<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/NCT03836365</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY19010073</org_study_id>
    <nct_id>NCT03836365</nct_id>
  </id_info>
  <brief_title>Patient Preparedness for Pelvic Organ Prolapse Surgery</brief_title>
  <acronym>PREOP</acronym>
  <official_title>Patient Preparedness for Pelvic Organ Prolapse Surgery: A Randomized Controlled Trial of Preoperative Counseling</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Pittsburgh Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</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>
      Patient preparedness has been associated with increased patient satisfaction, decreased&#xD;
      postoperative pain and decreased postoperative narcotic use; however, little is known&#xD;
      regarding the optimal way to prepare patients prior to pelvic reconstructive surgery. The&#xD;
      primary aim of this study is to determine if a preoperative counseling in person visit has&#xD;
      similar rates of patient preparedness as a preoperative counseling phone call for women&#xD;
      undergoing same-day pelvic organ prolapse surgery. Secondary aims evaluate patient&#xD;
      satisfaction, postoperative pain scores and postoperative narcotic usage. Women who plan to&#xD;
      undergo pelvic organ prolapse surgery will be randomized to a preoperative in person&#xD;
      counseling visit or a preoperative counseling phone call. Participants will complete&#xD;
      questionnaires to assess their preparedness, satisfaction and postoperative pain. The goal of&#xD;
      this study is to gather information that will allow clinicians to improve patient surgical&#xD;
      preparedness and satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a randomized controlled trial to assess patient preparedness following a&#xD;
      preoperative counseling in person visit when compared to a preoperative counseling phone&#xD;
      call.&#xD;
&#xD;
      Recruitment &amp; Enrollment: Participants will be recruited and enrolled from the urogynecology&#xD;
      office during their surgical planning visit. The study will be introduced at this visit and&#xD;
      participants will have the opportunity to bring the consent home to review and consider their&#xD;
      participation prior to signing.&#xD;
&#xD;
      Randomization: Participants will be block randomized in a 1:1 ratio in block size of 2.&#xD;
      Randomization will be done by REDCap. The participant will not be blinded given the nature of&#xD;
      the intervention. Additionally, the attending surgeon, fellow and office staff (advanced&#xD;
      practice providers, research staff, medical assistants) will be aware of the randomization&#xD;
      group as they will be participating in the preoperative intervention or perioperative&#xD;
      clinical care.&#xD;
&#xD;
      Intervention: Both the preoperative counseling visit and preoperative phone call will contain&#xD;
      the same components of discussion and counseling which include surgical details, risks and&#xD;
      benefits, preoperative and postoperative instructions and expectations. The visit will take&#xD;
      place in the urogynecology office and the visits and phone calls will be done by either a&#xD;
      fellow or advanced practice provider, all of whom have extensive experience with the&#xD;
      standardized preoperative visit.&#xD;
&#xD;
      Follow up: A postoperative phone call will be completed either POD#1 or POD#2 to remind the&#xD;
      participant to complete their daily pain diary. Each participant will follow up for their&#xD;
      standard postoperative visit approximately 4-6 weeks postoperative. All patients routinely&#xD;
      receive a call on POD#1 from our nurses to assess how they are doing postoperatively. This&#xD;
      phone call will continue unchanged for all participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2, 2019</start_date>
  <completion_date type="Actual">May 1, 2020</completion_date>
  <primary_completion_date type="Actual">May 1, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient preparedness</measure>
    <time_frame>At postoperative visit (about 4-6 weeks after surgery)</time_frame>
    <description>The percent of patients reporting preparedness on Preoperative Preparedness Questionnaire. Participants who answer &quot;strongly agree&quot; or &quot;agree&quot; to the statement &quot;Overall, I felt prepared for my surgery&quot; will be considered prepared. This instrument is a 9-item questionnaire and scored on a 5-point Likert scale with answers ranging from &quot;5=strongly disagree&quot; to &quot;1=strongly agree&quot; with &quot;3=neutral.&quot; Therefore, scores of &quot;1=strongly agree&quot; or &quot;2=agree&quot; will be considered a positive answer for preparedness. It was adopted from a study by Kenton et al in 2007.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction: Decision Scale-Pelvic Floor Disorders questionnaire</measure>
    <time_frame>At postoperative visit (about 4-6 weeks after surgery)</time_frame>
    <description>The percent of patients reporting satisfaction on the Satisfaction with Decision Scale-Pelvic Floor Disorders questionnaire. This is a validated, 5-item questionnaire with answers on a 5-point likert scale with &quot;1=strongly agree,&quot; &quot;3=neutral&quot; and &quot;5=strongly disagree.&quot; Answers of &quot;1=strongly agree&quot; or &quot;2=agree&quot; to the statement &quot;I am satisfied with my decision&quot; will be considered satisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain scores</measure>
    <time_frame>Postoperative days #1-7</time_frame>
    <description>Postoperative pain scores on postoperative days #1-7 on a scale of 0-10. Participants will complete a daily pain diary which will assess their pain score with 0=no pain and 10=worst pain imaginable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative narcotic use</measure>
