<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/NCT03237897</url>
  </required_header>
  <id_info>
    <org_study_id>07-16-05E</org_study_id>
    <nct_id>NCT03237897</nct_id>
  </id_info>
  <brief_title>Evaluation of a Preoperative Education Class for Colorectal Surgery Patients</brief_title>
  <official_title>Evaluation of a Preoperative Education Class for Colorectal Surgery Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</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>
      The purpose of the study is to evaluate the value and effectiveness of a newly-implemented&#xD;
      preoperative education class for patients undergoing colorectal surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a non-randomized study to be conducted in a cohort of patients who are scheduled to&#xD;
      undergo colorectal surgical procedures at Carolinas Medical Center (CMC)-Main. The primary&#xD;
      objective of this study is to determine the effect of preoperative education classes on&#xD;
      postoperative compliance with mobilization guidelines. Secondary objectives of this study are&#xD;
      to evaluate the effect of the preoperative education class on patient knowledge, anxiety, and&#xD;
      satisfaction, and postoperative outcomes such as inpatient length of stay, postoperative&#xD;
      complications, and 30-day readmission rates. Data will be compared between patients who are&#xD;
      scheduled to attend the class and attend and those who are scheduled to attend the class and&#xD;
      do not.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study withdrawn due to staff unavailability and limited resources&#xD;
  </why_stopped>
  <start_date type="Anticipated">April 2018</start_date>
  <completion_date type="Anticipated">November 2019</completion_date>
  <primary_completion_date type="Anticipated">April 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Time to ambulation</measure>
    <time_frame>from time of surgery until the time of first documented ambulation, assessed up to 90 days</time_frame>
    <description>time to first ambulation following surgery measured by pedometer and notations made by nursing staff in the patient records prior to patient discharge.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean number of steps</measure>
    <time_frame>from time of surgery until the time of discharge, up to 90 days</time_frame>
    <description>mean number of steps taken daily as measured by pedometer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knowledge level</measure>
    <time_frame>date of preoperative education class (up to 2 weeks prior to time of surgery) and date of first postoperative follow-up appointment (up to 90 days following surgery)</time_frame>
    <description>Knowledge level assessed by knowledge survey administered to patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient anxiety level</measure>
    <time_frame>date of enrollment and date of discharge, up to 90 days following surgery</time_frame>
    <description>Patient anxiety level assessed by anxiety survey administered to patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction score</measure>
    <time_frame>date of first postoperative follow-up appointment, up to 90 days following surgery</time_frame>
    <description>Patient satisfaction score assessed by satisfaction survey administered to patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day readmission rate</measure>
    <time_frame>30 days following surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inpatient length of stay</measure>
    <time_frame>from date of surgery until the date of discharge, up to 90 days</time_frame>
    <description>Inpatient length of stay measured in number of days</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Colorectal Surgery</condition>
  <arm_group>
    <arm_group_label>Class attendees</arm_group_label>
    <description>A cohort of patients who are scheduled to undergo colorectal surgical procedures and attend the preoperative education class. Patients will be affixed with a pedometer in the postoperative period until discharge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Class non-attendees</arm_group_label>
    <description>A cohort of patients who are scheduled to undergo colorectal surgical procedures and do not attend the scheduled preoperative education class. Patients will be affixed with a pedometer in the postoperative period until discharge.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Preoperative education class</intervention_name>
    <description>The preoperative enhanced recovery after surgery education class will be offered twice a week in coordination with anesthesia preoperative appointments to minimize inconvenience for patients. Patients will need to attend only one class. All participants will be offered the class. This class will be one hour in duration and will be taught by a surgical advanced care practitioner familiar with the details of colorectal surgery. The class will include detailed information about preoperative care, intraoperative care, and postoperative care.</description>
    <arm_group_label>Class attendees</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pedometer</intervention_name>
    <description>A pedometer will be affixed to patients in the immediate postoperative period and removed at time of discharge</description>
    <arm_group_label>Class attendees</arm_group_label>
    <arm_group_label>Class non-attendees</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will include only patients scheduled to undergo colorectal surgical&#xD;
        procedures at CMC-Main.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Scheduled to undergo surgical operations of the colon or rectum at Carolinas Medical&#xD;
             Center Main&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A medical condition, laboratory finding, or physical exam finding that precludes&#xD;
             participation&#xD;
&#xD;
          -  Develop a significant intra- or postoperative complication that precludes or delays&#xD;
             participation for longer than 4 weeks; or&#xD;
&#xD;
          -  Have anything that would place the individual at increased risk or preclude the&#xD;
             individual's full compliance with or completion of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Caroline E Reinke, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Carolinas Medical Center</affiliation>
  </overall_official>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 23, 2016</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>April 20, 2022</last_update_submitted>
  <last_update_submitted_qc>April 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ERAS</keyword>
  <keyword>Enhanced recovery after surgery</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03237897
org study id: 07-16-05E
nct id: NCT03237897
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to evaluate the value and effectiveness of a newly-implemented
      preoperative education class for patients undergoing colorectal surgery.
