<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/NCT03791697</url>
  </required_header>
  <id_info>
    <org_study_id>Telehealth Study</org_study_id>
    <nct_id>NCT03791697</nct_id>
  </id_info>
  <brief_title>Telehealth Postop Follow up RCT</brief_title>
  <official_title>Preferred Method of Postoperative Follow Up After Pelvic Reconstructive Surgery. (Phone Call Versus Clinic Visit): A Non-Inferiority Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jackson, Elisha</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of South Florida</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jackson, Elisha</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized controlled trial that will evaluate whether telephone two-week postoperative&#xD;
      follow up visits are an acceptable and safe alternative to traditional face-to-face-clinic&#xD;
      two-week postoperative visits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a two group, parallel randomized non-inferiority clinical trial at one institution&#xD;
      evaluating telephone postoperative visits as non-inferior in patient satisfaction, patient&#xD;
      preference, and patient safety, when compared with clinic postoperative visits. This protocol&#xD;
      was written in accordance with CONSORT (Consolidated Standards of Reporting Trials)&#xD;
      guidelines 2011.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 9, 2018</start_date>
  <completion_date type="Anticipated">July 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2019</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>Eligible patients will be randomized to Arm1 or Arm2 (Telephone follow up or clinic follow up). Permuted block randomization with randomly varying block sizes will be used. Generation of allocation sequences will be performed using a random-number table.&#xD;
The allocation sequence will be generated by our statistician who is neither responsible for patient recruitment or outcome assessment. Sequentially numbered opaque sealed envelopes will be used for concealment of treatment allocation.&#xD;
It is not possible to mask clinical staff or participants, as they will be aware of the follow-up care that is being delivered over the telephone or in clinic. As such this is not a blinded study.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Satisfaction (questionnaire)</measure>
    <time_frame>Survey will be provided at the six-week follow up visit.</time_frame>
    <description>Comparison of patient satisfaction as determined by completion of a non-validated, treatment non-specific satisfaction questionnaire between the two groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient safety (adverse events)</measure>
    <time_frame>Postoperative period up to 6 weeks</time_frame>
    <description>• Comparison of adverse events and Emergency Department (ED) visits between the two groups. Will be determined by reviewing the patient's record to identify adverse events as defined below</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time Spent (post op telephone follow up compared to clinic follow up [minutes])</measure>
    <time_frame>Calculated from time spent at the two week follow up visit</time_frame>
    <description>• Actual time spent on phone call during postoperative telephone follow up compared to time spent in clinic follow up measured in minutes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">142</enrollment>
  <condition>Patient Satisfaction</condition>
  <arm_group>
    <arm_group_label>Telephone Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patient randomized into the telephone follow up group, will be contacted, at the pre-scheduled date and time, by the urogynecology clinic nurse. The nurse will utilize a scripted series of postoperative questions, which are consistent with questions asked during our standard postoperative clinic visits.&#xD;
Vital signs and physical examination will be deferred for the patients in the telephone follow up group.&#xD;
Any patient responses that are not consistent with a usual postoperative course will be escalated to an in person visit. However, these patients will remain in the group, to which they were originally randomized, for research analysis purposes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>In Person Clinic Visit Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>For the patient randomized into the clinic group, the clinic visit will entail questions about common postoperative complications (including fever, nausea/vomiting, pain, urinary symptoms, constipation, etc.). As per usual, vital signs and a focused physical examination will be completed at the clinic visit. All clinic visits will be performed by an FPRMS fellow and/or attending physician</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Telehealth 2 week postoperative visit</intervention_name>
    <description>The patient randomized into the telephone follow up group, will be contacted, at the pre-scheduled date and time, by the urogynecology clinic nurse. The nurse will utilize a scripted series of postoperative questions, which are consistent with questions asked during our standard postoperative clinic visits.&#xD;
Vital signs and physical examination will be deferred for the patients in the telephone follow up group.&#xD;
Any patient responses that are not consistent with a usual postoperative course will be escalated to an in person visit. However, these patients will remain in the group, to which they were originally randomized, for research analysis purposes. (Intent to treat)</description>
    <arm_group_label>Telephone Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women &gt;18 desiring surgical management of prolapse or incontinence&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Willing and able to provide written and informed consent without assistance from&#xD;
             medical surrogate or interpreter&#xD;
&#xD;
          -  Immediate access to telephone services (landline, mobile phone, office phone)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women &lt;18&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Unwilling and unable to provide written and informed consent without assistance from&#xD;
             surrogate or interpreter&#xD;
&#xD;
          -  Hearing impairment&#xD;
&#xD;
          -  No access to telephone services (landline, mobile phone, office phone)&#xD;
&#xD;
          -  Grade 3 complication- a complication requiring surgical, endoscopic, or radiological&#xD;
             intervention. [3]&#xD;
&#xD;
          -  Patient who did not attend any postoperative follow up visit&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>Elisha J Jackson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of South Florida Morsani School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elisha J Jackson, MD</last_name>
    <phone>8166860222</phone>
    <email>elisha.jackson815@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Florida Health</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elisha Jackson, MD</last_name>
      <phone>816-686-0222</phone>
      <email>elisha.jackson815@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Renee Bassaly, DO</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 30, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>January 2, 2019</last_update_submitted>
  <last_update_submitted_qc>January 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jackson, Elisha</investigator_affiliation>
    <investigator_full_name>Elisha Jackson</investigator_full_name>
    <investigator_title>Physician-Fellow</investigator_title>
  </responsible_party>
  <keyword>Postoperative patient satisfaction</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>March 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT03791697/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03791697
org study id: Telehealth Study
nct id: NCT03791697
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A randomized controlled trial that will evaluate whether telephone two-week postoperative
      follow up visits are an acceptable and safe alternative to traditional face-to-face-clinic
      two-week postoperative visits.
