow up varied as clinically appropriate.</description>
        <time_frame>1 year 4 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Rural Veterans</title>
            <description>Originally the aim was to include VA sites who received the direct to patient facing app from OCC. Due to a lack of enrollment, the first arm or group has been redefined as Veterans with living in rural areas.&#xD;
Direct to patient facing mobile apps introduction: VA employees and Veterans begin use of OCC's direct to patient facing mobile app.</description>
          </group>
          <group group_id="O2">
            <title>Nonrural Veterans</title>
            <description>Originally VA sites to eventually receive the direct to patient facing apps but at present had not were in the second arm or control group. Since our enrollment at the facility level was low, this arm now consists of Veterans living in nonrural areas.&#xD;
Direct to patient facing mobile apps introduction: VA employees and Veterans begin use of OCC's direct to patient facing mobile app.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of Participants That Successfully Completed Remote Follow up</title>
          <description>Whether patient had a successful completion of a remote follow-up visit during the study period, which included 1 year and 4 months. The time frame of the follow up varied as clinically appropriate.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="357"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="182"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>We followed power calculations described in uploaded protocol document, using an incomplete design matrix with a 3-month transition period, a level of precision α=0.05 and a minimum power level of 0.80. We also assumed a total number of clusters I=36 as per the study design and the number of baseline measurements B=2. Due to insufficient sample size, we modified groups studied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7428</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.931</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.606</ci_lower_limit>
            <ci_upper_limit>1.429</ci_upper_limit>
            <estimate_desc>Referent group is Urban</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Number of Participants Who Ever Completed Remote Follow-up Requests</title>
        <description>Ever completed is defined as those who at first experienced an expired request or no show but eventually completed the request, after subsequent requests were submitted for the same problem. The time frame for the follow-up of each patient was clinically appropriate determined by the dermatologist and thus varied. The collection of whether or not the follow up of patients were ever completed took place over the study period of 1 year and 4 months.</description>
        <time_frame>1 year 4 months</time_frame>
        <population>Users of a direct-to-patient facing mobile app at participating sites.</population>
        <group_list>
          <group group_id="O1">
            <title>Rural Veterans</title>
            <description>The first group is defined as Veterans living in rural areas receiving a request to use the patient facing app.</description>
          </group>
          <group group_id="O2">
            <title>Nonrural Veterans</title>
            <description>This group consists of Veterans receiving a request to use the patient facing app, living in nonrural areas.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of Participants Who Ever Completed Remote Follow-up Requests</title>
          <description>Ever completed is defined as those who at first experienced an expired request or no show but eventually completed the request, after subsequent requests were submitted for the same problem. The time frame for the follow-up of each patient was clinically appropriate determined by the dermatologist and thus varied. The collection of whether or not the follow up of patients were ever completed took place over the study period of 1 year and 4 months.</description>
          <population>Users of a direct-to-patient facing mobile app at participating sites.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="357"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0031</p_value>
            <method>Regression, Logistic</method>
            <method_desc>2 degrees of freedom, Wald Chi-Square 11.5759</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.258</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.181</ci_lower_limit>
            <ci_upper_limit>4.315</ci_upper_limit>
            <estimate_desc>Veterans with expired requests = referent.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>5/13/2019-9/30/2020 1 1/2 years, over the entire study period. The study did not intervene in clinical practice but reviewed the data administratively. Adverse events for specific patients were reviewed operationally by appropriate clinical staff, the study reviewed if any adverse events took place over the course of the study.</time_frame>
      <desc>All-cause mortality was not monitored and thus data are not available.</desc>
      <group_list>
        <group group_id="E1">
          <title>Rural Veterans</title>
          <description>Rural Veterans use of OCC's direct to patient facing mobile app.&#xD;
Originally the aim was to include VA sites who received the direct to patient facing app from OCC. Due to a lack of enrollment, the first arm or group has been redefined as Veterans living in rural areas.</description>
        </group>
        <group group_id="E2">
          <title>Nonrural Veterans</title>
          <description>Nonrural Veterans use of OCC's direct to patient facing mobile app.&#xD;
Originally VA sites to eventually receive the direct to patient facing apps but at present had not were in the second arm or control group. Since our enrollment at the facility level was low, this arm now consists of Veterans living in nonrural areas.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="357"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="357"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Due to an unexpectedly small sample size resulting from poor adoption of the intervention by sites during the study, which was in part conducted during the novel coronavirus (COVID-19) pandemic, we were not able to follow the original cluster-randomized stepped wedge analysis plan.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Sara Peracca</name_or_title>
      <organization>VHA</organization>
      <phone>415-750-2091</phone>
      <email>sara.peracca@va.gov</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03241589
org study id: SDR 16-192
nct id: NCT03241589
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study was designed to measure the impact of two teledermatology apps to provide direct
      to patient teledermatology follow up care, Patient Viewer and My VA Images, with a trial on
      access to dermatology care. The overall hypothesis was that sites implementing Department of
      Veterans Affairs' (VA) teledermatology mobile apps would significantly augment the use of
      teledermatology and improve Veterans' access to skin care relative to control sites.