This is a non-randomized study to be conducted in a cohort of patients who are scheduled to
      undergo colorectal surgical procedures at Carolinas Medical Center (CMC)-Main. The primary
      objective of this study is to determine the effect of preoperative education classes on
      postoperative compliance with mobilization guidelines. Secondary objectives of this study are
      to evaluate the effect of the preoperative education class on patient knowledge, anxiety, and
      satisfaction, and postoperative outcomes such as inpatient length of stay, postoperative
      complications, and 30-day readmission rates. Data will be compared between patients who are
      scheduled to attend the class and attend and those who are scheduled to attend the class and
      do not.
observational model: Case-Control
time perspective: Prospective
measure: Time to ambulation
time frame: from time of surgery until the time of first documented ambulation, assessed up to 90 days
description: time to first ambulation following surgery measured by pedometer and notations made by nursing staff in the patient records prior to patient discharge.
measure: Mean number of steps
time frame: from time of surgery until the time of discharge, up to 90 days
description: mean number of steps taken daily as measured by pedometer
measure: Knowledge level
time frame: date of preoperative education class (up to 2 weeks prior to time of surgery) and date of first postoperative follow-up appointment (up to 90 days following surgery)
description: Knowledge level assessed by knowledge survey administered to patients
measure: Patient anxiety level
time frame: date of enrollment and date of discharge, up to 90 days following surgery
description: Patient anxiety level assessed by anxiety survey administered to patients
measure: Patient satisfaction score
time frame: date of first postoperative follow-up appointment, up to 90 days following surgery
description: Patient satisfaction score assessed by satisfaction survey administered to patients
measure: 30-day readmission rate
time frame: 30 days following surgery
measure: Inpatient length of stay
time frame: from date of surgery until the date of discharge, up to 90 days
description: Inpatient length of stay measured in number of days
arm group label: Class attendees
description: A cohort of patients who are scheduled to undergo colorectal surgical procedures and attend the preoperative education class. Patients will be affixed with a pedometer in the postoperative period until discharge.
arm group label: Class non-attendees
description: A cohort of patients who are scheduled to undergo colorectal surgical procedures and do not attend the scheduled preoperative education class. Patients will be affixed with a pedometer in the postoperative period until discharge.
intervention type: Behavioral
intervention name: Preoperative education class
description: The preoperative enhanced recovery after surgery education class will be offered twice a week in coordination with anesthesia preoperative appointments to minimize inconvenience for patients. Patients will need to attend only one class. All participants will be offered the class. This class will be one hour in duration and will be taught by a surgical advanced care practitioner familiar with the details of colorectal surgery. The class will include detailed information about preoperative care, intraoperative care, and postoperative care.
arm group label: Class attendees
intervention type: Behavioral
intervention name: Pedometer
description: A pedometer will be affixed to patients in the immediate postoperative period and removed at time of discharge
arm group label: Class attendees
arm group label: Class non-attendees
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Caroline E Reinke, MD
role: Principal Investigator
affiliation: Carolinas Medical Center
responsible party type: Sponsor
sharing ipd: Undecided