This is a two group, parallel randomized non-inferiority clinical trial at one institution
      evaluating telephone postoperative visits as non-inferior in patient satisfaction, patient
      preference, and patient safety, when compared with clinic postoperative visits. This protocol
      was written in accordance with CONSORT (Consolidated Standards of Reporting Trials)
      guidelines 2011.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Eligible patients will be randomized to Arm1 or Arm2 (Telephone follow up or clinic follow up). Permuted block randomization with randomly varying block sizes will be used. Generation of allocation sequences will be performed using a random-number table.
The allocation sequence will be generated by our statistician who is neither responsible for patient recruitment or outcome assessment. Sequentially numbered opaque sealed envelopes will be used for concealment of treatment allocation.
It is not possible to mask clinical staff or participants, as they will be aware of the follow-up care that is being delivered over the telephone or in clinic. As such this is not a blinded study.
primary purpose: Other
masking: None (Open Label)
measure: Patient Satisfaction (questionnaire)
time frame: Survey will be provided at the six-week follow up visit.
description: Comparison of patient satisfaction as determined by completion of a non-validated, treatment non-specific satisfaction questionnaire between the two groups.
measure: Patient safety (adverse events)
time frame: Postoperative period up to 6 weeks
description: • Comparison of adverse events and Emergency Department (ED) visits between the two groups. Will be determined by reviewing the patient's record to identify adverse events as defined below
measure: Time Spent (post op telephone follow up compared to clinic follow up [minutes])
time frame: Calculated from time spent at the two week follow up visit
description: • Actual time spent on phone call during postoperative telephone follow up compared to time spent in clinic follow up measured in minutes.
arm group label: Telephone Group
arm group type: Active Comparator
description: The patient randomized into the telephone follow up group, will be contacted, at the pre-scheduled date and time, by the urogynecology clinic nurse. The nurse will utilize a scripted series of postoperative questions, which are consistent with questions asked during our standard postoperative clinic visits.
Vital signs and physical examination will be deferred for the patients in the telephone follow up group.
Any patient responses that are not consistent with a usual postoperative course will be escalated to an in person visit. However, these patients will remain in the group, to which they were originally randomized, for research analysis purposes.
arm group label: In Person Clinic Visit Group
arm group type: No Intervention
description: For the patient randomized into the clinic group, the clinic visit will entail questions about common postoperative complications (including fever, nausea/vomiting, pain, urinary symptoms, constipation, etc.). As per usual, vital signs and a focused physical examination will be completed at the clinic visit. All clinic visits will be performed by an FPRMS fellow and/or attending physician
intervention type: Other
intervention name: Telehealth 2 week postoperative visit
description: The patient randomized into the telephone follow up group, will be contacted, at the pre-scheduled date and time, by the urogynecology clinic nurse. The nurse will utilize a scripted series of postoperative questions, which are consistent with questions asked during our standard postoperative clinic visits.
Vital signs and physical examination will be deferred for the patients in the telephone follow up group.
Any patient responses that are not consistent with a usual postoperative course will be escalated to an in person visit. However, these patients will remain in the group, to which they were originally randomized, for research analysis purposes. (Intent to treat)
arm group label: Telephone Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Elisha J Jackson, MD
role: Principal Investigator
affiliation: University of South Florida Morsani School of Medicine
last name: Elisha J Jackson, MD
phone: 8166860222
email: elisha.jackson815@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Jackson, Elisha
investigator full name: Elisha Jackson
investigator title: Physician-Fellow
sharing ipd: No
provided document: 