      Specifically, the investigators hypothesized that these apps would improve established
      patients' ability to follow-up with dermatology care remotely, reducing patient travel to
      dermatology clinics while opening up dermatology clinic space for other patients. Due to a
      lack of participation by sites during the study which was conducted during the novel
      coronavirus (COVID-19) pandemic, the groups examined are Veterans who live in rural areas
      compared to those in urban areas.

      Previously the study included a parallel trial to evaluate another teledermatology mobile
      app, VA Telederm. This trial was no longer feasible within this study's funding timeline due
      to limitations imposed on the mobile app by Office of Information & Technology that were not
      under the control of the PI or the operational partner, Office of Connected Care (OCC).
Access to healthcare is a key priority for the Department of Veterans Affairs (VA). The
      current practice of teledermatology in VA is effective but has not been uniformly
      implemented. Once patients establish care in a dermatology clinic, they often need follow-up
      visits to evaluate responses to treatment and to adjust management, neither of which
      necessarily requires a face-to-face visit. To improve clinic access to in-person dermatology
      clinics, VA Office of Connected Care developed a patient-facing mobile app, My VA Images, to
      be used in conjunction with the clinician-facing Patient Viewer app, to allow established
      dermatology clinic patients to follow-up remotely by submitting digital skin images and
      interval history. The mobile apps were planned for wide-spread implementation in the VA. The
      investigators conducted a trial of database review to understand how these two apps affected
      features of dermatology care, specifically related to access to care.

      The apps were made available over a 1 year and 4 month period in a cluster randomized,
      stepped-wedge design to Veterans Health Administration (VHA) facilities. The
      direct-to-patient facing apps were distributed to 31 facilities with dermatology clinics that
      had recent relatively high teledermatology activity and thus already had relatively mature
      teledermatology programs ready for advanced operations.

      By using a stop code unique to this process, the investigators planned to use the VA
      Corporate Data Warehouse (CDW) to measure effectiveness of the apps on all outcomes
      reflecting dermatology access. Due to an unexpectedly small sample size resulting from poor
      adoption of the intervention, in part during the COVID-19 pandemic, analysis using the
      cluster-randomized stepped wedge design evaluation was not warranted. Instead, we focused on
      understanding factors associated with successful completion of consults with the mobile apps,
      examining differences between rural and urban Veteran users. The results are of significance
      to VA as it develops and implements other mobile telehealth programs, and more generally to
      other healthcare organizations planning for large-scale telehealth interventions.