    <time_frame>Postoperative days #1-7</time_frame>
    <description>Postoperative narcotics used which will be assessed by the daily pain diary (question: &quot;How many narcotic pills did you use today?&quot; with the answer being the number of pills used that day).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <condition>Patient Preparedness</condition>
  <arm_group>
    <arm_group_label>Preoperative counseling office visit</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will present for an in-person preoperative counseling office visit (preoperative counseling session). This will occur within a few weeks of surgery. Preoperative counseling topics are standardized and will be identical with each arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Preoperative counseling phone call</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive a preoperative counseling phone call (preoperative counseling session). This will occur within a few weeks of surgery. Preoperative counseling topics are standardized and will be identical with each arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Preoperative counseling office visit</intervention_name>
    <description>All patients undergo a preoperative counseling session prior to surgery. Participants in this arm will have an in person preoperative counseling office visit.</description>
    <arm_group_label>Preoperative counseling office visit</arm_group_label>
    <other_name>Office</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Preoperative counseling phone call</intervention_name>
    <description>All patients undergo a preoperative counseling session prior to surgery. Participants in this arm will have a preoperative counseling phone call.</description>
    <arm_group_label>Preoperative counseling phone call</arm_group_label>
    <other_name>Call</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women planning to undergo same-day surgery to correct pelvic organ prolapse by the&#xD;
             University of Pittsburgh Division of Urogynecology. Women remain eligible if they are&#xD;
             admitted for observation following their surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking patients&#xD;
&#xD;
          -  A preoperative exam requirement that would necessitate an in person office visit (i.e.&#xD;
             need for pessary removal, self-catheterization teaching)&#xD;
&#xD;
          -  Plan for concomitant surgical management with gynecology oncology or colorectal&#xD;
             surgery&#xD;
&#xD;
          -  Residence in a nursing home&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jessica Sassani</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Magee-Womens' Hospital of UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Holmes-Rovner M, Kroll J, Schmitt N, Rovner DR, Breer ML, Rothert ML, Padonu G, Talarczyk G. Patient satisfaction with health care decisions: the satisfaction with decision scale. Med Decis Making. 1996 Jan-Mar;16(1):58-64. doi: 10.1177/0272989X9601600114.</citation>
    <PMID>8717600</PMID>
  </reference>
  <reference>
    <citation>Sung VW, Kauffman N, Raker CA, Myers DL, Clark MA. Validation of decision-making outcomes for female pelvic floor disorders. Am J Obstet Gynecol. 2008 May;198(5):575.e1-6. doi: 10.1016/j.ajog.2007.12.035. Epub 2008 Mar 7.</citation>
    <PMID>18313632</PMID>
  </reference>
  <results_reference>
    <citation>Kenton K, Pham T, Mueller E, Brubaker L. Patient preparedness: an important predictor of surgical outcome. Am J Obstet Gynecol. 2007 Dec;197(6):654.e1-6. doi: 10.1016/j.ajog.2007.08.059.</citation>
    <PMID>18060968</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Jessica Sassani</investigator_full_name>
    <investigator_title>Fellow, Division of Female Pelvic Medicine &amp; Reconstructive Surgery</investigator_title>
  </responsible_party>
  <keyword>Pelvic organ prolapse</keyword>
  <keyword>Patient preparedness</keyword>
  <keyword>Randomized controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to make IPD available to other researchers</ipd_description>
  </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/NCT03836365
org study id: STUDY19010073
nct id: NCT03836365
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patient preparedness has been associated with increased patient satisfaction, decreased
      postoperative pain and decreased postoperative narcotic use; however, little is known
      regarding the optimal way to prepare patients prior to pelvic reconstructive surgery. The
      primary aim of this study is to determine if a preoperative counseling in person visit has
      similar rates of patient preparedness as a preoperative counseling phone call for women
      undergoing same-day pelvic organ prolapse surgery. Secondary aims evaluate patient
      satisfaction, postoperative pain scores and postoperative narcotic usage. Women who plan to
      undergo pelvic organ prolapse surgery will be randomized to a preoperative in person
      counseling visit or a preoperative counseling phone call. Participants will complete
      questionnaires to assess their preparedness, satisfaction and postoperative pain. The goal of
      this study is to gather information that will allow clinicians to improve patient surgical
      preparedness and satisfaction.
This will be a randomized controlled trial to assess patient preparedness following a
      preoperative counseling in person visit when compared to a preoperative counseling phone
      call.

      Recruitment & Enrollment: Participants will be recruited and enrolled from the urogynecology
      office during their surgical planning visit. The study will be introduced at this visit and
      participants will have the opportunity to bring the consent home to review and consider their
      participation prior to signing.

      Randomization: Participants will be block randomized in a 1:1 ratio in block size of 2.
