<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/NCT03813537</url>
  </required_header>
  <id_info>
    <org_study_id>2018H0207</org_study_id>
    <nct_id>NCT03813537</nct_id>
  </id_info>
  <brief_title>Evaluation of Hospital Readmission Rate Dependent on Post-Operative Follow-Up Procedure</brief_title>
  <official_title>Evaluation of Hospital Readmission Rate Dependent on Post-Operative Follow-Up Procedure: A Randomized Prospective Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Syed Husain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University</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>
      This study is a randomized clinical trial among colorectal surgery patients that will compare&#xD;
      the efficacy of two different discharge protocols - current standard of care follow-up at two&#xD;
      weeks post-op versus a 3-day phone call intervention. The overall aim of the study is to&#xD;
      identify areas of improvement for discharging and following patients within 30 days of&#xD;
      colorectal surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a prospective clinical trial, in which colorectal surgery patients will be&#xD;
      randomly assigned to a control or experimental group. Patients will be consented and&#xD;
      randomized prior to discharge.The control group will be discharged with standard of care&#xD;
      follow-up instructions described by The Ohio State University Wexner Medical Center (OSUWMC),&#xD;
      and scheduled to come in for a standard follow-up clinic visit within 2-3 weeks. The&#xD;
      experimental group will also be scheduled for a 2-3 week post-op follow-up appointment, but&#xD;
      will also receive a phone call 3-days post procedure. During this phone call, the patient&#xD;
      will be asked questions using a study-specific questionnaire that is based on the most&#xD;
      frequent indications for readmission after colorectal surgery. Based on the responses,&#xD;
      patients will be advised to maintain the scheduled 2-3 week post-op appointment, visit the&#xD;
      clinic within 48 hours, or go to the Emergency Department immediately. To determine if&#xD;
      patients had visited an ED or been readmitted to a hospital within 30 days of colorectal&#xD;
      surgery, both the standard of care and intervention groups will receive a phone call 30-days&#xD;
      post-discharge. At this time we will also conduct the Hospital Consumer Assessment of&#xD;
      Healthcare Providers and Systems (HCAHPS) survey to measure patient satisfaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 19, 2018</start_date>
  <completion_date type="Anticipated">June 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2023</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>Patients will be randomized to two arms:&#xD;
Intervention: post operative phone call with protocol driven follow up pathway.&#xD;
Control: Current standard post operative follow up practice at our institution.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-Operative Phone Call (assess readmission rates)</measure>
    <time_frame>3 days</time_frame>
    <description>Assess readmission rates</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post Discharge Survey (assess patient satisfaction)</measure>
    <time_frame>30 days</time_frame>
    <description>Assess patient satisfaction</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">480</enrollment>
  <condition>Postoperative Complications</condition>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control will be discharged with standard of care follow-up instructions and scheduled for a standard follow-up clinic visit within 2-3 weeks post-op.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phone Call</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental group will receive a phone call intervention 3 days post-op. During this phone call, the patient will be asked questions using a study questionnaire based on the most frequent indications for readmission post colorectal surgery. Based on the responses, patients will be advised to maintain the scheduled appointment, visit the clinic within 48 hours, or go to the Emergency Department immediately.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Phone Call</intervention_name>
    <description>The experimental group will receive a phone call 3-days post procedure and asked questions based on the most frequent indications for readmission after colorectal surgery.</description>
    <arm_group_label>Phone Call</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than 18 years old&#xD;
&#xD;
          -  Patients who underwent colorectal surgery at The Ohio State University Wexner Medical&#xD;
             Center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 18 years old&#xD;
&#xD;
          -  Patients with limited ability to communicate&#xD;
&#xD;
          -  Patients who do not have a telephone&#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>Syed Husain, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>OSU Wexner Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kayla Diaz, BA</last_name>
    <phone>614-293-8549</phone>
    <email>kayla.diaz@osumc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Syed Husain, MBBS</last_name>
    <email>syed.husain@osumc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kayla Diaz, BA</last_name>
      <phone>614-293-8549</phone>
      <email>kayla.diaz@osumc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>May 24, 2018</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>April 19, 2022</last_update_submitted>
  <last_update_submitted_qc>April 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Syed Husain</investigator_full_name>
    <investigator_title>Assistant Professor - Colon and Rectal Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03813537
org study id: 2018H0207
nct id: NCT03813537
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a randomized clinical trial among colorectal surgery patients that will compare
      the efficacy of two different discharge protocols - current standard of care follow-up at two
      weeks post-op versus a 3-day phone call intervention. The overall aim of the study is to
      identify areas of improvement for discharging and following patients within 30 days of
      colorectal surgery.
This study will be a prospective clinical trial, in which colorectal surgery patients will be
      randomly assigned to a control or experimental group. Patients will be consented and
      randomized prior to discharge.The control group will be discharged with standard of care
      follow-up instructions described by The Ohio State University Wexner Medical Center (OSUWMC),
      and scheduled to come in for a standard follow-up clinic visit within 2-3 weeks. The
      experimental group will also be scheduled for a 2-3 week post-op follow-up appointment, but
      will also receive a phone call 3-days post procedure. During this phone call, the patient
      will be asked questions using a study-specific questionnaire that is based on the most
      frequent indications for readmission after colorectal surgery. Based on the responses,
      patients will be advised to maintain the scheduled 2-3 week post-op appointment, visit the
      clinic within 48 hours, or go to the Emergency Department immediately. To determine if
      patients had visited an ED or been readmitted to a hospital within 30 days of colorectal
      surgery, both the standard of care and intervention groups will receive a phone call 30-days
      post-discharge. At this time we will also conduct the Hospital Consumer Assessment of
      Healthcare Providers and Systems (HCAHPS) survey to measure patient satisfaction.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomized to two arms:
Intervention: post operative phone call with protocol driven follow up pathway.
Control: Current standard post operative follow up practice at our institution.
primary purpose: Prevention
masking: None (Open Label)
measure: Post-Operative Phone Call (assess readmission rates)
time frame: 3 days
description: Assess readmission rates
measure: Post Discharge Survey (assess patient satisfaction)
time frame: 30 days
description: Assess patient satisfaction
arm group label: Standard of Care
arm group type: No Intervention
description: The control will be discharged with standard of care follow-up instructions and scheduled for a standard follow-up clinic visit within 2-3 weeks post-op.
arm group label: Phone Call
arm group type: Experimental
description: The experimental group will receive a phone call intervention 3 days post-op. During this phone call, the patient will be asked questions using a study questionnaire based on the most frequent indications for readmission post colorectal surgery. Based on the responses, patients will be advised to maintain the scheduled appointment, visit the clinic within 48 hours, or go to the Emergency Department immediately.
intervention type: Other
intervention name: Phone Call
description: The experimental group will receive a phone call 3-days post procedure and asked questions based on the most frequent indications for readmission after colorectal surgery.
arm group label: Phone Call
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Syed Husain, MBBS
role: Principal Investigator
affiliation: OSU Wexner Medical Center
last name: Kayla Diaz, BA
phone: 614-293-8549
email: kayla.diaz@osumc.edu
last name: Syed Husain, MBBS
email: syed.husain@osumc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Ohio State University
investigator full name: Syed Husain
investigator title: Assistant Professor - Colon and Rectal Surgery
mesh term: Postoperative Complications
sharing ipd: No