      The planned study originally also included a parallel trial to evaluate another
      teledermatology mobile app, VA Telederm, designed to facilitate adoption of consultative
      teledermatology and enhance overall access to dermatology opinion in VA. Unforeseen changes
      in the app hosting environment imposed by VA Office of Information and Technology early in
      the study and not under the control of the PI or the operational partner, Office of Connected
      Care (OCC), rendered the app non-functional, and the trial was no longer feasible within this
      study's funding timeline were not under the control of the PI or the operational partner,
      Office of Connected Care (OCC). Organizational readiness for change for the VA Telederm app
      was measured.
observational model: Ecologic or Community
time perspective: Prospective
measure: Total Number of Participants That Successfully Completed Remote Follow up
time frame: 1 year 4 months
description: Whether patient had a successful completion of a remote follow-up visit during the study period, which included 1 year and 4 months. The time frame of the follow up varied as clinically appropriate.
measure: Total Number of Participants Who Ever Completed Remote Follow-up Requests
time frame: 1 year 4 months
description: Ever completed is defined as those who at first experienced an expired request or no show but eventually completed the request, after subsequent requests were submitted for the same problem. The time frame for the follow-up of each patient was clinically appropriate determined by the dermatologist and thus varied. The collection of whether or not the follow up of patients were ever completed took place over the study period of 1 year and 4 months.
arm group label: Rural Veterans
description: Originally the aim was to include VA sites who received the direct to patient facing app from OCC. Due to a lack of enrollment, the first arm or group has been redefined as Veterans living in rural areas receiving a request to use the patient facing app.
arm group label: Nonrural Veterans
description: Originally the comparison group consisted of VA sites to eventually receive the direct to patient facing apps. Since our enrollment at the facility level was low, this arm now consists of Veterans receiving a request to use the patient facing app, living in nonrural areas.
intervention type: Other
intervention name: Direct to patient facing mobile apps introduction
description: VA employees and Veterans begin use of OCC's direct to patient facing mobile app.
arm group label: Nonrural Veterans
arm group label: Rural Veterans
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dennis H. Oh, MD PhD
role: Principal Investigator
affiliation: San Francisco VA Medical Center, San Francisco, CA
facility: 
facility: 
facility: 
country: United States
citation: Peracca SB, Jackson GL, Jackson MA, Oh DH. Implementation of Teledermatology: Theory and Practice. Current Dermatology Reports. 2019 Jun 1; 8(2):35-45.
citation: Done N, Oh DH, Weinstock MA, Whited JD, Jackson GL, King HA, Peracca SB, Elwy AR, Prentice JC. VA Telederm study: protocol for a stepped-wedge cluster randomised trial to compare access to care for a mobile app versus a workstation-based store-and-forward teledermatology process. BMJ Open. 2018 Dec 14;8(12):e022218. doi: 10.1136/bmjopen-2018-022218.
PMID: 30552249
citation: Fonseca A, Peracca SB, Lachica O, Morris I, King H, Jackson G, Whited J, Oh DH, Weinstock MA. 379 Implementing a teledermatology patient-facing mobile application in the VA. [Abstract]. The Journal of Investigative Dermatology. 2020 Jul 1; 140(7):S48.
citation: Peracca S, Fonseca A, Grenga A, Jackson G, King H, Chapman J, Whited J, Weinstock M, Oh DH. 411 Implementation of a consultative teledermatology mobile application in Veterans Affairs. [Abstract]. The Journal of Investigative Dermatology. 2020 Jul 1; 140(7):S53.
citation: Peracca SB, Fonseca A, Hines A, King HA, Grenga AM, Jackson GL, Whited JD, Chapman JG, Lamkin R, Mohr DC, Gifford A, Weinstock MA, Oh DH. Implementation of Mobile Teledermatology: Challenges and Opportunities. Telemed J E Health. 2021 Dec;27(12):1416-1422. doi: 10.1089/tmj.2020.0500. Epub 2021 Mar 1.
PMID: 33691074
citation: Lewinski AA, Crowley MJ, Miller C, Bosworth HB, Jackson GL, Steinhauser K, White-Clark C, McCant F, Zullig LL. Applied Rapid Qualitative Analysis to Develop a Contextually Appropriate Intervention and Increase the Likelihood of Uptake. Med Care. 2021 Jun 1;59(Suppl 3):S242-S251. doi: 10.1097/MLR.0000000000001553.
PMID: 33976073
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to an unexpectedly small sample size resulting from poor adoption of the intervention by sites during the study, which was in part conducted during the novel coronavirus (COVID-19) pandemic, we were not able to follow the original cluster-randomized stepped wedge analysis plan.
point of contact: 