<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/NCT03809468</url>
  </required_header>
  <id_info>
    <org_study_id>FLA 18-095</org_study_id>
    <nct_id>NCT03809468</nct_id>
  </id_info>
  <brief_title>Patient Satisfaction With Initial Phone Call Versus Office Visit Following Minimally Invasive Hysterectomy, a Randomized Controlled Trial.</brief_title>
  <official_title>Patient Satisfaction With Initial Phone Call Versus Office Visit Following Minimally Invasive Hysterectomy, a Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</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>
      Patients will be randomized to clinic or telephone follow up after outpatient TLH. surveys&#xD;
      will document patient satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized controlled trial looking at patient satisfaction with a 1-2 week&#xD;
      postoperative visit versus phone call after minimally invasive hysterectomy. Patients will be&#xD;
      screened, enrolled, consented, and randomized during the preoperative office encounter, which&#xD;
      usually takes place 30 days prior to their scheduled surgery. Patients randomized to the&#xD;
      study group (1-2 week postoperative phone call) will be given a time and date when to expect&#xD;
      the postoperative phone call. Patients randomized to the control arm will receive a standard&#xD;
      postoperative visit appointment 7-21 days after surgery. Patients in both arms will receive&#xD;
      postoperative discharge instructions advising when to contact our office and when to present&#xD;
      to the emergency room with certain complaints. The patients in the study arm will have&#xD;
      instructions reinforcing that they will be contacted with a postoperative phone call instead&#xD;
      of a visit initially; however, patients in both arms will have a postoperative visit 6-8&#xD;
      weeks following surgery.&#xD;
&#xD;
      After surgery, patients randomized to the study arm will receive the phone call at 7-14 days&#xD;
      post-op. The physician performing the phone call will be a minimally invasive gynecology&#xD;
      fellow in our practice. The provider will use a script to review all of the typical review of&#xD;
      systems and pertinent postoperative functioning questions typically reviewed and documented&#xD;
      in our postoperative visit. They will also review the surgical pathology at this time. This&#xD;
      conversation will be documented in our electronic medical record.&#xD;
&#xD;
      Patients randomized to the control arm will undergo typical office visit at 7-21 days postop.&#xD;
&#xD;
      Patients in both arms will have postoperative office visits at 6-8 weeks postop, and will&#xD;
      complete a survey at that time. The survey is a modified version of the SCAHPS survey to&#xD;
      assess patient satisfaction with the surgical experience. There will also be some questions&#xD;
      about the patients' attitudes towards the number and timing of postoperative visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2019</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</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>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>patient satisfaction</measure>
    <time_frame>6-8 weeks postop</time_frame>
    <description>patient satisfaction scores</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>phone calls and visits (unplanned)</measure>
    <time_frame>6-8 weeks postop</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Abnormal Uterine Bleeding</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Routine follow up of a clinic visit at 1-2 weeks postop, and 6-8 weeks postop.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>study</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>phone call follow up instead of clinic visit follow up at 1-2 weeks, followed by 6-8 week clinic follow up</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>phone call follow up</intervention_name>
    <description>instead of a clinic visit, patients will be randomized to a phone call</description>
    <arm_group_label>study</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women undergoing minimally invasive hysterectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients without adequate phone or transportation access&#xD;
&#xD;
          -  patients with concern for underlying malignancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>Pamela Frazzini Padilla</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cleveland Clinic Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic Florida</name>
      <address>
        <city>Weston</city>
        <state>Florida</state>
        <zip>33331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>October 28, 2020</last_update_submitted>
  <last_update_submitted_qc>October 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>patient satisfaction, hysterectomy, follow up</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Hemorrhage</mesh_term>
  </condition_browse>
  <!-- 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/NCT03809468
org study id: FLA 18-095
nct id: NCT03809468
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients will be randomized to clinic or telephone follow up after outpatient TLH. surveys
      will document patient satisfaction.
This is a randomized controlled trial looking at patient satisfaction with a 1-2 week
      postoperative visit versus phone call after minimally invasive hysterectomy. Patients will be
      screened, enrolled, consented, and randomized during the preoperative office encounter, which
      usually takes place 30 days prior to their scheduled surgery. Patients randomized to the
      study group (1-2 week postoperative phone call) will be given a time and date when to expect
      the postoperative phone call. Patients randomized to the control arm will receive a standard
      postoperative visit appointment 7-21 days after surgery. Patients in both arms will receive
      postoperative discharge instructions advising when to contact our office and when to present
      to the emergency room with certain complaints. The patients in the study arm will have
      instructions reinforcing that they will be contacted with a postoperative phone call instead
      of a visit initially; however, patients in both arms will have a postoperative visit 6-8
      weeks following surgery.

      After surgery, patients randomized to the study arm will receive the phone call at 7-14 days
      post-op. The physician performing the phone call will be a minimally invasive gynecology
      fellow in our practice. The provider will use a script to review all of the typical review of
      systems and pertinent postoperative functioning questions typically reviewed and documented
      in our postoperative visit. They will also review the surgical pathology at this time. This
      conversation will be documented in our electronic medical record.

      Patients randomized to the control arm will undergo typical office visit at 7-21 days postop.

      Patients in both arms will have postoperative office visits at 6-8 weeks postop, and will
      complete a survey at that time. The survey is a modified version of the SCAHPS survey to
      assess patient satisfaction with the surgical experience. There will also be some questions
      about the patients' attitudes towards the number and timing of postoperative visits.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: patient satisfaction
time frame: 6-8 weeks postop
description: patient satisfaction scores
measure: phone calls and visits (unplanned)
time frame: 6-8 weeks postop
arm group label: control
arm group type: No Intervention
description: Routine follow up of a clinic visit at 1-2 weeks postop, and 6-8 weeks postop.
arm group label: study
arm group type: Experimental
description: phone call follow up instead of clinic visit follow up at 1-2 weeks, followed by 6-8 week clinic follow up
intervention type: Other
intervention name: phone call follow up
description: instead of a clinic visit, patients will be randomized to a phone call
arm group label: study
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Pamela Frazzini Padilla
role: Principal Investigator
affiliation: Cleveland Clinic Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Uterine Hemorrhage