<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/NCT02204605</url>
  </required_header>
  <id_info>
    <org_study_id>2014P000132</org_study_id>
    <nct_id>NCT02204605</nct_id>
  </id_info>
  <brief_title>Video-based Consensus Opinion for Hand and Upper Extremity Problems</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators would like to determine if there is a difference in patient satisfaction&#xD;
      among patients who have puzzling pain conditions and receive one evaluation from their&#xD;
      treating physician, and those that receive an evaluation from their treating physician and&#xD;
      from a group of consulting physicians by video. The investigators expect to enroll 128&#xD;
      patients at Massachusetts General Hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Before visiting a specialist, patients have assumptions regarding diagnosis, etiology,&#xD;
      prognosis, and preferred treatment for their condition. Naturally, some of these assumptions&#xD;
      may be inaccurate or incomplete or there may be room for debate and disagreement even among&#xD;
      specialists. We are looking for ways to make unexpected and indeterminate aspects of an&#xD;
      illness less unsettling for patients. When the hand surgeon's advice doesn't ring true, the&#xD;
      patient may lose confidence in that provider. Sometimes the interaction can feel&#xD;
      disrespectful and even adversarial. We are curious whether patient's satisfaction with&#xD;
      diagnosis, surgeon, and treatment plan would improve if they were able to get an opinion from&#xD;
      many surgeons at once. One feasible way to do that would be to show an edited and anonymized&#xD;
      video to a set of hand surgeons for their opinions on diagnosis and treatment.&#xD;
&#xD;
      Primary study question:&#xD;
&#xD;
        1. Among patients with initially puzzling pains, there is no difference in satisfaction&#xD;
           with diagnosis between patients that receive a video based consensus opinion and those&#xD;
           that receive routine care from a single hand surgeon controlling for psychological&#xD;
           factors, demographics, and initial and final diagnosis.&#xD;
&#xD;
           Secondary study questions:&#xD;
&#xD;
        2. Among patients with initially puzzling pains, there is no difference in pain intensity&#xD;
           and disability one month after the initial visit between patient that receive a&#xD;
           consensus diagnosis and those that receive routine care from a single surgeon.&#xD;
&#xD;
        3. There is no variation in diagnosis between observers (Observers are hand surgeons&#xD;
           viewing the visit video and consulting on the diagnosis).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The principal investigator left the institution.&#xD;
  </why_stopped>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Likert Scale for Satisfaction</measure>
    <time_frame>At enrollment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Likert Scale for Satisfaction</measure>
    <time_frame>4-6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Self-Efficacy Questionnaire (PSEQ-2)</measure>
    <time_frame>At enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Self-Efficacy Questionnaire (PSEQ-2)</measure>
    <time_frame>4-6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire (PHQ-2)</measure>
    <time_frame>at enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire (PHQ-2)</measure>
    <time_frame>4-6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QuickDASH (Disabilities of the Arm, Shoulder, and Hand)</measure>
    <time_frame>At enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QuickDASH (Disabilities of the Arm, Shoulder, and Hand)</measure>
    <time_frame>4-6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numerical Rating Scale for Pain</measure>
    <time_frame>at enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numerical Rating Scale for Pain</measure>
    <time_frame>4-6 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Visits are not videotaped</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Videoed Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will have their visit videotaped.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Video-based Consensus Opinion</intervention_name>
    <arm_group_label>Videoed Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients (&gt;18 years) presenting to Dr. David Ring with painful conditions that are&#xD;
             puzzling (A puzzling pain condition is defined as Dr. Ring being puzzled about what is&#xD;
             causing the pain. Subject eligibility based on this criterion will be determined by&#xD;
             Dr. Ring).&#xD;
&#xD;
          -  English fluency and literacy&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant Women&#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>David Ring, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>December 20, 2016</last_update_submitted>
  <last_update_submitted_qc>December 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>David C. Ring, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>patients</keyword>
  <keyword>puzzling</keyword>
  <keyword>conditions</keyword>
  <!-- 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/NCT02204605
org study id: 2014P000132
nct id: NCT02204605
lead sponsor: 
has dmc: No
The investigators would like to determine if there is a difference in patient satisfaction
      among patients who have puzzling pain conditions and receive one evaluation from their
      treating physician, and those that receive an evaluation from their treating physician and
      from a group of consulting physicians by video. The investigators expect to enroll 128
      patients at Massachusetts General Hospital.
Before visiting a specialist, patients have assumptions regarding diagnosis, etiology,
      prognosis, and preferred treatment for their condition. Naturally, some of these assumptions
      may be inaccurate or incomplete or there may be room for debate and disagreement even among
      specialists. We are looking for ways to make unexpected and indeterminate aspects of an
      illness less unsettling for patients. When the hand surgeon's advice doesn't ring true, the
      patient may lose confidence in that provider. Sometimes the interaction can feel
      disrespectful and even adversarial. We are curious whether patient's satisfaction with
      diagnosis, surgeon, and treatment plan would improve if they were able to get an opinion from
      many surgeons at once. One feasible way to do that would be to show an edited and anonymized
      video to a set of hand surgeons for their opinions on diagnosis and treatment.

      Primary study question:

        1. Among patients with initially puzzling pains, there is no difference in satisfaction
           with diagnosis between patients that receive a video based consensus opinion and those
           that receive routine care from a single hand surgeon controlling for psychological
           factors, demographics, and initial and final diagnosis.

           Secondary study questions:

        2. Among patients with initially puzzling pains, there is no difference in pain intensity
           and disability one month after the initial visit between patient that receive a
           consensus diagnosis and those that receive routine care from a single surgeon.

        3. There is no variation in diagnosis between observers (Observers are hand surgeons
           viewing the visit video and consulting on the diagnosis).
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Likert Scale for Satisfaction
time frame: At enrollment
measure: Likert Scale for Satisfaction
time frame: 4-6 weeks
measure: Patient Self-Efficacy Questionnaire (PSEQ-2)
time frame: At enrollment
measure: Patient Self-Efficacy Questionnaire (PSEQ-2)
time frame: 4-6 weeks
measure: Patient Health Questionnaire (PHQ-2)
time frame: at enrollment
measure: Patient Health Questionnaire (PHQ-2)
time frame: 4-6 weeks
measure: QuickDASH (Disabilities of the Arm, Shoulder, and Hand)
time frame: At enrollment
measure: QuickDASH (Disabilities of the Arm, Shoulder, and Hand)
time frame: 4-6 weeks
measure: Numerical Rating Scale for Pain
time frame: at enrollment
measure: Numerical Rating Scale for Pain
time frame: 4-6 weeks
arm group label: Control
arm group type: No Intervention
description: Visits are not videotaped
arm group label: Videoed Patients
arm group type: Experimental
description: Patients will have their visit videotaped.
intervention type: Behavioral
intervention name: Video-based Consensus Opinion
arm group label: Videoed Patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Ring, MD, PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: David C. Ring, MD
investigator title: Principal Investigator