      Randomization will be done by REDCap. The participant will not be blinded given the nature of
      the intervention. Additionally, the attending surgeon, fellow and office staff (advanced
      practice providers, research staff, medical assistants) will be aware of the randomization
      group as they will be participating in the preoperative intervention or perioperative
      clinical care.

      Intervention: Both the preoperative counseling visit and preoperative phone call will contain
      the same components of discussion and counseling which include surgical details, risks and
      benefits, preoperative and postoperative instructions and expectations. The visit will take
      place in the urogynecology office and the visits and phone calls will be done by either a
      fellow or advanced practice provider, all of whom have extensive experience with the
      standardized preoperative visit.

      Follow up: A postoperative phone call will be completed either POD#1 or POD#2 to remind the
      participant to complete their daily pain diary. Each participant will follow up for their
      standard postoperative visit approximately 4-6 weeks postoperative. All patients routinely
      receive a call on POD#1 from our nurses to assess how they are doing postoperatively. This
      phone call will continue unchanged for all participants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Patient preparedness
time frame: At postoperative visit (about 4-6 weeks after surgery)
description: The percent of patients reporting preparedness on Preoperative Preparedness Questionnaire. Participants who answer "strongly agree" or "agree" to the statement "Overall, I felt prepared for my surgery" will be considered prepared. This instrument is a 9-item questionnaire and scored on a 5-point Likert scale with answers ranging from "5=strongly disagree" to "1=strongly agree" with "3=neutral." Therefore, scores of "1=strongly agree" or "2=agree" will be considered a positive answer for preparedness. It was adopted from a study by Kenton et al in 2007.
measure: Patient satisfaction: Decision Scale-Pelvic Floor Disorders questionnaire
time frame: At postoperative visit (about 4-6 weeks after surgery)
description: The percent of patients reporting satisfaction on the Satisfaction with Decision Scale-Pelvic Floor Disorders questionnaire. This is a validated, 5-item questionnaire with answers on a 5-point likert scale with "1=strongly agree," "3=neutral" and "5=strongly disagree." Answers of "1=strongly agree" or "2=agree" to the statement "I am satisfied with my decision" will be considered satisfied.
measure: Postoperative pain scores
time frame: Postoperative days #1-7
description: Postoperative pain scores on postoperative days #1-7 on a scale of 0-10. Participants will complete a daily pain diary which will assess their pain score with 0=no pain and 10=worst pain imaginable.
measure: Postoperative narcotic use
time frame: Postoperative days #1-7
description: Postoperative narcotics used which will be assessed by the daily pain diary (question: "How many narcotic pills did you use today?" with the answer being the number of pills used that day).
arm group label: Preoperative counseling office visit
arm group type: Active Comparator
description: Participants will present for an in-person preoperative counseling office visit (preoperative counseling session). This will occur within a few weeks of surgery. Preoperative counseling topics are standardized and will be identical with each arm.
arm group label: Preoperative counseling phone call
arm group type: Active Comparator
description: Participants will receive a preoperative counseling phone call (preoperative counseling session). This will occur within a few weeks of surgery. Preoperative counseling topics are standardized and will be identical with each arm.
intervention type: Other
intervention name: Preoperative counseling office visit
description: All patients undergo a preoperative counseling session prior to surgery. Participants in this arm will have an in person preoperative counseling office visit.
arm group label: Preoperative counseling office visit
other name: Office
intervention type: Other
intervention name: Preoperative counseling phone call
description: All patients undergo a preoperative counseling session prior to surgery. Participants in this arm will have a preoperative counseling phone call.
arm group label: Preoperative counseling phone call
other name: Call
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 99 Years
healthy volunteers: No
last name: Jessica Sassani
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
citation: Holmes-Rovner M, Kroll J, Schmitt N, Rovner DR, Breer ML, Rothert ML, Padonu G, Talarczyk G. Patient satisfaction with health care decisions: the satisfaction with decision scale. Med Decis Making. 1996 Jan-Mar;16(1):58-64. doi: 10.1177/0272989X9601600114.
PMID: 8717600
citation: Sung VW, Kauffman N, Raker CA, Myers DL, Clark MA. Validation of decision-making outcomes for female pelvic floor disorders. Am J Obstet Gynecol. 2008 May;198(5):575.e1-6. doi: 10.1016/j.ajog.2007.12.035. Epub 2008 Mar 7.
PMID: 18313632
citation: Kenton K, Pham T, Mueller E, Brubaker L. Patient preparedness: an important predictor of surgical outcome. Am J Obstet Gynecol. 2007 Dec;197(6):654.e1-6. doi: 10.1016/j.ajog.2007.08.059.
PMID: 18060968
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Jessica Sassani
investigator title: Fellow, Division of Female Pelvic Medicine & Reconstructive Surgery
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
sharing ipd: No
ipd description: There is no plan to make IPD available to other researchers